107 年 Cancer of Clinical Guideline¨º療指引.pdf · 5. 非小細胞肺癌,第IV,...

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107 Cancer of Clinical Guideline

Transcript of 107 年 Cancer of Clinical Guideline¨º療指引.pdf · 5. 非小細胞肺癌,第IV,...

  • 107 年 Cancer of Clinical Guideline

  • 發行日期:2018年7月

    發行版次:第 1 版

    編輯人員:侯明鋒、莊捷翰、吳政毅、王遜模、陳煌麒、蔡東霖、鐘堉緁、梁博程、林宜竑、陳映哲、蘇家弘、王秋

    麟、張慧名、沈榮宗、楊凱富、唐世豪、方本詞、李欣樺、黃憶如、艾紀瑩、王亞婷、黃惠娟、洪麗君、

    黃麗如、賴妙君、張玲瑄。

  • 高雄市立小港醫院(委託財團法人高雄醫學大學經營)

    107年癌症診療指引

    目 錄

    診療指引修訂實證文獻參考來源 Page 1

    Cancer of the Lung 肺 癌 Non-Small-Cell Lung Cancer 非小細胞肺癌Small-Cell Lung Cancer 小細胞肺癌

    CCRT 的原則

    Esophageal Cancer 食道癌

    A

    A-1

    A-24

    A-30

    A-32

    Hepato-biliary Pancreatic Cancer 肝膽胰癌 Hepatoma 肝癌

    B

    B-1

    Cancer of the Gastrointestinal Tract 胃腸癌 Colon Cancer 結腸癌

    Rectum Cancer 直腸癌

    Gastric Cancer 胃癌

    C

    C-1

    C-14

    C-34

    Cancer of the Breast 乳 癌 Breast Cancer 乳 癌

    D

    D-1

    Gynecologic Cancer 婦 癌Cervical Cancer 子宮頸癌

    Endometrial Cancer 子宮內膜

    癌Ovarian cancer 卵巢癌

    E

    E-1

    E-10

    E-19

  • Cancer of the Head and Neck 頭頸癌Cancer of the Oral Cavity 口腔癌

    Nasopharyngeal carcinoma 鼻咽癌

    F

    F-1

    F-3

    Urinary tract cancer 泌尿道癌 Bladder cancer 膀胱癌Prostate cancer 攝護腺癌

    G

    G-1

    G-14

    Lymphoma 淋巴癌 Diffuse large B-cell Lymphoma 瀰漫性大型 B 細胞淋巴癌Follicular Lymphoma 濾泡型淋巴癌

    H

    H-1

    H-4

  • Cancer of the Lung

    Treatment Guideline

    KMHK

    制 定 日 期 : 97 年 1 月 1 日

    修 訂 日 期 : 107 年 6 月 5 日

  • 肺癌修訂記錄 修訂日期 修訂內容摘要 修訂頁次 版本

    97年 98年 99年 100年

    101年

    102年

    第一版依照NCCN guideline 制定本院治療準則多專科會議討論檢視未修改。 多專科會議討論檢視未修改。多專科會議討論檢視未修改。

    *non-small cell lung cancer 1.修訂non-small cell practice guideline 圖表中initial evaluation項 目將原有的CXR、Abdominal sonography刪除。

    2.stage I or II的 treatment plan改為consult chest surgery to evaluate the indication for surgery ± chemotherapy or chemoradiation。

    3.修訂non-small cell clinical presentation,將原本N0-2改為 N0-1,並將treatment plan中refer to KMUH刪除,原先的N3 or Metastatic disease改為N2的treatment plan。

    4.修訂small cell practice guideline 圖表中initial evaluation項目將 原有的CXR、Abdominal sonography刪除。

    *non-small cell lung cancer 1.新增surgical exploration and resection + mediastinal LN

    dissection or systematic LN sampling後 stage IA到IIIA的margin positive與negative的治療。

    2.修訂stage IIIA中N2-metastatic的treatment 3.新增stage IIIB治療流程之圖表。 4.修訂NSCLC中新增 stage IV,M1a與M1b的pretreatment

    evaluation圖表。 5.新增EGFR mutation 之治療流程。6.performance status 0-4建議治療方式圖表。 7.新增AJCC TNM 分期表*small cell lung cancer 1.新增SCLC中limited stage與extensive stage圖表說明。 2.新增biopsy之pathology結果後續的治療流程。 3.新增CCRT原則。

    A-1

    A-2

    A-3

    A-2

    A-3

    A-4

    A-5

    1.0

    2.0

    3.0

  • 肺癌修訂記錄

    修訂日期 修訂內容摘要 修訂頁次 版本 103年

    104年

    105年

    106年

    *non-small cell lung cancer 1.新增stage IIB、stage IIIA為unresectable disease治療流程。 2.新增stage IIIA (N2、N3 nodes negative or N2 nodes positive)治 療流程

    3.新增suspected multiple lung cancers治療流程。 4.新增metastatic disease在adrenal的治療流程。 5.修訂EGFR mutation positive治療流程。 6.新增ALK positive治療流程。 7.新增EGFR mutation and ALK negative or unknown治療流程。 8.新增squamous cell carcinoma first-line therapy治療流程。 9.新增third-line therapy治療流程。

    1.修改Sensitizing EGFR mutation positive,positive可選這三個藥物Erlotinib、Afatinib、Gefitinib。

    多專科會議討論檢視後未修改。

    1.非小細胞肺癌初步評估加入肺功能、心臟超音波、腹部超音 波、腫瘤指數(可考慮)

    2. 針對高風險IB-II期給予輔助型化療

    (1)分化不佳

    (2)血管侵犯

    (3)腫瘤>4公分

    (4)臟層肋膜侵犯 (5)Wedge resection (6)未明淋巴結

    3.全部Reresection修改為resection。 4.非小細胞肺癌,為分散肺腫瘤,同側肺葉(T3, N0)或同側非原發 肺葉(T4,N0)手術後為N0-1,可行化療 5. 非小細胞肺癌,第IV, M1b期:獨立腫瘤,轉移至其他部位可參 考A-14,刪除轉移針對腎上腺部分 6.原EGFR ± ALK testing should be conduced as part of multiplex/next-generation sequencing刪除,修改為PDL-1 testing

    7.在一線化療前或期間發現ALK受體重組,先行含鉑的化療,若有

    A-6

    A-7

    A-8~A-9 A-10~A-11

    A-13

    A-14

    A-4~ A-5

    A-7

    A-8~9

    A-12、A-14

    A-15 A-

    16 A-17

    A-18

    A-19

    A-15

    4.0

    5.0

    6.0

  • 肺癌修訂記錄

    修訂日期 修訂內容摘要 修訂頁次 版本

    107年

    惡化,可使用crizotinib,若有副作用或持續惡化多新增ceritinib(zykadia立克癌)之藥物選擇

    .原考慮雙白金類±Bevacizumab(Avastin癌思停),改Avastin± 雙白金類

    1.修改成AJCC 8th版

    A-1

    A-2

    A-20

    7.0

  • Non-Small Cell Lung Cancer

    Pathologic

    Diagnosis of

    NSCLC

    Initial

    Evaluation

    Clinical Stage

    Stage IA peripheral (T1ab,N0) Medistinal CT negative (lymph nodes

  • Non-Small Cell Lung Cancer

    Clinical Assessment Pretreatment Evaluation

    Operable See initial treatment and adjuvant

    treatment(A-3)

    Stage IA

    (peripheral T1ab,N0)

    *PFTs (If not previously done)

    *Bronchoscopy

    (intraoperative preferred) *Pathologic mediastinal lymph node

    evaluation *Bone scan (refer to KMUH)

    *PET/CT scan (refer to KMUH)

    Negative mediastinal nodes

    Positive mediastinal

    nodes

    Medically inoperable

    Definitive RT or stereotactic

    ablative radiotherapy (SABR)

    (refer to KMUH)

    See stage IIIA (A-7) or stage IIIAB(A-10)

    Stage IB(pheripheral

    T2a,N0)

    Stage I(central

    T1ab-T2a,N0)

    Stage

    II(T1ab-T2ab,N1;T2b,N0

    )

    Stage IIB(T3,N0)

    *PFTs (If not previously done)

    *Bronchoscopy

    (intraoperative preferred)

    *Bone scan(refer to KMUH)

    *Mediastinoscopy and/or

    EBUS/EUS(refer to KMUH)

    *PET/CT scan(refer to KMUH)

    *Brain MRI (stage II, stage IB)

    Negative mediastinal nodes

    Positive mediastinal

    nodes

    Operable Medically inoperable

    See initial treatment and adjuvant

    treatment(A-3)

    Adjuvant C/T for high Definitive RT

    N0 risk stages IBII including SABR

    N1 Definitive chemoradiation See stage IIIA (A-7) or stage

    IIIAB(A-10)

    A-2

  • Non-Small Cell Lung Cancer

    Initial treatment Findings at surgery Adjuvant treatment

    Stage IA

    (T1ab,N0)

    Stage IB

    Margins negative

    (R0)

    Margins positive

    (R1, R2) Margins negative

    (R0)

    Observe Reresection (preferred)

    or RT Observe or Chemotherapy for high risk

    patients

    Surgical exploration and

    resection + mediastinal

    lymph node diseeection

    or systematic lymph

    (T2a,N0)

    StageIIA

    (T2b,N0) Stage IIA

    Margins positive

    (R1, R2) Margins negative

    (R0)

    node sampling (T1ab-T2a,N1)

    Stage IIB

    (T3,N0;T2b,N1)

    Margins positive

    R1

    Resection + chemotherapy

    or chemoradiation

    R2 Resection + chemotherapy or Concurrent chemoradiation

    Margins negative (R0)

    Chemotherapy + RT or Sequential chemotherapy+RT (N2 only)

    Stage IIIA (T1-3,N2;T3,N1)

    Margins positive

    R1 R2

    Chemoradiation (sequential or concurrent)

    Concurrent chemoradiation

    Resection (preferred) ±chemotherapy or RT ±chemotherapy (chemotherapy for

    stage IIA)

    Chemotherapy

    A-3

  • Non-Small Cell Lung Cancer

    Clinical Assessment Pretreatment Evaluation Clinical Evaluation

    Stage IIB (T3 invasion, N0)

    Stage IIIA (T4 extension, N0-1;

    T3, N1)

    *PFTs (If not previously done) *Bronchoscopy * Pathologic mediastinal lymph node

    evaluation *Brain MRI *Bone scan(refer to KMUH) *MRI of spine + thoracic inlet for superior

    sulcus lesions abuttling the spine or

    subclavian vessels (option)

    *PET/CT scan (refer to KMUH)

    Superior sulcus tumor Chest wall Proximal airway or

    mediastinum

    Unresectable disease Metastatic disease

    See A-5 See A-5 See A-5 See A-5 See A-12 or A-13

    A-4

  • Non-Small Cell Lung Cancer

    Clinical Presentation

    Superior suicus tumor

    (T3 invasion, N0-1)

    Superior suicus tumor

    (T4 extension, N0-1)

