【AUA指南】非肌层浸润性膀胱癌的诊断与治疗

Diagnosis and treatment of non-muscle invasive bladder cancer

Guideline Statements

指 南 荟 萃

Diagnosis

诊断

1. At the time of resection of suspected bladder cancer, a clinician should perform a thorough cystoscopic examination of a patient’s entire urethra and bladder that evaluates and documents tumor size, location, configuration, number, and mucosal abnormalities. (Clinical Principle)

1. 在疑似膀胱癌进行诊断性切除时，临床医生应对患者的整个膀胱和尿道进行彻底的膀胱镜检查，评估并记录肿瘤大小、位置、形态、数量和粘膜异常。（临床原则）

2. At initial diagnosis of a patient with bladder cancer, a clinician should perform complete visual resection of the bladder tumor(s), when technically feasible. (Clinical Principle)

2. 在对膀胱癌患者进行初步诊断时，在技术可行的情况下，临床医生应将肉眼可见的膀胱肿瘤进行完全的切除。（临床原则）

3. A clinician should perform upper urinary tract imaging as a component of the initial evaluation of a patient with bladder cancer. (Clinical Principle)

3. 临床医生应该将上尿路影像检查作为膀胱癌患者初步评估的一部分。（临床原则）

4. In a patient with a history of NMIBC with normal cystoscopy and positive cytology, a clinician should consider prostatic urethral biopsies and upper tract imaging, as well as enhanced cystoscopic techniques (blue light cystoscopy, when available), ureteroscopy, or random bladder biopsies. (Expert Opinion)

4. 对于有非肌层浸润性膀胱癌病史，即使膀胱镜检查正常但细胞学检查阳性的患者，临床医生应考虑前列腺尿道活检和上尿路影像检查，也可行增强膀胱镜检查技术（如果具备蓝光膀胱镜检查条件）、输尿管镜检查或随机膀胱活检。（专家意见）

Risk Stratification

风险分层

5. At the time of each occurrence/recurrence, a clinician should assign a clinical stage and classify a patient accordingly as “low-,” “intermediate-,” or “high-risk.” (Moderate Recommendation; Evidence Strength: Grade C)

5. 在每次肿瘤发生/复发时，医生应评估临床分期，并相应地将患者分为“低危”、“中危”或“高危”组。（中度推荐；证据强度：C级）

Variant Histologies

组织学变异

6. An experienced genitourinary pathologist should review the pathology of a patient with any doubt in regards to variant or suspected variant histology (e.g., micropapillary, nested, plasmacytoid, neuroendocrine, sarcomatoid), extensive squamous or glandular differentiation, or the presence/absence of LVI. (Moderate Recommendation; Evidence Strength: Grade C)

6. 经验丰富的泌尿生殖病理学家应回顾分析每例患者的病理组织学变异或疑似变异（如微乳头状、巢状、浆细胞样、神经内分泌、肉瘤样变）、广泛的鳞状或腺样分化、是否存在淋巴血管侵犯。（中度推荐；证据强度：C级）

7. If a bladder sparing approach is being considered in a patient with variant histology, then a clinician should perform a restaging TURBT within four to six weeks of the initial TURBT. (Expert Opinion)

7. 如果考虑保留一个存在组织学变异患者的膀胱，那么临床医生应在初次TURBT后4到6周内重新进行TURBT再次分级。（专家意见）

8. Due to the high rate of upstaging associated with variant histology, a clinician should consider offering initial radical cystectomy. (Expert Opinion)

8.由于组织学变异时临床分期上调的概率很高，临床医生就应考虑初期根治性膀胱切除术。（专家意见）

Urine Markers after Diagnosis of Bladder Cancer

膀胱癌诊断的尿液标志物

9. In surveillance of NMIBC, a clinician should not use urinary biomarkers in place of cystoscopic evaluation. (Strong Recommendation; Evidence Strength: Grade B)

9. 在监测非肌层浸润性膀胱癌时，临床医生不应使用尿液生物学标记物代替膀胱镜检查。（强烈推荐；证据强度：B级）

10. In a patient with a history of low-risk cancer and a normal cystoscopy, a clinician should not routinely use a urinary biomarker or cytology during surveillance. (Expert Opinion)

