Docetaxel in elderly patients: Phase I and pharmacokinetic study

Abstract

2113 Background: Elderly patients (>70 years) receive chemotherapy less frequently than younger and usually are excluded from clinical trials. The taxanes are among the most active agents available for the therapy of a variety of solid tumors, particularly breast, non-small cell lung cancer (NSCLC) and prostate cancer. Methods: In order to determine the Dose Limiting Toxicity (DLT) and the Maximum Tolerated Dose (MTD) of Docetaxel in elderly patients with advanced disease, to characterize the pertinent pharmacokinetic parameters in this population and to evaluate the response rate, two strata were defined: (A) 70 to 75 years and (B) older than 75 years. Patients received Docetaxel from 50 mg/m2 (50/ 60/ 70/ 75/ 80 mg/m2), administrated as 1 hour infusion every 3 weeks. A geriatric evaluation was performed with the Mini Nutritional Assessment (MNA> or = 12), the Activity Daily Life scale (Katz scale > or = 5) and the mini-Mental Score (MMS) before inclusion. Results: The median number of cycles was 5 in 30 patients. Patients characteristics were: 16 pts >75, 14 pts 70–75, Tumor types : Metastatic Breast Cancer (21), prostate (7), NSCLC (2). EGOG PS 0–1 (27), 2 (3). The main toxicity was neutropenia grade 3–4 (12/150 cycles); fatigue, fluid retention, nausea-vomiting were common but rarely severe (grade 1–2). DLT: 1 febrile neutropenia in stratum A at dose level 70 mg/m2, 2 in stratum B at dose level 60 mg/m2 (1 febrile neutropenia and 1 sepsis). Conclusion: MTD was not reached, Docetaxel is well tolerated in elderly patients. Accrual at dose level 80 mg/m2 is ongoing in both strata. PK and response rate results will be presented. No significant financial relationships to disclose.