    Possibly

    resectable

    Initial treatment

    Preoperative

    concurrent

    chemoradiation

    Preoperative

    concurrent

    chemoradiation

    Surgical

    reevaluation

    Resectable

    Unresectable

    Adjuvant Treatment Surgery+ chemotherapy

    Surgery+ chemotherapy

    Complete definitive RT

    + chemotherapy

    Unresectable

    Definitive

    concurrent

    chemoradiation

    See A-13

    Chest wall, proximal

    airway or mediastinum

    (T3 invasion, N0-1;

    Resectable T4

    extension, N0-1)

    Concurrent

    chemoradiation

    or

    Chemorherapy

    Surgery

    Margins negative

    (R0)

    Margins

    positive(R1,R2)

    Chemotherapy

    Resection + chemotherapy or chemoradiation

    R1 (sequential or

    concurrent)

    Resection + chemotherapy

    R2 or

    Concurrent chemoradiation

    Stage III (T4, N0-1)

    Unresectable

    Definitive concurrent

    chemoradiation

    A-5

  • Non-Small Cell Lung Cancer

    Clinical Assessment Pretreatment Evaluation Mediastinal Biopsy Findings and Resectability

    N2, N3 nodes negative See A-7

    *PFTs (If not previously done)

    *Bronchoscopy

    * Pathologic mediastinal lymph node

    N2 nodes positive

    See A-7

    Stage IIIA (T1-3, N2) evaluation

    *Bone scan(refer to KMUH)

    *PET/CT scan (refer to KMUH)

    *Brain MRI

    N3 nodes positive

    Metastatic disease

    See A-10

    See A-12 or A-13

    Separate pulmonary

    nodule(s)

    (Stage IIB, IIIA,IV)

    *PFTs (If not previously done)

    *Bronchoscopy

    * Mediastinoscopy(option)

    *Bone scan(refer to KMUH)

    *Brain MRI

    *PET/CT scan (refer to KMUH)

    Separate pulmonary nodule(s), same lobe (T3, N0) or

    ipsilateral non-primary lobe (T4,N0)

    Stage IV (N0, M1a): Contralateral lung (solitary

    nodule)

    Extrathoracic metastatic disease

    See A-8

    See A-8 See A-12or A-13

    A-6

  • Non-Small Cell Lung Cancer

    Mediastinal Biopsy

    Findings

    Initial Treatment Surgical resection +

    N0-1

    Adjuvant Treatment

    See A-3

    Resectable

    mediastinal lymph

    node dissection or

    systematic lymph node sampling

    Margins negative

    Sequential chemotherapy +

    RT See A-13

    T1-3, N0-1 (including

    T3 with multiple

    nodules in same lobe

    Surgery

    N2 Margins positive

    R1

    Chemoradiation (sequential or concurrent)

    See A-13

    Medically

    inoperable

    See A-2

    R2

    Concurrent chemoradiation See A-13

    Negative for

    M1 disease

    Definitive concurrent chemoradiation or induction chemotherapy

    No apparent

    progression

    Surgery±chemotherapy±RT

    T1-2, T3(≧7cm),

    N2 nodes positive

    *Brain MRI

    *PET/CT(refer

    to KMUH)

    Progression

    Local

    Systemic

    RT±chemotherapy

    See A-12 or A-13

    Positive See A-12 or A-13

    T3(invasion), N2

    nodes positive

    *Brain MRI

    *PET/CT(refer

    to KMUH)

    Negative for

    M1 disease

    Positive

    Definitive concurrent

    chemoradiation See A-12 or A-13

    A-7

  • Non-Small Cell Lung Cancer

    Clinical Presentation Initial Treatment Adjuvant Treatment

    N0-1 Chemotherapy See A-13

    Separate pulmonary

    nodule(s), same lobe (T3,

    N0) or ipsilateral non-

    Surgery

    primary lobe (T4, N0) Margin negative (R0) Chemotherapy See A-13

    N2 Margins positive

    (R1,R2)

    Concurrent chemoradiation

    (if tolerated)

    See A-13

    Stage IV ( N0, M1a)

    Contralateral lung (solitary

    nodule)

    Suspected multiple lung

    cancers (based on the

    presence of biopsy-proven

    synchronous lesions or

    history of lung cancer

    Treat as two primary lung

    tumors if both curable

    *chest CT with contrast

    *PET/CT(refer to KMUH)

    *Brain MRI

    See A-1

    Disease outside of chest No disease outside of

    chest

    See A-14 Pathological

    mediastinal lymph

    node evaluation

    N2-3

    N0-1

    See A-14

    See A-9

    A-8

  • Non-Small Cell Lung Cancer

    Clinical Presentation Initial Treatment

    Low risk of becoming

    symptomatic

    Observation

    See A-13

    Multiple lesions

    Asymptomatic

    High risk of becoming

    symptomatic

    Definitive

    local therapy

    Parenchymal sparing

    resection (preferred) or

    Multiple lung

    cancers

    Solitary lesion

    (metachronous

    disease

    possible Definitive

    local therapy

    not possible

    radiation or ablation Consider palliative

    chemotherapy±local

    palliative therapy

    Symptomatic

    See A-14

    A-9

  • Non-Small Cell Lung Cancer

    Clinical Assessment Pretreatment Evaluation Initial Treatment

    Stage IIIB (T1-3, N3)

    *PFTs (If not previously done)

    *PET/CT scan (refer to KMUH)

    *Brain MRI

    *Bone scan(refer to KMUH) * Pathologic confirmation of N3 disease by

    either:

    -Mediastinoscopy

    -Superaclavicular lymph node biopsy

    -Thoracoscopy

    - Needle biopsy

    - Mediastinotomy

    - Endoscopic ultrasound (EUS)

    biopsy(refer to KMUH)

    - Endobronchial ultrasound (EBUS)

    biopsy(refer to KMUH)

    N3 negative

    N3 positive

    Metastatic disease

    See A-7

    Definitive concurrent

    chemoradiation

    See A-12 or A-13

    A-10

  • Non-Small Cell Lung Cancer

    Clinical Assessment Pretreatment Evaluation Initial Treatment

    Ipsilateral mediastinal

    node negative (T4, See A-7

    Contralateral N0-1)

    *PET/CT scan(refer to KMUH)

    *Brain MRI

    *Bone scan (refer to KMUH)

    * Pathologic confirmation of N2-3 disease

    mediastinal node negative

    Ipsilateral mediastinal

    node positive (T4, N2)

    Definitive

    concurrent

    chemoradiation

    Stage IIIB

    (T4 extension, N2-3)

    by either: -

    Mediastinoscopy

    -Superaclavicular lymph node biopsy -Thoracoscopy

    -Needle biopsy

    -Mediastinotomy -EUS biopsy (refer to KMUH) -

    EBUS biopsy (refer to KMUH)

    Contralateral

    mediastinal

    node positive

    (T4, N3)

    Metastatic

    disease

    Definitive

    concurrent

    chemoradiation

    See A-12 or A-13

    Negative See A-7

    Stage IV, M1a:

    Pleural or pericardial

    Thoracenfesis or pericardiocentesis ±

    thoracoscopy if thoracentesis indeterminate

    Local therapy if necessary (e.g.

    effusion Positive

    pleurodesis, ambulatory small

    catheter drainage, pericardial

    window) + See A-12 or A-13

    A-11

  • Non-Small Cell Lung Cancer

    Clinical

    Assessment

    Pretreatment

    Evaluation

    Initial Treatment

    Surgical resection of lung lesion

    or

    Stereotactic ablative

    Chemotherapy

    Surgical resection followed by

    T1-2, N0-1; T3, N0;

    radiotherapy (SABR) of lung lesion

    whole brain RT (WBRT) or

    stereotactic radiosurgery (SRS)

    or Chemotherapy

    Surgical

    resection of

    Brain or SRS + WBRT (category 1 for one

    lung lesion or SABR of lung

    *Pathologic metastasis) lesion

    Stage IV,

    M1b:

    Solitary site

    mediastinal lymph

    node evaluation

    *Bronchoscopy

    *Brain MRI

    *Bone scan(refer to

    KMUH) *PET/CT scan (refer

    to KMUH)

    or SRS alone

    T1-2, N2;

    T3, N1-2;

    Any T, N3;

    T4, Any N

    See A-14

    Other site See A-14

    A-12

  • Non-Small Cell Lung Cancer

    Surveillance

    Endobronchial

    obstruction

    Therapy for recurrence and metastasis

    *Laser/stent/other surgery

    * External-beam RT or brachytherapy

    *Photodynamic therapy

    Resectable

    recurrence

    *Reresection (preferred) * External-beam RT or SABR

    No evidence of

    disseminated

    disease

    Observation or

    systemic

    chemorherapy

    No evidence of

    clinical/radiographic disease

    Locoregional

    recurrence

    Mediadtinal lymph

    node recurrence

    No prior RT Prior RT

    Concurrent

    chemoradiation Systemic chemotherapy

    Evidence of

    disseminated

    disease

    See A-14

    (NED), stage I-IV.

    *History and physical and chest CT

    ± contrast every 6-12 mo for 2 y

    (category 2B), then H&P and a

    non-contrast- enchanced chest CT

    annually (category 2B)

    *Smoking cessation advice,

    counseling and pharmacotherapy

    *PET or brain MRI is not indicated

    for routine follow-up.

    Superior vena cava

    (SVC) obstruction

    Severe hemoptysis Localized symptom

    * Concurrent chemoradiation

    (if not previously given) *External-beam RT

    * SVC stent *External-beam RT or brachytherapy * Laser or photodynamic therapy or

    Embolization *Surgery

    Palliative external-beam RT

    Diffuse brain metastases

    Palliative external-beam RT

    * Palliative external-beam RT + orthopedic

    See A-14

    Distant

    metastases

    Bone metastasis

    stabilization, if risk of fracture

    *Consider bisphosphonate therapy or denosumab

    Solitary metastasis

    Disseminated metastases

    See A-12

    See A-14

    A-13

  • Non-Small Cell Lung Cancer

    Systemic Therapy for

    Metastatic Disease

    Evaluation

    Histologic Subtype

    *Adenocarcinoma

    *Large cell

    *NSCLC not otherwise

    *EGFR mutation testing

    *ALK testing * PDL-1 testing

    Sensitizing EGFR

    mutation positive

    ALK positive

    See A-15 See A-16

    *Establish histologic subtype specified (NOS)

    Metastatic

    disease

    with adequate tissue for

    molecular testing (consider

    rebiopsy if appropriate)

