修訂原則參與修訂科別 : 泌尿外科腫瘤治療科放射診斷科病理科血液腫瘤科診療指引需符合以下原則 : 一依據實證醫學精神, 並於指引中註明主要參考文獻 ( 至少為 peer review article), 若引用醫院之資料庫資料, 則需提供分析及討論紀錄二參酌國情並經院內共識討論,

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1 膀胱癌診療指引 2011 年 05 月 11 日一修 2012 年 02 月 15 日二修 2013 年 02 月 20 日三修泌尿道癌醫療團隊共同修訂

2 修訂原則參與修訂科別 : 泌尿外科腫瘤治療科放射診斷科病理科血液腫瘤科診療指引需符合以下原則 : 一依據實證醫學精神, 並於指引中註明主要參考文獻 ( 至少為 peer review article), 若引用醫院之資料庫資料, 則需提供分析及討論紀錄二參酌國情並經院內共識討論, 且有相關會議紀錄佐證三定期檢視改版 ( 至少每年一次, 且明確標示制訂或修訂日期 ) 四團隊共識後所訂之指引, 應提送癌委會核備後公告

3 圖一臨床診斷膀胱鏡發現 Staging work up ( 視臨床所需 ) 初步評估及手術治療臨床分期最初治療後續追蹤無任何侵犯 ± 病理檢查 ± 腎盂攝影 ± 逆行性腎盂攝影 ± 腎臟超音波 ± 骨盆腔電腦斷層 ± 骨盆腔核磁共振 ± 病理檢查 ± 腎盂攝影 ± 逆行性腎盂攝影 ± 腎臟超音波胸部 X 光 ± 骨盆腔電腦斷層 Ta-low grade Ta-high grade T1-low grade T1-high grade 膀胱鏡或腎盂攝影侵犯至肌肉層或細胞學檢查 ± 骨盆腔核磁共振 ( 疑似 TCC) T4b ± 血液生化檢查 ± 內視鏡腫瘤刮除如有症狀加做骨頭掃描內視鏡腫瘤刮除, 病理檢查若分級較高或原位癌之患者, 考慮切片或前列腺尿道切片檢查 Tis T2/T3,T4a No residual Residual BCG x q6months MMC 或觀察 BCG/MMC 或觀察 BCG/MMC 或重複 TURBT 或膀胱全切除或 R/T±C/T 圖 2 膀胱鏡 ±Biopsy / 尿液細胞學每 3 個月一次 ( 共做兩年 ), 之後每 6 個月一次 ( 共做兩年 ), 後每年一次腎盂攝影每年一次腎臟超音波每年一次轉移 ± 胸部電腦斷層 ± 腹部 / 骨盆腔電腦斷層或核磁共振 ± 心電圖 ± 內視鏡腫瘤刮除 ± 骨頭掃描轉移圖 3

4 圖二分期主要治療輔助治療 ct2 ct3 ct4a 無淋巴轉移 CT/MRI 有淋巴轉移無淋巴轉移 CT/MRI 有淋巴轉移膀胱全切除 ± 術前輔助性化療 ( 建議 ) 膀胱部分切除 (Highly selective) ± 術前輔助性化療 ( 建議 ) 選擇內視鏡腫瘤刮除視腫瘤對化學治療或 * 放射治療的反應 ( 若選擇先使用化學治療或放射治療 ) R/T+C/T( 建議 ) or C/T 病患併有其他疾病或心肺功能不佳, 則單獨選擇內視鏡腫瘤刮除術或化學治療或合併放射治療見圖三 ( 有 Lympho node metastasis) 膀胱全切除 ± 術前輔助性化療 ( 建議 ) 選擇膀胱保留, 則視腫瘤對化學治療或 * 合併放射治療的反應選擇內視鏡腫瘤刮除術 +C/T+R/T ( 建議 ) 病患併有其他疾病或心肺功能不佳, 則單獨選擇內視鏡腫瘤刮除術或化學治療或合併放射治療見圖三 ( 有 Lympho node metastasis) 如前項無加術前輔助治療考慮術後化學治療或放射治療 (pt3-t4 或有淋巴結 ) 考慮化學治療或放射治療 (Adjuvant R/T) ( 病理報告結果 :pt3-t4 有淋巴結手術邊緣陽性及高惡性度 ) 重新評估腫瘤情形高風險考慮術後輔助性化學治療重新評估腫瘤情形仍有腫瘤 : 1. 可切除者, 則做膀胱全切除 2. 無法手術者, Chemoradiation ±C/T 沒腫瘤 : 1. 觀察 2. 完整放射治療 (66Gy) 3. 考慮化學治療仍有腫瘤 : 1. 可手術者, 則做膀胱全切除 2. 無法手術者,Chemoradiation± C/T 沒腫瘤 : 1. 觀察 2. 完整放射治療 (66Gy) 3. 化學治療圖四 * 註 : 40-45Gy 3weak 後或 60-65Gy 2-3 月後

