Elderly advanced non-small-cell lung cancer (NSCLC) patients (p) treated with vinorelbine (vrb) plus gemcitabine (gem): Molecular correlates

Abstract

17043 Background: The clinical benefit of non-cisplatin doublets (vrb/gem) vs a single agent (vrb or gem) in elderly p is still controversial. The present study focuses on clinical outcome with vrb/gem in the elderly and the role of functional status. Genetic predictive markers of response to vrb/gem will also be examined in genomic and cDNA from tumor and circulating tumor DNA. Methods: NSCLC p with stage IIIB (pleural effusion or supraclavicular lymph nodes)-IV or recurrent disease and age ≥ 70 years were treated with vrb (25 mg/m2 iv or 60–80 mg/m2 oral) plus gem 1200 mg/m2, days 1,8 every 21 days. Activities of daily living (ADL), instrumental activities of dalily living (IADL) and comorbidities were evaluated. Primary tumor and baseline serum DNA were collected for assessment of microtubule associated protein 4 (MAP4) in tumor and checkpoint with forkhead-associated and ring finger (CHFR) methylation in serum. A preliminary analysis of response and toxicity was performed on 51 p. Results: From April 2004 to December 2005, 145 p were included. Data on 68 p is available: median age 74.5 years (70–83); stage IIIB: 21.2%, IV: 78.7%; PS 0: 23.4%, 1: 54.6%, 2: 21.8%. Self-sufficiency in ADL and IADL was 56.2% and 25% of the p analyzed. All p but 8 had comorbidities. Response rate for 51 p: partial response, 12% (95% CI, 8.9–20%); stable disease, 32% (95% CI, 19.2–44.8%). Main hematological toxicities: grade 3/4 neutropenia, 8.3/4.1%; grade 3 thrombocytopenia, 4.1%; grade 3 anemia, 4.1% of the p respectively. Conclusions: Preliminary findings indicate that vrb/gem is feasible in elderly p with acceptable toxicity. Complete data on response, survival and genetic markers will be presented. No significant financial relationships to disclose.