Soltanzadeh Sara, Saeedian Arefeh, Ghalehtaki Reza, Ayati Mohsen, Nowroozi Mohammadreza, Haddad Peiman, Sabet Mahdieh Shafiee, Kheirolahi Amin
Department of Radiation Oncology, Tehran University of Medical Sciences, School of Medicine, Tehran, Iran.
Department of Radiation Oncology, Tehran University of Medical Sciences, School of Medicine, Tehran, Iran.
Clin Genitourin Cancer. 2023 Feb;21(1):105.e1-105.e6. doi: 10.1016/j.clgc.2022.07.007. Epub 2022 Jul 19.
To evaluate the feasibility, tolerance and efficacy of cisplatin+capecitabine as a proposed combination in concurrent chemoradiotherapy for patients with muscle-invasive bladder cancer (MIBC).
MIBC patients with stage T2-T4aN0M0 participated in this single-arm clinical trial. After maximal TURBT, 66Gy/33 daily fractions of radiation were administered with concurrent chemotherapy of cisplatin (35 mg/m) and capecitabine (625 mg/m). The primary endpoint was treatment tolerability, defined as receiving capecitabine+cisplatin combination for at least 5 weeks during radiation therapy. The secondary endpoints included complete response (CR) and acute toxicity rates.
This study included 19 MIBC patients from 2018 to 2019. Eighteen patients (94.7%, 95%CI: 75.4-99.0) completed the planned treatment course. Only one patient (5.26%, 95%CI: 0.9-24.6) discontinued the treatment due to grade-3 GI toxicity. Among those who completed the treatment, CR was seen in 12 patients (66.7%, 95% CI = 44.4-88.9) with no grade ≥ 3 toxicities. The most common grade-2 side effects during therapy were renal complications (57.9%), and the only grade-2 complication after therapy was urinary-related (11.1%). The median follow-up was 31 months and the median overall survival (OS) was 31 months. The 2-year OS was 78% (95% CI 58.4-97.6), Cystectomy-free survival was 61% (95% CI: 37.5-84.5), and the median OS after recurrence was 13 months. Distant metastases were the first type of recurrence in most patients with a recurrence, which occurred in 7 (36.8%) patients. Median metastasis-free survival (MFS) was 30 months, and 2-year MFS was 66% (95% CI:45-87).
The promising tolerability rate seen with concurrent cisplatin+capecitabine in this study was comparable to the available literature. Thus, this combination concurrently with radiation warrants further studies in the context of chemoradiotherapy of MIBC.
评估顺铂联合卡培他滨作为肌层浸润性膀胱癌（MIBC）患者同步放化疗方案的可行性、耐受性及疗效。
T2 - T4aN0M0期的MIBC患者参与了这项单臂临床试验。在最大程度经尿道膀胱肿瘤电切术后，给予66Gy/33次每日分割的放疗，并同步进行顺铂（35mg/m²）和卡培他滨（625mg/m²）化疗。主要终点为治疗耐受性，定义为在放疗期间接受卡培他滨 + 顺铂联合治疗至少5周。次要终点包括完全缓解（CR）率和急性毒性发生率。
本研究纳入了2018年至2019年的19例MIBC患者。18例患者（94.7%，95%CI：75.4 - 99.0）完成了计划的治疗疗程。仅1例患者（5.26%，95%CI：0.9 - 24.6）因3级胃肠道毒性而中断治疗。在完成治疗的患者中，12例（66.7%，95%CI = 44.4 - 88.9）达到CR，且无≥3级毒性反应。治疗期间最常见的2级副作用是肾脏并发症（57.9%），治疗后唯一的2级并发症是泌尿系统相关并发症（11.1%）。中位随访时间为31个月，中位总生存期（OS）为31个月。2年总生存率为78%（95%CI 58.4 - 97.6），无膀胱切除术生存率为61%（95%CI：37.5 - 84.5），复发后的中位总生存期为13个月。远处转移是大多数复发患者的首发复发类型，7例（36.8%）患者出现远处转移。中位无转移生存期（MFS）为30个月，2年无转移生存率为66%（95%CI：45 - 87）。
本研究中顺铂联合卡培他滨同步治疗显示出的良好耐受性与现有文献相当。因此，在MIBC同步放化疗背景下，这种联合放疗的方案值得进一步研究。
