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Bevacizumab may prolong PFS after progression of advanced NSCLC
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Continued treatment with bevacizumab demonstrated a modest improvement in PFS among patients with advanced nonsquamous non–small cell lung cancer whose disease progressed after treatment with bevacizumab and a platinum doublet, according to results of an open-label phase 2 study.
Bevacizumab (Avastin, Genentech) in combination with platinum-based chemotherapy currently serves as a first-line standard of care for patients with advanced nonsquamous NSCLC, according to study background.
John V. Heymach
However, little research has been conducted on the efficacy of bevacizumab beyond disease progression in this patient population.
Thus, Isamu Okamoto, MD, of the Research Institute for Diseases of the Chest at Kyushu University’s Graduate School of Medical Sciences in Japan, and colleagues from the West Japan Oncology Group sought to determine the efficacy of bevacizumab in patients whose disease progressed after first-line treatment.
The multicenter study included data from 100 patients with recurrent or metastatic NSCLC. Researchers randomly assigned patients to receive 60 mg/m2 docetaxel alone (n = 50; mean age, 67 years; 64% men) or with 15 mg/kg bevacizumab (n = 50; mean age, 64.5 years; 66% men) every 3 weeks.
PFS served as the primary endpoint.
Median follow-up was 11.2 months (interquartile range, 6.4-17.8).
Median PFS was 4.4 months among patients assigned docetaxel plus bevacizumab, compared with 3.3 months among patients assigned docetaxel alone (HR = 0.71; 95% CI, 0.47-1.09).
The stratified log-rank P value (P = .058) met the study’s predefined criterion for statistical significance (P < .2).
Further, bevacizumab appeared associated with increased OS; however, these results did not reach statistical significance (median OS, 13.1 months vs. 11 months; HR = 0.74; 95% CI, 0.46-1.19).
Patients assigned bevacizumab had an objective response rate of 36% (95% CI, 22.9-50.8), compared with 26% (95% CI, 14.6-40.3) among patients assigned docetaxel alone. Both groups had a disease control rate of 62% (95% CI, 47.2-75.3).
Patients assigned bevacizumab experienced a greater incidence of grade 3 or higher leukopenia (64% vs. 52%) and neutropenia (90% vs. 80%). Twenty-six percent of patients in both treatment groups reported febrile neutropenia.
Two deaths were attributable to treatment-related adverse events (n = 1 for each group).
The researchers acknowledged limitations of their study, including the small sample size and the hypothesis-generating, nonconfirmatory design.
However, they noted that a phase 3 study is currently under way to assess the use of bevacizumab in this patient population.
“Our study has demonstrated an improved PFS in patients treated with docetaxel plus bevacizumab in patients with NSCLC whose disease has progressed after first-line treatment with bevacizumab and a platinum-based doublet,” Okamoto and colleagues wrote. “Although our results met the threshold significance level for the log-rank test, they require careful interpretation because of the marginal effect of the addition of bevacizumab to docetaxel.”
Although these data mark an “important contribution” to the literature on bevacizumab’s role in the NSCLC treatment arena, further study is needed to determine the agent’s optimal use in this setting, Irene Guijarro-Muñoz, PhD, Emily B. Roarty, PhD, and John V. Heymach, MD, PhD, all of the department of thoracic/head and neck medical oncology at The University of Texas MD Anderson Cancer Center, wrote in an accompanying editorial.
“It is unclear whether such additional studies would be worthwhile, however, because of the availability of other vascular epithelial growth factor [VEGF] pathway inhibitors such as ramucirumab [Cyramza, Lilly] in the U.S. and nintedanib [Ofev, Boehringer Ingelheim] in the European Union for use with docetaxel in platinum-refractory NSCLC,” they wrote. “There are, in fact, theoretical reasons to believe that switching to a broader tyrosine kinase inhibitor or mechanistically distinct VEGF inhibitor may be preferable to continuing bevacizumab.” – by Cameron Kelsall
Disclosure: Okamoto reports personal fees from Chugai Pharmaceutical. Please see the full study for a list of all other researchers’ relevant financial disclosures. Heymach reports grant support from and/or advisory board positions with AstraZeneca, Bayer, Boehringer Ingelheim, Exelixis, Genentech, GlaxoSmithKline, Lilly, Novartis and Synta. Guijarro-Muñoz and Roarty report no relevant financial disclosures.
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