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

Sally Temraz; Fadi Nasr; Joseph Kattan; Dany Abigerges; Walid Moukadem; Fadi Farhat; Layal Maatouk; Georges Chahine; Ali Shamseddine

doi:10.2147/BTT.S340525

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

Biologics. 2022 Feb 21:16:7-15. doi: 10.2147/BTT.S340525. eCollection 2022.

Authors

Sally Temraz¹, Fadi Nasr², Joseph Kattan³, Dany Abigerges⁴, Walid Moukadem⁵, Fadi Farhat⁶, Layal Maatouk⁷, Georges Chahine⁸, Ali Shamseddine¹

Affiliations

¹ Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.
² Department of Hematology and Oncology, Mount Lebanon Hospital, Beirut, Lebanon.
³ Department of Hematology and Oncology, Saint- Joseph University, Beirut, Lebanon.
⁴ Department of Hematology and Oncology, Middle East Institute of Health, Bsalim, Lebanon.
⁵ Department of Hematology and Oncology, Haykal Hospital, Tripoli, Lebanon.
⁶ Department of Hematology and Oncology, Hammoud Hospital University Medical Center, Saida, Lebanon.
⁷ Roche Lebanon SARL, Beirut, Lebanon.
⁸ Department of Hematology and Oncology, Hôtel-Dieu de France University Hospital, Beirut, Lebanon.

Abstract

Purpose: 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: FOLFOX; XELOX; bevacizumab; metastatic colorectal cancer.