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

Authors Cortellini A, Cannita K, Parisi A, Lanfiuti Baldi P, Venditti O, D'Orazio C, Dal Mas A, Calvisi G, Giordano AV, Vicentini V, Vicentini R, Felicioni L, Marchetti A, Buttitta F, Russo A, Ficorella C

Received 15 November 2018

Accepted for publication 29 January 2019

Published 25 March 2019 Volume 2019:12 Pages 2159—2170

DOI https://doi.org/10.2147/OTT.S194745

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Colin Mak

Peer reviewer comments 2

Editor who approved publication: Dr Leo Jen-Liang Su


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

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