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Comparison of CA-125 and Standard Definitions of Progression of Ovarian Cancer in the Intergroup Trial of Cisplatin and Paclitaxel Versus Cisplatin and Cyclophosphamide

From the Department of Medical Oncology, Mount Vernon Cancer Centre, Northwood, Middlesex; Gray Cancer Institute, Mount Vernon Hospital, Northwood; Scottish Group Data Centre, Beatson Oncology Centre, Western Infirmary Glasgow, United Kingdom; European Organisation for Research and Treatment of Cancer (EORTC) –Gynecological Cancer Cooperative Group, EORTC Data Centre, Brussels, Belgium; Nordic Gynecological Cancer Study Group Centre, Odense University Hospital, Denmark; and National Cancer Institute of Canada, Clinical Trials Group Data Centre, Queen's University, Kingston, Ontario, Canada

Address reprint requests to Gordon J.S. Rustin, MD, Department of Medical Oncology, Mount Vernon Cancer Centre, Northwood, Middlesex, HA62RN, United Kingdom. e-mail: grustin{at}nhs.net

PURPOSE: A definition for progression of ovarian cancer has been proposed based on either a confirmed doubling of CA-125 levels from the upper limit of normal or from the nadir level if levels are persistently elevated. Retrospectively, we determined whether the use of this CA-125 definition in a randomized trial would have shown the same magnitude of difference between the treatment arms as was shown when the standard progression definition was used.

PATIENTS AND METHODS: A retrospective analysis was performed on 680 patients in the Taxol Intergroup Trial with advanced epithelial ovarian carcinoma, of whom 628 were assessable according to CA-125. The date of progression according to clinical or radiologic criteria was compared with the date of progression according to CA-125.

RESULTS: Of the 628 patients assessable for both definitions, 556 clinical or radiologic progressions were determined compared with 389 according to the CA-125 definition. There was a highly significant difference in the hazard of progression between the paclitaxel and cisplatin arm (TP) compared with the cyclophosphamide and cisplatin arm (CP) when either standard or CA-125 criteria were used to define progression (standard, P = .002; CA-125, P = .011). The hazard ratio of TP/CP over time was similar when comparing the different methods of defining progression.

CONCLUSION: The results of this analysis show that the magnitude of the therapeutic benefit was similar whether CA-125 or standard criteria were used to define progression.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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