E400P in advanced seminoma of good prognosis according to the International Germ Cell Cancer Collaborative Group (IGCCCG) classification: The SpanishGerm Cell Cancer Group experience

Purpose: To evaluate the efficacy and toxicity of primary chemotherapy with the schedule E400P in the treatment of patients with early stage II (IIa a nd IIb) and advanced seminoma of good prognosis according to the internatio nal classification (IGCCCG). Patients and methods: Sixty-four patients were included. E400P consisted of cisplatin 25 mg/m(2)/day and etoposide 100 mg/m(2)/day for four days, ever y three weeks. Royal Marsden stages were IIab: 53% and IIc-IV: 47%. Twenty- three percent had high BHCG levels, twenty-seven percent had LDH >2 x N. Si xty-two patients were of good prognosis according to the Medical Research C ouncil classification. Results: Response rate was 98% (69% complete remission, 29% residual diseas e). After a median follow-up of 34 months, treatment failure was seen in 7 patients (11%). Neutropenia (32%) was the most relevant grade 3-4 toxicity. Other important grade 3-4 side effects were found in less than 5%. Three-y ear time to treatment failure (TTF) was 89% (95% confidence intervals (CI): 80%-97%) for all patients, 91% (95% CI: 80%-99%) for stages IIa-b, and 87% (95% CI: 74%-99%) for stages IIc-IV. Three-year overall survival (OS) was 97% (95% CI: 93%-99%) for all patients and 95% (95% CI: 85%-99%) for stages IIa-b. Conclusions: E400P was a very active and safe regimen in good-prognosis adv anced seminoma, with low toxicity rates. Definitive comparisons of this reg imen with radiotherapy in stages IIa-b or with the more standard E500P or B EP, could be of interest.