修訂內容頁數原文修訂 / 新增前言..前言..修訂為年膀胱癌死亡人數占全部惡性腫瘤死亡人數的 3.5%; 2014 年膀胱癌死亡人數占全部惡性腫瘤死亡人數的 2.07%; 死亡率排行第 1 頁死亡率排行於男性為第 11 位女性為第 12 位於男性為第 12 位女性為第 15 位

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1 中山醫學大學附設醫院膀胱癌診療指引臨床指引參考台灣國家衛生研究院與美國 NCCN 版本再依據中山醫學大學附設醫院泌尿道癌小組經驗作編修泌尿道癌醫療小組 2017/12/01 Version /11/04 Version /11/20 Version /12/19 Version /12/27 Version /12/07 Version /11/18 Version /01/21 Version /05/28 Version /12/16 Version 1.0 癌症委員會主任委員癌症委員會執行長癌症防治中心主任團隊負責人

修訂內容頁數原文修訂 / 新增前言..前言..修訂為 - 2012 年膀胱癌死亡人數占全部惡性腫瘤死亡人數的 3.5%; 2014 年膀胱癌死亡人數占全部惡性腫瘤死亡人數的 2.

2 修訂內容頁數原文修訂 / 新增前言..前言..修訂為年膀胱癌死亡人數占全部惡性腫瘤死亡人數的 3.5%; 2014 年膀胱癌死亡人數占全部惡性腫瘤死亡人數的 2.07%; 死亡率排行第 1 頁死亡率排行於男性為第 11 位女性為第 12 位於男性為第 12 位女性為第 15 位 Practice Guide-lines in Bladder Cancer V 版 Practice Guide-lines in Bladder Cancer V 版分期..依據 AJCC/UICC TNM, 7th edition (2010) 分期..修訂為 - 分期 : 修改為依據 AJCC/UICC TNM, 8th edition (2018) 依據 AJCC 8th 更改 TNM 分期表及新增 stage 表格第 4 頁

4 治療指引 : 治療指引 : 修訂為 - 第 6 頁治療指引 : 治療指引 : 修訂為 - 第 7 頁

5 目錄一前言 P.1 二症狀診斷和檢查 P.2 三組織病理分類與分化 P.3 四分期 P.4 五膀胱癌的治療指引 P.6 六膀胱癌的外科治療處置 P.9 七膀胱癌的化學及放射線治療 P.10 八安寧緩和照護原則 P.14 九參考文獻 P.14 十膀胱癌 Stage IV 完治率定義 P.16

6 一前言本共識手冊內所提之各種診治意見, 為原則性之建議, 希望能為癌症患者及其家屬提供一個正確的指引 ; 但對臨床醫師之醫療行為無絕對之法律性約束力! 由於醫藥科技持續在進步, 每位患者的病情亦不盡相同 ; 醫師應就病人之病情做個別的考量, 病人和家屬亦應與醫師溝通討論, 以決定最適當之診治方式在台灣地區, 膀胱惡性腫瘤病患每年均有增加的趨勢, 男性發生率約為女性的 2.5 倍 2014 年膀胱癌死亡人數占全部惡性腫瘤死亡人數的 2.07%; 死亡率排行於男性為第 12 位女性為第 15 位有鑒於此, 本院自 2009 年 6 月開始由泌尿外科病理科醫學影像部放射腫瘤科與血液 / 腫瘤內科組成膀胱癌團隊本院膀胱癌治療, 藉由科際合作及定期開會討論, 得到很好的治療成果尤其是本院的病人群中有一定的比例是腎移植後併發癌病的泌尿移形上皮細胞癌, 他們的移形上皮細胞癌, 常是多發性, 散見於病人本身已衰竭的腎臟, 或是輸尿管及膀胱上, 我們認為若能在病人發生血尿或腰痛時作篩檢, 將可提早發現癌症這個併發症這也讓我們累積了相當豐富的處理經驗及成為中台灣腎移植病人照顧中心本膀胱癌診斷及治療指引的建立, 除了依據已發表的實證醫學證據及專家意見外, 並參考國家衛生研究院膀胱癌臨床指引美國 National Comprehensive Cancer Netwk (NCCN) 的 Practice Guide-lines in Bladder Cancer V 版及中山醫學大學附設醫院膀胱癌治療經驗進行編修 1

