Phase II study of docetaxel monotherapy in elderly patients with advanced non-small-cell lung cancer (NSCLC)

Abstract

8192 Background: Treatment of elderly patients with lung cancer is of particular concern, since the incidence of lung cancer peaks at the age of more than 75 years. Methods: Chemotherapy-naïve elderly patients (age ≥ 76 years) with locally advanced or metastatic NSCLC were accrued. Docetaxel was given at a dose of 60 mg/m2 on day 1 and repeated every 3 to 4 weeks. Patients who were considered ineligible for this study were also registered. Assessment of symptom control using a questionnaire was performed during the treatment period. In addition, the pharmacokinetics of docetaxel were evaluated. Results: Between Nov. 1999 and Dec. 2001, 35 elderly patients with advanced NSCLC were accrued in this study. Of them, 15 (43%) met the study eligibility criteria. The reasons for ineligibility consisted mainly of poor PS, poor bone marrow function and hypoxemia. Six patients achieved a PR (40%; 95% CI, 15 to 65%). Median survival time was 15.6 months (95% CI, 11.4 to 19.8 months). The major toxicity was hematologic, with grade 3 or greater neutropenia and grade 3 neutropenic fever developing in 13 (87%) and five (33%) patients, respectively. However, symptoms assessed by symptom control score did not clearly decline during treatment period. The pharmacokinetic profile of docetaxel (n = 12) exhibited a considerable degree of interpatient variability. In addition, Cmax, T1/2 and AUC0→inf in the elderly patients were each somewhat lower than in the non-elderly population. Conclusions: Toxicities were more frequent than expected, however, this therapy was considered manageable from the view point of symptom control assessment. Usefulness of docetaxel monotherapy in selected elderly patients with advanced NSCLC should be examined in a phase III study. No significant financial relationships to disclose.