EFFICACY AND SAFETY OF BEVACIZUMAB IN COLORECTAL CANCER

Oncologist. 2013;18(9):1004-12. doi: 10.1634/theoncologist.2013-0107. Epub 2013 Jul 23.

Efficacy and safety of bevacizumab in metastatic colorectal cancer: pooled analysis from seven randomized controlled trials.

Hurwitz HI, Tebbutt NC, Kabbinavar F, Giantonio BJ, Guan ZZ, Mitchell L, Waterkamp D, Tabernero J.

Source

Duke University Medical Center, Division of Hematology and Oncology, Durham, North Carolina, USA;

Abstract

This analysis pooled individual patient data from randomized controlled trials (RCTs) to more thoroughly examine clinical outcomes when adding bevacizumab to chemotherapy for patients with metastatic colorectal cancer (mCRC). Patients and Methods. Patient data were pooled from the first-line AVF2107, NO16966, ARTIST, AVF0780, AVF2192, and AGITG MAX RCTs and the second-line E3200 RCT. All analyses were based on the intent-to-treat population. To assess differences in time-to-event variables by treatment (chemotherapy with or without placebo vs. chemotherapy plus bevacizumab), stratified random-effects (overall) and fixed-effects (subgroup comparisons) models were used to estimate pooled hazard ratios (HRs) and 95% confidence intervals (CIs). Results. The analysis population comprised 3,763 patients (1,773 chemotherapy with or without placebo; 1,990 chemotherapy plus bevacizumab). The addition of bevacizumab to chemotherapy was associated with statistically significant increases in overall survival (OS; HR, 0.80; 95% CI, 0.71-0.90) and progression-free survival (PFS; HR, 0.57; 95% CI, 0.46-0.71). The effects on OS and PFS across subgroups defined by chemotherapy backbone (oxaliplatin-based, irinotecan-based), extent of disease (liver metastases only, extensive disease), age (<65 across="" analysis.="" and="" benefit="" bevacizumab="" bleeding="" chemotherapy="" clinically="" complications="" conclusion.="" consistent="" cooperative="" eastern="" events="" examined.="" extended="" for="" gastrointestinal="" grade="" group="" hypertension="" in="" incidence="" increased="" increases="" individual="" kras="" mcrc.="" mutant="" nbsp="" observed="" of="" oncology="" os="" overall="" p="" patients="" perforations="" performance="" pfs="" profile="" proteinuria="" rates="" relevant="" reported="" resulted="" safety="" significant="" statistically="" status="" subgroups="" that="" the="" thromboembolic="" treatment.="" trials.="" use="" was="" were="" wild-type="" with="" wound-healing="" years="">