Phase II study of biweekly carboplatin and paclitaxel as first-line treatment for elderly patients with advanced non-small cell lung cancer.

Abstract

e18013 Background: Incidence of elderly advanced non-small cell lung cancer (NSCLC) is increasing and the establishment of optimal treatment for the elderly patients is desired. Currently, as the elderly are underrepresented in clinical trials, only limited data exist. Standard chemotherapy by platinum doublet of elderly patients with advanced NSCLC is still controversial. This study has been conducted to assess the efficacy and toxicity of biweekly carboplatin plus paclitaxel in elderly patients with advanced NSCLC. Methods: Patients ≥70 years old with cytological or histological confirmation of advanced (stage IIIB/IV) NSCLC were included. Other eligibility criteria were PS≤2, measurable lesions according RECIST criteria, adequate organ function. Patients with prior systemic therapy for NSCLC and/or symptomatic brain metastases were not allowed. Patients received biweekly paclitaxel 90 mg/m2 and carboplatin 2.5 AUC on days 1 and 14 of each 28-day cycle. The primary endpoint was the overall response rate (ORR), and secondary endpoints were progression-free survival (PFS), overall survival, and the toxicity profile. Results: We enrolled 47 pts from multiple institutions (Jan. 2007 – Oct. 2010). Males were 76.6%, median age was 77 years (range 70-85). PS was 0-1 in 95.7%. The median number of treatment cycle was 3 (1-6). The objective responses were CR 0; PR 10; SD 12; PD 14; and NE 11, resulting in an ORR of 21.3% (95% confidence interval [CI], 9.6- 33.0). The overall disease control rate was 46.8% (95% CI, 32.5-61.1). Median PFS was 4.17 month (95% CI: 2.18- 6.16). Hematological toxicities of grade 3/4 included neutropenia (28%), leucopenia (19%) and anemia (11%). Nonhematological toxicities (all grade 3) included infusion reaction (2%), anorexia (2%), infection (13%), thrombosis (2%), fatigue (2%), diarrhea (2%) and gastrointestinal bleeding (2%). No grade 4 nonhematological toxicity was observed. There was 1 possible treatment-related death due to interstitial pneumonia. Conclusions: The combination of biweekly carboplatin and paclitaxel is an active first line treatment with a tolerable toxicity profile for advanced NSCLC in elderly patients.