    *Smoking cessation advice,

    counseling *Intergrate palliative care

    Sensitizing EGFR

    mutation and ALK

    negative or unknown *Consider EGFR mutation and ALK testing

    especially in nerver smokers or small biopsy,

    See A-17

    Squamous cell

    carcinoma

    specimens, or mixed histology

    * PDL-1 testing See A-18

    A-14

  • Non-Small Cell Lung Cancer

    Adenocarcinoma, large cell, NSCLC NOS: sensitizing EFGR mutation positive

    First-line therapy Second-line therapy

    Isolated

    lesion

    Consider local therapy

    and continue erlotinib

    or afatinib or Gefitinib

    brain

    EGFR

    Multiple lesions

    Consider WBRT and

    continue erlotinib or

    afatinib or Gefitinib

    mutation

    discovered

    prior to first-

    line

    chemotherapy

    EGFR mutation

    discovered

    during first-line

    chemotherapy

    Progre-

    ssion

    Symptomatic

    Asymptomatic

    Consider local

    therapy and continue erlotinib or afatinib

    or Gefitinib systemic

    Consider platinum

    double ± bevacizumab ±

    erlotinib

    Continue erlotinib or afatinib or

    Gefitinib

    Progre-

    ssion

    See A-19

    Sensitizing

    EGFR

    mutation

    positive

    Erlotinib or Afatinib or Gefitinib

    Interrupt or

    complete planned

    chemotherapy,

    start erlotinib or

    afatinib or

    Gefitinib or

    May add erlotinib

    or afatinib to

    current

    chemotherapy

    Multiple lesions

    Isolated lesion

    A-15

  • Non-Small Cell Lung Cancer

    Adenocarcinoma, large cell, NSCLC NOS: ALK positive

    First-line therapy Second-line therapy

    Isolated

    lesion

    Consider local therapy

    and continue crizotinib

    brain

    Multiple lesions

    Consider WBRT and continue crizotinib

    ALK

    rearrangement

    Symptomatic

    Sensitizing

    EGFR

    mutation

    positive

    discovered

    prior to first-

    line

    chemotherapy

    ALK

    rearrangement

    discovered

    during first-line

    chemotherapy

    Progre-

    ssion

    Asymptomatic

    Isolated

    lesion systemic

    Multiple lesions

    Continue crizotinib

    Consider local

    therapy and continue

    crizotinib Avastin±雙白金類

    Progre-

    ssion

    See A-19

    Crizotinib

    Interrupt or

    complete planned

    chemotherapy,

    start crizotinib

    A-16

  • Non-Small Cell Lung Cancer

    Adenocarcinoma, large cell, NSCLC NOS: EGFR mutation and ALK negative or unknown

    First-line Therapy

    Doublet

    chemotherapy

    or

    PS 0-2

    Second-line Therapy

    If not already given:

    Docetaxel or Pemetrexed or

    Erlotinib or Gemcitabine

    See A-19

    Bevacizumab+ Progression

    PS 0-1 chemotherapy

    or PS 3-4 Best supportive care

    Erlotinib

    or

    Cetuximab/vinorelbin

    Tumor

    response

    evaluation

    Progression

    See second-line

    therapy, above

    PS 2

    PS 3-4

    Chemotherapy Best supportive care

    Reaponse

    or stable

    disease

    4-6

    cycles

    (total)

    Tumor

    response

    evaluation

    Reaponse

    or stable

    disease

    Continuation maintenance *bevacizumab

    *cetuximab

    *pemetrexed *bevacizumab+ pemetrexed

    *gemcitavine or *Switch maintenance * pemetrexed or erlotinib

    or Close observation

    Progression,

    see second-

    line therapy,

    above

    A-17

  • Non-Small Cell Lung Cancer

    Squamous cell carccinoma

    First-line Therapy

    Second-line Therapy

    If not already given:

    PS 0-2 Docetaxel or Erlotinib or See A-19

    Doublet Gemcitabine

    chemotherapy Progression

    PS 0-1 or Cetuximab/

    PS 3-4

    Best supportive care

    vinorelbine/

    cisplatin

    Tumor

    response

    evaluation

    Progression

    See second-line

    therapy, above

    PS 2

    PS 3-4

    Chemotherapy

    Best supportive care

    Response

    or stable

    disease

    4-6

    cycles

    (total)

    Tumor

    response

    evaluation

    Response

    or stable

    disease

    Continuation maintenance *cetuximab

    *gemcitavine

    or Switch maintenance

    or Close observation

    Progression,

    see second-

    line therapy,

    above

    A-18

  • Non-Small Cell Lung Cancer

    Adenocarcinoma, large cell, NSCLC NOS, or Squamous cell carccinoma

    Third-line Therapy

    PS 0-2

    If not already given:

    Docetaxel

    or Pemetrexed( non-squamous) or

    Erlotinib

    or

    Gemcitabine

    Progression

    PS 0-2 PS 3-4

    Best supportive care or Clinical trial

    Best supportive care

    Progression

    PS 3-4

    Erlotinib or Best supportive care

    A-19

  • AJCC8th TNM (Tumor-Node-Metastasis) Stage:

    Definition of Primary Tumor(T)

    T Category T Criteria

    TX Primary tumor cannot be assessed, or tumor proven by the presence of malignant cells in sputum or

    bronchial washings but not visualized by imaging or bronchoscopy

    T0 No evidence of primary tumor

    Tis Carcinoma in situ

    Squamous cell carcinoma in situ (SCIS) Adenocarcinoma in situ (AIS): adenocarcinoma with pure lepidic pattern, ≤ 3 cm in greatest dimension

    T1 Tumor ≤ 3 cm in greatest dimension, surrounded by lung or visceral pleura, without bronchoscopic

    evidence of invasion more proximal than the lobar bronchus (i.e., not in the main bronchus)

    T1mi Minimally invasive adenocarcinoma: adenocarcinoma (≤ 3 cm in greatest dimension) with a

    predominantly lepidic pattern and ≤ 5 mm invasion in greatest dimension

    T1a Tumor ≤1 cm in greatest dimension. A superficial, spreading tumor of any size whose invasive

    component is limited to the bronchial wall and may extend proximal to the main bronchus also is

    classified as T1a, but these tumors are uncommon.

    T1b Tumor> 1 cm but ≤ 2 cm in greatest dimension

    T1c Tumor> 2 cm but ≤ 3 cm in greatest dimension

    T2 Tumor > 3 cm but ≤ 5 cm or having any of the following features: ●Involves the main bronchus regardless of distance to the carin, but without involvement of the carina ●Invades visceral pleura (PL1 or PL2) ●Associated with atelectasis or obstructive pneumonitis that extends to the hilar region, involving part or

    all of the lung T2 tumors with these features are classified as T2a if ≤ 4 cm or if the size cannot be determined and T2b

    if > 4 cm but ≤ 5 cm.

    A-20

  • T2a Tumor> 3 cm but ≤4 cm in greatest dimension

    T2b Tumor> 4 cm but ≤5 cm in greatest dimension

    T3 Tumor > 5 cm but ≤ 7 cm in greatest dimension or directly invading any of the following: parietal pleural

    (PL3), chest wall (including superior sulcus tumors), phrenic nerve, parietal pericardium; or separate

    tumor nodule(s) in the same lobe as the primary

    T4 Tumor > 7 cm or tumor of any size invading one or more of the following: diaphragm, mediastinum,

    heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, or carina; separate

    tumor nodule(s) in an ipsilateral lobe different from that of the primary

    Definition of Regional Lymph Node(N)

    N Category N Criteria

    NX Regional lymph nodes cannot be assessed

    N0 No regional lymph node metastasis

    N1 Metastasis in ipsilateral peribronchial and/or ipsilateral hilar lymph nodes and intrapulmonary nodes, including involvement by direct extension

    N2 Metastasis in ipsilateral mediastinal and/or subcarinal lymph node(s)

    N3 Metastasis in contralateral mediastinal, contralateral hilar, ipsilateral or contralateral scalene, or

    supraclavicular lymph node(s)

    Definition of Distant Metastasis(M)

    M Category M Criteria

    M0 No distant metastasis

    M1 Distant metastasis

    A-21

  • M1a Separate tumor nodule(s) in a contralatearl lobe; tumor with pleural or pericardial nodules or malignant pleural

    or pericardial effusion. Most pleural (pericardial) effusion with lung cancer

    are a result of the tumor. In a few patients, however, multiple microscopic examinations of pleural (pericardial) fluid are negative for tunor, and the fluid is nonbloody and not an exudates. If these

    elements and clinical judgment dictate that the effusion is not related to the tumor, the effusion should be

    excluded as a staging descriptor.

    M1b Single extrathoracic metastasis in a single organ (including involvement of a single nonregional node)

    M1c Multiple extrathoracic metastases in a single organ or in multiple organs

    AJCC PROGNOSTIC STAGE GROUPS T N M GROUP

    TX

    Tis

    T1mi

    T1a

    T1a

    T1a

    T1a

    T1b

    T1b

    T1b

    T1b

    T1c

    T1c

    T1c

    N0

    N0

    N0

    N0

    N1

    N2

    N3

    N0

    N1

    N2

    N3

    N0

    N1

    N2

    M0

    M0

    M0

    M0

    M0

    M0

    M0

    M0

    M0

    M0

    M0

    M0

    M0

    M0

    Occult carcinoma

    0

    IA1

    IA1

    IIB

    IIIA

    IIIB

    IA2

    IIB

    IIIA

    IIIB

    IA3

    IIB

    IIIA

    A-22

  • T1c N3 M0 IIIB

    T2a N0 M0 IB

    T2a N1 M0 IIB

    T2a N2 M0 IIIA

    T2a N3 M0 IIIB

    T2b N0 M0 IIA

    T2b N1 M0 IIB

    T2b N2 M0 IIIA

    T2b N3 M0 IIIB

    T3 N0 M0 IIB

    T3 N1 M0 IIIA

    T3 N2 M0 IIIB

    T3 N3 M0 IIIC

    T4 N0 M0 IIIA

    T4 N1 M0 IIIA

    T4 N2 M0 IIIB

    T4 N3 M0 IIIC

    Any T Any N M1a IVA

    Any T Any N M1b IVA

    Any T Any N M1c IVB

    A-23

  • Small Cell Lung Cancer

    Diagnosis Initial Evaluation

    *H & P

    *Pathology review

    Stage Limited stage (T any, N any, M0; except T3-4 due to multiple lung

    * WBC, DC, Hgb, platelets

    *Electrolytes, liver function

    nodules that do not fit in a tolerance radiation on field)

    See A-25

    Small cell or combined small

    cell/non-small cell lung

    cancer on biopsy or cytology

    of primary or metastatic site

    *BUN, creatinine *Chest/liver/adrenal CT with IV contrast

    whenever possible *Head MRI (preferred) or CT

    *Bone scan (refer to KMUH)

    *PET/CT scan (if limited stage is

    suspected) (option)

    *Smoking cessation counseling and

    intervention

    Extensive stage (T any, N any,

    M1a/b; T3-4 due to multiple lung

    nodules)

    See A-27

    A-24

  • Small Cell Lung Cancer

    Stage Additional Workup

    *If pleural effusion is present,

    thoracentesis is recommended; if

    Clinical stage

    (T1-2, N0)

    PET/CT (if not

    previous

    obtained)

    Pathologic

    mediastinal

    staging is

    considered

    See A-26

    Limited stage (T any, N any, M0;

    except T3-4 due to multiple lung

    nodules that do not fit in a

    tolerable radiation field)

    thoracentesis inconclusive, consider

    thoracoscopy

    *Pulmonary function tests (PFTs) (if

    clinically indicated) *Bone imaging(radiographs or MRI) as

    appropriate if PET-CT equivocal *Unilateral marrow aspiration/biopsy in

    select patients

    Limited stage in

    excess of T1-2,

    N0

    Bone marrow

    biopsy,

    thoracentesis, or

    bone studies

    consistent with

    malignancy

    See A-26

    See A-27

    A-25

  • Small Cell Lung Cancer

    Testing Results Initial Treatment Adjuvant Treatment

    Pathologic mediastinal

    staging negative

    Lobectomy (preferred) and

    mediastinal lymph node

    dissection or sampling

    N0

    N+

    Chemotherapy Concurrent

    chemotherapy +

    mediastinal RT

    Clinical stage

    T1-2, N0

    Good performance status (PS 0-2)

