A randomized phase II trial comparing carboplatin pleurodesis with cisplatin pleurodesis in patients with stage IIIB/IV non-small cell lung cancer (NSCLC) with malignant pleural effusions (MPE)

Abstract

17012 Background: We previously reported that carboplatin pleurodesis in patients with advanced lung adenocarcinoma with MPE, renal insufficiency, and poor performance status (PS) was an effective palliative therapy. However, the efficacy and toxicity profile of carboplatin pleurodesis in patients with NSCLC with MPE in comparison with those of cisplatin pleurodesis have not been reported. Methods: Thirty patients with stage IIIB/IV NSCLC accompanied with MPE who did not have an indication for systemic chemotherapy because of poor PS more than 2 were randomized to carboplatin pleurodesis (target area under the curve as 5 μg-min/ml using Calvert’s formula) and cisplatin pleurodesis (80 mg/m2) in a single-blind and controlled trial. Enrollment took place between Oct 2004 and Dec 2005. Primary efficacy endpoints were the best confirmed response rate, time to progression (TTP) in controlling MPE and adverse effects. Results: Fifteen of 30 patients were treated by carboplatin pleurodesis, and resting 15 of 30 patients were treated by cisplatin pleurodesis to control MPE. The response rate in carboplatin pleurodesis was not statistically different from that for patients in cisplatin pleurodesis (P = .226). The use of anticancer drugs for pleurodesis was not significantly associated with response rate in logistic regression analysis (relative risk = 14.2, 95% CI: 0.6–320.5, P = .095). Median TTP in carboplatin pleurodesis was not different from that in cisplatin pleurodesis (96 days vs 83 days). The use of carboplatin for pleurodesis (P = .016) and gender (P = .005) were associated with prolongation of TTP in the Cox regression method. Kaplan-Meier analysis showed that the progression free probability curve in carboplatin pleurodesis was not different from that in cisplatin pleurodesis (P = .275). The rate of Grade 3 thrombocytopenia in carboplatin pleurodesis (25%) was higher than that in cisplatin pleurodesis (0%), but there was no statistical significance (P = .096). Conclusions: Carboplatin pleurodesis and cisplatin pleurodesis may be feasible and acceptable toxicity profiles. No significant financial relationships to disclose.