747 MODIFIED CISPLATIN, ETOPOSIDE AND IFOSFAMIDE (PEI) SALVAGE THERAPY FOR MALE GERM-CELL TUMORS (GCT). LONG-TERM EFFICACY AND SAFETY OUTCOMES (2013)

You have accessJournal of UrologyPenis/Testis/Urethra: Benign & Malignant Disease (II)1 Apr 2013747 MODIFIED CISPLATIN, ETOPOSIDE AND IFOSFAMIDE (PEI) SALVAGE THERAPY FOR MALE GERM-CELL TUMORS (GCT). LONG-TERM EFFICACY AND SAFETY OUTCOMES Andrea Necchi, Luigi Mariani, Patrizia Giannatempo, Nicola Nicolai, Daniele Raggi, Elena Fare', Luigi Piva, Davide Biasoni, Mario Catanzaro, Tullio Torelli, Silvia Stagni, Giorgio Pizzocaro, Alessandro Gianni, and Roberto Salvioni Andrea NecchiAndrea Necchi Milan, Italy More articles by this author , Luigi MarianiLuigi Mariani Milan, Italy More articles by this author , Patrizia GiannatempoPatrizia Giannatempo Milan, Italy More articles by this author , Nicola NicolaiNicola Nicolai Milan, Italy More articles by this author , Daniele RaggiDaniele Raggi Milan, Italy More articles by this author , Elena Fare'Elena Fare' Milan, Italy More articles by this author , Luigi PivaLuigi Piva Milan, Italy More articles by this author , Davide BiasoniDavide Biasoni Milan, Italy More articles by this author , Mario CatanzaroMario Catanzaro Milan, Italy More articles by this author , Tullio TorelliTullio Torelli Milan, Italy More articles by this author , Silvia StagniSilvia Stagni Milan, Italy More articles by this author , Giorgio PizzocaroGiorgio Pizzocaro Milan, Italy More articles by this author , Alessandro GianniAlessandro Gianni Milan, Italy More articles by this author , and Roberto SalvioniRoberto Salvioni Milan, Italy More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.310AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Second-line chemotherapy (CT) of advanced GCT is vividly debated and no standard of care has been established. Since 1985 we introduced the modified PEI combination with the aim to reduce toxicity while maintaining efficacy over the original regimen. METHODS We retrieved data of pts who received ifosfamide at 2.5 gr/m2 (with mesna) on days 1-2, etoposide, and cisplatin at 100 mg/m2 and 33 mg/m2, respectively, on days 3-5 every 21 days for a maximum of 4 cycles, followed by surgery of residuals. Multivariable analysis (MVA) was undertaken for pre-specified variables and IGCCCG-2 score was analysed as a continuous covariate. ITT analysis was applied. RESULTS From 02/85 to 01/12, 189 pts failing cisplatin, bleomycin, and vinblastine (PVB, N=25) or etoposide (PEB, N=164) were treated. 87% had a gonadal primary, 50.3% were MSKCC poor risk, 74.7% were IGCCCG-2 intermediate-to-very high risk, 21.8% had liver, bone or brain (LBB) mets, 16.7% were late relapses. 35 pts (18.5%) had a complete response (CR), 68 (35.9%) a marker normalization (PRm-) (major response-rate: 54.4%). 41/68 PRm-were rendered disease-free (total NED-rate: 40.2%). After a median follow-up of 122.1 mos (IQR 71.4-232), median (95%CI) PFS was 7.2 mos (6.2-9.5) and median OS was 21.7 mos (16.7-69.5). 2yr PFS was 34.3% (28.1-41.9) and 5yr OS was 42.1% (35.3-50.2). Mediastinal primary (HR 3.06, 95%CI, 1.68-5.58), LBB mets (HR 2.02, 95%CI, 1.30-3.16), and AFP>1000 ng/mL (HR 2.78, 95%CI, 1.51-5.14) were negative prognostic factors for OS at MVA while no effect was seen according to IGCCCG-2 category. 70.3% of grade 3-4 neutropenia (25% febrile neutropenia), 48.1% thrombocytopenia, 21.1% anemia, 3% neurotoxicity, and no severe renal toxicity were recored. 81 pts (78% before 2000) had a dose reduction of ≥1 drug for ≥1 cycle. No discontinuations for toxicity occurred. CONCLUSIONS Dose-modified Italian PEI showed activity comparable with the best one achievable by conventional-dose CT (CDCT) in an unselected patient population, and a favorable toxicity profile. Results are among the most robust available for a CDCT, and should be considered as an appropriate benchmark to be compared with high-dose CT. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e307-e308 Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Andrea Necchi Milan, Italy More articles by this author Luigi Mariani Milan, Italy More articles by this author Patrizia Giannatempo Milan, Italy More articles by this author Nicola Nicolai Milan, Italy More articles by this author Daniele Raggi Milan, Italy More articles by this author Elena Fare' Milan, Italy More articles by this author Luigi Piva Milan, Italy More articles by this author Davide Biasoni Milan, Italy More articles by this author Mario Catanzaro Milan, Italy More articles by this author Tullio Torelli Milan, Italy More articles by this author Silvia Stagni Milan, Italy More articles by this author Giorgio Pizzocaro Milan, Italy More articles by this author Alessandro Gianni Milan, Italy More articles by this author Roberto Salvioni Milan, Italy More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...