TY - JOUR
T1 - Modified cisplatin, etoposide, and ifosfamide (PEI) salvage therapy for male germ cell tumors
T2 - Long-term efficacy and safety outcomes
AU - Necchi, A.
AU - Nicolai, N.
AU - Mariani, L.
AU - Raggi, D.
AU - Farè, E.
AU - Giannatempo, P.
AU - Catanzaro, M.
AU - Biasoni, D.
AU - Torelli, T.
AU - Stagni, S.
AU - Milani, A.
AU - Piva, L.
AU - Pizzocaro, G.
AU - Gianni, A. M.
AU - Salvioni, R.
PY - 2013/11
Y1 - 2013/11
N2 - 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.
AB - 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.
KW - Combination chemotherapy
KW - Salvage therapies
KW - Testicular neoplasms
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U2 - 10.1093/annonc/mdt271
DO - 10.1093/annonc/mdt271
M3 - Article
C2 - 23860612
AN - SCOPUS:84887044918
VL - 24
SP - 2887
EP - 2892
JO - Annals of Oncology
JF - Annals of Oncology
SN - 0923-7534
IS - 11
M1 - mdt271
ER -