Docetaxel in combination with gemcitabine plus rhG-CSF support as second-line treatment in non-small cell lung cancer. A multicenter phase II study

Background: Docetaxel in combination with gemcitabine is an active front-li ne chemotherapy regimen against non-small cell lung cancer (NSCLC) with acc eptable toxicity. A multicenter phase II study was conducted in order to de termine the toxicity and efficacy of this combination, as salvage treatment in patients progressing after a cisplatin-based front line regimens. Patie nts and methods: Thirty-two patients with histologically confirmed, bidimen sionally measurable NSCLC, who failed prior cisplatin-based chemotherapy we re enrolled. The patients' median age was 62.5 years, 29 (91%) were male, 2 3 (72%) had disease stage IV, and 22 (69%) had a performance status (WHO) 0 -1. Gemcitabine (900 mg/m(2)) was administered on days 1 and 8 and docetaxe l (100 mg/m(2)) on day 8, after appropriate premedication, rhG-CSF (150 mug /m(2)) was given prophylactically from day 9 to 15. Treatment was repeated on an outpatient basis every three weeks. Results: A total of 127 chemother apy cycles were administered. In an intention-to-treat analysis five patien ts (15.6%; 95% CI: 3.04-28.21%) achieved a partial response, 11 (34.4%) sta ble disease, and 16 (50%) progressive disease. The median duration of respo nse was 9 months, the median TTP 7 months, and the overall median survival 6.5 months; the overall 1-year survival probability was 27.6%. Grade 3/4 ne utropenia was observed in five (15.6%) patients and in two of them associat ed with fever. Grade 3 anemia and thrombocytopenia occurred in three (9'%) and two (6.5%,) patients, respectively. Non-hematologic toxicity was very m ild with only one episode of grade 4 diarrhea and mucositis, respectively; two (6%) patients complained for grade 3 asthenia. Conclusion: The combinat ion of gemcitabine and docetaxel with prophylactic use of rhG-CSF is a safe and well-tolerated regimen for the treatment of patients with advanced NSC LC, who failed front-line treatment with cisplatin-based regimens. (C) 2001 Elsevier Science ireland Ltd. All rights reserved.