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Maintenance sunitinib extends PFS in extensive-stage small cell lung cancer
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Maintenance sunitinib safely and effectively prolonged PFS in patients with small cell lung cancer, according to study results.
Neal E. Ready, MD, PhD, of the department of medical oncology at Duke University Medical Center, and colleagues evaluated data from 95 patients with small cell lung cancer (SCLC) enrolled on the Cancer and Leukemia Group B 30504 trial. All patients achieved a complete response, partial response or stable disease with chemotherapy.
Neal E. Ready
Eighty-five of these patients received maintenance therapy. Researchers randomly assigned 44 of them to maintenance therapy with 37.5 mg daily sunitinib (Sutent, Pfizer). The other 41 patients received placebo.
Median follow-up was 17.2 months.
Patients assigned maintenance sunitinib demonstrated a significant improvement in median PFS (3.7 months vs. 2.1 months; HR = 1.62; 70% CI, 1.27-2.08).
Median OS was 9 months (95% CI, 8-12.7) in the sunitinib arm vs. 6.9 months (95% CI, 5.4-11.8) in the placebo arm. However, this difference did not reach statistical significance.
Eighteen patients assigned placebo crossed over to treatment with sunitinib after disease progression. Retrospective PFS data were available from 13 of these patients. Among these patients, median PFS was 4.9 months (95% CI, 2.9-5.9) on cross-over sunitinib vs. 2.6 months (95% CI, 1.6-4.5) on placebo.
The most common grade 3 adverse events associated with sunitinib included fatigue (19%), decreased neutrophils (14%), decreased leukocytes (7%) and decreased platelets (7%). One patient assigned sunitinib experienced grade 4 gastrointestinal hemorrhage, and one patient experienced grade 4 pancreatitis, hypocalcemia and elevated lipase.
Patients who crossed over to sunitinib at the time of progression were more likely to experience a grade 3 or worse adverse event than patients who received immediate sunitinib maintenance (94.2% vs. 53.5%; P = .002).
“Maintenance sunitinib in CALGB 30504 was safe and significantly less toxic than the same dose of sunitinib given at the time of progression, providing a strong rationale for studying novel therapies in a maintenance trial design in SCLC,” Ready and colleagues wrote. “Sunitinib given after standard chemotherapy in extensive-stage SCLC improved PFS, and OS was promising despite the cross-over design. … A randomized phase 2 trial studying maintenance sunitinib with OS as the primary end point would be the appropriate next step, especially if the trial design incorporated a candidate sunitinib benefit predictive biomarker for retrospective validation.” – by Cameron Kelsall
Disclosure: The researchers report research funding from, consulting/advisory roles with or speakers bureau roles with Bristol-Myers Squibb, Celgene, Genentech, GlaxoSmithKline, Merck, Novartis, Onyx, Pfizer and other pharmaceutical companies.
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