A Phase Ii Trial Of Weekly Cisplatin And Docetaxel In Advanced Non-Small Cell Lung Cancer (Nsclc)-Final Report

19105 Background: Every 3-week cisplatin doublets used to treat advanced NSCLC carry a significant risk of renal and other toxicities and can be difficult for patients with co-morbidities. To reduce these toxicities, we conducted a phase II study to evaluate the efficacy and toxicity of weekly cisplatin and docetaxel in patients with advanced NSCLC. Methods: Eligibility included patients with advanced/recurrent NSCLC, ECOG PS=0–1, no prior chemotherapy for metastatic disease. This Cancer Institute of New Jersey network, single stage phase II clinical trial was designed to give 3 weekly doses of cisplatin at 25 mg/m2 and docetaxel at 35 mg/m2 every 28 days, for a total of 6 cycles. Toxicity was monitored weekly, and disease evaluation performed every 2 cycles. The primary endpoint was response rate (RR); secondary endpoints included time to progression (TTP), median and 1-year survival. Results: From 12/03 to 12/07, 47 patients were enrolled. The median age of patients is 63 (range 34–83), the majority is white (n=40) with an ECOG PS=1, 35 have stage IV disease, and 21 are women. Histologic subtypes are: adenocarcinoma (n=29), NSCLC NOS (n=11), squamous (n=7). Fourteen patients received ≥ 4 cycles of therapy; median number of cycles delivered is 2.5. Reasons for treatment discontinuation include completion of therapy (n=7), progression of disease (n=19), adverse events (n=9), and patient preference (n=6). Four patients continue on therapy at this time. No complete responses were observed; 10 patients (21%) achieved a partial response, 11 had stable disease, 12 progressed, and 9 came off study before first disease evaluation. Median TTP was 3.8 months (mo) (95% CI 2.3,5.8), median survival is 9.1 mo (95% CI 5.8,14.9) and 1-year survival is 38% (95% CI 22%,54%). Most related toxicities were mild but also included neutropenia (grade 3, n=4; grade 4, n=2), neutropenic fever (n=1), renal toxicity (grade 3, n=2), nausea/vomiting (grade 3, n=2), fatigue (grade 3, n=3), diarrhea (grade 3, n=7) and metabolic abnormalities (grade 3, n=4). This trial is closed to accrual and final data are being collected. Conclusion: Weekly cisplatin and docetaxel is well tolerated with a low incidence of toxicity and demonstrates activity similar to every 3-week treatment in patients with advanced NSCLC. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration sanofi-aventis