5016 Background: We performed a multicentre randomised trial for good-prognosis germ-cell tumours of two standard chemotherapy regimens containing bleomycin (B), etoposide (E) and cisplatin (P). Accrual was stopped early, after interim analysis with a median follow-up of 33 months found a survival benefit for the regimen similar to Indiana University BEP, compared with the less dose-intense regimen (Toner, Lancet 2001). Here we report on long-term outcomes and patterns of relapse. Methods: Patients with a good prognosis defined by modified Memorial Sloan-Kettering criteria were randomised to 3B90E500P (3 cycles every 21 days of B 30 kU on days 1, 8 and 15, E 100 mg/m2 on days 1–5, and P 20 mg/m2 on days 1–5); or 4B30E360P (4 cycles every 21 days of B 30 kU on day 1, E 120 mg/m2 on days 1–3, and P 100 mg/m2 on day 1). Overall survival was the primary endpoint. Progression-free survival (PFS) was a secondary endpoint. All analyses were by intention-to-treat and with 2-sided p-values. Results: 166 patients were randomised, 83 to each regimen. Median follow-up is now 8.5 years and all but 5 have been followed ≥ 5 years. Overall survival remains substantially better with 3B90E500P than 4B30E360P (8YS 92% vs 83%, hazard ratio 0.38, 95% CI 0.15 to 0.97, p=0.037), and remains significant when analyses were restricted to 138 patients with good prognosis by IGCCCG criteria (p=0.035). Trends for PFS favour 3B90E500P but are not statistically significant (8YPFS 86% vs 79%, hazard ratio 0.6, 95% CI 0.3 to 1.1, p=0.15). 7 of 15 relapses occurring within 2 years after randomisation were fatal, but all 4 relapses occurring > 2 years after randomisation were fatal. Conclusions: The survival benefit of 3B90E500P compared to 4B30E360P was maintained with long-term follow-up. The occurrence of relapses beyond 2 years affirms the importance of long-term follow-up. Late relapses in this study were associated with uniformly poor outcomes. [Table: see text] No significant financial relationships to disclose.
Expression of HGF, pMet, and pAkt is related to benefit of radiotherapy after breast‐conserving surgery: a long‐term follow‐up of the SweBCG91‐RT randomised trial