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Bladder preservation with twice-a-day radiation plus fluorouracil/cisplatin or once daily radiation plus gemcitabine for muscle-invasive bladder cancer: NRG/RTOG 0712—a randomized phase II trial

Journal of Clinical Oncology Jan 04, 2019

Coen JJ, et al. - In patients with cT2-4a muscle-invasive bladder cancer, two chemoradiation (CRT) regimens were assessed: fluorouracil plus cisplatin and radiation twice a day (FCT) vs gemcitabine and once daily radiation (GD). Patients had transurethral resection and induction CRT to 40 Gy and were randomly assigned to FCT or GD. Consolidation CRT to 64 Gy was used to treat those who achieved a complete response (CR) and others underwent cystectomy. Adjuvant gemcitabine/cisplatin chemotherapy was given. Whether either regimen exceeded a DMF3 (the rate of freedom from distant metastasis at 3 years) benchmark of 75%, was assessed. Also, researchers evaluated toxicity and efficacy end points, including CR and bladder-intact distant metastasis free survival at 3 years (BI-DMFS3). Of 70 patients enrolled, 33 per arm were analyzed during median follow-up of 5.1 years. According to findings, DMF3 was 78% and 84% for FCT and GD, respectively. BI-DMFS3 was 67% and 72%, respectively. Postinduction CR rates were 88% and 78%, respectively. With GD, fewer toxicities were observed.
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