Cox-2 inhibitors in the treatment of small cell lung cancer patients

Abstract

Background: Several preclinical and clinical studies have demonstrated that cyclooxygenase-2 (Cox-2) inhibitors have anti-tumor activity in the treatment of non-small-cell lung cancer. However, there is little data on the use of Cox2 inhibitors in patients with small cell carcinoma (SCLC). The aim of this prospective study was to evaluate the role of Rofecoxib , a selective Cox2 inhibitor in combination with conventional chemotherapy in SCLC treatment. Methods: Patients with extensive small-cell lung cancer and median age 62±11.7 years, were randomized to receive oral rofecoxib 12.5 mg twice daily every day plus cisplatin 25 mg/m(2) and etoposide 100 mg/m2 or chemotherapy alone. Both regimens were repeated every 4 weeks until disease progression. Primary end points of our study were survival and time to progression Results: 98 patients were enrolled. 44 pts were randomly assigned chemotherapy plus rofecoxib and 54 chemotherapy alone. Median OS was 14 months (95% CI, 11.5 to 16 mo) for the cox-2 arm and 7.7 months (95% CI, 6 to 9.4) for chemotherapy(control) arm, which is statistically significant (p= 0.001). Median time to progression was 9.2 months (95% CI, 7.4 to 11) for the cox-2 arm and 5 months (95% CI, 3.7 to 6.5) for the control arm (p= 0.004). The response rates were 48.0 and 29.6%, respectively. Toxicity was mild, and no increase in cardiovascular events was observed. Conclusion: In advanced SCLC, rofecoxib in combination with chemotherapy improves survival , but the results must be interpreted with caution due to the limited number of patients.