    Chemotherapy + concurrent thoracic RT

    See A-28

    Pathologic mediastinal

    staging positive or

    medically inoperable

    Poor PS (3-4) due to

    SCLC

    Poor PS (3-4) not

    due to SCLC

    Chemotherapy ± RT Individualized treatment

    including supportive care

    Limited stage

    excess T1-2, N0

    Good performance

    status (PS 0-2)

    Poor PS (3-4) due to

    SCLC

    See A-28

    Poor PS (3-4) not

    due to SCLC

    Individualized treatment

    including supportive care

    Chemotherapy ±RT

    Chemotherapy +concurrent thoracic RT

    A-26

  • Small Cell Lung Cancer

    Stage Initial Treatment

    Extensive stage (T any,

    N any, M1a/b; T3-4 due

    to multiple lung nodules)

    Extensive stage without

    localized symptomatic

    sites or brain metastases

    Extensive stage +

    localized symptomatic

    sites

    Extensive stage with

    brain metastases

    *Good PS (0-2)

    *Poor PS (3-4) due to

    SCLC

    *Poor PS (3-4) not due

    to SCLC *SVC syndrome

    *Lobar obstruction

    *Bone metastases

    Spinal cord

    compression

    Asymptomatic

    Symptomatic

    Combination chemotherapy including supportive care

    See NCCN Palliative Care Guidelines

    Individualized therapy including supportive care See

    NCCN Palliative Care Guidelines

    Chemotherapy± RT to symptomatic sites If high risk of fracture due to osseous structural

    impairment, consider palliative external-beam RT and

    orthopedic stabilization

    RT to symptomatic sites before chemotherapy unless

    immediate systemic therapy is required.

    May administer chemotherapy first, with whole-brain

    RT after chemotherapy

    Whole-brain RT before chemotherapy, unless

    immediate systemic therapy is required

    See A-28

    A-27

  • Small Cell Lung Cancer

    Response Assessment Following Initial Therapy Adjuvant Treatment Surveillance

    *Chest x-ray (optional)

    *Chest/liver/adrenal CT with IV

    contrast whenever possible

    *Brain MRI (preferred) or CT with IV

    contrast whenever possible, if

    prophylactic cranical irradiation

    (PCI) to be given

    *Other image studies, to assess prior

    sites of involvement, as clinically

    indicated

    *CBC, platelets

    *Electrolytic, LFTs, Ca, BUN,

    creatinine

    Complete response or

    partial response

    Stable disease Primary progressive

    disease

    Limited or extensive

    stage: PCI

    After recovery from primary therapy:

    *Oncology follow-up visits every 3-4 mo

    during y 1-2, at least every 6 mo during

    y 3-5, then annually

    -At every visit: H&P, chest imaging,

    bloodwork as clinically indicated

    *New pulmonary nodule should initiate

    workup for potential new primary

    *Smoking cessation intervention

    *PET/CT is not recommended for routine

    follow-up See A-24

    See A-29

    A-28

  • Small Cell Lung Cancer

    Progressive Disease Subsequent Therapy/Palliative Therapy

    Subsequent chemotherapy

    (category 1 for topotecan)

    or

    Continue until two cycles beyond

    best response or progression of

    disease or development of

    unacceptable toxicity

    Palliative symptom management,

    including localized RT to

    symptomatic sites

    PS 0-2 palliative symptom management,

    including localized RT to

    symptomatic sites

    Relapse or primary

    progressive disease

    PS 3-4 Palliative symptom management, including localized RT to

    symptomatic sites

    A-29

  • CCRT 的原則

    NSCLC Dose: up to 60-66Gy/1.8-2Gy/day Limited SCLC

    1.年齡小於等於70歲,PS:0~1,接受CCRT DOSE:50~60 Gy/1.8Gy/day。

    排程:放療自開始持續做至50~60 Gy,而化學治療自開始先做三個療程後休息,須重新評估病患治療反應,之後再依實際情形

    安排接續的治療。

    如有CR,加做预防性全腦放射治療 (prophylactic cranial irradiation, PCI) 。

    DOSE: 30Gy/ 2Gy/ day x15 fractions(一天一次共十五次)。

    如有PR,持續化學治療,但不做PCI。

    2.年齡大於70歲,PS:0~1,採用接續性化放療(sequential chemoradiotherapy),DOSE:50~60 Gy/1.8Gy/day。

    排程:連續的三個療程的化學治療後休息,在二週內重新評估。

    如有CR,加做PCI, DOSE: 30Gy/ 2Gy/ day x15 fractions(一天一次共十五次)。

    如有PR,加做胸腔的放療及三個療程的化學治療,但不做PCI。

    3.如有PD,接受第二線化療。

    Principles of chemotherapy regimen

    1.Chemotherapy at systemic doses results in superior outcome but at the cost of an increased toxicity.

    2.Platinum-based regimen is preferred

    3.Reference regimens with combination of platinum

    –Etoposide

    –Vinorelbine or Vinblastine

    A-30

  • 4.Alternative regimens with combination of platinum

    –Paclitaxel -Docetaxel -Pemetrexed

    5.High-risk drugs for CCRT

    –Gemcitabine -EGFR-TKI (gefitinib, erlotinib) - Bevacizumab

    -Doxorubicin

    A-31

  • 參考文獻

    1. Small Cell Lung Cancer NCCN V1.2017 from http://www.nccn.org

    2. Non-Small Cell Lung Cancer NCCN V4.2017from http://www.nccn.org

    3. Paumier, A. and C. Le Pechoux, Radiotherapy in small-cell lung cancer:where should it go Lung Cancer, 2010. 69: 133-40.

    4. Sorensen, M., M. Pijls-Johannesma, and E. Felip, Small-cell lung cancer:ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.

    Ann Oncol, 2010. 21 Suppl 5: v120-5.

    5. Khan, A.J., P.S. Mehta, T.W. Zusag, et al., Long term disease-free survival resulting from combined modality management of patients presenting with

    oligometastatic, non-small cell lung carcinoma (NSCLC). Radiother Oncol, 2006. 81: 163-7.

  • Cancer of the Esophagus

    Treatment Guideline

    KMHK

    制 定 日 期 : 104 年 1 月 1 日

    修 訂 日 期 : 107 年 6 月 5 日

  • 食道癌修訂記錄

    修訂日期 修訂內容摘要 修訂頁次 版本

    104年

    105年

    106年

    第一版依照 NCCN guideline 制定本院治療準則

    多科會議討論檢視後未修改

    1.Endoscopic mucosal resection (EMR)修改為 Endoscopic resection (ER)並加入建議

    分期為 T1a or T1b 之附註(A-29)

    2.分期 Stage I-III (locoregional disease)Adenocarcinoma See ESOPH-10 改為 See A-29

    3.分期 Stage IV (metastatic disease) Squamous cell carcinoma See ESOPH-9 改為 See A-29 4. Multidisciplinary evaluation-Consider nasogastric or J-tube for preoperative nutritional support 增加 PEG 亦可 support preoperative nutrition (A-30) 5.刪除 Squamous cell carcinoma Stage I-III (locoregional disease) Medically unfit

    for surgery or surgery not ...(A-30)

    6.新增 Non-surgical candidate(Refer to KMUH) (A-30)

    7.修改 Squamous cell carcinoma (A-31) Tis 建議行Endoscopic therapies or Esophagectomy

    T1a 建議行 Endoscopic therapies (preferred) or esophagectomy

    T1b, N0 建議行 Eesophagectomy

    T1b, N+, T2-T4a, N0- N+建議行 Chemoradiation (Refer to KMUH) or esophagectomy T4b(Refer to KMUH)

    8.刪除 A-32、A-33、A-34 頁數全部內容

    9.Palliative/Salvage therapy 更改為 Palliative therapy(A32) 10.Esophageal Cancer (squamous cell carcinoma) recurrent Palliative therapy See ESOPH-9 改為 See A32

    11. Esophageal Cancer (squamous cell carcinoma) Unresectable locally advanced,

    A-29

    A-30

    A-31

    A-32

    1.0

    2.0

  • 食道癌修訂記錄

    修訂日期 修訂內容摘要 修訂頁次 版本

    107年

    locally recurrent or metastatic disease Karnofsky performance score ≥ 60%

    or ECOG

    performance score≤ 2 修改建議 cheotherapy/Radiotherapy 更改為 Systemic

    therapy

    and/or best supportive care(A33)

    12. Esophageal Cancer (squamous cell carcinoma) Unresectable locally

    advanced, locally recurrent or metastatic disease ,ECOG performance score≥

    2,改為≥ 3 建議 Best

    supportive care(A33)

    13. Esophageal Cancer Adenocarcinoma Stage I-III (locoregional

    disease) See ESOPH-11 改為 See A35、新增 Non-surgical

    candidate(Refer to KMUH)、移除

    Medically unfit for surgery... (A-34) 14. Esophageal Cancer (Adenocarcinoma) Tis、T1a 建議行 Endoscopic

    therapies(preferred)or Esophagectomy(A-35) T1b, N0 建議行

    Eesophagectomy

    T1b, N+, T2-T4a, N0- N+建議行 Chemoradiation (Refer to KMUH) or

    esophagectomy

    T4b(Refer to KMUH)

    1.刪除 T4b 之(Refer to KMUH)改為 Chemoradiation or Chemotherapy or

    Radiation or Best support care And/or hospice care or clinical trial (refer

    to KMUH)、加入 R/T 說明。

    A-33

    A-34

    A-35

    A-31、A-35

    3.0

  • Esophageal Cancer

    Workup Clinical stage Histologic classification

    Squamous cell carcinoma See A33

    *H & P

    *Upper GI endoscopy and biopsy

    * Chest/abdomen CT with oral and IV contrast

    Stage I-III

    (locoregional

    disease)

    *PET-CT evaluation if no evidence of M1 disease(refer to KMUH)

    *CBC and chemistry profile

    *Endoscopic resection (ER) is essential for the accurate staging of

    early stage cancers(T1a or T1b)

    *Nutritional assessment and counseling

    *Biopsy of metastatic disease as clinically indicated

    *HER2-neu testing if metastatic adenocarcinoma is

    documented/suspected

    *Bronchoscopy, if tumor is at or above the carina with no evidence of

    Adenocarcinoma Squamous cell carcinoma

    See A37 See A36

    M1 disease

    *Assign Siewert category

    *Smoking cessation advice, counseling, and pharmacotherapy

    Stage IV

    (metastatic

    disease

    Adenocarcinoma Palliative therapy

    A-32

  • Esophageal Cancer

    Histology Clinical stage Additional Evaluation

    (as clinically indicated)

    Medically fit for surgery See A34

    Squamous

    cell

    carcinoma

    Stage I-III

    (locoregional

    disease)

    *Multidisciplinary evaluation -

    Consider nasogastric or J-tube or PEG for preoperative nutritional

    support

    Non-surgical candidate(Refer to KMUH)

    A-33

  • Esophageal Cancer

    Histology Tumor

    classifications

    Primary treatment options for medically fit patients

    Tis

    T1a

    Endoscopic therapies or Esophagectomy Endoscopic therapies (preferred) or esophagectomy

