WCLC: Adding Bevacizumab to Chemotherapy Does Not Improve Overall Survival in Early-Stage NSCLC
Adding the monoclonal antibody bevacizumab (Avastin) to chemotherapy for patients with surgically removed non–small cell lung cancer (NSCLC) did not improve overall survival, according to research (Abstract PLEN04.03) presented at the 16th World Conference on Lung Cancer (WCLC) in Denver, Colorado. The Conference was hosted by the International Association of the Study of Lung Cancer.
Bevacizumab has been shown to improve outcomes when added to platinum-based chemotherapy in advanced-stage nonsquamous NSCLC. Research presented earlier in the WCLC showed that adding bevacizumab to standard treatment for malignant pleural mesothelioma increases life expectancy without severe toxicity.
Researchers led by Heather Wakelee, MD, Associate Professor of Medicine (Oncology) at the Stanford University Medical Center, on behalf of the ECOG-ACRIN Cancer Research Group, set out to determine whether the therapy also aided patients with resected early-stage NSCLC.
Study Details
Between 2007 and 2013, the research team enrolled 1,501 patients with NSCLC. The study randomly assigned patients to receive either chemotherapy alone or chemotherapy with bevacizumab every 3 weeks for 1 year.
Patients with resected stage IB (> 4 cm) to IIIA NSCLC were enrolled within 6 to 12 weeks of surgery and stratified by chemotherapy regimen, stage, histology, and sex. All patients were to receive adjuvant chemotherapy consisting of a planned four cycles of every-3-week cisplatin at 75 mg/m2, with vinorelbine, docetaxel, gemcitabine, or pemetrexed (Alimta).
The research randomly assigned patients 1:1 to chemotherapy alone or chemotherapy plus bevacizumab (adding bevacizumab at 15 mg/kg every 3 weeks starting with cycle 1 of chemotherapy and continuing for 1 year). Postoperative radiation therapy was not allowed. The study had 85% power to detect a 21% reduction in the overall survival hazard rate with a one-sided 0.025-level test.
Study Results
The addition of bevacizumab to adjuvant chemotherapy failed to improve survival for patients with surgically resected early-stage NSCLC. At the time of interim analysis (median follow-up of 41 months), the overall survival hazard ratio comparing the bevacizumab arm with the chemotherapy-alone arm was 0.99 (95% confidence interval [CI] = 0.81–1.21, P = .93), and the disease-free survival hazard ratio was 0.98 (95% CI = 0.84–1.14, P = .75).
“The study highlights the importance of randomized trials to prove—or disprove—the utility of drugs in different stages of disease,” Dr. Wakelee said. “With the development of other active agents in metastatic lung cancer, it will be important to investigate them fully in earlier stages, and not assume the benefit seen in advanced stage will also be proven in earlier stages, though we can remain hopeful.”
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