BACKGROUND: Since 1985, we introduced a modified combination of etoposide, ifosfamide, and cisplatin (PEI) as second-line therapy of adult male germ cell tumors with the aim to reduce toxic effect while maintaining efficacy over the original regimen.
PATIENTS AND METHODS: Patients received four cycles of ifosfamide at 2.5 g/m2 on days 1-2, etoposide, and cisplatin at 100 and 33 mg/m2, respectively, on days 3-5 every 21 days, followed by surgery. Results were stratified according to the International Germ Cell Consensus Classification Group-2 (IGCCCG-2).
RESULTS: From February 1985 to January 2012, 189 patients were treated. 72.6% were IGCCCG-2 intermediate-to-very high risk. Thirty-five patients (18.5%) had a complete response, 67 (35.4%) a marker normalization (PRm-). Median follow-up was 122.1 months (inter-quartile range [IQR]: 71.4-232.0). Two-year progression-free and 5-year overall survival were 34.3% [95% confidence interval (CI) 28.1% to 41.9%] and 42.1% (95% CI 35.3% to 50.2%), respectively. Survival estimates compared favorably with those obtained by conventional dose chemotherapy (CDCT) regimens in each prognostic category. 70.4% of grade 3-4 neutropenia (25.5% febrile neutropenia), 48.1% thrombocytopenia, 21.2% anemia, 3.2% neurotoxic effect, and no severe renal toxic effect were recorded.
CONCLUSION: Dose-modified Italian PEI should be considered as an appropriate benchmark for CDCT in the first salvage setting.
Written by:
Necchi A, Nicolai N, Mariani L, Raggi D, Farè E, Giannatempo P, Catanzaro M, Biasoni D, Torelli T, Stagni S, Milani A, Piva L, Pizzocaro G, Gianni AM, Salvioni R. Are you the author?
Department of Medical Oncology, Medical Oncology 2 Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Via G. Venezian 1, 20133 Milano, Italy.
Reference: Ann Oncol. 2013 Jul 16. Epub ahead of print.
doi: 10.1093/annonc/mdt271
PubMed Abstract
PMID: 23860612
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