Abstract
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/m2) and capecitabine (625 mg/m2). 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.
Keywords
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Article info
Publication history
Published online: July 18, 2022
Accepted:
July 9,
2022
Received in revised form:
July 5,
2022
Received:
October 10,
2021
Identification
Copyright
© 2022 Elsevier Inc. All rights reserved.
