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

Research output: Contribution to journalArticle

1213 Citations (Scopus)

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

Fingerprint

docetaxel
Ifosfamide
Platinum
Non-Small Cell Lung Carcinoma
Drug Therapy
Survival
vinorelbine
Paclitaxel
Disease-Free Survival

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

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

In: Journal of Clinical Oncology, Vol. 18, No. 12, 06.2000, p. 2354-2362.

Research output: Contribution to journalArticle

Fossella, FV, DeVore, R, Kerr, RN, Crawford, J, Natale, RR, Dunphy, F, Kalman, L, Miller, V, Lee, JS, Moore, M, Gandara, DR, 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, vol. 18, no. 12, pp. 2354-2362.
Fossella, Frank V. ; DeVore, Russell ; Kerr, Ronald N. ; Crawford, Jeffrey ; Natale, Ronald R. ; Dunphy, Frank ; Kalman, Leonard ; Miller, Vincent ; Lee, Jin Soo ; Moore, Melvin ; Gandara, David R ; Karp, Daniel ; Vokes, Everett ; Kris, Mark ; Kim, Yong ; Gamza, Francis ; Hammershaimb, Luz. / 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. In: Journal of Clinical Oncology. 2000 ; Vol. 18, No. 12. pp. 2354-2362.
@article{bfeb46e8cd534722aa82ca4e36dde5ad,
title = "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",
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.",
author = "Fossella, {Frank V.} and Russell DeVore and Kerr, {Ronald N.} and Jeffrey Crawford and Natale, {Ronald R.} and Frank Dunphy and Leonard Kalman and Vincent Miller and Lee, {Jin Soo} and Melvin Moore and Gandara, {David R} and Daniel Karp and Everett Vokes and Mark Kris and Yong Kim and Francis Gamza and Luz Hammershaimb",
year = "2000",
month = "6",
language = "English (US)",
volume = "18",
pages = "2354--2362",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "12",

}

TY - JOUR

T1 - 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

AU - Fossella, Frank V.

AU - DeVore, Russell

AU - Kerr, Ronald N.

AU - Crawford, Jeffrey

AU - Natale, Ronald R.

AU - Dunphy, Frank

AU - Kalman, Leonard

AU - Miller, Vincent

AU - Lee, Jin Soo

AU - Moore, Melvin

AU - Gandara, David R

AU - Karp, Daniel

AU - Vokes, Everett

AU - Kris, Mark

AU - Kim, Yong

AU - Gamza, Francis

AU - Hammershaimb, Luz

PY - 2000/6

Y1 - 2000/6

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=0034095853&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0034095853&partnerID=8YFLogxK

M3 - Article

C2 - 10856094

AN - SCOPUS:0034095853

VL - 18

SP - 2354

EP - 2362

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 12

ER -