前言膀胱是肌肉性囊狀結構, 上接來自兩側腎臟的輸尿管, 收集腎臟排出的尿液, 暫時貯積起來, 其量約為 200~300 毫升, 即可生產強烈尿意, 但可隨各種精神狀況及疾病而變化在各種人類癌症中, 膀胱癌與肺癌一樣, 是少數幾種發病率逐漸增加的癌症最主要的原因可能與工業產物及人工色素有關在苯

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1 膀胱癌診療指引泌尿道癌多專科團隊擬定修訂檢視修訂修訂修訂修訂修訂修訂修訂 1

2 前言膀胱是肌肉性囊狀結構, 上接來自兩側腎臟的輸尿管, 收集腎臟排出的尿液, 暫時貯積起來, 其量約為 200~300 毫升, 即可生產強烈尿意, 但可隨各種精神狀況及疾病而變化在各種人類癌症中, 膀胱癌與肺癌一樣, 是少數幾種發病率逐漸增加的癌症最主要的原因可能與工業產物及人工色素有關在苯胺色素工廠工作的工人, 其發病率為平常人的 30 倍高, 各工業先進國家中不乏此類報告吸菸的人得病的機會也遠比不吸菸者高患膀胱癌的病人尿中含色氨代謝物的量, 據報告比正常人高, 這些因素都可能與膀胱癌有關根據 106 年 12 月底國民健康署公布的癌症年報統計, 民國 104 年膀胱惡性腫瘤發生個案數占全部惡性腫瘤發生個案數的 2.07%, 當年因此惡性腫瘤死亡人數占全部惡性腫瘤死亡人數的 1.93% 發生率的排名於男性為第 10 位女性為第 16 位 ; 死亡率的排行於男性為第 12 位女性為第 15 位民國 104 年初次診斷為膀胱惡性腫瘤者共計 2,177 人, 占泌尿器官個案數的 43.19%; 當年死因為膀胱惡性腫瘤者共計 902 人膀胱癌的最主要症狀是血尿, 特別是無痛性的血尿約 80% 的膀胱癌病人皆因血尿出現始接受檢查, 血尿可以持續或反覆發生如果年紀較大的人發現這種症狀, 首先一定要考慮膀胱癌的可能性, 一定要請泌尿科醫師檢查, 早期診斷和早期治療是應付癌症最好對策, 祇要大家提高警覺, 充分與醫師合作, 雖然膀胱癌可怕但一定會有滿意的治療效果本院自民國 97 年召集相關次專科制定膀胱癌治療指引, 並於民國 99 年藉由多專科醫師參與團隊會議共同討論的機制, 參酌 NCCN 指引及國內外相關文獻, 進行指引改版, 以期更貼近國內民情及國際膀胱癌診療潮流 2

3 膀胱癌診療指引修訂紀錄版本生效日期文件制定記錄新訂定未修定依據 NCCN 2010 Bladder cancer treatment guideline 重新修訂未修定依據 NCCN 2011 Bladder cancer treatment guideline 重新修訂檢查 Bone scan 修改為 Bone scan(option) Systemic chemotherapy 3 cycles then CT or MRI ± cystoscopy 治療前 ± Radical TURBT 依據 NCCN 2015 Bladder cancer treatment guideline 重新修訂 2.Bone scan(option) 修改為 (option, if ALP abnormal) 3.Ta, low grade F/U 修改為 Cystoscopy on Q3-6 mons. Increase Interval by Dr. Upper tract image Q1yr. 4.T2, T3, T4aN0M0 之治療 Radical TUR-BT± Systemic chemotherapy 3cycles 再增加 ± R/T 的治療 5.T4b, N1-3, M1 增加 R/T 的治療 3

4 版本生效日期文件制定記錄檢視未修訂 1. 依據 Bladder cancer treatment guideline NCCN Guideline Version 重新修訂 2. 將 Birth place 改 Residency 3.Any Tis 往前移至 TUR-BT 之後, 追蹤改 (1) Cystoscopy + Urine cytology Q3-6 mo for2yr then increase intervals by Dr. (2)Upper tract imaging Q1-2yr if failed, cystectomy or changed intravesical agents. 4.Ta, low grade 之治療 induction intravesical C/T, 追蹤 Upper tract image Q1-2yr; Urinalysis & cytology Q1yr ( 改 optional) 5.Ta, high grade 之治療及追蹤改與 T1 一致, 但不需考慮 Radical cystectomy 6.Radical TUR-BT ± Systemic chemotherapy 3 cycles ± R/T then CT or MRI ± cystoscopy 改 Maximal TUR-BT + CCRT 7.Trimodality 改 Maximal TUR-BT + CCRT 8.T4b, N1-3, M1 之治療 (1)Systemic Chemotherapy 加 CCRT Ta 及 T1 治療路徑之 Intravesical BCG or C/T, 於 C/T 前加上 Intravesical;Consider Cystectomy(for high grade), 於 for high grade 加上 or residual tumor 4

