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
Articolo
Data di Pubblicazione:
2003
Citazione:
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 / J.B. Trimbos, M. Parmar, I. Vergote, D. Guthrie, G. Bolis, N. Colombo, J.B. Vermorken, V. Torri, C. Mangioni, S. Pecorelli, A. Lissoni, A.M. Swart. - In: JOURNAL OF THE NATIONAL CANCER INSTITUTE. - ISSN 0027-8874. - 95:2(2003 Jan), pp. 105-112.
Abstract:
Background: Adjuvant chemotherapy has been suggested as
a possible strategy to improve survival in women with earlystage
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 earlystage
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 followup
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.
Tipologia IRIS:
01 - Articolo su periodico
Elenco autori:
J.B. Trimbos, M. Parmar, I. Vergote, D. Guthrie, G. Bolis, N. Colombo, J.B. Vermorken, V. Torri, C. Mangioni, S. Pecorelli, A. Lissoni, A.M. Swart
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