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Baptist J Trimbos - One of the best experts on this subject based on the ideXlab platform.

  • 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
    Journal of the National Cancer Institute, 2003
    Co-Authors: Baptist J Trimbos, Ignace Vergote, G Bolis, Jan B Vermorken, Constantino Mangioni, Caterina Madronal, Massimo Franchi, Saverio Tateo, Gerardo Zanetta, Giovanna Scarfone
    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 two-sided. 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.

  • 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
    Journal of the National Cancer Institute, 2003
    Co-Authors: Baptist J Trimbos, Mahesh K B Parmar, Valter Torri, Nicoletta Colombo, David Guthrie, Ignace Vergote, G Bolis, Jan B Vermorken, Constantino Mangioni, Sergio Pecorelli
    Abstract:

    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.

G Bolis - One of the best experts on this subject based on the ideXlab platform.

  • 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
    Journal of the National Cancer Institute, 2003
    Co-Authors: Baptist J Trimbos, Ignace Vergote, G Bolis, Jan B Vermorken, Constantino Mangioni, Caterina Madronal, Massimo Franchi, Saverio Tateo, Gerardo Zanetta, Giovanna Scarfone
    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 two-sided. 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.

  • 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
    Journal of the National Cancer Institute, 2003
    Co-Authors: Baptist J Trimbos, Mahesh K B Parmar, Valter Torri, Nicoletta Colombo, David Guthrie, Ignace Vergote, G Bolis, Jan B Vermorken, Constantino Mangioni, Sergio Pecorelli
    Abstract:

    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.

Jan B Vermorken - One of the best experts on this subject based on the ideXlab platform.

  • 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
    Journal of the National Cancer Institute, 2003
    Co-Authors: Baptist J Trimbos, Ignace Vergote, G Bolis, Jan B Vermorken, Constantino Mangioni, Caterina Madronal, Massimo Franchi, Saverio Tateo, Gerardo Zanetta, Giovanna Scarfone
    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 two-sided. 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.

  • 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
    Journal of the National Cancer Institute, 2003
    Co-Authors: Baptist J Trimbos, Mahesh K B Parmar, Valter Torri, Nicoletta Colombo, David Guthrie, Ignace Vergote, G Bolis, Jan B Vermorken, Constantino Mangioni, Sergio Pecorelli
    Abstract:

    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.

Ignace Vergote - One of the best experts on this subject based on the ideXlab platform.

  • 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
    Journal of the National Cancer Institute, 2003
    Co-Authors: Baptist J Trimbos, Ignace Vergote, G Bolis, Jan B Vermorken, Constantino Mangioni, Caterina Madronal, Massimo Franchi, Saverio Tateo, Gerardo Zanetta, Giovanna Scarfone
    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 two-sided. 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.

  • 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
    Journal of the National Cancer Institute, 2003
    Co-Authors: Baptist J Trimbos, Mahesh K B Parmar, Valter Torri, Nicoletta Colombo, David Guthrie, Ignace Vergote, G Bolis, Jan B Vermorken, Constantino Mangioni, Sergio Pecorelli
    Abstract:

    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.

Constantino Mangioni - One of the best experts on this subject based on the ideXlab platform.

  • 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
    Journal of the National Cancer Institute, 2003
    Co-Authors: Baptist J Trimbos, Ignace Vergote, G Bolis, Jan B Vermorken, Constantino Mangioni, Caterina Madronal, Massimo Franchi, Saverio Tateo, Gerardo Zanetta, Giovanna Scarfone
    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 two-sided. 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.

  • 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
    Journal of the National Cancer Institute, 2003
    Co-Authors: Baptist J Trimbos, Mahesh K B Parmar, Valter Torri, Nicoletta Colombo, David Guthrie, Ignace Vergote, G Bolis, Jan B Vermorken, Constantino Mangioni, Sergio Pecorelli
    Abstract:

    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.