5 目錄一膀胱癌診療指引流程圖二診斷共識三治療共識四追蹤共識五膀胱癌院內通用抗癌藥物處方六參考資料

6 一膀胱癌診療指引流程圖 Bladder cancer 初版日期 :97.11 更新版日期 : WORKUP ADJUVANT TREATMENT(INTRAVESICAL) FOLLOW-UP IVP upper tract image( 註一 ) Cytology (option) Cystoscopy CXR, Abd/pelvis CT or MRI Bone scan (option, if ALP abnormal) Ta, low grade Ta, high grade or observation or single does MMC 30mg in 24 hours and/or induction intravesical C/T uncertain complete resection: No muscle in specimen Inadequate staging Cystoscopy at Q3-6 mons Increase Interval by Dr Upper tract image Q1-2 yr Urinalysis & cytology Q1yr (Option) Re do TUR-BT if muscle invasion then as invasive type recurrence Intravesical BCG (preferred) or Intravesical C/T or Observation Re stage Hematuria or irritable Voiding Any abnormal in test results Transurethral resection of bladder tumor (TUR-BT) Papillary or solid T1, low grade T1, high grade uncertain complete resection: No muscle in specimen Inadequate staging Re do TUR-BT if muscle invasion then as invasive type Completely resected 1. intravesical BCG (preterred) or Intravesical C/T (induction ) 2. Consider radical cystectomy (for high grade or residual tumor) History: Smoking, Chinese herb use, Residency place, Occupation, Physical examination any Tis BCG 1. Cystoscopy + urine cytology Q3-6mo for 2 yr then increase intervals by Dr.) 2. upper tract imaging Q1-2 yr if failed, Cystectomy or changed intravesical agents 註一 :upper tract image include CT urography or renal ultrasoung or retrograde pyelogram or MRI urogram 參考資料來源 : 1. V NCCN Bladder cancer Guidelines ALP: Alikaline phosphatase 鹼性磷酸酶 1 6

7 Bladder cancer 初版日期 :97.11 更新版日期 : WORKUP ADJUVANT TREATMENT(INTRAVESICAL) FOLLOW-UP Definitive treatment Radical cystectomy consider neoadjuvant chemotherapy Maximal TUR-BT + CCRT PR.SD.PD CR After aradical cystectomy urine cytology, creatinine, electrolytes, every 3-6 month for 2 yrs and then as clinically indicated imaging of the chest abdomen, and pelvic every 3-12 months for 2 yrs based on risk of recurrence and then as clinically indicated urthral wash cytology, every 6-12 months, particularly if Tis was found within the bladder or prostatic urethr if a continent diversion was created, monitor for VitB12 deficiency annually for Maximal TUR-BT + CCRT cystoscopy, urine cytology and CXR q3m,ct or MRI q 6 months No recurrence Recurrence No recurrence Recurrence Observation Systemic chemotherapy, CCRT F/U T2,T3,T4a, N0,M0 partial cystectomy (highly selected patients with solitary lesion in a suitable location; no Tis and consider neoadjuvant cisplatinbased combination chemotherpay After a partial cystectomy same follow-up as above, in addition to the followind; serial cytologic (optional) examnations and cystoscopies at 3-6 months intervals to monitor for relaspe in the bladder Re stage Systemic chemotherapy, Radical cystectomy Non-muscle invasive Muscle-invasive recurrence Metastasis for patients with extensive comorbid disease or poor performance status: TUR-BT alone or RT or Concurrant chemotherapy T4b,N1-3,M1 1.Systemic Chemotherapy, CCRT 2. consider radical cystectomy after systemic chemoterapy in selected casese ( <T4a and N1-2 cases without distant metastais, and feasible for LN dissection) 3.R/T TUR-BT + IVT Radical cystectomy Systemic C/T 參考資料來源 : 1. V NCCN Bladder cancer Guidelines 2 7

8 二診斷共識 1. 病史評估 : 抽菸史居住地職業中藥服用生理評估 2. 表淺性 (Ta T1) 膀胱癌行膀胱腫瘤刮除後, 依情況決定是否需要行 Bone Scan, 針對 Clinical N 及 Clinical M 以 chest X-ray 及 abd/ pelvis CT or MRI 和臨床依據及症狀推估判定 3. 侵犯肌肉層 (T2 以上 ) 膀胱癌須執行 Bone Scan 4. TNM 分期採用 AJCC 8th edition 2018 年版 8

9 三治療共識 1. 臨床分期第 0 1 期 (cta-1n0m0) 以 TUR-BT±IVC(Intravesical Chemotherapy, 膀胱內化學藥物灌注 ) 為主要治療模式, 若為 Ta 或 low grade, 亦可直接追蹤 2. 臨床分期第 2 3 期 ( ct2-4an0m0) 可先 Radical cystectomy consider neoadjuvant C/T, Maximal TUR-BT + CCRT,Partial cystectomy; 若 poor performance or extensive comorbid, 則治療為 TUR-BT alone or RT or Concurrant chemotherapy 3. 臨床分期第四期 (ct4b,n1-3,m1):systemic Chemotherapy, CCRT, RT 9