    Squamous cell

    carcinoma

    T1b, N0 Eesophagectomy

    T1b, N+, Chemoradiation or esophagectomy

    T2-T4a, N0- N+

    Chemoradiation or Chemotherapy or Radiation or Best support

    T4b care

    And/or hospice care or clinical trial (refer to KMUH) 說明:因本院無放射治療設備,故治療需放射線治療及同步化學治療病患協助轉診至高醫或他院治療

    A-34

  • Esophageal Cancer

    Follow-up for squamous

    cell carcinoma

    Recurrence Palliative therapy

    *H & P

    -if asymptomatic: H & P every

    3-6 mo for 1-2y, every 6-12 mo

    Locoregional only

    recurrence: prior

    esophagectomy, no

    prior chemoradiation

    Concurrent chemoradiation

    (fluoropyrimidine- or

    taxane-based) preferred or

    surgery or chemotherapy or

    best supportive care

    Recurrence

    See A36

    for 3-5y, then annually

    * Chemistry profile and CBC, as

    Resectable and

    medically

    esophagectomy

    Recurrence

    See A36

    clinically indicated

    *Imaging study

    *Upper GI endoscopy and biopsy

    *Dilatation for anastomotic

    stenosis

    *Nutritional assessment and

    counseling

    Locoregional only

    recurrence: prior

    chemoradiation, no

    prior esophagectomy

    Metastatic disease

    operable Unresectable or

    medically

    inoperable

    See A36

    A-35

  • Esophageal Cancer

    For squamous cell

    carcinoma

    Performance status

    Palliative therapy

    Karnofsky performance score ≥

    60%

    or

    ECOG performance score≤ 2

    Systemic therapy and/or best supportive care

    Unresectable locally advanced,

    locally recurrent or metastatic

    disease

    Karnofsky performance

    score

  • Esophageal Cancer

    Histology Clinical status Additional evaluation

    (as clinically indicated)

    *Multidisciplinary evaluation -

    Consider nasogastric or J-tube or

    PEG for preoperative nutritional

    Medically fit for surgery See A38

    Adenocarcinoma

    Stage I-III

    (locoregional

    disease)

    support -Laparoscopy (optional)

    if no evidence of M1 disease and

    tumor is at esophagogastric

    junction(EGJ)

    Chemoradiation or Chemotherapy or Radiation or Best support

    care

    And/or hospice care or clinical trial (refer to KMUH)

    A-37

  • Esophageal Cancer

    Tumor classification Primary treatment options for medically fit patients

    Endoscopic therapies(preferred)or Esophagectomy

    T1b,N0 Esophagectomy

    Adenocarcinoma Chemoradiation

    T1b,N+

    T2-T4a, N0-N+

    T4b

    Esophagectomy

    Chemoradiation or Chemotherapy or Radiation or Best support

    care

    And/or hospice care or clinical trial (refer to KMUH)

    說明:因本院無放射治療設備,故治療需放射線治療及同步化學治療病患協助轉診至高醫或他院治療

    T1a

    Tis

    A-38

  • Esophageal Cancer

    Follow-up for

    adenocarcinomas

    Recurrence

    Palliative/salvage therapy

    *H & P

    -if asymptomatic: H & P every 3-6 mo for

    1-2y, every 6-12 mo for 3-5y, then

    Locoregional only

    recurrence: Prior

    esophagectomy, no prior

    chemoradiation

    Surgery or

    Chemotherapy or

    Best supportive care

    Recurrence

    Palliative therapy

    annually

    * Chemistry profiles and CBC, as clinically

    indicated

    *Imaging studies

    *Upper GI endoscopy and biopsy

    *Dilatation for anastomotic stenosis

    *Nutritional assessment and counseling

    Locoregional only

    recurrence: Prior

    chemoradiation, no prior

    esophagectomy

    Metastatic disease

    Resectable and

    medically

    operable

    Unresectable or

    medically

    inoperable

    Esophagectomy

    Palliative

    therapy

    A-39

  • 參考文獻

    1. Esophagus Cancer V2.2017 from http://www.nccn.org

    2. van Hagen P, Hulshof MC, van Lanschot JJ, et al.Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med

    2012;366:2074-2084.

    3. Tepper J, Krasna MJ, Niedzwiecki D, et al. Phase III trial of trimodality therapy with cisplatin, fluorouracil, radiotherapy,and surgery compared with

    surgery alone for esophageal cancer: CALGB 9781. J Clin Oncol 2008;26:1086-1092.

    4. Bedenne L, Michel P, Bouche O, et al. Chemoradiation followed by surgery compared with chemoradiation alone in squamous cancer of the

    esophagus: FFCD 9102. J Clin Oncol 2007;25:1160-1168.

    http://www.nccn.org/

  • Cancer of the Liver

    Treatment Guideline

    KMHK

    制 定 日 期 : 97 年 1 月 1 日

    修 訂 日 期 : 107 年 6 月 1 5 日

  • 肝癌修訂記錄

    修訂日期 修訂內容摘要 修訂頁次 版本

    97年

    98年

    99年

    100年

    101年

    102年

    肝癌診療指引新制訂

    多科會議討論檢視後未修改多

    多科會議討論檢視後未修改多

    多科會議討論檢視後未修改多

    多科會議討論檢視後未修改多

    ※診療指引 1.原甲種胎兒蛋白≧400ng/ml,無其他癌症,且無急性肝炎發作

    或懷孕→修改為甲種胎兒蛋≧400ng/ml ,腫瘤>1cm,無其他癌症,且無急性肝炎發作或懷孕。

    2.原甲種胎兒蛋白:>400ng/ml,但同時有其他癌症或急性發作‧

  • 肝癌修訂記錄

    修訂日期 修訂內容摘要 修訂頁次 版本

    103年

    104年

    105年

    ※肝癌各種治療法適應症指引

    1.手術切除符合條件新增主治醫師認為手術對病患病情控

    制較有利時,仍可與病人討論後採用手術治療。

    2.局部消除治療:經皮藥物注射治療(PEI):大型肝癌一般不建

    議,但可施行血管內肝癌注射者或特殊情況時亦可嘗試,

    請會診肝癌團隊會議→修改為大型肝癌一般不建議,但可施

    行血管內肝癌注射者或特殊情況時亦可嘗試,可與其他治療併

    用為輔助治療。

    3.新增微波凝固治療(micro-wave)治療。

    ※修訂肝癌治療流程圖如附件

    ※新增分期:

    1.HCC Staging :BCLC 新增 TNM 路徑

    2.AJCC 7th TNM (Tumor-Node-Metastasis)

    Stage 3.The Child-Pugh stage of Liver

    cirrhosis

    ※修訂抗癌藥物處方

    ※診療指引

    1.新增 TNM 治療路徑

    ※診療指引

    1.新增術前建議評估:Chest x-ray、Cardio echo。

    2.修訂 Strategy for staging and treatment assignment in

    patients diagnose with HCC according to the BCLC

    proposal 流程圖。

    3. 新增 BCLC classification

    ※診療指引

    1.刪除 : 做多次稀釋檢查 (multipledilution) .術前建議評估-Lung function test、Chest x-ray、

    B-2

    B-3

    B-4

    B-6~7

    B-8~9

    B-5

    B-2

    B-7

    B-8

    B-2

    B4 B7

    3.0

    4.0

    5.0

  • 106年

    107年

    Cardio echo修改為開刀術前建議評估-Lung function

    test、Chest x-ray、Cardio echo

    3.刪除: (目前為每個月第二周禮拜二上午及第四周禮拜五

    下午) 1.刪除 Child-pugh C 的治療中的標靶治療。

    2.非常早期(0)新增治療方式為切除

    ※局部消除治療

    1. 新增九、姑息性治療

    (一)經導管動脈栓塞術

    (二)放射性治療

    (三)化學或標靶治療

    2. (三)化學或標靶治療

    動脈內灌注化學治療、全身靜脈化學治療---建議轉高醫

    接受此治療

    ※肝癌治療準則

    2.1.AJCC7th修改為AJCC8th

    6.0 7.0

  • 一、肝癌診斷導引

    疑似病例

    a.影像學檢查:Abdomen echo或CT或MRI

    b.甲種胎兒蛋白檢查 或 c.組織學檢查:細針穿刺細胞學或切片病理學檢查

    細胞學或病理診斷有

    且為確定診斷進入肝

    癌治療

    細胞學或病理學檢查未能

    確診,或因特殊原因未做細

    胞學或病理學檢查

    未發現腫瘤、非惡性腫瘤或無法確定

    甲種胎兒蛋白

    ≧400ng/ml,腫

    瘤≧1cm,無其

    他癌症,且無急

    性肝炎發作或

    懷孕。

    甲種胎兒蛋

    白:‧≧400ng/ml ,

    腫瘤≧1cm,但同

    時有其他癌症或

    急性肝炎發

    作‧

  • 二、肝癌治療前評估項目建議檢查清單

    (一)病因: HBsAg、Anti-HCV、飲酒及酗酒史、肝硬化家族史 Option: HBeAg、HBeAb、HBV-DNA、HCV-RNA

    (二)診斷依據:

    1.腫瘤標記:甲種胎兒蛋白(alpha-fetoprotein),其他CEA、Ca19-9。

    2.影像檢查:CT 或做 MR with enhancement dynamic is phase。 三、建議診斷(依據共識會議診斷)

    (一)細針抽吸細胞學診斷。

    (二)管針切片病理學檢查。 四、功能評估:

    (一)Liver function Evaluation:膽色素、白蛋白、凝血酶原時間、GOT、GPT、腹水、肝昏迷。 (二)Performance :WHO Performance Scale (ECOG) (三)Routine exam: EKG、BUN、Creatinine、CBC、urine、stool、開刀術前建議評估-Lung function test、Chest x-ray、Cardio echo

    五、肝癌分級:Staging and TNM classification

    影像學檢查含: 1.基本之胸、腹部X光片。 2.腹部超音波,有顯影之腹部電腦斷層掃瞄或磁振掃瞄(在開始治療之前),血管攝影(可與治療同時安排)等評估 腫瘤大小、腫瘤侵犯、及腹部 淋巴節轉移之檢查。

    3.核醫科骨骼掃瞄(Bone scan)及正子電腦斷層掃描 PET(高度懷疑儘可能檢查)。---建議轉高醫接受此檢查 。 六、肝癌各種治療法適應症指引,有任何不確定或疑慮者,請會診肝癌團隊會議,肝癌各種

    治療可單獨使用或合併治療。 七、手術切除 :需符合下列條件

    (一)單一肝癌或多發位於同一肝葉且少於三個之肝癌。 (二)肝功能Child pugh classification A,或可施行小範圍切除之Child pugh classification B。

    (三)無其他不適合手術之病況。 4.主治醫師認為手術對病患病情控制較有利時,仍可與病人討論後採用手術治療

    八、局部消除治療:最大直徑小於三公分,少於三個之肝癌;或單一 5 公分以下肝癌,無嚴重出血傾向且可在超音波或電腦斷層導引下施行者。肝能 child-pugh classification A或B,及部分C者。

    (一)經皮藥物注射治療(PEI):大型肝癌一般不建議,但可施行血管內肝癌注射者或特殊情況時亦可嘗試,可與其他治療併用為輔助治療。

    (二)高週波治療(RFA)及微波凝固治療(micro-wave):肝功能及血液凝固能力要求較經皮藥物注射治療為嚴格。大型肝癌雖亦可使用,但最好在全 身麻醉下施行,需可承受麻醉 者方可使用。