10. 对于有低危癌症病史并且膀胱镜检查正常的患者，在随访监测期间不推荐临床医生常规进行尿生物标记物或细胞学检查。（专家意见）

11. In a patient with NMIBC, a clinician may use biomarkers to assess response to intravesical BCG (UroVysion® FISH) and adjudicate equivocal cytology (UroVysion® FISH and ImmunoCyt™). (Expert Opinion)

11. 对于非肌层浸润性膀胱癌患者，临床医生可使用生物标记物评估膀胱内BCG（FISH检测）治疗的反应，以及难以判定的细胞学检测的辅助诊断（FISH和免疫细胞检测）。（专家意见）

TURBT/Repeat resection: Timing，Technique，Goal，Indication

经尿道膀胱肿瘤电切术/重复切除：时机、技术、目标、适应症

12. In a patient with non-muscle invasive disease who underwent an incomplete initial resection (not all visible tumor treated), a clinician should perform repeat transurethral resection or endoscopic treatment of all remaining tumor if technically feasible. (Strong Recommendation; Evidence Strength: Grade B)

12. 对于非肌层浸润性膀胱癌且初次切除不彻底（不是所有肉眼可见的肿瘤都被切除干净）的患者，如果技术可行，临床医生应考虑对所有残余的肿瘤再次进行经尿道切除或内窥镜治疗。（强烈推荐；证据强度：B级）

13. In a patient with high-risk, high-grade Ta tumors, a clinician should consider performing repeat transurethral resection of the primary tumor site within six weeks of the initial TURBT. (Moderate Recommendation; Evidence Strength: Grade C)

13. 对于高危、高级别Ta期肿瘤，临床医生应考虑在初次TURBT后6周内对原发肿瘤部位再次进行经尿道切除术。（中度推荐；证据强度：C级）

14. In a patient with T1 disease, a clinician should perform repeat transurethral resection of the primary tumor site to include muscularis propria within six weeks of the initial TURBT. (Strong Recommendation; Evidence Strength: Grade B)

14. 对于T1期肿瘤的患者，临床医生应在初次TURBT后6周内对原发肿瘤部位再次进行包括固有肌层在内的经尿道切除。（强烈推荐；证据强度：B级）

Intravesical Therapy; BCG/Maintenance; Chemotherapy/ BCG Combinations

膀胱灌注疗法；卡介苗/维持疗法；化疗/卡介苗联合疗法

15. In a patient with suspected or known low- or intermediate-risk bladder cancer, a clinician should consider administration of a single postoperative instillation of intravesical chemotherapy (e.g., mitomycin C or epirubicin) within 24 hours of TURBT. In a patient with a suspected perforation or extensive resection, a clinician should not use postoperative chemotherapy. (Moderate Recommendation; Evidence Strength: Grade B)

15. 对于怀疑或已知为低危或中危膀胱癌的患者，临床医生应考虑在TURBT后24小时内单次膀胱内灌注化疗（如丝裂霉素C或表阿霉素）。对于怀疑有膀胱穿孔或切除范围广泛的患者，临床医生不应使用术后即刻膀胱内灌注化疗。（中度推荐；证据强度：B级）

16. In a low-risk patient, a clinician should not administer induction intravesical therapy. (Moderate Recommendation; Evidence Strength: Grade C)

16. 对于低危患者，临床医生不应进行诱导性膀胱腔内治疗。（中度推荐；证据强度：C级）

17. In an intermediate-risk patient a clinician should consider administration of a six week course of induction intravesical chemotherapy or immunotherapy. (Moderate Recommendation; Evidence Strength: Grade B)

17. 对于中危患者，临床医生应考虑给予为期6周的诱导性膀胱腔内化疗或免疫治疗。（中度推荐；证据强度：B级）

18. In a high-risk patient with newly diagnosed CIS, high-grade T1, or high-risk Ta urothelial carcinoma, a clinician should administer a six-week induction course of BCG. (Strong Recommendation; Evidence Strength: Grade B)

18. 对于高危的尿路上皮癌患者（新确诊且合并原位癌、高级别T1期或高危Ta期），临床医生应给予为期6周的BCG诱导治疗。（强烈推荐；证据强度：B级）

19. In an intermediate-risk patient who completely responds to an induction course of intravesical chemotherapy, a clinician may utilize maintenance therapy. (Conditional Recommendation; Evidence Strength: Grade C)

19. 对于膀胱腔内诱导治疗反应完全的中危膀胱癌患者，临床医生可采用维持治疗。（有条件推荐；证据强度：C级）

20. In an intermediate-risk patient who completely responds to induction BCG, a clinician should consider maintenance BCG for one year, as tolerated. (Moderate Recommendation; Evidence Strength: Grade C)