10 四追蹤共識 1.Tis 追蹤 :cystoscopy + Urine cytology Q3-6 mo for2yr then increase intervals by Dr; Upper tract imaging Q1-2yr if failed, cystectomy or changed intravesical agents 2.Stage 0~I 追蹤 (TUR-BT+IVC): 前兩年每 3-6 個月追蹤 cystoscopy, 之後每 1-2 年 Upper tract imaging; Urinalysis & cytology 每年 ( 視情況 ) 3. Stage II~III(cT2-4aN0M0) 追蹤 : 手術前 2 年每 3-6 個月追蹤 10

11 五膀胱癌院內通用抗癌藥物處方最初出版日期 :99.01 最後更新日期 : 癌別 : 膀胱癌 CCRT Neoadjuvant & Adjuvant Palliative 最近改版日期 (1) Cisplatin 30 mg/m 2 (N/S 500 c.c.; 3hrs) / wk (JCO Nov.1996 pp ) 處方內容 (2) 5-FU 600 mg/m 2 / wk (N/S 500 c.c.; 3hrs) / wk (JCO Nov.1993 pp ) 最近改版日期 (1)Cisplatin 60 mg/m 2 (N/S 500 c.c.; 4hrs) q 4 wks + Gemcitabine 1000 mg/m 2 (N/S 100 c.c.; 30 mins) q 2 wks (JCO Sep.2000 pp ) 處方內容 (2)Cisplatin 60 mg/m 2 + MTX 100 mg/m 2 (N/S 100 c.c.; 1hr) + Oncovin 2mg (N/S 100c.c.; 30 mins)+ Epirubicin 50 mg/m 2 (N/S 100 c.c.; 30 mins) q 4 wks (JCO : ) 最近改版日期處方內容 (1)Cisplatin 60 mg/m 2 (N/S 500 c.c.; 4hrs) q 4 wks + Gemcitabine 1000 mg/m 2 (N/S 100 c.c.; 30 mins) q 2 wks (2)Cisplatin 60 mg/m 2 + MTX 100 mg/m 2 (N/S 100 c.c.; 1hr) + Oncovin 2mg (N/S 100c.c.; 30 mins)+ Epirubicin 50 mg/m 2 (N/S 100 c.c.; 30 mins) q 4 wks 亦可考慮下列藥物 : *Bleomyin 8 mg / m 2 q 3-4 wks (JAMA 1976; 235(9) : ) *Docetaxel 35,40 mg / m 2 q 2 wks (Oncology Jun.01, 2002) *Paclitaxel 85 mg / m 2 q 2 wks (Br J Cancer 1997; 75(4): ) *Pemetrexed 500 mg/m 2 q 3-4 wks (Oncology Nov.2, 2004) *Ifosfamide 2 g/ m 2 /d 3-5days q 4 wks (Semin Oncol 1996 Jun; 23 (3Supp1 6) :50-5) 11

12 六參考資料 ( 一 ) 診療指引參考文獻 1. National Comprehensive Cancer Network [NCCN]. Clinical practice guidelines in oncology: bladder cancer v ( 二 ) 抗癌藥物處方參考文獻 1. JCO Nov.1996 pp JCO Nov.1993 pp JCO Sep.2000 pp JCO : JAMA 1976; 235(9) : Oncology Jun.01, Br J Cancer 1997; 75(4): Oncology Nov.2, Semin Oncol 1996 Jun; 23 (3Supp1 6) : Roberts JT, von der MH, Sengelov L et al. Long-term survival results of a randomized trial comparing gemcitabine/cisplatin and methotrexate/vinblastine/doxorubicin/cisplatin in patients with locally advanced and metastatic bladder cancer. Ann Oncol 2006;17 Suppl 5:v118-v James ND, Hussain SA, Hall E et al. Radiotherapy with or without chemotherapy in muscle-invasive bladder cancer. N Engl J Med 2012;366(16): Vogelzang NJ, Stadler WM. Gemcitabine and other new chemotherapeutic agents for the treatment of metastatic bladder cancer. Urology 1999;53(2): Kaufman D, Raghavan D, Carducci M et al. Phase II trial of gemcitabine plus cisplatin in patients with metastatic urothelial cancer. J Clin Oncol 2000;18(9): Roth BJ. The role of paclitaxel in the therapy of bladder cancer. Semin Oncol 1995;22(5 Suppl 12): Sweeney CJ, Roth BJ, Kabbinavar FF et al. Phase II study of pemetrexed for second-line treatment of transitional cell cancer of the urothelium. J Clin Oncol 2006;24(21): Roth BJ. Ifosfamide in the treatment of bladder cancer. Semin Oncol 1996;23(3 Suppl 6):

2013

2013 膀胱癌診療指引泌尿道癌多專科團隊擬定 2010.01.21 修訂 2011.02.17 檢視 2012.03.29 修訂 2013.05.16 修訂前言膀胱是肌肉性囊狀結構, 上接來自兩側腎臟的輸尿管, 收集腎臟排出的尿液, 暫時貯積起來, 其量約為 200~300 毫升, 即可生產強烈尿意, 但可隨各種精神狀況及疾病而變化在各種人類癌症中, 膀胱癌與肺癌一樣, 是少數幾種發病率逐漸增加的癌症