Assessment of Tolerability, Response and Complications of Concurrent Chemoradiation With Capecitabine and Cisplatin in Muscle-Invasive Bladder Cancer; A Single Arm Study.

Autor: Soltanzadeh S; Department of Radiation Oncology, Tehran University of Medical Sciences, School of Medicine, Tehran, Iran. Electronic address: s-soltanzadeh@alumnus.tums.ac.ir., Saeedian A; Department of Radiation Oncology, Tehran University of Medical Sciences, School of Medicine, Tehran, Iran., Ghalehtaki R; Department of Radiation Oncology, Tehran University of Medical Sciences, School of Medicine, Tehran, Iran., Ayati M; Department of Urology, Tehran University of Medical Sciences, School of Medicine, Tehran, Iran., Nowroozi M; Department of Urology, Tehran University of Medical Sciences, School of Medicine, Tehran, Iran., Haddad P; Department of Radiation Oncology, Tehran University of Medical Sciences, School of Medicine, Tehran, Iran., Sabet MS; Department of Radiation Oncology, Iran University of Medical Sciences, School of Medicine, Tehran, Iran., Kheirolahi A; Department of psychiatry, Iran University of Medical Sciences, School of Medicine, Tehran, Iran.
Jazyk: angličtina
Zdroj: Clinical genitourinary cancer [Clin Genitourin Cancer] 2023 Feb; Vol. 21 (1), pp. 105.e1-105.e6. Date of Electronic Publication: 2022 Jul 19.
DOI: 10.1016/j.clgc.2022.07.007
Abstrakt: Purpose: 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).
Methods: 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 2 ) and capecitabine (625 mg/m 2 ). 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.
Results: 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).
Conclusion: 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.
Competing Interests: Disclosure All authors declare that they have no conflicts of interest.
(Copyright © 2022 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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