Pilot study of docetaxel for cisplatin- or irinotecan-refractory non- small cell lung cancer

Purpose: We conducted a pilot study of Docetaxel (60mg/m²) in patients with advanced non-small cell lung cancer (NSCLC) who were refractory to prior cisplatin (CDDP) or irinotecan (CPT-11) - containing chemotherapy regiments. Subjects: Twelve patients were entered into the study, and were treated with 60mg/m² of Docetaxel intravenously over 1.5 hours every 3 or 3 weeks. Most patients had a performance status (PS) (ECOG) of 1, the predominant histologic type was adenocarcinoma (58%), and all patients had stage IV disease. Prior chemotherapy had resulted in no change in of seven 12 patients and progressive disease in two of 12 patients. Results: Two of 12 assessable patients achieved a partial response (16.7%) to treatment. The response duration (from response to progression) was 5.8 and 2.3 months, and the projected median survival time of all patients was 170 days (285 days for PS 0,1 and 116 days for PS 2). Grade 3/4 neutropenia occurred in 58% of patients and was not associated with fever. Other acute side effects included easily treated nonhematologic toxicities. Primary side effects were neutropenia. Conclusions: Although our data are preliminary, it is possible that Docetaxel administered at a based 60mg/m²intravenously every 3 or 4 weeks has notable activity against CDDP or CPT-11 -refractory NSCLC with good PS.