742 COMBINATION OF PACLITAXEL, CISPLATIN AND GEMCITABINE (TPG) PLUS SURGERY AS 3RD-4TH LINE THERAPY FOR MALE GERM CELL TUMORS (GCT)

You have accessJournal of UrologyPenis/Testis/Urethra: Benign & Malignant Disease II1 Apr 2012742 COMBINATION OF PACLITAXEL, CISPLATIN AND GEMCITABINE (TPG) PLUS SURGERY AS 3RD-4TH LINE THERAPY FOR MALE GERM CELL TUMORS (GCT) Andrea Necchi, Nicola Nicolai, Patrizia Giannatempo, Daniele Raggi, Giuseppa Napoli, Davide Biasoni, Mario Catanzaro, Tullio Torelli, Angelo Milani, Silvia Stagni, Luigi Piva, and Roberto Salvioni Andrea NecchiAndrea Necchi Milan, Italy More articles by this author , Nicola NicolaiNicola Nicolai Milan, Italy More articles by this author , Patrizia GiannatempoPatrizia Giannatempo Milan, Italy More articles by this author , Daniele RaggiDaniele Raggi Milan, Italy More articles by this author , Giuseppa NapoliGiuseppa Napoli 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 , Angelo MilaniAngelo Milani Milan, Italy More articles by this author , Silvia StagniSilvia Stagni Milan, Italy More articles by this author , Luigi PivaLuigi Piva 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.2012.02.828AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Rescue of patients (pts) who fail to be cured following 2-3 chemotherapy (CT) combinations ± high dose CT (HDCT) or who are cisplatin-refractory is still an unmet need. The identification of novel active agents/combinations is a priority. METHODS We reviewed the characteristics of consecutive pts who received TPG combination at our Institution for relapse/progression after 2 or 3 previous platinum-based CT lines. Treatment consisted of the administration of paclitaxel 80 mg/m2 IV, cisplatin 50 mg/m2 IV and gemcitabine 800 mg/m2 IV on days 1 and 8 q3w. Program provided up to 8 administrations of TPG followed by surgery of all resectable masses. Paraffin slides of all cases with residual viable cancer after TPG were retrieved: CD30 staining and somatic mutation analysis by Sequenom OncoCarta Panel v.1.0™ were planned. RESULTS From 04/1999 to 07/2011, 74 pts have been treated with TPG, 64 in 3rd and 10 pts in 4th line. Median age was 32 (20-55), median number of prior CDDP cycles was 7 (4-10), 10 pts (13%) had already received HDCT, 4 pts had primary mediastinal GCT, 42 (57%) were CDDP-refractory/abs refractory, 25 pts (34%) had either liver, bone or brain metastases before TPG. 40% developed G3-4 hematologic and 2 pts G3 renal toxicity, none of them being dose-limiting. No treatment delays have been observed. Median number of administrations was 7 (1-10). 8 complete responses (CR), 28 partial responses with normal markers (PRm-) and 13 incomplete response/stable disease have been recorded, for a major response rate (CR+PRm-) of 49%. 34 pts (46%) underwent post-CT surgery which was radical in 15 cases (44%) and led to 7 pathologic CR. 3-, 6- and 12-month PFS was 68% (95% CI 55-76%), 31% (21-42) and 20% (12-30), respectively. 1-yr PFS after HDCT only was 24% (4-53). 12- and 24-month OS was 46% (34-57) and 26% (16-37), respectively. Median PFS and OS were 5 (1-104) and 12 mos (1-116). CONCLUSIONS TPG combination rates first among salvage therapies for refractory GCT, even after failure of HDCT. Benchmark survival endpoints for trials on new agents/combinations have been set. Results of the biomarker analysis will be available in May 2012 and may help to corroborate a window of opportunity for targeted agents in GCT. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e304 Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information Andrea Necchi Milan, Italy More articles by this author Nicola Nicolai Milan, Italy More articles by this author Patrizia Giannatempo Milan, Italy More articles by this author Daniele Raggi Milan, Italy More articles by this author Giuseppa Napoli 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 Angelo Milani Milan, Italy More articles by this author Silvia Stagni Milan, Italy More articles by this author Luigi Piva Milan, Italy More articles by this author Roberto Salvioni Milan, Italy More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...