Impact of Adjuvant Chemotherapy and Surgical Staging in Early-Stage Ovarian Carcinoma: European Organisation for Research and Treatment of Cancer–Adjuvant ChemoTherapy in Ovarian Neoplasm Trial
Articolo
Data di Pubblicazione:
2003
Citazione:
Impact of Adjuvant Chemotherapy and Surgical Staging in Early-Stage Ovarian Carcinoma: European Organisation for Research and Treatment of Cancer–Adjuvant ChemoTherapy in Ovarian Neoplasm Trial / J.B. Trimbos, I. Vergote, G. Bolis, J.B. Vermorken, C. Mangioni, C. Madronal, M. Franchi, S. Tateo, G. Zanetta, G. Scarfone, L. Giurgea, P. Timmers, C. Coens, S. Pecorelli. - In: JOURNAL OF THE NATIONAL CANCER INSTITUTE. - ISSN 0027-8874. - 95:2(2003 Jan), pp. 113-125.
Abstract:
Background: All randomized trials of adjuvant chemotherapy
for early-stage ovarian cancer have lacked the statistical
power to show a difference in the effect on survival
between adjuvant chemotherapy and no adjuvant chemotherapy.
They have also not taken into account the adequacy
of surgical staging. We performed a prospective unblinded,
randomized phase III trial to test the efficacy of adjuvant
chemotherapy in patients with early-stage ovarian cancer,
with emphasis on the extent of surgical staging. Methods:
Between November 1990 and January 2000, 448 patients
from 40 centers in nine European countries were randomly
assigned to either adjuvant platinum-based chemotherapy
(n = 224) or observation (n = 224) following surgery. Endpoints
were overall survival and recurrence-free survival,
and the analysis was on an intention-to-treat basis. The
Kaplan–Meier method was used to perform time-to-event
analysis, and the log-rank test was used to compare differences
between treatment arms. Statistical tests were twosided.
Results: After a median follow-up of 5.5 years, the
difference in overall survival between the two trial arms
was not statistically significant (hazard ratio [HR] = 0.69,
95% confidence interval [CI] = 0.44 to 1.08; P = .10).
Recurrence-free survival, however, was statistically significantly
improved in the adjuvant chemotherapy arm
(HR = 0.63, 95% CI = 0.43 to 0.92; P = .02). Approximately
one-third of patients (n = 151) had been optimally staged and
two-thirds (n = 297) had not. Among patients in the observation
arm, optimal staging was associated with a statistically
significant improvement in overall and recurrence-free
survival (HR = 2.31 [95% CI = 1.08 to 4.96]; P = .03 and
HR = 1.82 [95% CI = 1.02 to 3.24] P = .04, respectively).
No such association was observed in the chemotherapy arm.
In the non-optimally staged patients, adjuvant chemotherapy
was associated with statistically significant improvements
in overall and recurrence-free survival (HR = 1.75
[95% CI = 1.04 to 2.95]; P = .03 and HR = 1.78 [95% CI =
1.15 to 2.77]; P = .009, respectively). In the optimally staged
patients, no benefit of adjuvant chemotherapy was seen.
Conclusion: Adjuvant chemotherapy was associated with
statistically significantly improved recurrence-free survival
in patients with early-stage ovarian cancer. The benefit of
adjuvant chemotherapy appeared to be limited to patients
with non-optimal staging, i.e., patients with more risk of unappreciated residual disease.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
Ovarian diseases ; Female genital diseases ; Malignant tumor ; Platinum II Complexes ; Human ; Surgery ; Clinical stage ; Prognosis ; Adjuvant treatment ; Phase III trial ; Chemotherapy ; Antineoplastic agent ; Postoperative ; Therapeutic protocol ; Carboplatin ; Alkylating agent ; Cisplatin ; Early stage ; Ovary ; Carcinoma
Elenco autori:
J.B. Trimbos, I. Vergote, G. Bolis, J.B. Vermorken, C. Mangioni, C. Madronal, M. Franchi, S. Tateo, G. Zanetta, G. Scarfone, L. Giurgea, P. Timmers, C. Coens, S. Pecorelli
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