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

Antonio Galvano, Antonio Russo, Gemma Bruera, Sergio Carducci, Alessandra Di Sibio, Rosa Manetta, Eugenio Ciacco, Silvia Massacese, Stefania Candria, Enrico Ricevuto, Aldo Victor Giordano, Alessandro Carducci, Elena Ricevuto, Jessica Silvana Giordano

Risultato della ricerca: Articlepeer review

3 Citazioni (Scopus)

Abstract

Background: 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. Methods: Simon two-step design: p010%, p130%, power 80%, a5%, 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. Results: 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%, mucositis 7%, vomiting 3%, anemia 3%, thrombocytopenia 3%. LTS were 27.5% overall, 38.4% in elderly. At 3 months median follow-up, PFS 4 months, OS 11 months. PS2 patients showed significantly worse OS (P 0.022). Conclusion: Intensive first-line triplet FIr/FOx is tolerable at modulated doses, and confirms high activity/efficacy in metastatic PDAC. Patients' careful selection, and exclusion of PS2, can maintain safety profile and efficient dose intensity.
Lingua originaleEnglish
pagine (da-a)31861-31876
Numero di pagine16
RivistaOncotarget
Volume9
Stato di pubblicazionePublished - 2018

All Science Journal Classification (ASJC) codes

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