Biweekly docetaxel as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC) and performance status (PS) 2: A phase II study of the Galician Lung Cancer Group

Abstract

19108 Background: There is no standard treatment for patients (pts) with advanced NSCLC and PS 2. Docetaxel (D) is active and well tolerated on a biweekly schedule. Methods: Pts with stage IIIB (with pleural effusion) and IV NSCLC, measurable disease, ECOG PS 2 and adequate organ function were included. D was administered at 50 mg/m2, iv, days 1 and 14. Cycles were repeated every 28 days until disease progression, occurrence of unacceptable toxicity or voluntary withdrawal. Results: A total of 15 pts were included (M/F, 12/3), with median age 61 years (46–72). Tumor histology included adenocarcinoma (60%), large cell (26.7%) and squamous (13.3%). Tumor stage was IIIB (13.3%) and IV (86.7%). Median number of metastatic lesions was 2 (66.7% with 2 or more), located mainly in bone (25%), lung (25%), liver (17.8%) and adrenal glands (14.3%). A total of 44 cycles (median 3, range 1–6) were administered. Median relative dose intensity for biweekly D was 98.7%. Toxicity: There were no grade III/IV hematologic toxicities. Grade III/IV non-hematologic toxicities per patient included mucositis ( 6.7%), nail changes (6.7%) and neurotoxicity (6.7%). Efficacy: Of 15 intent-to-treat patients, 2 achieved PR, 1 SD and 5 progressed, resulting in an ORR of 13% (95% CI: 1,6–40%). 7 patients could not be evaluated for response due to early withdrawal (3 tumor-related exitus and 4 PS deterioration). Median TTP and OS were 102 days (95% CI: 38,85–165,15) and 123 days (95% CI: 71–175), respectively. Conclusions: Although biweekly D has a very low toxicity profile, these results confirm the poor prognosis associated with a PS of 2, and new approaches are needed in this subset of patients. No significant financial relationships to disclose.