A Non-Interventional Multicenter Study of First-Line Bevacizumab in Combination with Chemotherapy in Patients with Metastatic Colorectal Cancer in Lebanon

Sally Temraz,1 Fadi Nasr,2 Joseph Kattan,3 Dany Abigerges,4 Walid Moukadem,5 Fadi Farhat,6 Layal Maatouk,7 Georges Chahine,8 Ali Shamseddine1 1Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon; 2Department of Hematology and Oncology, Mount Lebanon Hospital, Beirut, Lebanon; 3Department of Hematology and Oncology, Saint- Joseph University, Beirut, Lebanon; 4Department of Hematology and Oncology, Middle East Institute of Health, Bsalim, Lebanon; 5Department of Hematology and Oncology, Haykal Hospital, Tripoli, Lebanon; 6Department of Hematology and Oncology, Hammoud Hospital University Medical Center, Saida, Lebanon; 7Roche Lebanon SARL, Beirut, Lebanon; 8Department of Hematology and Oncology, Hôtel-Dieu de France University Hospital, Beirut, LebanonCorrespondence: Ali Shamseddine, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon, Tel +961 1 374374, Fax +961 1 370814, Email as04@aub.edu.lbPurpose: When combined with chemotherapy, bevacizumab improves progression-free survival (PFS) in metastatic colorectal cancer (mCRC). This observational trial was designed to assess the safety and efficacy of bevacizumab plus first-line chemotherapy in a real-world setting in Lebanon.Patients and Methods: A non-interventionaL multicenter study of first-LIne AVastin® (bevacizumab) in combination with chEmotherapy in patients with metastatic colorectal cancer (LLIVE) is a multicenter, prospective, Lebanon-based, observational study that enrolled mCRC patients who received first-line bevacizumab plus chemotherapy combination. The primary end point of the study was PFS. Secondary endpoints comprised the overall response rate (ORR) and the safety and tolerability of bevacizumab.Results: A total of 196 patients were enrolled between July 2010 and August 2013. The median duration of follow-up was 11 months. Median duration of bevacizumab treatment was 4 months with FOLFOX being the chiefly chemotherapy regimen used in the first-line setting (26%). Median PFS was 8.22 months (95% confidence interval (CI): 7.005– 9.443). The ORR was 50.3% (complete response 7.5%, partial response 42.8%). The most common adverse event encountered was hypertension (28%) followed by epistaxis (4.8%), diarrhea (4%), anemia (4%) and headache (4%). Grade 3/4 adverse events occurred in 15.2% of patients.Conclusion: The trial further substantiated the efficacy and safety of bevacizumab and chemotherapy in the first-line treatment of mCRC patients in Lebanon.Keywords: metastatic colorectal cancer, bevacizumab, FOLFOX, XELOX