5 圖三分期主要治療輔助治療 ct4b 轉移 CT/ MRI CT or MRI Bone scan 無淋巴結有淋巴結只有淋巴結轉移多發瀰漫性轉移化學治療 ± 放射線治療化學治療或化學治療 + 放射線治療化學治療化學治療 2-3 次做膀胱鏡及電腦斷層或核磁共振 TURBT and 有反應無反應有反應 ( 無殘留腫瘤 ) 無反應 ( 有殘留腫瘤 ) 化學治療 ± 放射線治療姑息性放射線治療化學治療 (UB-1-1 or UB-1-2 or UB-1-3) ± 放射線治療或膀胱切除後線化學治療 (UB-1-1 or UB-1-2 or UB-1-3) ± 放射線治療或更改化學治療藥物或膀胱全切除安寧緩和

6 圖四 : 追蹤侵犯肌肉層之腫瘤 (stage T2-T4) 追蹤復發復發後治療 Electrolyte, urine cytology LFT/RFT/CXR 每 6-12 月 IVP/RE 每 6-12 月上泌尿道腹部骨盆影像檢查每 3-6 個月共 2 年, 再追蹤保留膀胱之局部復發侵犯性復發 Tis/Ta/T1 膀胱全切除或化學治療 (UB-1-1 or UB-1-2 or UB-1-3) 或放射線治療或內視鏡腫瘤刮除卡介苗灌注 Or cystectomy 無效膀胱全切除假如保留膀胱 FCS+cytology ± Biopsy 每 3-6 月 ( 共做 2 年 ) 而後增加檢查間距如果膀胱造口 + 經皮尿液分流, 則需自尿留細胞學檢查每 6-12 月一次保留膀胱細胞學檢查陽性但膀胱鏡及切片為陰性上泌尿道檢查 + 前列腺尿道切片上泌尿道檢查 (+) 前列腺尿道切片見輸尿管治療指引見攝護腺泌尿上皮癌治療指引如果膀胱全切除, 尿液細胞學檢查每 6-12 月一次如果膀胱全切除 + 骨轉移每年需補充維他命 B12 轉移或膀胱全切除術後局部復發化學治療 (UB-1-1 or UB-1-2 or UB-1-3) +/- 放射線治療或單獨放射線治療安寧緩和註 : 目前 BCG 缺貨, 供應中斷, 以 MMC 代替 BCG 使用, 做為膀胱灌注用藥 *FCS= 膀胱境 Biopsy= 切片 MMC= 膀胱內 mitomycin C 灌注 IVP= 腎盂攝影 LFT= 肝功能檢查 CXR= 胸部 X 光 RE= 腎臟超音波 RFT= 腎功能檢查 CT= 電腦斷層檢查 Cytology= 細胞學檢查 BCG= 膀胱內卡介苗灌注 CIS= 原位癌

7 膀胱癌化療處方 Chemotherapy regimen 治療目的組套編碼處方內容 CCRT UBRT-1 Cisplatin + Fluorouracil Cisplatin 20 mg/m 2 /day IV over 4 hour,days 1 to 5 Fluorouracil 375 mg/m 2 /day IV continuous infusion 24 hours, days 1-5 During wk 1 and 5 of XRT UBRT-2 Weekly Gemcitabine 27 Gemcitabine 1000mg/m 2 IV over 30 min, days 1,8,15,22,29,36 weekly * 6 cycles UBRT-3 Weekly Cisplatin 26 Cisplatin 30 mg/m 2 IV over 4 hour, days 1,8,15,22,29,36 weekly * 6 cycles UBRT-4 Weekly Carboplatin 26 Carboplatin AUC 2 IV over 90 min, days 1,8,15,22,29,36 weekly * 6 cycles UBRT-5 Mitomycin-C + Fluorouracil 25 Mitomycin-C 12mg/m 2 IV bolus over 10 min, day 1 Fluorouracil 500mg/m 2 /day IV continuous infusion 24 hours, days 1-5 & 16-20

