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OBJECTIVES: To compare the safety and efficacy of thalidomide in combination with carboplatin to carboplatin alone as a first-line therapy in women with ovarian cancer and to evaluate the anti-angiogenic effects of thalidomide by measurement of surrogate markers of angiogenesis. METHODS: Forty patients with Stage IC-IV ovarian cancer were randomly assigned to receive either carboplatin (AUC 7) intravenously every four weeks for up to six doses (n = 20) or carboplatin at the same dose and schedule, plus thalidomide 100 mg orally daily for six months (n = 20). RESULTS: After median follow-up of 1.95 years, there was no difference in the overall response rate (90% in carboplatin arm, 75% in combination arm; p = 0.41). Increased incidence of symptoms of constipation, dizziness, tiredness and peripheral neuropathy was observed in the combination arm. There was a significant fall in CA-125 and E-selectin in both arms after treatment and VCAM-1 in the carboplatin arm. No significant difference between the two arms was observed in any of the markers analysed. CONCLUSIONS: In our trial the addition of thalidomide to carboplatin was well tolerated with no increased efficacy. The fall in some of the angiogenic markers in both groups may reflect tumour response rather than any specific anti-angiogenic effect of thalidomide.

Type

Journal article

Journal

Eur J Gynaecol Oncol

Publication Date

2011

Volume

32

Pages

253 - 258

Keywords

Adult, Aged, Aged, 80 and over, Angiogenesis Inhibitors, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, CA-125 Antigen, Carboplatin, Carcinoma, E-Selectin, Female, Humans, Middle Aged, Neovascularization, Pathologic, Ovarian Neoplasms, Thalidomide, Treatment Outcome, Vascular Cell Adhesion Molecule-1