Dr. Frederick P. Smith received speaking honoraria (not exceeding $2000 per year) from Aventis and also has 100 shares of stock in Aventis and Lilly.
A Phase II trial of gemcitabine and docetaxel in patients with chemotherapy-naive, advanced nonsmall cell lung carcinoma
Article first published online: 3 OCT 2002
Copyright © 2002 American Cancer Society
Volume 95, Issue 8, pages 1714–1719, 15 October 2002
How to Cite
Popa, I. E., Stewart, K., Smith, F. P. and Rizvi, N. A. (2002), A Phase II trial of gemcitabine and docetaxel in patients with chemotherapy-naive, advanced nonsmall cell lung carcinoma. Cancer, 95: 1714–1719. doi: 10.1002/cncr.10843
- Issue published online: 3 OCT 2002
- Article first published online: 3 OCT 2002
- Manuscript Accepted: 15 MAY 2002
- Manuscript Received: 26 MAR 2002
- Aventis and Lilly
- Phase II trial;
- nonsmall cell lung carcinoma;
The goals of the current study were to determine the safety and efficacy of a nonplatinum-containing doublet, gemcitabine and docetaxel, in the treatment of patients with chemotherapy-naive nonsmall cell lung carcinoma (NSCLC).
Thirty-two patients with advanced, chemotherapy-naive NSCLC were treated with gemcitabine (1000 mg/m2) and docetaxel (40 mg/m2) administered on Days 1 and 8 every 21 days. All patients were evaluable for toxicity and survival and 27 patients were evaluable for response.
This combination was extremely well tolerated with Grade 3 or 4 neutropenia occurring in 6 of 32 patients (19%) (grading was based on the National Cancer Institute Common Toxicity Criteria). There were two episodes of Grade 3 thrombocytopenia and no episodes of Grade 3 or 4 anemia. Grade 3 or 4 nonhematologic toxicities included nausea (occurring in 1 of 32 patients), diarrhea (occurring in 1 of 32 patients), fatigue (occurring in 10 of 32 patients), fluid retention (occurring in 2 of 32 patients), anorexia (occurring in 4 of 32 patients), and transaminitis (occurring in 2 of 32 patients). Six patients experienced Grade 3 pneumonitis that was at least possibly related to the combination of gemcitabine and docetaxel. There was 1 complete response and 7 partial responses for an overall response rate of 30%. The 1-year and median survivals were 35% and 7.9 months, respectively.
In the current study, the regimen of gemcitabine (1000 mg/m2) and docetaxel (40 mg/m2) administered on Days 1 and 8 every 21 days was well tolerated with manageable hematologic and nonhematologic toxicities. The responses were comparable to those achieved with platinum-based combination chemotherapy and the 2-year survival was an encouraging 19%. These data would support the further study of this nonplatinum doublet in patients with advanced NSCLC. Cancer 2002;95:1714–19. © 2002 American Cancer Society.