6533b860fe1ef96bd12c360d

RESEARCH PRODUCT

Weekly alternate intensive regimen FIrB/FOx in metastatic colorectal cancer patients: an update from clinical practice

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Alessio Cortellini,1,2 Katia Cannita,1 Alessandro Parisi,1,2 Paola Lanfiuti Baldi,1 Olga Venditti,1 Carla D’Orazio,1,2 Antonella Dal Mas,3 Giuseppe Calvisi,3 Aldo V Giordano,4 Vincenzo Vicentini,5 Roberto Vicentini,5 Lara Felicioni,6 Antonio Marchetti,7 Fiamma Buttitta,6 Antonio Russo,8 Corrado Ficorella1,2 1Medical Oncology, St Salvatore Hospital, University of L’Aquila, L’Aquila, Italy; 2Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila, L’Aquila, Italy; 3Department of Pathology, St Salvatore Hospital L’Aquila, L’Aquila, Italy; 4Diagnostic and Interventional Radiology, St Salvatore Hospital, University of L’Aquila, L’Aquila, Italy; 5Department of Hepatobiliar-Pancreatic and Emergency Surgery, St Salvatore Hospital, L’Aquila, Italy; 6Oncological and Cardiovascular Molecular Medicine Department, Center for Excellence on Ageing and Translational Medicine (CeSI-MeT), University of Chieti-Pescara, Chieti, Italy; 7Center of Predictive Molecular Medicine, Center for Excellence on Ageing and Translational Medicine (CeSI-MeT), University of Chieti-Pescara, Chieti, Italy; 8Medical Oncology Unit, Department of Surgical, Oncological and Stomatological Sciences, University of Palermo, Palermo, Italy Background: Several trials evaluated the role of intensive regimens, made of triplet chemotherapies plus bevacizumab, as first-line treatment for patients with metastatic colorectal cancer (mCRC). We previously reported, in a Phase II prospective study, the efficacy and the tolerability of FIrB/FOx regimen, reporting interesting results in terms of received dose intensities (rDIs) and safety.Methods: We reported a retrospective update of 85 patients treated with FIrB/FOx, an intensive regimen of 5-fluorouracil, bevacizumab, and weekly alternate irinotecan and oxaliplatin, to confirm its feasibility in “real life”. Subgroup analyses were performed, particularly among patients treated with standard and modified FIrB/FOx (based on age, performance status, and/or comorbidities).Results: Overall, 3-month objective response rate (ORR) and 6-month ORR were 75.9% and 55.3%, respectively. Median progression-free survival (PFS) and median overall survival (OS) were 14.4 and 34.9 months, respectively. Among the patients treated with standard and modified regimens, 3-month ORR, PFS, and OS were 75.8% and 76% (P=1.0000), 14.4 and 14.4 months (P=0.8589), and 37.8 and 26.6 months (P=0.7746), respectively. Among the K/NRAS wild-type and K/NRAS mutant patients, 3-month ORR, PFS, and OS were 95.2% and 74.5% (P=0.0526), 15.3 and 14.4 months (P=0.8753), and 37.8 and 51.4 months (P=0.8527), respectively. The rDIs were ≥80% of full doses both in the standard and in the modified regimens subgroups. Cumulative G3/4 toxicities were neutropenia (14.1%), diarrhea (17.6%), asthenia (9.4%), vomiting (5.6%), and hypertension (16.5%).Conclusion: This update shows that intensive regimens such as FIrB/FOx are also feasible options for first-line treatment of mCRC patients in the “real-life” setting. Keywords: metastatic colorectal cancer, intensive chemotherapy regimen, bevacizumab, clinical practice, 5-fluorouracil infusion