EFFICACY OF THE COMBINATION BEVACIZUMAB PLUS CHEMOTHERAPY (BEV-CT) COMPARED TO CT ALONE IN PREVIOUSLY UNTREATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC)- SYSTEMATIC REVIEW (SR) AND META-ANALYSIS (MA)
Author(s)
Botrel TEA, Clark O, Clark LGO, Paladini L, Faleiros E, Pegoretti BMedInsight-Evidências, Campinas, Brazil
OBJECTIVES: To perform SR with MA of all randomized controlled trials (RCT) comparing the efficacy of BEV-CT versus CT alone in previously untreated locally advanced or metastatic NSCLC. METHODS: We searched MEDLINE, EMBASE, LILACS, and CENTRAL among others. Primary endpoints were overall survival (OS) and progression-free survival (PFS). Adverse events (AE) were analyzed. Extracted data were combined using Hazard Ratio (HR) or Risk Ratio (RR) with 95% Confidence Intervals (CI95%). RESULTS: 544 references were identified and screened, 3 trials comprising 2,020 patients were included. Overall response rate (RR=0.53; CI95%=0.44 to 0.64; p<0.00001) and PFS were higher in BEV-CT (HR=0.71, CI95%=0.63 to 0.80; p<0.00001), however with significant heterogeneity (Chi2 = 4.9, df = 2 (P=0.09); I2 = 59%) and (Chi2 = 4.33, df = 2 (P=0.11); I2 = 54%), respectively. Random-efffects model analysis favored BEV-CT. OS was higher in BEV-CT but with significant heterogeneity (Chi2 = 5.92, df = 3 (P=0.12); I2 = 49%) and random-effects model analysis was not statistically significant (HR=0.86, CI95%=0.71 to 1.05; p=0.15). Neutropenia (RR=0.77; CI95%=0.65 to 0.91; p=0.002) and febrile neutropenia (RR=0.42; CI95%=0.22 to 0.81; p=0.009) were higher on BEV-CT. Rates of anemia (RR=1.41; CI95%=0.93 to 2.13; p=0.1) and thrombocytopenia RR=0.91; CI95%=0.69 to 1.20; p=0.50) were similar. Non-hematologic toxicities were higher on BEV-CT: haemoptysis (RR=0.28; CI95%=0.09 to 0.90; p=0.03), hypertension (RR=0.15; CI95%=0.07 to 0.30; p<0.00001), proteinuria (RR=0.05; CI95%=0.01 to 0.41; p=0.005), venous thromboembolic events (RR=0.87; CI95%=0.51 to 1.47; p=0.6), vomiting (RR=0.41; CI95%=0.22 to 0.77; p=0.005), rash (RR=0.19; CI95%=0.04 to 0.88; p=0.03), epistaxis (RR=0.32; CI95%=0.03 to 3.10; p=0.33) and bleeding events (RR=0.27; CI95%=0.13 to 0.56; p=0.0004). CONCLUSIONS: The combination BEV-CT increased the response rate and PFS in patients with NSCLC. Benefits in overall survival remain uncertain, and toxicity rates were higher in the combination group.
Conference/Value in Health Info
2010-11, ISPOR Europe 2010, Prague, Czech Republic
Value in Health, Vol. 13, No. 7 (November 2010)
Code
CN1
Topic
Clinical Outcomes, Epidemiology & Public Health
Topic Subcategory
Comparative Effectiveness or Efficacy, Relating Intermediate to Long-term Outcomes, Safety & Pharmacoepidemiology
Disease
Oncology