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Early-Stage Ovarian Cancer: Is Adjuvant Chemotherapy Warranted?

Chemotherapy provided some mortality benefit among women with early-stage cancers who underwent extirpative surgery.

Almost one third of women with epithelial ovarian cancer present with early-stage disease that is localized to the ovary or pelvis, but, after surgical excision of ovarian malignancies, 50% of these women eventually relapse and die. These disturbing statistics have led to efforts to develop effective adjuvant therapies that can be used after surgery. Two large, prospective, European trials (planned so that they could be analyzed together as well as separately) included a total of 925 patients who were randomized to receive platinum-based adjuvant chemotherapy or observation after extirpative surgery.

Patient inclusion criteria were different in the 2 trials. One (ICON1) study included all patients with early stages, grades, and histologic cell types and allowed entry of any woman for whom "a responsible clinician" thought immediate adjuvant chemotherapy might be beneficial. The other (ACTION) provided guidelines for comprehensive surgical staging and tumor typing and grading, with a goal of enrolling only patients with stage I-IIa tumors; however, for various reasons, only one third of the women were optimally staged. Despite these differences, results were remarkably similar. At 5 years, combined data analysis showed significantly better outcomes with chemotherapy than with observation for overall survival (82% vs. 74%) and recurrence-free survival (76% vs. 65%).

Comment: Although the ICON1 investigators conclude (and the combined analysis suggests) that adjuvant chemotherapy improves survival in women with early-stage ovarian cancer, the ACTION investigators and an editorialist express reservations: They note that these studies provide no definitive answers because, in both trials, optimally staged women did not benefit from adjuvant chemotherapy. Only those who were incompletely staged from the outset (of whom 25% might have had occult advanced disease) appeared to benefit. The quest for optimal therapy continues.

— Robert W. Rebar, MD

Published in Journal Watch General Medicine February 7, 2003

Citation(s):

International Collaborative Ovarian Neoplasm 1 (ICON1) and European Organisation for Research and Treatment of Cancer Collaborators-Adjuvant ChemoTherapy in Ovarian Neoplasm (EORTC-ACTION). 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 Natl Cancer Inst 2003 Jan 15; 95:105-12.

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Trimbos JB et al. 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 Natl Cancer Inst 2003 Jan 15; 95:113-25.

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International Collaborative Ovarian Neoplasm (ICON1) Collaborators. International Collaborative Ovarian Neoplasm Trial 1: A randomized trial of adjuvant chemotherapy in women with early-stage ovarian cancer. J Natl Cancer Inst 2003 Jan 15; 95:125-32.

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Young RC. Early-stage ovarian cancer: To treat or not to treat. J Natl Cancer Inst 2003 Jan 15; 95:94-5.

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