8 膀胱癌化療處方 Chemotherapy regimen 治療目的組套編碼處方內容 Neo-adjuvant Adjuvant Metastasis UBNAP1 CG regimen 1 (v) Gemcitabine 1000mg/m 2 IV over 30 minutes, days 1,8,15 Cisplatin 70mg/m 2 IV over 6 hours, day 2 Repeat every 28 days UBNAP2 UBNAP3 MVAC 1 (v) Methotrexate 30 mg/m 2 IV over 15 minutes, days 1, 15, 22 Vinblastine 3 mg/m 2 IV over 10 minutes, days 2, 15, 22 Doxorubicin 30 mg/m 2 IV over 10 minutes, day 2 Cisplatin 70 mg/m 2 IV over 6 hours, day 2 Repeat every 28 days TC regimen 2 (v) Paclitaxel 225 mg/m 2 IV over 3 hours, day 1 Carboplatin AUC=6x(GFR+25) IV over 90 minutes, day 1 Repeat every 21 days With GCSF support ; UBNAP4 CMV regimen,q3w 23 Methotrexate 30 mg/m 2 IV bolus, days 1,8 Vinblastine 4 mg/m 2 IV bolus, days 1,8 Cisplatin 100mg/m 2 IV over 6 hour, day 2 Folinic acid 15mg (oral or IV) Q6H x 4 doses, 24hrs after MTX on D2-9 Repeat every 21 days

9 Radiation therapy Treatment type RT technique Total dose Fraction size / # Fractions Neoadjuvant RT T3b or T4 Adjuvant CT Radical radiotherapy (post TURBT) T2-T4 Conventionally Fractionated RT Conventionally Fractionated RT Conventionally Fractionated RT 45-50Gy to UB 45Gy to UB (or pelvic node) 55-60Gy to tumor bed (sparing small intestine) 45Gy to pelvic node 50.4Gy to UB 60-66Gy to primary tumor 1.8-2Gy/ fraction 1.8-2Gy/ fraction 1.8-2Gy/ fraction Note Indications: (1)Extravesicle disease (2)Postive surgical margin (3)Postive pelvic lymph node (4)Locally advanced disease(t3-t4) (5)High grade tumors 註 : 實際治療分次劑量總治療次數, 應與處方劑量差異在 ±1Gy 內註 : 放射治療詳細流程清參照膀胱癌放射治療標準政策與執行規範

10 膀胱癌 Reference 1.Von der Maase H, Hansen SW, Roberts JT, et al. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol. 2000;18: Vaughn DJ, Malkowicz SB, Zoltick B, et al. Paclitaxel plus carboplatin in advanced carcinoma of the urothelium: an active and tolerable outpatient regimen. J Clin Oncol. 1998;16: Poortmans PM, Richaud P, Collette L, et al. Results of the phase II EORTC trial evaluating combined accelerated external radiation and chemotherapy with 5FU and cisplatin in patients with muscle invasive transitional cell carcinoma of the bladder. Acta Oncol. 2008;47: NCCN Clinical Practice Guidelines in Oncology Bladder cancer, Version NCCN Clinical Practice Guidelines in Oncology Bladder cancer, Version Whitmore Jr WF, Batata MA, Ghoneim MA, et al: Radical cystectomy with or without prior irradiation in the treatment of bladder cancer. J Urol 1977; 118: Shipley WU, Cummings KB, Coombs LJ, et al: 4,000 RAD preoperative irradiation followed by prompt radical cystectomy for invasive bladder carcinoma. A prospective study of patient tolerance and pathologic downstaging. J Urol 1982; 127: Zaghloul M, Awaad H, Akoush H, et al: Post-operative radiotherapy of carcinoma in bilharzial bladder. Improved disease free survival through improving local control. Int J Radiat Oncol Biol Phys 1992; 23: Reisinger SA, Mohuiddin M, Mulholland SG: Combined pre- and post-operative adjuvant radiation therapy for bladder cancer a ten-year experience. Int J Radiat Oncol Biol Phys 1992; 24: Duncan W, Quilty PM: The results of a series of 963 patients with transitional cell carcinoma of the urinary bladder primarily treated by radical megavoltage x-ray therapy. Radiother Oncol 1986; 7: Blandy JP, Jenkins BJ, Fowler CG, et al: Radical radiotherapy and salvage cystectomy for T2/3 cancer of the bladder. Prog Clin Biol Res 1988; 260:

