© 2003 by Oxford University Press
Journal of the National Cancer Institute, Vol. 95, No. 2, 125-132,
January 15, 2003
© 2003 Oxford University Press
ARTICLE |
International Collaborative Ovarian Neoplasm Trial 1: A Randomized Trial of Adjuvant Chemotherapy in Women With Early-Stage Ovarian Cancer
International Collaborative Ovarian Neoplasm (ICON1) Collaborators1
Affiliations of Writing Committee: N. Colombo, European Institute of Oncology, Milan, Italy; D. Guthrie, M. Parmar, W. Qian, A. M. Swart, Medical Research Council Clinical Trials Unit, London, U.K.; S. Chiari, A. Lissoni, C. Bonazzi, Ospedale San Gerado, Monza, Italy; V. Torri, Mario Negri Institute, Milan; C. Williams, Cochrane Cancer Network, Oxford, U.K.
Correspondence to: Mahesh Parmar, Ph.D., Medical Research Council Clinical Trials Unit, 222 Euston Rd., London NW1 2DA, U.K. (MP{at}ctu.mrc.ac.uk).
Background: The question of whether platinum-based adjuvant chemotherapy can improve outcomes in patients with early-stage epithelial ovarian cancer is an important one. We carried out a multicenter, open randomized trial to determine whether adjuvant chemotherapy would improve overall survival and prolong recurrence-free survival in women with early-stage epithelial ovarian cancer. Methods: Between August 1991 and January 2000, 477 patients in 84 centers in five countries were randomly assigned to receive either adjuvant chemotherapy immediately following surgery (n = 241) or no adjuvant chemotherapy until clinically indicated (n = 236). KaplanMeier curves of overall survival and recurrence-free survival were compared using the MantelCox version of the log-rank test. All statistical tests were two-sided. Results: Women who received adjuvant chemotherapy had better overall survival than women who did not (hazard ratio [HR] of 0.66, 95% confidence interval [CI] = 0.45 to 0.97; P = .03). These results translate into 5-year survival figures of 70% for women who did not receive adjuvant chemotherapy and 79% for women who did receive adjuvant chemotherapy, a difference of 9% (95% CI = 1% to 15%). Adjuvant chemotherapy also improved recurrence-free survival (HR = 0.65; 95% CI = 0.46 to 0.91; P = .01). These results translate into 5-year recurrence-free survival figures of 62% for women who did not receive adjuvant chemotherapy and 73% for women who did receive adjuvant chemotherapy, a difference of 11% (95% CI = 3% to 18%). Conclusion: These results suggest that platinum-based adjuvant chemotherapy improves survival and delays recurrence in patients with early-stage ovarian cancer.
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