20. 对于卡介苗诱导治疗反应完全的中危膀胱癌患者，能耐受的情况下临床医生应考虑卡介苗维持治疗1年。（中度推荐；证据强度：C级）

21. In a high-risk patient who completely responds to induction BCG, a clinician should continue maintenance BCG for three years, as tolerated. (Moderate Recommendation; Evidence Strength: Grade B)

21. 对于卡介苗诱导治疗反应完全的高危膀胱癌患者，能耐受的情况下临床医生应考虑卡介苗维持治疗3年。（中度推荐；证据强度：B级）

BCG Relapse and Salvage Regimens

卡介苗复发与挽救方案

22. In an intermediate- or high-risk patient with persistent or recurrent disease or positive cytology following intravesical therapy, a clinician should consider performing prostatic urethral biopsy and an upper tract evaluation prior to administration of additional intravesical therapy. (Conditional Recommendation; Evidence Strength: Grade C)

22. 对于膀胱腔内治疗后肿瘤持续或复发，或细胞学检查阳性的中高危膀胱癌患者，临床医生在实施进一步膀胱腔内治疗前应考虑进行前列腺尿道活检和上尿路评估。（有条件推荐；证据强度：C级）

23. In an intermediate- or high-risk patient with persistent or recurrent Ta or CIS disease after a single course of induction intravesical BCG, a clinician should offer a second course of BCG. (Moderate Recommendation; Evidence Strength: Grade C)

23. 对于一个疗程的膀胱腔内卡介苗诱导治疗后，肿瘤持续或复发的Ta期的中、高危患者或合并原位癌的膀胱癌患者，临床医生应提供第二个疗程的卡介苗治疗。（中度推荐；证据强度：C级）

24. In a patient fit for surgery with high-grade T1 disease after a single course of induction intravesical BCG, a clinician should offer radical cystectomy. (Moderate Recommendation; Evidence Strength: Grade C)

24. 对于一个疗程的膀胱腔内卡介苗诱导治疗后，条件适宜手术的高级别T1期膀胱癌患者，临床医生应实施根治性膀胱切除术。（中度推荐；证据强度：C级）

25. A clinician should not prescribe additional BCG to a patient who is intolerant of BCG or has documented recurrence on TURBT of high-grade, non-muscle-invasive disease and/or CIS within six months of two induction courses of BCG or induction BCG plus maintenance. (Moderate Recommendation; Evidence Strength: Grade C)

25. 对于不能耐受卡介苗治疗的患者，以及在两个疗程卡介苗的诱导治疗或者卡介苗诱导加维持治疗后6个月内通过TURBT证实有高级别、非肌层浸润性膀胱癌复发和/或CIS的患者，临床医生不应再进行卡介苗治疗。（中度推荐；证据强度：C级）

26. In a patient with persistent or recurrent intermediate- or high-risk NMIBC who is unwilling or unfit for cystectomy following two courses of BCG, a clinician may recommend clinical trial enrollment. A clinician may offer this patient intravesical chemotherapy when clinical trials are unavailable. (Expert Opinion)

26. 对于经过两个疗程的卡介苗治疗后持续或复发的中、高危非肌层浸润性膀胱癌患者，不愿意或不适宜进行膀胱切除术的，临床医生可建议进行临床试验性治疗。当无法实施临床试验性治疗时，临床医生可以给患者提供膀胱腔内化疗。（专家意见）

Role of Cystectomy in NMIBC

膀胱切除术在非肌层浸润性膀胱癌治疗中的作用

27. In a patient with Ta low- or intermediate-risk disease, a clinician should not perform radical cystectomy until bladder-sparing modalities (staged TURBT, intravesical therapies) have failed. (Clinical Principle)

27. 对于Ta期低危或中危风险的患者，临床医生不应进行根治性膀胱切除术，直到保留膀胱的治疗方法（分期TURBT、膀胱腔内治疗）失败。（临床原则）

28. In a high-risk patient who is fit for surgery with persistent high-grade T1 disease on repeat resection, or T1 tumors with associated CIS, LVI, or variant histologies, a clinician should consider offering initial radical cystectomy. (Moderate Recommendation; Evidence Strength: Grade C)