7 二症狀診斷和檢查膀胱癌的一些常見症狀包括 : (1) 血尿 ( 顏色呈淺褐色至深紅色 ) (2) 解尿疼痛 (3) 頻尿或是常有尿意感但卻無小便當上述這些症狀產生時, 並不確定是膀胱癌也有可能是因為感染, 良性腫瘤膀胱結石或其它原因所造成, 必須靠醫師來確定診斷 ( 所以當有上述症狀時, 應去看家庭醫師或泌尿科醫師, 泌尿科醫師是專長於泌尿系統疾病的醫師 ) 任何疾病都應立刻去看醫師, 如此才能早期診斷, 早期治療為了找出症狀的原因, 醫生會詢問患者的病史並執行一些身體檢查身體檢查包括直腸或陰道檢查, 來幫助醫師檢查是否有腫瘤的存在另外, 尿液檢體會被送到實驗室檢驗來檢查是否有血液和癌細胞的存在會使用膀胱鏡檢查直接檢查膀胱, 檢查過程可能需要採局部或全身麻醉, 可藉由膀胱鏡取出組織標本做切片檢查, 這是唯一可以確定是否有癌細胞的方法如果整個癌症在膀胱鏡下切片時被移除, 膀胱癌便在單一的治療程序下被診斷及治療膀胱癌的分期可能在診斷的同時就可以確定, 或者它可能需要再做一些其它的檢查這些檢查可能包括影像學檢查 -- 電腦斷層掃描磁振造影超音波靜脈腎盂攝影術骨骼掃描或胸腔 X 光 2

8 三組織病理分類與分化膀胱泌尿上皮癌的病理組織分化依 2004 WHO grading 分為 : Urothelial papilloma Papillary urothelial neoplasm of low malignant potential (PUNLMP) Low-grade papillary urothelial carcinoma High-grade papillary urothelial carcinoma 3

9 四分期依據 AJCC/UICC TNM, 8th edition (2018): TNM Described TX Primary tum cannot be assessed T0 Ta Tis T1 T2 No evidence of primary tum Non-invasive papillary carcinoma Urothelial carcinoma in situ: flat tum Tum invades lamina propria (subepithelial connective tissue) Tum invades muscularis propria pt2a Tum invades superficial muscularis propria (inner half) pt2b Tum invades deep muscularis propria (outer half) T3 Tum invades perivesical soft tissue pt3a Tum invades perivesical soft tissue microscopically pt3b Tum invades perivesical soft tissue macroscopically (extravesical mass) T4 Extravesical tum directly invades any of the following: prostatic stroma, seminal vesicles, uterus, vagina, pelvic wall, abdominal wall T4a Extravesical tum invades directly into prostatic stroma, seminal vesicles, uterus, vagina T4b Extravesical tum invades pelvic wall, abdominal wall 4

10 NX Lymph nodes cannot be assessed N0 No lymph node metastasis N1 N2 N3 Single regional lymph node metastasis in the true pelvis (perivesical, obturat, internal and external iliac, sacral lymph node) Multiple regional lymph node metastasis in the true pelvis (perivesical, obturat, internal and external iliac, sacral lymph node metastasis) Lymph node metastasis to the common iliac lymph nodes M0 No distant metastasis M1 Distant metastasis Distant metastasis limited to lymph nodes beyond M1a the common iliacs M1b Non-lymph node distant metastasis When T is And N is And M is Then the stage group is Ta N0 M0 0a Tis N0 M0 0is T1 N0 M0 I T2a N0 M0 II T2b N0 M0 II T3a, T3b, T4a N0 M0 IIIA T1 - T4a N1 M0 IIIA T1 - T4a N2, N3 M0 IIIB T4b Any N M0 IVA Any T Any N M1a IVA Any T Any N M1b IVB 5

11 五膀胱癌治療指引 INITIAL DIAGNOSIS STAGING WORK-UP CLINICAL STAGE INITIAL THERAPY ADJUVANT THERAPY Ta Low grade Observation Intravesical chemotherapy High grade If incomplete resection, repeat TURBT If no muscle in specimen, strongly consider repeat TURBT BCG (preferred) Intravesical chemotherapy Observation Cystoscopy Urine cytology TURBt T1 Low grade High grade Strongly advise repeat TURBT Consider cystectomy f high grade residual disease NO residual disease BCG Cystectomy BCG (preferred) (categy 1) Intravesical chemotherapy Observation in highly selected cases Tis BCG >T2 Muscle invasive bladder cancer Metastatic, unresectable bladder cancer 6 詳見 P7