    B-2

  • 九、姑息性治療:

    (一)經導管動脈栓塞術:為姑息性治療,腫瘤數目範圍大小較無限制。肝功能Child pugh A及B之早期,無主肝門靜脈侵犯者;無肝腦病變或嚴重 腹水,總膽色素需在3mg/dl以下,但總膽管阻塞者例外。需先評估出血傾向及血液凝固時間。

    (二)放射線治療:任何可定位之病灶均可施行,通常為合併栓塞之輔助治療或在上述治療不適合時,做為主要治療適應症如下:無法手術切除或 經導管動脈栓塞術的原發部位,肝癌轉移性病灶,肝門靜脈侵犯,總膽管侵犯。---建議轉高醫接受此治療

    (三)化學或標靶治療:無法施行根除性治療且無法或不適合栓塞之肝癌,或併發多發轉移性病灶者。---建議轉高醫接受1、2治療 1.動脈內灌注化學治療。 2.全身靜脈化學治療。 3.口服藥物化學治療。 4.標靶治療或實驗用藥。

    十、肝臟移植:需接受根除性治療,但肝功能不足無法手術者,而全身狀況可接受麻醉手術者,需無遠處轉 移且影像學上沒有血管侵犯。

    ---建議轉高醫接受此治療(一)全肝(屍肝移植): 1.單一肝癌,最大直徑小於5 公分。 2.多發性腫瘤,小於或等於 3 顆,最大直徑小於 3 公分。

    (二)活體肝臟移植:

    1.單一肝癌,最大直徑小於 6.5 公分。

    2.多發性腫瘤,小於或等於 3 顆,其中最大肝癌不大於 4.5 公分或三顆直徑總和不大小於 8公分。

    B-3

  • 十一-1、肝癌治療流程圖:

    確診病例

    肝功能及影像學評估分

    治療後經醫

    師評估後可

    行curative治

    非主門靜脈侵犯

    Child-pugh A-B

    ‧經導管動脈腫瘤 栓塞術

    ‧標靶治療 ‧放射線治療

    主門靜脈侵犯 Child- Child-pugh A-B pugh C ‧標靶治療 ‧放射線治療 ‧臨床試驗 ‧動脈或全身化學 治療

    醫師評估後無 法行curative治

    支持性療法

    *手術切除 療

    肝臟移植 *局部消除治療 *酒精注射

    支持性療法

    *高週波微波治療

    •單一肝癌>5cm 或

    •兩葉多發性肝癌,或

    •主要門靜脈或其他主要血管侵犯,或有遠處

    轉移病灶或

    •肝功能或全身狀況不適合施行根除性治療

    •單一肝癌≦5cm 或

    •多發但少於 3 顆於同一

    肝葉或

    •無轉移或位於同一小葉

    或 •無主要血管及門靜脈侵犯

    1.Child-pugh C 或

    Child-pughA-B,但

    肝癌位置、數目無

    法接受根治性治療。

    2.全肝移植(屍肝):

    單一肝癌,最大直徑

  • Hepatocellular carcinoma

    十一-2、肝癌治療流程圖:

    TNM Directed

    T1 T2 T3 or T4 N1 or M1

    1.治癒性治療: Resection Local ablation

    2.無法進行治癒性治 療: TACE 其他替代治療

    腫瘤數3個以內儘可能

    治癒性治療: TACE Combined

    Therapy

    TACE Combined

    therapy Irradiation Chemotherapy Targeting

    therapy Resection when

    possible

    Irradiation Targeting

    therapy Local or

    systemic Chemotherapy

    Single may try

    curative therapy

    B-5

  • Hepatocellular carcinoma

    十二、HCC Post- treatment Follow Up Flowchart

    (一)追蹤影像:

    OP、RFA、PEI、TACE(TAE) (首次療程)

    2 個月內

    F/U Abd echo、CT、

    1年內

    F/U Abd echo、CT、MRI 需3次或以上

    (二)追蹤AFP elevated:

    第一次治療前AFP>20ng/ml 的肝癌病人有行(首次療程)

    OP、RFA、PEI、TACE(TAE)

    2 個月內

    F/U AFP elevated

    1年內

    F/U AFP elevated需3次或以上

    B-6

  • Hepatocellular carcinoma

    十三、分期:1 .Strategy for staging and treatment assignment in patients diagnose with HCC according to the BCLC proposal

    Hepatocellular carcinoma

    Stage:0

    PST:0

    child-turcotte-pugh:A

    stage:A-C

    PST:0-2

    child-turcotte-pugh:A or B

    stage:D

    PST:>2

    child-turcotte-pugh:C

    Very early

    stage(0)

    single< 2cm

    Early stage:A single nodule< 5cm or 3 nodules≦3cm

    PST:0

    Intermediate stage: B

    Multinodular,

    PST:0

    Advanced stage:C portal invasion

    N1,M1, PST:1-2

    Terminal stage:D

    carcinoma in situ single

    Increased portal pressure

    and elevated bilirubin level

    yes

    3 nodules≦3cm

    Association disease

    TAE or TACE Supportive care

    no Sorafenib

    resection

    no

    Liver transplantion(CLT orLDLT)

    yes

    PEI orRFA

    or target

    therapy

    B-7

  • 2. AJCC8th TNM (Tumor-Node-Metastasis) Stage:

    TX

    T0

    T1

    T1a

    T1b

    T2 T3

    T4

    Primary Tumor (T) Primary tumor cannot be assessed No evidence of primary tumor Solitary tumor ≦2cm,or >2cm without vascular invasion Solitary tumor ≦2cm Solitary tumor >2cm without vascular invasion Solitary tumor >2cm with vascular invasion,or multiple tumors,none>5cm Multiple tumors,at least one of which is >5cm Single tumor or multiple tumors of any size involving a major branch of the

    portal vein or hepatic vein,or tumor(s) with direct invasion of adjacent organs other than the gallbladder or with perforation of visceral peritonem.

    NX

    N0

    N1

    Regional Lymph Nodes (N) Regional lymph nodes cannot be assessed

    No regional lymph node metastasis

    Regional lymph node metastasis

    M0 M1

    Distant Metastasis (M) No distant metastasis

    Distant metastasis

    A NATOMIC S TAGE / P ROGNOSTIC G ROUPS CLINICAL PATHOLOGIC

    GROUP T N M

    IA T1a N0 M0 IB T1b N0 M0 II T2 N0 M0

    IIIA T3 N0 M0 IIIB T4 N0 M0 IVA Any T N1 M0

    IVB Any T Any N M1

    GROUP T N M

    IA T1a N0 M0 IB Tb N0 M0 II T2 N0 M0

    IIIA T3 N0 M0 IIIB T4 N0 M0 IVA Any T N1 M0

    IVB Any T Any N M1

    B-8

  • 3. Barcelona-Clinic Liver Cancer (BCLC) classification

    Stage Tumor Features Child-Pugh Score Performane Status

    Test

    Stage 0 Single≤2cm Carcinoma in situ

    Child-Pugh A 0

    Stage A Single≤ 5cm or 3

    nodulars ≤ 3cm

    Child-Pugh A-B 0

    Stage B Single>5cm or

    Multinodulars

    Child-Pugh A-B 0

    Stage C Portal invasion N1,M1†

    Child-Pugh A-B 1-2

    Stage D Any Child-Pugh C 3-4

    *BCLC期別摘錄規則依據行政院衛生署國民健康局 書函(發文字號:國健癌字第1000302045號)

    4. The Child-Pugh stage of Liver cirrhosis

    Score 1 2 3

    Total bilirubin (mg/dl) 3.0 Albumin (g/dl)

    >3.5

    2.8-3.5

    normal

    time,sec )

    6 sec

    Total score:

    Child A: 5-6

    Child B: 7-9

    Child C: 10-15

    B-9

  • (十)抗癌藥物治療處方:---建議轉高醫接受此治療

    1.When WBC

  • ---Subselective intra-aortic ---

    Regimen I (A)

    Continuous infusion of 5FU (50~250mg) a day using a portable pump

    Regimen I (B)

    Intermittent one shot of Epirubicin (10~20mg) + Mitomycin C(2~8mg)

    Regimen I (C) Continuous infusion of 5FU (50~250mg) a day using a portable pump

    Intermittent one shot of Epirubicin (10~20mg) + Mitomycin C(2~8mg)

    regimenⅡ Intermittent one shot of Oncovin(2mg)

    RegimenⅢ Intermittent one shot of Cisplatin(10-30mg)

    RegimenⅣ

    Day1 VP-16(50mg~mg)×30min + Cisplatin(150mg~mg) ×30min + Epirubicin (60mg~mg) ×30min

    Day2 5FU(500mg- mg)×24hr×一天,每15天為1 cycle(每15天打一次)

    ---Intra-hepatic artery Chemotherapy A ---

    Regimen I(A)

    1st week 5FU(50-500mg)

    2nd week 5FU(50-500mg)+Epirubcin(10-40mg)

    3rd week 5FU(50-500mg)

    4th week5FU(50-500mg)+Epirubcin(10-40mg)+Mitomycin-C (2-10mg)

    Regimen I(B)

    Cisplatin(2-40mg) in N/S or D5W 150cc keep 150CC/hr × 5 days×4weeks 5FU(50-500mg) + Leucovorin (25-100 mg)in N/S or D5W 250cc keep 50CC/hrfor total 5hr ×5 days×4weeks

    B-11

  • Regimen I(C)

    Cisplatin(2-40mg) in N/S or D5W 150cc keep 150CC/hr × 5 days×4weeks

    Mitomycin-C(2-10mg) in N/S or D5W 150cc keep 150CC/hr × 5 days×4weeks

    5FU(50-500mg) + Leucovorin (25-100 mg)in N/S or D5W 250cc keep 50CC/hrfor total 5hr ×5 days×4weeks

    --- Intra-hepatic artery Chemotherapy B---

    Regimen I(A)

    Cisplatin(2-40mg) in N/S or D5W,50CC KEEP 100CC/HR × 5 days

    5FU(50-500mg) in N/S or D5W 250cc KEEP 10CC/HR × 5 days 與Leucovorin (25-100 mg)+N/S100CC KEEP 5CC/HR × 5 days同步使用

    Regimen I(B)

    Cisplatin(2-40mg) in N/S or D5W 50CC KEEP 100CC/HR × 5 days

    Mitomycin-C (2-10mg) in N/S or D5W 50CC KEEP 100CC/HR × 5 days

    5FU(50-500mg) in N/S or D5W 250cc KEEP 10CC/HR × 5 days 與Leucovorin (25-100 mg)+N/S100CC KEEP 5CC/HR × 5 days同步使用

    Systemic Chemotherapy therapy

    (concesus Date:2011.2.17)

    (1) Doxorubicin(or Epirubcin) is current acceptable mono-chemotherapy

    (2) Encourage patents who are suitable for chemotherapy enter clinical trial

    (3) All other therapy stated as experiment therapy.

