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Pancreatic Neoplasms: HELP
Articles by Simonetta Longoni
Based on 1 article published since 2010
(Why 1 article?)
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Between 2010 and 2020, Simonetta Longoni wrote the following article about Pancreatic Neoplasms.
 
+ Citations + Abstracts
1 Clinical Trial A randomized phase II trial of two different 4-drug combinations in advanced pancreatic adenocarcinoma: cisplatin, capecitabine, gemcitabine plus either epirubicin or docetaxel (PEXG or PDXG regimen). 2012

Reni, Michele / Cereda, Stefano / Rognone, Alessia / Belli, Carmen / Ghidini, Michele / Longoni, Simonetta / Fugazza, Clara / Rezzonico, Sara / Passoni, Paolo / Slim, Najla / Balzano, Giampaolo / Nicoletti, Roberto / Cappio, Stefano / Doglioni, Claudio / Villa, Eugenio. ·Department of Oncology, San Raffaele Scientific Institute, via Olgettina 60, 20132 Milan, Italy. reni.michele@hsr.it ·Cancer Chemother Pharmacol · Pubmed #21626049.

ABSTRACT: PURPOSE: PEFG regimen (P:cisplatin, E:epirubicin, F:5-fluorouracil, G:gemcitabine) significantly prolonged progression-free (PFS) and overall survival (OS) of patients with advanced pancreatic adenocarcinoma (PA) with respect to standard gemcitabine. The current trial was aimed at assessing whether the replacement of E with docetaxel (D) may improve 6 months PFS (PFS6). METHODS: Chemo-naive patients with stage III or metastatic PA received P (30 mg/m(2) day 1 and 15), G (800 mg/m(2) day 1 and 15), and capecitabine (1,250 mg/m(2)/day days 1-28, without a break) and were randomized to receive either D at 25-30 mg/m(2) day 1 and 15 (arm A: PDXG regimen) or E at 30 mg/m(2) day 1 and 15 (arm B: PEXG regimen). Cycles were repeated every 28 days for a maximum of 6 months. The Fleming design was used to calculate the sample size on the probability of being PFS6. Assuming P0 = 40% and P1 = 60%, α = 0.05 and β = 0.10; the study was to enroll 52 patients per arm. RESULTS: Between July 2005 and September 2008, 105 patients were enrolled, stratified by stage and randomized. Patients' characteristics were (A/B) the following: median age 61/59, PS >70 92/88%, metastatic disease 66/65%. PFS6 was 58%, and median OS was 11 months in both arms. A partial response was observed in 60/37% of patients. Main per cycle G3-4 toxicity was the following: neutropenia 4/13%, thrombocytopenia 2/4%, anemia 4/4%, and fatigue 6/3%. CONCLUSIONS: The inclusion of D instead of E yielded more objective response and less G3-4 neutropenia but did not improve PFS and OS. The present trial confirms the relevant impact on outcome of advanced PA of 4-drug regimens.