International Collaborative Ovarian Neoplasm Trial 1: A Randomized Trial of Adjuvant Chemotherapy in Women With Early-Stage Ovarian Cancer

• Published in: JNCI : Journal of the National Cancer Institute 2003-01, Vol.95 (2), p.125-132
• Main Authors: Colombo, Nicoletta, Guthrie, David, Chiari, Stefania, Parmar, Mahesh, Qian, Wendi, Swart, Ann Marie, Torri, Valter, Williams, Christopher, Lissoni, Andrea, Bonazzi, Cristina
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Antineoplastic agents; Antineoplastic Agents - therapeutic use; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Carboplatin - administration & dosage; Carcinoma - drug therapy; Carcinoma - pathology; Carcinoma - surgery; Chemotherapy; Chemotherapy, Adjuvant; Cisplatin - administration & dosage; Clinical outcomes; Clinical trials; Confidence Intervals; Disease-Free Survival; Drug Administration Schedule; Female; Humans; International Cooperation; Medical sciences; Middle Aged; Neoplasm Staging; Observation; Odds Ratio; Ovarian cancer; Ovarian Neoplasms - drug therapy; Ovarian Neoplasms - pathology; Ovarian Neoplasms - surgery; Pharmacology. Drug treatments; Survival Analysis; Treatment Outcome
• ISSN: 0027-8874; 1460-2105
• DOI: 10.1093/jnci/95.2.125

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). Kaplan–Meier curves of overall survival and recurrence-free survival were compared using the Mantel–Cox 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.