Real life triplet FIr/FOx chemotherapy in first-line metastatic pancreatic ductal adenocarcinoma patients: recommended schedule for expected activity and safety and phase II study

Oncotarget
Gemma BrueraOncology Network ASL1 Abruzzo, Italy

Abstract

Gemcitabine/nab-paclitaxel and FOLFIRINOX demonstrated significantly increased survival compared with gemcitabine in metastatic pancreatic ductal adenocarcinoma (PDAC): objective response rate (ORR) 23 and 31.6%, progression-free survival (PFS) 5.5 and 6.4 months, overall survival (OS) 8.7 and 11.1 months. Present phase II study evaluated recommended first-line triplet FIr/FOx schedule. Simon two-step design: p010%, p130%, power 80%, α5%, β20%. Projected ORR: I step, 1/10; II 5/29. Schedule: 12h-timed-flat-infusion/5-fluorouracil 750-800-900 mg/m2 d1-2,8-9,15-16,22-23; irinotecan 120-140-160 mg/m2 d1,15; oxaliplatin 70-80 mg/m2 d8,22; every 4 weeks, according to clinical parameters (age, comorbidities, performance status (PS), liver function). Activity and efficacy were evaluated, and compared using log-rank; limiting toxicity syndromes (LTS), using chi-square. Twenty-nine consecutive patients were enrolled, according to primary/intermediate/secondary Cumulative Illness Rating Scale (CIRS). Median age 62; elderly 13 (44.7%); PS2 3 (10.4%), secondary CIRS 5 (17.2%). Primary endpoint was met: ORR 53% (7/13 patients) as-treated, 50% intent-to-treat. Cumulative G3-4 toxicities: diarrhea 17%, asthenia 14%, hypertransaminasemy 7%, mu...Continue Reading

References

Mar 1, 1989·Controlled Clinical Trials·R Simon
Jun 1, 1997·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·H A BurrisD D Von Hoff
Apr 29, 1998·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·M ExtermannL Balducci
Aug 1, 2002·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Jordan D BerlinAl Bowen Benson
Jul 30, 2003·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Margaret TemperoJames Abbruzzese
Jul 1, 2004·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Henry Q XiongJames L Abbruzzese
Sep 15, 2004·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Caio M Rocha LimaLangdon L Miller
May 24, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·C LouvetUNKNOWN GISCAD
Nov 1, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Hedy L KindlerEverett E Vokes
Aug 22, 2006·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Volker HeinemannRalf Wilkowski
Apr 25, 2007·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Malcolm J MooreUNKNOWN National Cancer Institute of Canada Clinical Trials Group
Jun 1, 2007·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Richard HerrmannUNKNOWN Central European Cooperative Oncology Group
Jan 7, 2009·Genetics in Medicine : Official Journal of the American College of Medical Genetics·UNKNOWN Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group
Mar 25, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Eric Van CutsemMalcolm J Moore
Oct 28, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·David CunninghamJohn P Neoptolemos
Oct 28, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Matthew H KulkeRobert J Mayer
Mar 3, 2010·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Giuseppe ColucciUNKNOWN Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC)
Apr 30, 2010·The New England Journal of Medicine·Manuel Hidalgo
Jul 8, 2010·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Hedy Lee KindlerRichard M Goldberg
May 13, 2011·The New England Journal of Medicine·Thierry ConroyUNKNOWN PRODIGE Intergroup
Oct 5, 2011·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Daniel D Von HoffManuel Hidalgo
Dec 6, 2012·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Sophie Gourgou-BourgadeThierry Conroy
Oct 18, 2013·The New England Journal of Medicine·Daniel D Von HoffMarkus F Renschler
Oct 23, 2014·The New England Journal of Medicine·Fotios LoupakisAlfredo Falcone
Feb 2, 2015·Journal of the National Cancer Institute·David GoldsteinDaniel D Von Hoff
Mar 19, 2015·British Journal of Clinical Pharmacology·Felicia Stefania FalvellaFilippo Pietrantonio

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