Introduction: Systemic chemotherapy and surgery for patients with recurrent ovarian cancer (ROC) constitute a therapeutic challenge. Venous thromboembolism (VTE) seems to have a negative prognostic impact in patients with solid tumors including primary ovarian cancer in many series. Only limited contemporary data exist regarding the impact of VTE on ROC.
Patients and methods: Two large multicenter prospective controlled phase I/II-III studies on 2nd-line topotecan-based chemotherapy with platinum-sensitive or resistant ROC (N=525) were conducted on both operated and non-operative patients by the North-Eastern German Society of Gynaecologic Oncology Ovarian Cancer Study Group (NOGGO). Analysis was performed to identify incidence, predictors and prognosis of VTE. Survival analysis, univariate and Cox-regression analysis were performed to identify independent predictors of VTE, overall and progression free survival.
Results: Thirty-seven (7%) VTE-episodes during chemotherapy were identified; 70% of them occurred within the first 2 months after initiation of chemotherapy. Ascites, as a sign of peritoneal carcinomatosis and advanced tumor disease, was identified as independent predictor of VTE. Advanced age and high BMI did not appear to affect significantly the VTE-incidence. High performance status, platinum-sensitivity, serous-papillary histology, lack of ascites and surgery appeared to positively affect survival by multivariate analysis. Overall survival and progression free survival were similar between the VTE and no-VTE patients.
Conclusion: ROC-patients appear to have the highest risk for developing VTE when ascites exists and during the first 2 months following chemotherapy initiation. In contrast to primary ovarian cancer, VTE could not be identified to affect overall survival in relapsed malignant ovarian disease.
Trial registration: ClinicalTrials.gov NCT00170625 NCT00312988.