28. 对于适合手术治疗的高危膀胱癌患者，如果重复切除均提示存在高级别T1期肿瘤、T1期肿瘤合并原位癌、存在淋巴血管侵犯或组织学变异，临床医生应初步考虑实施根治性膀胱切除术。（中度推荐；证据强度：C级）

29. In a high-risk patient with persistent or recurrent disease within one year following treatment with two induction cycles of BCG or BCG maintenance, a clinician should offer radical cystectomy. (Moderate Recommendation; Evidence Strength: Grade C)

29. 在接受两个周期的卡介苗诱导或维持治疗后一年内有持续或复发的高危膀胱癌患者，临床医生应实施根治性膀胱切除术。（中度推荐；证据强度：C级）

Enhanced Cystoscopy

增强膀胱镜检查

30. In a patient with NMIBC, a clinician should offer blue light cystoscopy at the time of TURBT, if available, to increase detection and decrease recurrence. (Moderate Recommendation; Evidence Strength: Grade B)

30. 对于非肌层浸润性膀胱癌患者，临床医生应在TURBT时提供蓝光膀胱镜检查（如果具备条件），以提高检测率并减少复发。（中度推荐；证据强度：B级）

31. In a patient with NMIBC, a clinician may consider use of NBI to increase detection and decrease recurrence. (Conditional Recommendation; Evidence Strength: Grade C)

31. 对于非肌层浸润性膀胱癌患者，临床医生可以考虑使用NBI来增加检测和减少复发。（有条件推荐；证据强度：C级）

Risk Adjusted Surveillance and Follow-up Strategies

风险调整监测和随访策略

32. After completion of the initial evaluation and treatment of a patient with NMIBC, a clinician should perform the first surveillance cystoscopy within three to four months. (Expert Opinion)

32. 在完成对非肌层浸润性膀胱癌患者的初步评估和治疗后，临床医生应在3至4个月内进行第一次膀胱镜检查。（专家意见）

33. For a low-risk patient whose first surveillance cystoscopy is negative for tumor, a clinician should perform subsequent surveillance cystoscopy six to nine months later, and then annually thereafter; surveillance after five years in the absence of recurrence should be based on shared-decision making between the patient and clinician. (Moderate Recommendation; Evidence Strength: Grade C)

33. 对于首次随访膀胱镜监测肿瘤阴性的低危患者，临床医生应在6至9个月后进行后续的膀胱镜监测，此后每年进行一次；在无复发的情况下，五年后的监测频率应基于患者和临床医生的共同决策。（中度推荐；证据强度：C级）

34. In an asymptomatic patient with a history of low-risk NMIBC, a clinician should not perform routine surveillance upper tract imaging. (Expert Opinion)

34. 对于有低危非肌层浸润性膀胱癌病史的无症状患者，临床医生不应进行常规上尿路成像监测。（专家意见）

35. In a patient with a history of low-grade Ta disease and a noted sub-centimeter papillary tumor(s), a clinician may consider in-office fulguration as an alternative to resection under anesthesia. (Expert Opinion)

35. 对于有低级别Ta期肿瘤病史且有亚厘米级乳头状肿瘤的患者，临床医生可考虑将门诊电灼作为麻醉下切除的替代方法。（专家意见）

36. For an intermediate-risk patient whose first surveillance cystoscopy is negative for tumor, a clinician should perform subsequent cystoscopy with cytology every 3-6 months for 2 years, then 6-12 months for years 3 and 4, and then annually thereafter. (Expert Opinion)

36．对于首次膀胱镜监测为阴性的中危膀胱癌患者，临床医生应在随后2年内每3-6个月进行一次膀胱镜检查，然后在3-4年内每6-12个月进行一次，之后每年进行一次。（专家意见）

37. For a high-risk patient whose first surveillance cystoscopy is negative for tumor, a clinician should perform subsequent cystoscopy with cytology every three to four months for two years, then six months for years three and four, and then annually thereafter. (Expert Opinion)

37. 对于首次膀胱镜监测为阴性的高危膀胱癌患者，临床医生应在随后两年内每3-4个月进行一次膀胱镜检查，然后在3-4年内每6个月进行一次，之后每年进行一次。（专家意见）

38. For an intermediate- or high-risk patient, a clinician should consider performing surveillance upper tract imaging at one to two year intervals. (Expert Opinion)

38. 对于中危或高危膀胱癌患者，临床医生应考虑每隔一到两年进行一次上尿路成像监测。（专家意见）

*翻译仅供学习交流，不作为临床实践标准

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