Patients with small-cell lung cancer derived no survival benefit from cholesterol-lowering medication, according to a phase 3 randomized, double blind, multicenter, placebo-controlled study published in Journal of Oncology.
“There’s no reason for people to stop taking statins to manage their cholesterol, but it’s extremely unlikely, for patients with small-cell lung cancer, that taking statins will make any difference to their cancer treatment outcome,” Michael J. Seckl, MD, professor of molecular cancer medicine at Imperial College London, said in a press release. “Because all statins work in a similar way to lower cholesterol, it’s relatively unlikely that statins other than pravastatin would have a different, more beneficial effect.”
Michael J. Seckl
Small-cell lung cancer (SCLC) accounts for nearly 20% of all new cases of lung cancer worldwide and carries a median survival of 12 to 14 months for patients with limited-stage disease and 8 to 12 months for those with extensive-stage disease.
Previous experimental and preclinical studies have indicated that cholesterol-lowering statins, such as pravastatin, can inhibit tumor growth in several tumor types, including pancreatic carcinoma, mesothelioma, breast cancer and SCLC cells.
Researchers randomly assigned 846 adults (51% men; median age, 64 years) with limited (43%) or extensive (57%) SCLC to receive 40 mg pravastatin daily or placebo. Patients also received six cycles of etoposide plus cisplatin or carboplatin every 3 weeks for 2 years or until disease progression or intolerable toxicity.
OS served as the primary endpoint. PFS, response rate and toxicity served as secondary endpoints.
The median length of time on treatment was 8.6 months for pravastatin and 7.8 months for placebo; the amount of chemotherapy administered was similar between the two groups.
PFS events occurred in 787 patients, and 758 patients died.
Median OS was similar between treatment groups (pravastatin, 10.7 months vs. placebo, 10.6 months; HR = 1.01; 95% CI, 0.88-1.16). The corresponding 2-year OS rates were 14.1% (95%, CI, 10.9-17.7) for pravastatin and 13.2% (95% CI, 10.0-16.7) for placebo.
Median OS was the same for patients with limited-stage disease receiving either pravastatin or placebo (14.6 months for both). Among patients with extensive-stage disease, median OS was 9.1 months with pravastatin and 8.8 months with placebo.
Median PFS was 7.7 months in the pravastatin group and 7.3 months in the placebo group (HR = 0.98; 95% CI, 0.85-1.13). The corresponding 2-year PFS rates were 7.5% (95% CI, 5.2-10.3) for pravastatin and 7.2% (95% CI, 4.9-10.0) for placebo.
Tumor response rates (pravastatin, 69% vs. placebo, 69.1%) and adverse events (81.2% vs. 81.4%) were nearly identical in the two groups.
Trials comparing statins in other cancer types are ongoing.
“Our results match those of other randomized trials examining different types of cancers, but these were much smaller than our own study, and they have also shown no benefit to using statins in cancer treatment,” Allan Hackshaw, MD, deputy director of Cancer Research UK, said in the release. “Collectively, this evidence seems quite persuasive.” – by Chuck Gormley
Cancer Research UK funded this study. The researchers report no relevant financial disclosures.