Phase I/II trial of carboplatin (CBDCA)/ weekly paclitaxel in patients with advanced non-small cell lung cancer in Japanese population: WJTOG 9907

Abstract

7341 Background: Weekly paclitaxel is superior to conventional every-three week delivery in metastatic breast cancer (Seidman D, et al. ProcASCO 2004). Peripheral neuropathy and arthralgia were less frequent with weekly doses in non-small cell lung cancer (Belani CP, et al. ProcASCO 2004). Methods: In the phase I part, the doses of paclitaxel were increased 70, 80, 90, and 100 mg/m2 on days 1, 8, and 15 q4w with the fixed dose of CBDCA (AUC=6 mg/mL · min) on day 1. The phase II was followed. Eligibility included ECOG PS 0 to 1, advanced IIIB-IV chemo-naïve non-small cell lung cancer. Results: The Phase I part was consisted of 12 patients (pts), 3 pts in each step. Recommended dose of paclitaxel was 90 mg/m2. In the phase II part, 26 pts (male/female 19/7) were entered. Median age was 63.5 (range 42–74). Pts with IIIB/IV/relapsed after resection were 6/16/4, respectively. PS 0 in 10 pts, adeno in 20 pts, and weight loss (< 5%) in 21 pts. Response rate was 37% (n=19). Grade 4 leukopenia, neutropenia, anemia were observed in 1, 4, 1 pt(s) respectively. No grade 3 or 4 non-hematologic toxicity was observed except 1 pt with grade 3 infection. No toxic death was reported. Conclusions: The antitumor effect was moderate. Grade 3 or 4 peripheral neuropathy was not observed in Japanese population. No significant financial relationships to disclose.