12 INITIAL DIAGNOSIS STAGING WORK-UP CLINICAL STAGE INITIAL THERAPY ADJUVANT THERAPY T2 CT scan CXR Bone scan T2 Muscle invasive bladder cancer Negative nodes Neoadjuvant cisplatin-based combination chemotherapy followed by radical cystectomy Neoadjuvant cisplatin-based combination chemotherapy followed by partial cystectomy (hight selected patients with solitary lesion in suitable location ; no Tis) Maximal TURBt with concurrent chemadiotherapy. adjuvant chemotherapy based on pathologic *risks( pt3-4, positive node, high grade(grade2-3), positive margin Reassess tum status 3 weeks after 40-45Gy 2-3 months after full dose (60-65Gy) No tum have tum Completion of definitive RT Observation Cystectomy b,y (preferred) Metastatic, unresectable bladder cancer Positive nodes Non-cystectomy candidates: concurrent chemadiotherapy. R/T TURBT and intravesical BCG Chemotherapy and radiation* Chemotherapy and/ radiation** Observation cystectomy reassess tum status 2 3 months after treatment w No tum have tum Salvage cystectomy Urinary diversion Observation if pri BCG, maintenance BCG Chemadiotherapy concurrent Chemadiotherapy (if no pri RT) Palliative TURBT and Best supptive care 7 po perfmance: ECOG 2 old age: 70 y/o

13 FOLLOW UP TREATMENT OF RECURRENCE OR PERSISTENT DISEASE Noninvasive Bladder Cancer Urine cytology and cystoscopy q3 m f2 years, then at increasing interval, Image of upper urinary tract URS,if clinical indicated Preserved bladder with local recurrence persistent Dx Invasive Noninvasive (Tis,Ta,T1) Cystectomy Chemotherapy and / radiation if no pri RT Palliative TURBt Intravesical instillation (BCG/MMC), Cystectomy Invasive Bladder Cancer Image of upper urinary tract CT f recurrence q3-6 m f 2 years In bladder sparing, Urine cytology and cystoscopy q3 m f 2 years, then at increasing interval Preserved bladder with positive urine cytology Survey of upper urinary tract Prostatic urethra Bx Nephroureterectomy with bladder cuff excision, Cystoprostatectomy Selective adj. XRT# Or CCRT* if no pri RT Postcystectomy metastatic local recurrence Chemotherapy and / Radiation* if no pri RT Metastatic Bladder Cancer Chemotherapy and / radiation if no pri RT 8

14 六膀胱癌的外科治療處置 Principles of Surgical Management TURBt: (Ta/T1) Adequate resection with muscle if papillary high-grade lesion Reresection if incomplete initial resection, no muscle in specimen large lesion TURBt: Tis Multiple random biopsies Biopsy adjacent to tum Prostate urethral biopsies TURBt: invasive Repeat resection: Any T1, any grade If no muscle in biopsy Small fragment of T2 insufficient to attribute risk Repeat TURBt should be considered if first TURBt does not allow adequate staging attribution of risk fact f treatment selection when using bladder preserving treatment by chemotherapy and/ RT SEGMENTAL ( PARTIAL ) CYSTECTOMY Solitary lesion in location amenable to partial resection with adequate margin, no Tis Pelvic lymphadenectomy may be perfmed in conjunction with the partial cystectomy RADICAL CYSTECTOMY Radical cystectomy should include bilateral node dissection at a minimum including common,internal and external iliac nodes and obturat nodes 9