    B-12

  • --- Systemic oral chemotherapy ---

    (1) 5FU 200mg-400mg qd in divided dose

    Systemic Chemotherapy therapy

    (1) Nexavar(sorafenib) 2# -4#/day in divided dose

    參考文獻

    1. Hepatobiliary Cancer NCCN V1.2017 from http://www.nccn.org

    2. Song MJ. Hepatic artery infusion chemotherapy for advanced hepatocellular carcinoma.(2015) World J Gastroenterol ; 21(13): 3843-3849.

    3. Tsai W-L, Lai K-H, Liang H-L, Hsu P-I, Chan H-H, et al. (2014) Hepatic Arterial Infusion Chemotherapy for Patients with Huge

    Unresectable Hepatocellular Carcinoma. PLoS ONE 9(5),1-5.

    4. Wang .S-N, Chuang. S-C, Lee. K-T,(2014) Efficacy of sorafenib as adjuvant therapy to prevent early recurrence of hepatocellular carcinoma

    after curative.

    5. Xiao C, Hai-Peng, Mei L, Liang Q.Advances in non-surgical management of primary liver cancer. World J Gastroenterol 2014 November 28;

    20(44): 16630-16638

    B-13

  • Cancer of the Colon

    Treatment Guideline

    KMHK 制 定 日 期 : 97 年 1 月 1 日

    修 訂 日 期 : 107 年 7 月 1 0 日

  • 大腸癌修訂紀錄

    修訂日期 修訂內容摘要 修訂頁次 版本

    97 年

    98 年

    99 年

    100 年

    101 年

    102 年

    大腸癌診療指引新制訂

    多科會議討論檢視後未修改

    多科會議討論檢視後未修改

    多科會議討論檢視後未修改

    (1)大腸直腸癌 MONITORING/SURVEILANCE Colonscopy 2-5 years:

    Q3-6m,Q12m 改 Q5Y。 (2)結腸癌追蹤準則:對於有高度復發危險者,腹部及骨盆腔電腦斷層檢查

    (3)High Risk Stage II or Stage III 門診第一線用藥準則(1

    m2 Weekly for 6 of 8 weeks 改 Weekly for 6 of 8 weeks2-

    (4)High Risk Stage II or Stage III IV 門診第一線用藥準則

    劑量改 900-1000 mg/m2 bid(Stage II 需自費)。

    (5)直腸癌治療準則 Lesion 5cm 改 8cm。

    (6)直腸癌 Stage B1 改 T2N0M0,治療 Transanal or posterior

    and chemotheraopy 刪除 chemotheraopy、新增 LAR or APR

    (7)直腸癌 Stage B2 改 T3N0M0, Stage C 改 T1-3N1-2M0,Pre-

    改 LV and 5-FU、新增 LAR or APR。

    (8)直腸癌 Stage B3, C3 T4 N0-2 M0 治療準則 Pre-op chemotherapy

    anterior resection ± intraoperative brachytherapy 改

    then OP or low anterior resection ±then RT。

    (1)修訂 Pedunculated or Sessile polyp(adenoma [tubular,

    Invasive cancer 治療準則。

    (2)修訂 Colon cancer Appropriate for Resection(non-

    Obstruction lesion for new lesion,

    ,連續執行三年改二年。

    ):5FU 500 mg/m2 + Leucorvin 100mg/

    3 cycle。

    (3): Capecitabine 1250 mg/m2

    local excision + post-op radiotherapy

    operative chemotherapy (MMC and 5-FU)

    + radiotherapy, then AP or low

    Pre-op chemotherapy + radiotherapy,

    C-3

    C-4

    C-6

    C-7

    C-11

    C-12

    C-12

    C-14

    C-6

    C-7

    1.0

    2.0

    3.0

    Tubulovillous,or Villous]) with

    metastatic) 治療準則。

  • 103 年

    104 年

    105 年

    106 年 7 月 21 日

    (3)修訂 Patient appropriate for intensive therapy (metastasis)治療準則。

    (1)修訂 Pedunculated or Sessile polyp(adenoma [tubular, Tubulovillous,or Villous]) with

    Invasive cancer 治療準則。

    (2)修訂 Suspected or proven metastatic adeno- carcinoma form large bowel (Duke`s D or stage

    IV) 治療準則。

    (3)修訂 Colon cancer Appropriate for Resection(non- metastatic) 治療準則。

    (4)修訂大腸癌 MONITORING/SURVEILANCE Abdominal CT or sonography≦2 years: Q6m 改 Q3-6m。

    (5)修訂直腸癌 MONITORING/SURVEILANCE Pelvis CT/MRI or sonography≦2 years: Q6m 改 Q3-6m。

    (6)修訂結腸癌第四期合併肝轉移追蹤準則。

    (7)修訂結腸癌(Adjuvant therapy)治療準則。

    (8)修訂 Patient appropriate for intensive therapy (metastasis)治療準則。

    (9)修訂 Rectal Cancer T3 N0 M0(high risk),T1-3 N1-2 M0 治療準則。

    (10)修訂 Rectal Cancer stage B3,C3 T4N0-2M0、stage D Any T and N M1 治療準則。

    (1)增訂大腸直腸癌目的、參考文件、範圍、定義、內容。

    (2)增訂大腸癌簡易治療指引、直腸癌簡易治療指引。

    (3)增訂大腸直腸 AJCC 分期、化療藥物、文獻查證。

    (1)修訂大腸直腸癌治療準則

    (1) 增訂 colon cancer colectomy with en bloc removal of regional lymph node or Observe

    (2) 刪除 colon cancer workup PET-CT scan 、核子醫學須轉至高醫

    增加 colon cancer surgery colostomy

    (3) 增加 colon cancer treatment FOLFIRI ±Panitumumab or cetuximab

    C-10~12

    C-2 C-

    3

    C-4

    C-5

    C-6

    C-8

    C-9~10

    C-12~13

    C-14

    C-1

    C-2~3

    C-18~21

    C-3

    C-4

    C-5

    C-7

    C-11

    C-8

    4.0 5.0

    6.0 7.0

  • 107 年 7 月 10 日

    (4)增加 colon cancer therapy after second progression 可用 Stivarga

    (5)增加 rectum cancer findings fragmented specimen or margin cannot be assessed or unfavorable histological

    features 可 operation 或 observe

    (6)刪除 rectal cancer patients with medical contraindication to combined modality therapy

    (7)刪除 primary treatment 5-FU/RT 或轉介高醫

    (8)刪除 rectal cancer resectable 後續 workup

    (9)增加 rectal cancer therapy after second progression 可用 Stivarga

    (10)增加大腸直腸癌化療藥物 Vectibix、Stivarga、Ziv-aflibercept

    (1)增加 4.14 RAS基因突變測試(RAS test):RAS基因突變也可以評估轉移性結大腸直腸癌 (mCRC)患者

    對EGFR標靶治療的主要預測因子之一。

    (2)增加 T3, N0, M0 (no high risk features)治療藥物 UFUR

    (3)刪除 Neoadjuvant therapy (for 2-3 months)

    (4)增加 FOLFIRI ± (bevacizumab or ziv-aflibercept or ramucirumab )

    (5)刪除 Irinotecan ± (bevacizumab or ziv-aflibercept )

    (6)刪除 Irinotecan + (cetuximab or panitumumab) [RAS WT only]

    (7)更新AJCC分期為8TH

    (8)更新參考文獻National Comprehensive Cancer Network. Clinical Practice Guideline in Oncology: Colon

    Cancers V2.2018

    (9)更新參考文獻National Comprehensive Cancer Network. Clinical Practice Guideline in Oncology: Rectal

    Cancers V2.2018

    C-9

    C-14

    C-17

    C-20

    C-22

    C-24

    C-25

    C-31

    C-2

    C-5

    C-7,C-23

    C-11,C-24,C-25

    C-11,C-24,C-25

    C-12,C-25

    C-28

    C-31

    C-31

    8.0

  • 1. 目的:高雄市立小港醫院大腸直腸癌擬參考相關國內外治療指引與相關文獻,依據現有的設施、健保給付制度,大腸直腸癌團對相關研究成果與

    臨床經驗修訂完成「高雄市立小港醫院大腸直腸癌之診療共識」 。

    2. 範圍:大腸直腸癌治療。

    3. 定義:泛指臨床科醫療人員皆可參考適用。

    4. 內容:

    4.1. 大腸直腸癌診斷及評估。

    4.2. 糞便潛血反應:為大腸直腸癌篩檢廣泛使用之初步檢查方式,以檢驗大便中是否有潛血反應。

    4.3. 肛門指診:病人不需要任何準備,由醫師戴手套以Xylocaine Jelly 潤滑右手食指慢慢插入至直腸7~8公分,直腸癌患者一半以上可以摸到硬塊,

    是最簡單的檢查方法。

    4.4. 肛門鏡檢(Anoscopy):長約8公分,屬於硬的管狀器械,由肛門插入以肉眼直接檢查。

    4.5. 直腸乙狀結腸鏡檢(Sigmoidoscopy):此乃利用約 60 公分長的腸鏡,從肛門進入直腸乙狀結腸作診斷,約有 60%的結腸癌可由此法發現,檢

    查時應使肌肉放鬆,採左側臥或膝胸臥式。

    4.6. 結腸鋇劑灌腸攝影術:須做清潔灌腸後,從肛門灌入鋇劑,簡單省時,對於結腸內之病灶,雙對比鋇劑照影可偵測出較小的病變。

    4.7. 大腸鏡檢查(Colonoscopy):須做清潔灌腸後,由肛門進入結腸,直接觀看整條大腸黏膜內部情形,若發現瘜肉可同時切除,如無法切除必須

    切片檢查,且再確認其他結腸處有無同時發生之腫瘤病變。

    4.8. 組織切片檢查(Bioposy):使用內視鏡檢查時對可疑的部分取出體外,再作組織切片,以判定是否為惡性腫瘤。亦可先行瘜肉切除再作切片,

    以確定是否有惡性變化及侵蝕至黏膜下肉層。

    4.9. 腫瘤記號蛋白(CEA):又稱腫瘤胚胎抗原,係從大腸直腸癌細胞分離出來的蛋白,它在血中濃度會隨著大腸直腸癌的發生而升高,臨床上腫瘤

    記號蛋白用於手術後,大腸直腸癌有否局部再發或遠端轉移之偵測參考。

    4.10. 腹部及骨盆腔之電腦斷層掃描(Abdominal and Pelvic CT):藉由腹部及骨盆腔之電腦斷層掃描檢查,可以整體評估腫瘤所在位置,和腹

    腔與骨盆腔內腫瘤細胞侵犯鄰近組織與器官的情形,以及是否已有肝臟等部位之轉移。

    4.11. 核磁共振掃描(MRI):與電腦斷層掃描同為影像學之檢查,當上述影像學檢查無法確定診斷時,或病人因腎功能不全或對於電腦斷層顯影

    劑過敏時使用,屬於第二線的檢查,用來評估直腸癌局部侵犯深度及CCRT之反應。

    4.12. 胸部 X 光檢查(Chest X-ray ):胸部 X 光片可以初步篩檢肺部有無病後灶,評估腫瘤細胞是否已有肺部轉移的情形。

    4.13. 全身正子攝影(PET-CT):利用腫瘤組織對放射性藥物(氧化去氧葡萄糖)的吸收與代謝,轉換成體內分布影像,並結合電腦斷層,達到準 確定位的功能,屬全身性的檢查。此檢查雖然比單獨電腦斷層掃描或單獨一正子放射更靈敏,但仍有約 10 %的偽陰性或偽陽性發生,並非常

    規術前檢查。

    C-1

  • 4.14. RAS基因突變測試(RAS test):RAS基因突變也可以評估轉移性結大腸直腸癌 (mCRC)患者對EGFR標靶治療的主要預測因子之一。

    *intraoperative radiation therapy(IORT),if available , should be considered for patients with T4 or recurrent cancers as an additional boost.

