Maintenance therapy (MT) with weekly paclitaxel improves outcome for advanced non-small cell lung cancer (NSCLC) patients

Abstract

7143 Background: There is no defined role for MT beyond 4 cycles of combination chemotherapy for advanced NSCLC. Our previously reported randomized, Phase III trial (Belani et al, Proc Am Soc Clin Oncol, 23:619, 2004) evaluated weekly paclitaxel as MT for patients with CR, PR or SD after 4 cycles of chemotherapy. We now present results of the MT phase of that study. Methods: Patients were randomized to Arm 1 (carboplatin AUC=6 mg/ml.min every 4 weeks with paclitaxel 100 mg/m2 weekly for 3 out of 4 weeks) or Arm 2 (carboplatin AUC= 6 mg/ml.min and paclitaxel 225 mg/m2, both administered every 3 weeks). Following 4 cycles of therapy, patients with CR, PR or SD were eligible to receive MT with paclitaxel at 70 mg/m2 weekly for 3 of 4 weeks until progression. Results: Of the 444 patients enrolled, 183 were eligible for MT; 141 (77%) entered the MT phase. Sixty two percent of patients were male and median age was 63 years (35–83). For patients who participated in MT, the median number of paclitaxel doses was10 (1–51) for Arm 1 and 9 (1–80) for Arm 2. Median TTP was 33 weeks and 29 weeks respectively for Arms 1 and 2 for those patients receiving MT (n=141), compared to 12 weeks (Arm 1) and 11 weeks (Arm 2) for patients not eligible for MT (n=261) or who chose not to receive MT (n=42) combined (no MT). Median survival was 76 weeks (MT) versus 29 weeks (no MT). One- and 2-year survival rates were 69% and 33% (MT) versus 25% and 9% (no MT), respectively. Among those patients eligible for MT, median survival was significantly greater (p=0.016) for those who received MT (76 weeks) than for those who refused MT (50 weeks). The incidence of gr3/4neutropenia was 1.4% without any febrile neutropenia and gr3/4 neuropathy was 3.5%. Conclusions: Maintenance weekly paclitaxel for patients who achieve CR/PR/SD with initial therapy is associated with improved survival and minimal toxicity. MT therapy with weekly paclitaxel may be considered a potential therapeutic option for advanced NSCLC. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bristol-Myers Squibb Bristol-Myers Squibb Bristol-Myers Squibb Bristol-Myers Squibb