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Addition of aflibercept to topotecan improved PFS in SCLC
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CHICAGO — The addition of aflibercept with topotecan — compared with standard topotecan alone — significantly improved PFS in patients with platinum-resistant small cell lung cancer, according to results of a phase 2 trial.
“Small cell lung cancer accounts for about 15% of lung cancer cases in the United States,” Jeffrey Warren Allen, MD, associate director of clinical research at the University of Tennessee Cancer Institute, said during a press conference. “A majority of patients are diagnosed with extensive stage disease and are treated with platinum-based chemotherapy. While response rates are high to first-line chemotherapy, relapse is nearly universal, and long-term survival is very limited.”
As the only FDA-approved second-line chemotherapy for patients with SCLC, topotecan (Hycamtin, GlaxoSmithKline) in weekly doses has been associated with less toxicity than the five times daily regimen.
To evaluate the efficacy and toxicity of weekly IV topotecan (4 mg/m2) with or without aflibercept (Zaltrap, Sanofi and Regeneron Pharmaceuticals) in patients with relapsed SCLC, Allen and colleagues randomly assigned 96 patients to receive topotecan or topotecan plus aflibercept.
Eligible study patients exhibited adequate organ function, ECOG performance status of 0 to 1, and had experienced no recent bleeding or cardiac events. Patients with brain metastases stable for at least 3 months before study entry were allowed.
According to study results, 3-month PFS was 26% in the topotecan plus aflibercept group vs. 9% in patients who had received topotecan alone (P=.01). OS was observed to be similar in each arm, with 4.6 months in the aflibercept with topotecan group vs. 3.9 months in the topotecan group (P=.25). In addition, disease control rates were found to be 28% in the topotecan plus aflibercept group and 12% with topotecan alone.
Toxicity was found to be primarily hematologic, with 14% of the topotecan group and 19% of the topotecan plus aflibercept group experiencing grade-4 events; one treatment-related death in the topotecan group was also observed in the study.
“While the objective response rate was low, disease control was improved with the combination,” Allen said. “Toxicity was mainly hematologic and was less than seen with standard dose topotecan. However, nonhematologic toxicities were increased in the combination arm but were generally manageable and did not lead to a large increase in discontinuation.”
For more information:
Allen JW. Abstract #7005. Presented at: the 2012 American Society of Clinical Oncology Annual Meeting; June 1-5, 2012; Chicago.
Disclosure: The researchers reported funding from GlaxoSmithKline.