medwireNews: Trial findings indicate that adding bevacizumab to adjuvant chemotherapy does not improve survival for patients with surgically resected early-stage, non-small-cell lung cancer (NSCLC).
The phase III E1505 trial showed that neither overall survival (OS) nor disease-free survival (DFS) improved with the addition of the monoclonal antibody directed against vascular endothelial growth factor.
Reporting their findings in The Lancet Oncology, the researchers conclude: “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 open-label trial enrolled 1501 adults with an ECOG performance status of 0 or 1 who had completely resected stage IB (≥4 cm) to IIIA NSCLC. Of 1458 patients with complete staging information, 26% had stage IB, 44% had stage II, and 30% had stage IIIA disease. Squamous cell histology was reported for 28% of the cohort.
Participants were recruited between 6 and 12 weeks after surgery and randomly assigned to receive 4 cycles of one of four cisplatin-based chemotherapy regimens alone (n=749) or alongside a 1-year course of bevacizumab 15 mg/kg every 21 days (n=752).
Overall, 25% of patients received vinorelbine, 23% received docetaxel, 19% received gemcitabine, and 33% received pemetrexed, report Heather Wakelee (Stanford University, California, USA) and colleagues.
After a sixth planned interim analysis, the data and safety monitoring committee recommended releasing the study results at which point 475 deaths had occurred, equating to 70% of the 676 planned number of events.
Results showed that after a median follow up of 50.3 months, neither the primary endpoint of OS nor the secondary endpoint of DFS improved with the addition of bevacizumab to chemotherapy.
Grade 3–5 toxicities of note were reported more frequently in patients receiving bevacizumab than in those treated with chemotherapy alone, at 83% versus 67%, with hypertension observed in a corresponding 30% versus 8% of participants, and neutropenia in 37% versus 33%.
The number of deaths on treatment did not differ, at 19 in the bevacizumab group and 15 in the group given chemotherapy alone. Of these, 10 in the bevacizumab group and three in the chemotherapy alone group were considered at least possibly related to treatment.
In an editorial accompanying the study, Jared Weiss (University of North Carolina, Chapel Hill, USA) writes: “Although the results of E1505 cannot be celebrated, the trial’s results can direct clinical efforts away from bevacizumab and cytotoxic regimen choice.”
Highlighting the durvalumab findings from the PACIFIC trial, as well as the awaited ALCHEMIST results for erlotinib and crizotinib in patients with key biomarkers, and the ANVIL results for nivolumab therapy, he concludes: “Together, these trials might provide further direction to improved treatment regimens for patients with non-metastatic NSCLC.”
By Anita Chakraverty
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