A phase II study of carboplatin and paclitacel with meloxicam.

BACKGROUND

Cyclooxygenase (COX-2) overexpression is seen in many malignancies including lung cancer. Recent pre-clinical studies have shown that selective COX-2 inhibitors have demonstrated promising results when used with chemotherapy. Based on these observations, we assessed the efficacy and tolerability of the combination chemotherapy consisting of carboplatin and paclitaxel with meloxicam, a selective COX-2 inhibitor.

METHODS

Forty-four patients with stage IIIB or IV non-small cell lung cancer (NSCLC), Eastern Cooperative Oncology Group performance status (PS) 0 or 1, who had adequate organ function, were eligible. Patients received paclitaxel 70 mg/m(2) weekly for 3 of 4 weeks with carbopltin (AUC 6) on day 1, as well as daily meloxicam (10 mg/day). The response rate was the primary endpoint. Secondary endpoints were overall survival, toxicity profile and quality of life (using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and LC13).

RESULTS

From March 2005 to September 2006, 44 patients were evaluated in this study. Gender M/F, 31/13; median age, 64 years (range, 34-75); stage IIIB/IV, 11/33; PS0/1, 22/22; histology Ad/Sq/Other, 29/6/9. Partial response was observed in 19 patients (43%) with stable disease, and there was no complete response, for an overall response rate of 43% (95% confidence interval, 28.5-57.8%). Ten patients (23%) had grade (G) 3 and three (7%) had G4 neutropenia. Three patients (7%) had G3 thrombocytopenia. As for non-hematological toxicities, one case of G4 toxicity (perforation of jejunum) was observed, but other toxicities were mild (one muscle pain, two liver dysfunction, one fatigue and one nausea G3). Grade 2 peripheral neuropathy was observed in only one patient. Using the EORTC QLQ questionnaire, the global health status did not change significantly during this therapy (before and 4 and 8 weeks later). Median follow-up was 13.6 months (range, 1.8-31.3 months). By the time of the final analysis (October 2007), 26 of the initial 44 patients had died. The 1-year survival rate was 64% and median survival time was 15.9 months.

CONCLUSIONS

Meloxicam in combination with carboplatin and weekly paclitaxel chemotherapy showed promising activity with encouraging survival. This therapy is relatively well tolerated in advanced NSCLC.