Phase I/II study of weekly docetaxel in patients with previously treated non-small cell lung cancer (NSCLC)

Abstract

7243 Objective: Docetaxel is useful in the treatment of previously treated non-small cell lung cancer (NSCLC). However adequate treatment schedule is not well established. To assess the maximum-tolerated dose (MTD), dose limiting toxicity(DLT), and tumor response, we conducted a phase I/II trial of weekly docetaxel treatment in previously treated NSCLC patients (pts). Patient and Method: Eligibility criteria of pts included were histologically confirmed, relapsed tumor (phase I) and NSCLC (phase II), ECOG PS 0–1, adequate organ functions, measurable disease (phase II). Docetaxel was administered weekly for 3 consecutive weeks every 4 weeks. Patients were treated at the following dose levels; 25, 30, 35, 40 mg/m2 /wk (phase I). DLT was defined as grade (G) 4 neutropenia > 4 days, neutropenic fever, G 4 thrombocytopenia > 4 days, any nonhematologic G 3 or 4 toxicity with the exception of alopecia, nausea and vomiting, dose held for hematologic toxicity of grade 3 or 4 on days 8 and 15. The MTD was determined when greater than one third of patients experienced DLT at a given dose. Results: Thirty-nine patients were enrolled. Patient characteristics: NSCLC/small cell lung cancer/breast cancer: 29/6/4, median age 62 range (42–72), male/female 20/19, PS 0/1: 10/29,. The DLT of this weekly schedule was leukopenia. The MTD was 40mg/m2 /wk, so that recommend dose for phase II study was 35mg/m2/wk. There were no complete responses. Two patients had a partial response (overall response rate, 10%). Frequent hematologic toxicities were neutropenia (G 3/4, 21%) and leukocytopenia (G 3/4, 21%). Frequent nonhematologic toxicities were nausea, neuropathy and hair loss, but these side effects did not exceed grade 2. These toxicities were moderate and transient without no specific supportive cares. Conclusion: Second-line weekly schedule of docetaxel has less toxic and compatible activity with the previously reported three weeks schedule. No significant financial relationships to disclose.