    C-2

  • Cancer of the Colon Treatment Guideline

    結腸癌治療準則

    Clinical presentation

    workup findings surgery

    Pedunculated or

    sessile polyp

    (adenoma) with

    invasion cancer

    • Pathology review • Colonoscopy • Marking of

    cancerous polyp site

    (at time of

    colonoscopy or

    within 2 wks)

    Single specimen

    completely removed

    with favorable

    histological features and

    clear margins

    Fragmented specimen or

    margin cannot be

    assessed or unfavorable

    histological features

    Pedunculated

    polyp with

    invasive cancer

    Senssile polyp

    with invasive

    cancer

    Observe Observe (告知觀

    察,有較高機會復

    發或轉移) or Radical colectomy

    Radical colectomy

    or Observe

    See pathologic

    stage adjuvant

    therapy(C-5)

    and surveillance(C-9)

    C-3

  • Cancer of the Colon Treatment Guideline

    結腸癌治療準則

    Clinical

    presentation

    workup findings surgery

    Locally unresectable or medically inoperable

    Discuss with patient, may consider

    systemic therapy (C-12,C-13)

    Colon cancer

    Appropriate for

    resection

    (non-metastatic)

    Radical

    colectomy Diversion colostomy

    • Colonoscopy • CBC,chemistry

    profile,CEA • Chest X-ray • Abdominal pelvic

    CT

    Radical colectomy or radical

    colectomy with diversion

    Radical colectomy

    Resectable obstructing

    Resectable

    Non-obstructing See pathologic

    stage adjuvant

    therapy (C-5)

    and

    surveillance

    (C11)

    C-4

  • Cancer of the Colon Treatment Guideline

    結腸癌治療準則

    Pathologic stase

    Tis; T1, N0, M0

    T2, N0, M0

    T3, N0, M0 (no high risk features)

    T3, N0, M0 with high risk

    for systemic recurrence or

    T4, N0, M0

    T any,N1-2,M0

    Adjuvant treatment

    Observation

    Observation or

    UFUR

    or

    5-FU/leucovorin

    or

    Capecitabine UFUR or

    Capecitabine.

    or 5-FU/leucovorin or

    FOLFOX

    or

    XELOX

    or Observation FOLFOX

    or

    XELOX

    or Capecitabine

    See Surveillance(C-9) See Surveillance(C-9) See Surveillance(C-9) See Surveillance(C-9)

    or 5-

    FU/leucovorin or UFUR

    C-5

  • Cancer of the Colon Treatment Guideline

    結腸癌治療準則

    Clinical presentation Workup Findings

    Suspected or proven

    metastatic synchronous

    adenocarcinoma from

    large bowel (Any T, any N ,M1)

    • colonoscopy • chest X-ray • abdominal/pelvic CT • CBC, chemistry profile • Determination of RAS gene

    status • Multidisciplinary team

    evaluation including a

    surgeon experienced in the

    resection of hepatobiliary

    and lung metastases

    Synchronous liver only

    and/or lung only metastases Synchronous

    abdominal/peritoneal

    metastases Synchronous unresectable

    metastases

    Resectable or potential resectable

    (C-7) See Treament (C-8) See Systemic Therapy (C-15,C-16)

    C-6

  • Cancer of the Colon Treatment Guideline

    結腸癌治療準則

    Treatment Therapy after resection

    Synchronous or staged colectomy with liver or lung

    resection or Neoadjuvant therapy FOLFOX or XELOX or FOLFIRI ±bevacizumab or

    FOLFIRI or FOLFOX ± panitumumab or cetuximab

    [RAS WT only] followed by synchronous or staged

    colectomy and resection of metastatic disease or Colectomy, followed by chemotherapy FOLFOX or XELOX or FOLFIRI ±bevacizumab or

    FOLFIRI or FOLFOX ± panitumumab or cetuximab

    [RAS WT only]and staged resection of metastatic disease

    FOLFOX or XELOX or FOLFIRI ±

    bevacizumab or FOLFIRI or FOLFOX ± panitumumab or

    cetuximab [RAS WT only]

    See Surveillance (C-9)

    C-7

  • Cancer of the Colon Treatment Guideline

    結腸癌治療準則

    Finding Primary treatment

    Nonobstructing See Systemic Therapy (C-15,C-16)

    Synchronous

    abdominal/

    Peritoneal

    merastases

    Colon resection

    or

    Obstructing Diverting colostomy or Bypass surgery

    See Systemic Therapy (C-15,C-16)

    C-8

  • Cancer of the Colon Treatment Guideline

    結腸癌治療準則 surveillance

    StageⅠ, II, III

    Stage IV

    • History and physical every 3-6 mo for 2 y, then every 6 mo for a total of 5 y • CEA every 3-6 mo x 2 y, then every 6 mo x 3-5 y

    • Chest/abdominal/pelvic CT scan every 3-6 mo x 2 y, then every 6-12 mo for a total of 5 y

    • Colonoscopy in 1 y except if no preoperative colonoscopy due to obstructing lesion, colonoscopy in 3-6 mo

    • History and physical every 3-6 mo for 2 y, then every 6 mo for a total of 5 y • CEA every 3-6 mo for 2 y, then every 6 mo for a total of 5 y

    • Chest/abdominal/pelvic CT every 6-12 mo for a total of 5 y • Colonoscopy in 1 y except if no preoperative colonoscopy due to obstructing lesion, colonoscopy in 3-6 mo

    Serial CEA

    elevation or

    documented

    recurrence

    C-9

  • Cancer of the Colon Treatment Guideline

    結腸癌治療準則

    Recurrence workup

    Serial

    CEA

    elevation

    • physical exam • colonoscopy • chest/abdominal/ • pelvic CT • Abdominal echo • bone scan if

    necessary

    Negative findings

    Conside PET-CT Scan 轉介

    高醫檢查

    Negative findings

    Positive findings

    See treatment for

    documented

    metastases, below

    Documented

    metastases

    by CT, MRI,

    PET

    Resectable Unresectable

    See Systemic Therapy (C-15,C-16)

    or Observation See Systemic Therapy (C-15,C-16)

    C-10

  • Cancer of the Colon Treatment Guideline

    結腸癌治療準則

    Unresectable metastases

    Primary treatment

    Previous adjuvant

    FOLFOX within 6-12

    months

    FOLFIRI±Bevacizumab or

    ziv-aflibercept or ramucirumab

    FOLFIRI±panitumumab or

    cetuximab [RAS WT only]

    Resection

    Converted to resectable

    See Systemic Therapy(C-15,C-16)

    or Observation

    Previous adjuvant

    FOLFOX

    Re-evaluate for

    conversion to resectable

    every 2-3 mo

    Remains unresectable

    See Systemic Therapy(C-15,C-16)

    more then 6-12 months

    Previous 5-FU/LV or

    capecitabine NO previous

    chemotherapy

    See Systemic Therapy

    (C-15,C-16)

    C-11

  • Cancer of the Colon Treatment Guideline

    結腸癌治療準則

    Systemic treatment

    Initial therapy Subsequent Therapy Therapy after second progression

    FOLFOX±Bevacizumab

    or

    XELOX±Bevacizumab

    or FOLFOX+panitumumab or

    cetuximab [RAS WT only]

    FOLFIRI ± (bevacizumab or ziv-

    aflibercept or ramucirumab ) or FOLFIRI

    + (cetuximab or panitumumab) [RAS

    WT only]

    Regorafenib

    Best supportive care

    or

    Patient

    Appropriate

    For

    Intensive

    therapy

    FOLFIRI±Bevacizumab or

    FOLFIRI+ panitumumab

    or cetuximab [RAS WT

    only]

    FOLFOX ± bevacizumab or

    XELOX ± bevacizumab

    Regorafenib

    Best supportive care

    or

    5-FU/leucovorin or

    Capecitabine±

    Bevacizumab

    FOLFOX ± Bevacizumab or XELOX ± Bevacizumab

    Regorafenib

    Best supportive care

    or FOLFIRI ± (bevacizumab

    or ziv-aflibercept or ramucirumab)

    FOLFOX

    or

    XELOX

    Regorafenib

    Best supportive care

    FOLFOXIRI±

    Bevacizumab

    Regorafenib

    Best supportive care

    C-12

  • Cancer of the Colon Treatment Guideline

    結腸癌治療準則

    Initial therapy

    Systemic treatment

    Therapy after first progression

    Improvement in Consider initial therapy as function status above

    Patients not

    appropriate for

    intensive

    therapy

    Infusional 5-FU + leucovorin

    ±bevacizumab or Capecitabine ± bevacizumab or

    (Cetuximab or panitumumab) [RAS

    WT only]

    No improvement

    in function status

    Best supportive care

    C-13

  • Cancer of the Rectum

    Treatment Guideline

    KMHK

    制 定 日 期 : 97 年 1 月 1 日

    修 訂 日 期 : 107 年 7 月 1 0 日

    C-14

  • Cancer of the Rectum Treatment Guideline

    直腸癌治療準則

    Clinical presentation Workup Findings

    Pedunculated polyp

    with invasive cancer

    Observe

    Pedunculated

    polyp or sessile

    polyp(adenoma)

    with invasive

    cancer

    • Pathology review • Colonscopy • Marking of cancerous

    polyp site(at time of

    colonscopy or within 2

    wks if deemed necessary

    by the surgeon)

    Single specimen,

    completely removed with

    favorable histological

    feature and clear margins

    Sessile polyp with

    invasive cancer

    Observe

    (會告知僅觀察有

    較高機會復發或

    轉移) or Transanal excision

    if appropriate or

    Fragmented specimen or

    margin cannot be assessed

    or unfavorable histological

    features

    Transanal excision

    if appropriate or Transabdominal resection

    or Observe

    (會告知僅觀察有較高機

    會復發或轉移)

    Transabdominal resection

    C-15

  • Cancer of the Rectum Treatment Guideline

    直腸癌治療準則

    Clinical presentation Workup Clinical stage

    T1-2, N0 (C-17)

    Rectal cancer

    appropriate for

    resection

    • Biopsy • Pathology review • Chest X-ray • Colonscopy • Abdominal/pelvic CT or MRI • CEA • Colonoscopy marking if small tumor

    T3, N0 (C-18) or T any, N1-2 (C-18)

    Suspected or proven

    metastatic

    adenocarcinoma

    T4 and/or locally

    unresectable (C-18)

    T any, N any, M1

    Resectable metastases

    (C-19) See management of suspected or proven metastatic synchronous adenocarcinoma

    (C-20)

    C-16

  • Cancer of the Rectum Treatment Guideline

    直腸癌治療準則

    Clinical primary treatment stage Adjuvant treatment (6mo perioperative treatment preferred)

    T1,Nx;

    Margins

    negative

    Observe

    pT1-2, N0, M0

    Observ