Long-term results of a single-center prospective randomized trial assessing efficacy of a shortened course of adjuvant chemotherapy after radical cystectomy in patients with locally advanced bladder cancer
| Autor: | Oleg Sukonko, A. Minich, Sergey L. Polyakov, Sergey Krasny, A. Rolevich, A. Mokhort, Alexander G. Zhegalik, Alexander N Volkov, Vladimir Ju Vasilevich |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
medicine.medical_treatment antineoplastic combined chemotherapy protocols 030232 urology & nephrology Urology chemotherapy law.invention survival analysis Cystectomy 03 medical and health sciences 0302 clinical medicine cystectomy Randomized controlled trial adjuvant law Medicine Cisplatin Chemotherapy Original Paper Bladder cancer business.industry Hazard ratio General Medicine medicine.disease Gemcitabine Tolerability 030220 oncology & carcinogenesis randomized controlled trial business urinary bladder neoplasms medicine.drug |
| Zdroj: | Central European Journal of Urology |
| ISSN: | 2080-4873 2080-4806 |
| Popis: | Introduction This study assesses the efficacy and tolerability of two cycles of adjuvant chemotherapy (AC) with gemcitabine and cisplatin after radical cystectomy in patients with a high risk of progression of muscle-invasive urothelial bladder cancer as compared to chemotherapy at relapse, in a prospective randomized study. Material and methods From 2008 to 2013, all patients after radical cystectomy at our institution for primary or recurrent urothelial bladder cancer with stage pT3-4 and/or pN+ on histopathology and without contraindications to combination cisplatin-based chemotherapy, were randomized either to two cycles of gemcitabine and cisplatin chemotherapy or to follow-up and chemotherapy at the time of relapse. The study endpoints were overall, cancer-specific, and disease-free survival. Results The study included 100 patients, of whom 53 received AC and the other 47 were assigned to the control arm. Out of 53 allocated to AC arm, 16 patients did not start chemotherapy or received only one cycle of AC. The median follow-up for patients in the AC and control arms was 88 and 86 months, respectively. In the AC arm the hazard ratio for death from any cause, death from bladder cancer, and disease relapse were 0.70 (95% CI 0.45-1.11; p = 0.13), 0.84 (95% CI 0.50-1.41; p = 0.51), and 0.77 (95% CI 0.46-1.28; p = 0.31), respectively. Conclusions Two cycles of AC with gemcitabine and cisplatin in patients with high-risk urothelial bladder cancer after radical cystectomy does not improve overall, cancer-specific, and disease-free survival. Only 53% of patients randomized to AC received the entire planned treatment. |
| Databáze: | OpenAIRE |
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