Adjuvant Chemotherapy With or Without Monoclonal Antibody in Resected NSCLC


Key Points

  • The addition of bevacizumab to chemotherapy did not improve overall survival in patients with resected NSCLC.
  • The median overall survival was not reached in the chemotherapy group vs 85.8 months in the bevacizumab group.

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 Oncology article.

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