The addition of pravastatin to the first-line standard of care failed to provide benefit for patients with small-cell lung cancer (SCLC) with limited or extensive disease, according to the LUNGSTAR results published in the Journal of Clinical Oncology.1
Observational studies suggest that statins provide an additive or synergistic effect to chemotherapy in multiple tumor types, including SCLC. The purpose of this trial was to determine if there is benefit in adding a statin to the standard of care treatment in SCLC.
In the multicenter, double-blind, phase 3 LUNGSTAR (ClinicalTrials.gov Identifier: NCT00433498) trial, patients with SCLC received first-line etoposide plus cisplatin or carboplatin every 3 weeks and were randomly assigned to receive 40 mg pravastatin once daily or placebo. The primary endpoint was overall survival (OS) and the secondary endpoints included progression-free survival (PFS), response rate, and toxicity.
The trial enrolled 846 patients with a median age of 64. The rate of adherence was similar in the pravastatin and placebo arms.
Pravastatin provided no additional benefit in median OS compared with placebo (10.9 vs 10.7 months). The 2-year OS rate in the pravastatin arm was 13.2% (95% CI, 10.0-16.7%) compared with 14.1% (95% CI, 10.9-17.7) in the placebo arm (hazard ratio [HR], 1.01; 95% CI, 0.88-1.16; P = .90). Subgroup analyses, including disease extent, found no difference between the arms.
PFS was similar, with a median of 7.7 months with pravastatin compared with 7.3 months with placebo (adjusted HR, 1.01; 95% CI, 0.88-1.17; P = .86). Tumor response was 69% in the pravastatin and placebo groups.
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The rate of grade 3/4 adverse events were similar between the pravastatin and placebo arms. Myalgia and myositis, which are associated with statin use, were also similar between arms.
- Seckl MJ, Ottensmeier CH, Cullen M, et al. Multicenter, phase III, randomized, double-blind, placebo-controlled trial of pravastatin added to first-line standard chemotherapy in small-cell lung cancer (LUNGSTAR). J Clin Oncol. 2017 Feb 27. doi: 10.1200/JCO.2016.69.7391 [Epub ahead of print]