Purpose: We conducted a pilot study of Docetaxel (60mg/m
2) in patients with advanced non-small cell lung cancer (NSCLC) who were refractory to prior cisplatin (CDDP) or irinotecan (CPT-11)-containing chemotherapy regimens.
Subjects: Twelve patients were entered into the study, and were treated with 60mg/m
2 of Docetaxel intravenously over 1.5 hours every 3 or 4 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 of 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/m
2 intra-venously every 3 or 4 weeks has notable activity against CDDP or CPT-11 -refractory NSCLC with good PS.
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