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Incidence of Venous Thromboembolism in Patients With Ovarian Cancer Undergoing Platinum/Paclitaxel–Containing First-Line Chemotherapy: An Exploratory Analysis by the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group

Christina Fotopoulou, Andreas duBois, Alexandros N. Karavas, Ralf Trappe, Behnaz Aminossadati, Barbara Schmalfeldt, Jacobus Pfisterer, Jalid Sehouli

From the Department of Gynecology and Obstetrics, Charité University Hospital, Berlin; Department of Hematology and Oncology, Charité University Hospital, Campus Virchow Klinikum; Department of Gynecology and Gynecologic Oncology, Dr Horst Schmidt Klinik, Wiesbaden; Coordinating Center for Clinical Trials, University Marburg, Marburg; Department of Obstetrics and Gynecology, Klinikum rechts der Isar Technical University Munich, Munich; Department of Obstetrics and Gynecology, University Hospital Schleswig-Holstein, Kiel, Germany; and the Department of Surgery, St Elizabeth's Medical Center, Tufts University School of Medicine, Boston, MA

Corresponding author: Christina Fotopoulou, MD, Department of Gynecology and Obstetrics, Charité University Hospital, Augustenburger Platz 1, 13353 Berlin, Germany; e-mail: christina.fotopoulou{at}charite.de

Purpose: Venous thromboembolism (VTE) has been associated with negative prognosis in cancer patients. Most series reporting on VTE have included different tumor types not differentiating between recurrent or primary disease. Data regarding the actual impact of VTE on primary advanced ovarian cancer (AOC) are limited.

Patients and Methods: Between 1995 and 2002, the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study group (AGO–OVAR) recruited 2,743 patients with AOC in three prospectively randomized trials on platinum paclitaxel-based chemotherapy after primary surgery. Pooled data analysis was performed to evaluate incidence, predictors, and prognostic impact of VTE in AOC. Survival curves were calculated for the VTE incidence. Univariate analysis and Cox regression analysis were performed to identify independent predictors of VTE and mortality.

Results: Seventy-six VTE episodes were identified, which occurred during six to 11 cycles of adjuvant chemotherapy; 50% of them occurred within 2 months postoperatively. Multivariate analysis identified body mass index higher than 30 kg/m² and increasing age as independent predictors of VTE. International Federation of Gynecology and Obstetrics stage and surgical radicality did not affect incidence. Overall survival was significantly reduced in patients with VTE (median, 29.8 v 36.2 months; P = .03). Multivariate analysis identified pulmonary embolism (PE), but not deep vein thrombosis alone, to be of prognostic significance. In addition, VTE was not identified to significantly affect progression-free survival.

Conclusion: Patients with AOC have their highest VTE risk within the first 2 months after radical surgery. Only VTE complicated by symptomatic PE have been identified to have a negative impact on survival. Studies evaluating the role of prophylactic anticoagulation during this high risk postoperative period are warranted.

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