15 七膀胱癌的化學及放射線治療 Principles of chemotherapy Intravesical chemotherapy f Tis,Ta 及 T1 cancer Mitomycin (Miomycin-C) 30mg qw x6 and / qm x3 Phamarubicin 30mg qw x6 and/ qm x3 BCG 81 mg qw (x6) since 2nd post-op week and/ qw (x3) since 3rd post-op month, qw (x3) since 6th post-op month, qw (x3) since 12th post-op month Intravesical chemotherapy Neoadjuvant adjuvant chemotherapy f stage II, III and non-metastatic stage IV cancer MVAC Methotrexate 30 mg/m 2 iv d1, 15 and 22 Vinblastine 3 mg/m 2 iv d2, 15 and 22 Doxubicin 30 mg/m 2 iv d2 Cisplatin 70 mg/m2 iv Carboplatin AUC 4-6 d1 2 Q4w x 3 cycles Grossman HB et al. Neuadjuvant chemotherapy plus cystectomy compared with cystectomy alone f locally advanced bladder cancer. N Eng J Med 2003; 349:859 Gemcitabine ( 自費 )+ Cisplatin (Carboplatin) Gemcitabine mg/m 2 iv d1, 8 and 15 Cisplatin 70 mg/m2 iv Carboplatin AUC 4-6 d1 Q4w x 3 cycles Von der Maase H et al. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxubicin and cisplatin in advanced metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol 2000; 18:

16 CMV Cisplatin 70 mg/m 2 iv d2 Vinblastine 4 mg/m 2 iv d1, 8 Methotrexate 30 mg/m 2 iv d1, 8 Q3w x 3 cycles Internationa Collabation of Trialists. Neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy f muscle invasive bladder cancer: a randomized controlled trial. Lancet 1999; 354:533 Concurrent chemadiation f stage II, III and non-metastatic stage IV cancer Cisplatin Cisplatin mg/m2 iv Carboplatin AUC 2 d1 Q1w x 6 cycles Tunio MA et al. Bladder preservation by neoadjuvant chemotherapy followed by concurrent chemadiation f muscle-invasive bladder cancer: experience at Sindh Institute of Urology & Transplantation (SIUT). J Pak Med Assoc 2011; 61:6. Chemotherapy f metastatic cancer Principles of systemic therapy First-line chemotherapy f locally advanced metastatic disease Standard regimens Cisplatin eligible Gemcitabine and cisplatin4 (categy 1) DDMVAC with growth fact suppt (categy 1) Cisplatin ineligible with po kidney function po PS Cisplatin ineligible due to hearing/ neuropathy but with good kidney function, and good PS Gemcitabine and carboplatin Alternate regimens f select patients Gemcitabine Gemcitabine and paclitaxel Ifosfamide, doxubicin and gemcitabine 11

17 Second-line systemic therapy f locally advanced metastatic disease Standard regimens Alternate regimens f select patients Atezolizumab Nab-paclitaxel ( 自費 ) Paclitaxel docetaxel ( 自費 ) Ifosfamide Gemcitabine Methotrexate Pemetrexed ( 自費 ) Ifosfamide, doxubicin, and gemcitabine Gemcitabine and paclitaxel ( 自費 ) Gemcitabine and cisplatin DDMVAC MVAC Methotrexate 30 mg/m 2 iv d1, 15 and 22 Vinblastine 3 mg/m 2 iv d2, 15 and 22 Doxubicin 30 mg/m 2 iv d2 Cisplatin 70 mg/m2 iv Carboplatin AUC 4-6 d1 2 Q4w x 6 cycles Han KS et al. Methotrexate, vinblastine, doxubicin and cisplatin combination regimen as salvage chemotherapy f patients with advanced metastatic transitional cell carcinoma after failure of gemcitabine and cisplatin chemotherapy. Br J Cancer 2008; 98:86. Logothetis CJ et al. A prospective randomized trial comparing MVAC with CISCA chemotherapy f patients with metastatic urothelial tums. J Clin Oncol 1990; 8:1050. Gemcitabine + Cisplatin(Carboplatin) Gemcitabine mg/m 2 iv d1, 8 and 15 Cisplatin 70 mg/m 2 iv d2 Q4w x 6 cycles von der Maase H et al. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxubicin and cisplatin in advanced metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol 2000; 18:3068 Paclitaxel +/- Cisplatin(Carboplatin) Paclitaxel 80 mg/m 2 iv d1, 8, 15 Cisplatin 70 mg/m2 iv Carboplatin AUC 4-6 d1 Q4w x 6 cycles von der Maase H et al. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxubicin and cisplatin in advanced metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol 2000; 18:

18 Principles of radiation Selective adjuvant radiotherapy # If margin positive/residual LN positive,dose of 50~70Gy depends on the tum position and the patient condition Definitive radiotherapy * 60~70Gy,depended on the tum position and the patient status. Palliative radiotherapy ** 20~40Gy,depended on the disease condition and the patient status. 13

19 八安寧緩和照護原則若預期疾病難以治癒時, 病人存活期小於 6 個月便適合安寧療護 (Pomeranz & Brustman, 2005;Waldrop & Rinfrette, 2009) 若藉由症狀檢驗數據及確切的腫瘤診斷, 證實臨床上該惡性腫瘤已經廣泛侵犯或進展快速 ; 功能分數 (Palliative Perfmance Scale) 低於 70%; 拒絕進一步腫瘤治癒性治療, 或者在治療之下仍持續惡化者, 即可轉介緩和醫療團隊 ( 彭等,2006) 九參考文獻 1. 衛生福利部國民健康屬 (Health Promotion Administration,Ministry of Health and Welfare): 中華民國 104 年癌症登記報告 2. 林口長庚泌尿科 ( 6/files/12d6c8b560a6c28631e8c64d360b html) 3. van der Meijden A, Oosterlinck W, Brausi M, Kurth KH, Sylvester R, de Balincourt C. Significance of bladder biopsies in Ta,T1 bladder tums: a rept of the EORTC Genito-Urinary Tract Cancer Cooperative Group. EORTC-GU Group Superficial Bladder Committee. Eur Urol 1999 Apr;35(4): Sylvester RJ, Oosterlinck W, van der Meijden AP. A single immediate postoperative instillation of chemotherapy decreases the risk of recurrence in patients with stage Ta T1 bladder cancer: a metaanalysis of published results of randomized clinical trials. J Urol 2004 Jun;171(6 Pt 1): Miller DC, Taub DA, Dunn RL, Montie JE, Wei JT. The impact of co-mbid disease on cancer control and survival following radical cystectomy. J Urol 2003 Jan;169(1): Stenzl A, Nagele U, Kuczyk M, Sievert K, Anastasiadis A, Seibold J, Cvin S. Cystectomy Technical Considerations in Male and Female Patients. EAU Update Series 2005;3: NCCN Clinical Practice Guidelines in Oncology Bladder Cancer.Version Grossman HB et al. Neuadjuvant chemotherapy plus cystectomy compared with cystectomy alone f locally advanced bladder cancer. N Eng J Med 2003; 349: Von der Maase H et al. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxubicin and cisplatin in advanced metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol 2000; 18:

20 10. Tunio MA et al. Bladder preservation by neoadjuvant chemotherapy followed by concurrent chemadiation f muscle-invasive bladder cancer: experience at Sindh Institute of Urology & Transplantation (SIUT). J Pak Med Assoc 2011; 61: Han KS et al. Methotrexate, vinblastine, doxubicin and cisplatin combination regimen as salvage chemotherapy f patients with advanced metastatic transitional cell carcinoma after failure of gemcitabine and cisplatin chemotherapy. Br J Cancer 2008; 98: Logothetis CJ et al. A prospective randomized trial comparing MVAC with CISCA chemotherapy f patients with metastatic urothelial tums. J Clin Oncol 1990; 8: NCCN Clinical Practice Guidelines in Oncology Bladder Cancer.Version NCCN Clinical Practice Guidelines in Oncology Bladder Cancer.Version

21 十膀胱癌 Stage IV 完治率定義 1. STAGE IV 接受化療一次 2. STAGE IV 接受放射治療一個療程 3. STAGE IV 接受安寧緩和 16

攝護腺癌抗癌藥物治療指 Men with High-Volume, ADT-naïve, Metastatic Disease Docetaxel without Prednisolone with ADT 參考文獻 1, 2 Docetaxel 參考文獻 2, 3 Docetaxel

泌尿道癌抗癌藥物治療指討論日期團隊討論 : 105 年 10 月 20 日三院討論 : 105 年 12 月 7 日團隊確認 : 106 年 2 月 9 日核備日期 : 106 年月 18 日攝護腺癌抗癌藥物治療指 Men with High-Volume, ADT-naïve, Metastatic Disease Docetaxel without Prednisolone with