Paclitaxel/carboplatin/etoposide versus paclitaxel/topotecan for extensive stage small cell lung cancer: A Minnie Pearl Cancer Research Network randomized prospective phase II trial.

7205 Background: Platinum plus etoposide chemotherapy is currently standard for patients (pts) with extensive stage small cell lung cancer. Nonplatinum doublets of active newer drugs may be superior. METHODS The purpose of this randomized phase II trial was to compare the toxicity, response rates, and progression-free survival (PFS) of platinum/etoposide-based chemotherapy to paclitaxel plus topotecan. Between December 1999 and June 2003, 120 pts with extensive stage small cell lung cancer were randomized to receive either Arm A (60 pts): paclitaxel 200mg/m2 day 1, carboplatin AUC 6 day 1, oral etoposide 50mg alternating with 100mg for 10 consecutive days for 4 cycles (repeated every 3 weeks) versus Arm B (60 pts): paclitaxel 175mg/m2 day 1, and topotecan 1.5mg/m2 days 1, 2, and 3, for 4 cycles (repeated every 3 weeks). Eligibility required no prior chemotherapy, ECOG performance status (PS) 0-1, and normal organ function. RESULTS Pts were evenly matched with respect to PS, visceral metastases, number of metastatic sites, and gender. There were 68 men and 52 women. Grade 3/4 neutropenia/thrombocytopenia: Arm A - 20 pts (33%)/6 pts (10%); Arm B - 27 pts (45%)/14 pts (23%). Nonhematologic toxicity was similar in both arms. Overall response rates were 77% (38 pts) in Arm A and 49% (25 pts) in Arm B (p=0.03) with 13% (8 pts) with complete responses in Arm A and 6.5% (4 pts) in Arm B (p=0.12), respectively. The median PFS in Arm A was 7.4 months versus 5.5 months for Arm B (p=0.0043). Progression-free survival at 12 months and 18 months was 15% and 8% in Arm A and 8% and 0% in Arm B, respectively. Median survival in Arm A was 10.6 months versus 9.1 months in Arm B (p=0.2581). The 12-month and 18-month survival was 38% and 20% in Arm A and 30% and 13% in Arm B, respectively. CONCLUSIONS The overall toxicity profile, response rate, and PFS of paclitaxel/carboplatin/etoposide (Arm A) is superior to the nonplatinum doublet of paclitaxel plus topotecan (Arm B). [Table: see text].