Many patients with muscle-invasive bladder cancer are poor candidates for radical cystectomy or trimodality therapy with maximal transurethral resection of bladder tumor (TURBT) and chemoradiotherapy with cisplatin or mitomycin C. Given the benefit of chemotherapy in bladder-preserving therapy, less-intense concurrent chemotherapy regimens are needed. This study reports on efficacy and toxicity for patients treated with trimodality therapy using single-agent concurrent capecitabine. Patients deemed ineligible for radical cystectomy or standard chemoradiotherapy by a multidisciplinary tumor board and patients who refused cystectomy were included. Following TURBT, patients received twice-daily capecitabine (goal dose 825 mg/m) concurrent with radiotherapy to the bladder +/˗ pelvis depending on nodal staging and patient risk factors. Toxicity was evaluated prospectively in weekly on-treatment visits and follow-up visits by the treating physicians. Descriptive statistics are provided. Overall, progression-free, cancer-specific, distant metastasis-free, and bladder recurrence-free survival were estimated using the Kaplan-Meier method. Twenty-seven consecutive patients met criteria for inclusion from 2013 to 2023. The median age was 79 with 9 patients staged cT3-4a and 7 staged cN1-3. The rate of complete response in the bladder and pelvis was 93%. Overall, progression-free, cancer-specific, distant metastasis-free, and bladder recurrence-free survival at 2 years were estimated as 81%, 65%, 91%, 75%, and 92%, respectively. There were 2 bladder recurrences, both noninvasive. There were 7 grade 3 acute hematologic or metabolic events but no other grade 3+ toxicities. Maximal TURBT followed by radiotherapy with concurrent capecitabine offers a high rate of bladder control and low rates of acute and late toxicity.

中文翻译：

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卡培他滨保膀胱三联疗法

许多肌层浸润性膀胱癌患者不适合接受根治性膀胱切除术或三联治疗（经尿道膀胱肿瘤最大切除术 (TURBT)）以及顺铂或丝裂霉素 C 放化疗。考虑到化疗在膀胱保留治疗中的益处，强度较低的并发治疗需要化疗方案。本研究报告了同时使用单药卡培他滨三联疗法治疗患者的疗效和毒性。多学科肿瘤委员会认为不适合根治性膀胱切除术或标准放化疗的患者以及拒绝膀胱切除术的患者均被纳入其中。 TURBT 后，患者接受每日两次卡培他滨（目标剂量 825 mg/m2），同时根据淋巴结分期和患者危险因素对膀胱 +/˗ 骨盆进行放射治疗。由治疗医生每周进行治疗访视和随访，对毒性进行前瞻性评估。提供了描述性统计数据。总体而言，使用 Kaplan-Meier 方法评估无进展生存期、癌症特异性生存期、无远处转移生存期和膀胱无复发生存期。 2013 年至 2023 年，连续 27 名患者符合纳入标准。中位年龄为 79 岁，其中 9 名患者分期为 cT3-4a，7 名患者分期为 cN1-3。膀胱和骨盆的完全缓解率为 93%。总体而言，2 年无进展生存率、癌症特异性生存率、无远处转移生存率和膀胱无复发生存率估计分别为 81%、65%、91%、75% 和 92%。膀胱复发 2 例，均为非侵入性复发。发生 7 起 3 级急性血液学或代谢事件，但没有其他 3 级以上毒性事件。最大 TURBT 后并发卡培他滨放疗可实现较高的膀胱控制率以及较低的急性和晚期毒性发生率。