NO BENEFIT OF ADJUVANT AVASTIN IN NSCLC

The phase III E1505 trial has shown no benefit of adding bevacizumab (Avastin) to adjuvant therapy in early-stage resected non–small cell lung cancer (NSCLC). These results were reported by Wakelee et al in The Lancet Oncology.

Study Details

In the open-label trial, 1,501 patients from across the U.S. National Clinical Trials Network were randomized within 6 to 12 weeks of surgery between June 2007 and September 2013 to receive chemotherapy plus bevacizumab (n = 752) or chemotherapy alone (n = 749). Patients had completely resected stage IB (≥ 4 cm) to IIIA disease. Chemotherapy consisted of four 21-day cycles of cisplatin (75 mg/m2 on day 1 in all regimens) in combination with investigator’s choice of vinorelbine (30 mg/m2 on days 1 and 8; 25% of patients), docetaxel (75 mg/m2 on day 1; 23%), gemcitabine (1,200 mg/m2 on days 1 and 8; 19%), or pemetrexed (500 mg/m2 on day 1; 33%). Patients in the bevacizumab group received bevacizumab at 15 mg/kg every 21 days starting with cycle 1 of chemotherapy and continuing for 1 year. Randomization was stratified by chemotherapy regimen, stage of disease, histology, and sex. Among patients with complete staging information, 26% had stage IB, 44% had stage II, and 30% had stage IIIA disease; 28% had squamous histology.

Overall Survival

The median follow-up was 50.3 months. Estimated median overall survival was not reached in the chemotherapy group vs 85.8 months in the bevacizumab group (hazard ratio = 0.99, P = .90).

Adverse Events

Grade ≥ 3 adverse events occurred in 67% of the chemotherapy group vs 83% of the bevacizumab group, with those more common in the bevacizumab group including hypertension (8% vs 30%) and neutropenia (33% vs 37%). Death on treatment occurred in 15 vs 19 patients and was considered at least possibly related to treatment in 3 vs 10 patients.

The investigators concluded: “Addition of bevacizumab to adjuvant chemotherapy did not improve overall survival for patients with surgically resected early-stage NSCLC. Bevacizumab does not have a role in this setting and should not be considered as an adjuvant therapy for patients with resected early-stage NSCLC.”

The study was funded by the National Cancer Institute.

Heather Wakelee, MD, of the Stanford Cancer Institute, is the corresponding author of The Lancet Oncologyarticle.