11 膀胱癌 Reference 12.Jenkins BJ, Caulfield MJ, Fowler CG, et al: Reappraisal of the role of radical radiotherapy and salvage cystectomy in the treatment of invasive (T2/T3) bladder cancer. Br J Urol 1988; 62: Greven KM, Solin LJ, Hanks GE, et al: Prognostic factors in patients with bladder carcinoma treated with definitive irradiation. Cancer 1990; 65: Smaaland R, Akslen L, Tonder B, et al: Radical radiation treatment of invasive and locally advanced bladder cancer in elderly patients. Br J Urol 1991; 67: Gospodarowicz MK, Rider WD, Keen CW, et al: Bladder cancer. Long term follow-up results of patients treated with radical radiation. Clin Oncol 1991; 3: Jahnson S, Pedersen J, Westman G, et al: Bladder carcinoma a 20-year review of radical irradiation therapy. Radiother Oncol 1991; 22: Pollack A, Zagars GK, Swanson DA: Muscle-invasive bladder cancer treated with external beam radiotherapy. Prognostic factors. Int J Radiat Oncol Biol Phys 1994; 30: Moonen L van der Voet H, de Nijs R, et al: Muscle-invasive bladder cancer treated with external beam radiotherapy. Pretreatment prognostic factors and the predictive value of cystoscpic re-evaluation during treatment. Radiother Oncol 1998; 49: Quilty PM, Duncan W, Chisholm GD, et al: Results of surgery following radical radiotherapy for invasive bladder cancer. Br. J Urol 1986; 58: Davidson SE, Symonds RP, Snee MP, et al: Assessment of factors influencing the outcome of radiotherapy for bladder cancer.br J Urol 1990; 66: Borgaonkar S, Jain A, Bollina P, et al: Radical radiotherapy and salvage cystectomy as the primary management of transitional cell carcinoma of the bladder. Results following the introduction of a CT planning technique. Clin Oncol 2002; 14:

12 膀胱癌 Reference 22.Mameghan H, Fisher R, Mameghan J, et al: Analysis of failure following definitive radiotherapy for invasive transitional cell carcinoma of the bladder. Int J Radiat Oncol Biol Phys 1995; 31: JCO.June 1,2011;29(16): NCCN Clinical Practice Guidelines in Oncology Bladder cancer, Version James ND, Hussain SA, Hall E,et al. Radiotherapy with or without chemotherapy in muscle-invasive bladder cancer. N Engl J Med 2012;366: George L, Bladou F, Bardou VJ,Clinical outcome in patients with locally advanced bladder carcinoma treated with conservative multimodality therapy.urology Sep;64(3): Tunio MA, Hashmi A, Rafi M, Bladder preservation by neoadjuvant chemotherapy followed by concurrent chemoradiation for muscle-invasive bladder cancer: experience at Sindh Institute of Urology & Transplantation (SIUT).J Pak Med Association Jan;61(1): Perez and Braddy s Principle and Practice of Radiation Oncology, Fifth Edition. 29.Efstathiou JA, Spiegel DY, Shipley WU, et al. Long-term outcomes of selective bladder preservation by combined-modality therapy for invasive bladder cancer: the MGH experience. Eur Urol 2012;61: Zapatero A, Martin De Vidales C, Arellano R, et al. Long-term Results of Two Prospective Bladder-sparing Trimodality Approaches for Invasive Bladder Cancer: Neoadjuvant Chemotherapy and Concurrent Radio-chemotherapy. Urology James ND, Hussain SA, Hall E, et al. Radiotherapy with or without chemotherapy in muscle-invasive bladder cancer. N Engl J Med 2012;366:

膀胱癌指引修訂.doc

膀胱癌指引修訂.doc 膀胱癌診療指引 2010 年 07 月 13 日制定 2011 年 05 月 11 日一修 2012 年 02 月 15 日二修泌尿道癌醫療團隊共同修訂 1 修訂原則參與修訂科別 : 泌尿科腫瘤科放射科核子醫學科病理科血液腫瘤科診療指引需符合以下原則 : 一依據實證醫學精神, 並於指引中註明主要參考文獻 ( 至少為 peer review article), 若引用醫院之資料庫資料,