Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens

Frank V. Fossella, Russell DeVore, Ronald N. Kerr, Jeffrey Crawford, Ronald R. Natale, Frank Dunphy, Leonard Kalman, Vincent Miller, Jin Soo Lee, Melvin Moore, David R Gandara, Daniel Karp, Everett Vokes, Mark Kris, Yong Kim, Francis Gamza, Luz Hammershaimb

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1237 Scopus citations

Abstract

Purpose: To confirm the promising phase II results of docetaxel monotherapy, this phase III trial was conducted of chemotherapy for patients with advanced non-small-cell lung cancer (NSCLC) who had previously failed platinum-containing chemotherapy. Patients and Methods: A total of 373 patients were randomized to receive either docetaxel 100 mg/m2 (D100) or 75 mg/m2 (D75) versus a control regimen of vinorelbine or ifosfamide (V/I). The three treatment groups were well-balanced for key patient characteristics. Results: Overall response rates were 10.8% with D100 and 6.7% with D75, each significantly higher than the 0.8% response with V/I (P = .001 and P = .036, respectively). Patients who received docetaxel had a longer time to progression (P = .046, by log-rank test) and a greater progression-free survival at 26 weeks (P = .005, by χ2 test). Although overall survival was not significantly different between the three groups, the 1-year survival was significantly greater with D75 than with the control treatment (32% v 19%; P = .025, by χ2 test). Prior exposure to paclitaxel did not decrease the likelihood of response to docetaxel, nor did it impact survival. There was a trend toward greater efficacy in patients whose disease was platinum- resistant rather than platinum-refractory and in patients with performance status of 0 or 1 versus 2. Toxicity was greatest with D100, but the D75 arm was well-tolerated. Conclusion: This first randomized trial in this setting demonstrates that D75 every 3 weeks can offer clinically meaningful benefit to patients with advanced NSCLC whose disease has relapsed or progressed after platinum-based chemotherapy. (C) 2000 by American Society of Clinical Oncology.

Original languageEnglish (US)
Pages (from-to)2354-2362
Number of pages9
JournalJournal of Clinical Oncology
Volume18
Issue number12
StatePublished - Jun 2000
Externally publishedYes

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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    Fossella, F. V., DeVore, R., Kerr, R. N., Crawford, J., Natale, R. R., Dunphy, F., Kalman, L., Miller, V., Lee, J. S., Moore, M., Gandara, D. R., Karp, D., Vokes, E., Kris, M., Kim, Y., Gamza, F., & Hammershaimb, L. (2000). Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. Journal of Clinical Oncology, 18(12), 2354-2362.