© 2003 by Oxford University Press
Journal of the National Cancer Institute, Vol. 95, No. 2, 105-112,
January 15, 2003
© 2003 Oxford University Press
ARTICLE |
International Collaborative Ovarian Neoplasm Trial 1 and Adjuvant ChemoTherapy In Ovarian Neoplasm Trial: Two Parallel Randomized Phase III Trials of Adjuvant Chemotherapy in Patients With Early-Stage Ovarian Carcinoma
International Collaborative Ovarian Neoplasm 1 (ICON1), European Organisation for Research and Treatment of Cancer Collaborators–Adjuvant ChemoTherapy In Ovarian Neoplasm (EORTC–ACTION)1
Affiliations of Writing Committee: J. B. Trimbos, Leiden University Medical Center, Leiden, The Netherlands; M. Parmar, D. Guthrie, A. M. Swart, Medical Research Council Clinical Trial Unit, London, U.K.; I. Vergote, University Hospital Gasthuisberg, Leuven, Belgium; G. Bolis, Istituto Mangiagalli/Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy; N. Colombo, European Institute of Oncology, Milan; J. B. Vermorken, University Hospital Antwerp, Antwerp, Belgium; V. Torri, Istituto Mario Negri, Milan; C. Mangioni, A. Lissoni, Ospedale San Gerardo, Monza, Italy; S. Pecorelli, Universita di Brescia, Brescia, Italy.
Correspondence to: J. Baptist Trimbos, M.D., Ph.D., Department of Gynecology, Leiden University Medical Center, POB 9600, 2300 RC, Leiden, The Netherlands (J.B.M.Z.Trimbos{at}lumc.nl) or Mahesh Parmar, Ph.D., Medical Research Council Clinical Trials Unit Cancer Division, 222 Euston Rd., London NW1 2DA, U.K. (Mahesh.Parmar{at}ctu.mrc.ac.uk).
Background: Adjuvant chemotherapy has been suggested as a possible strategy to improve survival in women with early-stage ovarian cancer; however, all randomized studies to date have been too small to answer this question reliably. Methods: We performed a preplanned combined analysis of two parallel randomized clinical trials (International Collaborative Ovarian Neoplasm 1 [ICON1] and Adjuvant ChemoTherapy In Ovarian Neoplasm [ACTION]) in early-stage ovarian cancer that compared platinum-based adjuvant chemotherapy with observation following surgery. Between November 1990 and January 2000, 925 patients (477 in ICON1 and 448 in ACTION) who had surgery for early-stage ovarian cancer were randomly assigned to receive platinum-based adjuvant chemotherapy (n = 465) or observation (n = 460) until chemotherapy was indicated. Kaplan–Meier analysis was used to compare overall and recurrence-free survival by treatment allocation. In subgroup analyses of pretreatment age, tumor stage, histologic cell type, and differentiation grade, the differences in relative size of effect were tested using a chi-square test for interaction or a chi-square test for trend. All tests of statistical significance were two-sided. Results: After a median follow-up of over 4 years, 245 patients had died or had a recurrence (ICON1: 133, ACTION: 112). Overall survival at 5 years was 82% in the chemotherapy arm and 74% in the observation arm (difference = 8% [95% confidence interval (CI) = 2% to 12%]; hazard ratio [HR] = 0.67, 95% CI = 0.50 to 0.90; P = .008). Recurrence-free survival at 5 years was also better in the adjuvant chemotherapy arm than it was in the observation arm (76% versus 65%, difference = 11% [95% CI = 5% to 16%]; HR = 0.64, 95% CI = 0.50 to 0.82; P = .001). Subgroup analyses provided no evidence of a difference in the size of effect of chemotherapy on survival in any pretreatment subcategory. Conclusions: Platinum-based adjuvant chemotherapy improved overall survival and recurrence-free survival at 5 years in this combined group of patients with early-stage ovarian cancer defined by the inclusion criteria of the ICON1 and ACTION trials.
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