Randomised phase III study of neoadjuvant chemotherapy with methotrexate, doxorubicin, vinblastine and cisplatin followed by radical cystectomy compared with radical cystectomy alone for muscle-invasive bladder cancer: Japan Clinical Oncology Group Study JCOG0209

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Kitamura H., Tsukamoto T., Shibata T., Masumori N., Fujimoto H., Hirao Y., Fujimoto K., Kitamura Y., Tomita Y., Tobisu K., Niwakawa M., Naito S., Eto M., Kakehi Y.

Annals of Oncology 2014 25:6 (1192-1198)

Background: This study aimed to determine the clinical benefit of neoadjuvant methotrexate, doxorubicin, vinblastine, and cisplatin (MVAC) in patients with muscle-invasive bladder cancer (MIBC) treated with radical cystectomy. Patients and methods: Patients with MIBC (T2-4aN0M0) were randomised to receive two cycles of neoadjuvant MVAC followed by radical cystectomy (NAC arm) or radical cystectomy alone (RC arm). The primary end point was overall survival (OS). Secondary end points were progression-free survival, surgery-related complications, adverse events during chemotherapy, proportion with no residual tumour in the cystectomy specimens, and quality of life. To detect an improvement in 5-year OS from 45% in the RC arm to 57% in the NAC arm with 80% power, 176 events were required per arm. Results: Patients (N = 130) were randomly assigned to the RC arm (N = 66) and the NAC arm (N = 64)…(ver más)


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