Do cytokines improve survival in patients with metastatic renal cell carcinoma (MRCC) of intermediate prognosis? Results of the prospective randomized PERCY Quattro trial
- 1 June 2005
- journal article
- genitourinary cancer
- Published by American Society of Clinical Oncology (ASCO) in Journal of Clinical Oncology
- Vol. 23 (16_suppl) , LBA4511
- https://doi.org/10.1200/jco.2005.23.16_suppl.lba4511
Abstract
LBA4511 Background: Interleukin-2 (IL2), used to treat MRCC, is not known to improve survival. To assess this potential benefit, the French Immunotherapy Intergroup designed a multicenter trial for patients (pts) with intermediate prognosis for response to cytokine treatment (Negrier et al NEJM 1998). Methods: Untreated pts with more than one metastatic site and Karnofsky score ≥80 were randomized to medroxyprogesterone (MPA: control group), α-Interferon (IFN), sc IL2 or IFN+sc IL2 in a 2x2 factorial design. Patients were evaluated after 3 months; pts without progression continued treatment for up to 6 months. The primary endpoint was overall survival (OS). The planned sample size was 456 pts based on a minimum expected difference of 10% in OS at 2 years with 5% α error and 80% power. Intent-to-treat analysis was planned 6 months after last enrollment. OS analysis (1 interaction check test and 2 log-rank tests) will be performed after α-level adjustment to maintain overall α risk at 0.05. Results: From Ja...Keywords
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