c omparison of t wo Standard c hemotherapy r egimens for Good-Prognosis Germ c ell t umors: Updated Analysis of a r andomized t rial

2010 
2 etoposide on days 1-3, and 100 mg/m 2 cisplatin on day 1; n = 83). Endpoints included overall survival, progression-free survival, and quality of life and side effects, which were assessed using the Spitzer Quality of Life Index and the GLQ-8, respectively, before random assignment and during and after treatment. All analyses were by intention to treat. All P values are two-sided. Results The median follow-up was 8.5 years. All but five survivors (3%) were followed up for at least 5 years. Overall survival remained better in those assigned to 3B90E500P than in those assigned to 4B30E360P (8-year survival: 92% vs 83%; hazard ratio of death = 0.38, 95% confidence interval = 0.15 to 0.97, P = .037). Progression-free survival favored 3B90E500P but was not statistically significantly different between the treatment groups (8-year progression- free survival, 3B90E500P vs 4B30E360P: 86% vs 79%; hazard ratio of progression = 0.6, 95% confidence interval = 0.3 to 1.1, P = .15). At the end of treatment, average scores for most side effect scales favored 3B90E500P. After the com- pletion of treatment, average GLQ-8 scores for numbness (P = .003) and hair loss (P = .04) and the Spitzer Quality of Life Index (P = .05) favored 3B90E500P. Conclusion The survival benefit of 3B90E500P over 4B30E360P was maintained with long-term follow-up.
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