Adding a third cytotoxic agent to the standard regiment of Taxol® (paclitaxel) and Paraplatin® (carboplatin) in women with advanced-stage ovarian cancer provides no benefit in progression-free survival or overall survival, according to the results of a study published in the Journal of Clinical Oncology.1
Advanced-stage ovarian cancer refers to cancer that has spread from the ovary. Cure rates for advanced ovarian cancer remain quite low both because it is difficult to completely remove the cancer with surgery and because standard chemotherapy is unable to completely eradicate the disease.
Standard treatment for advanced ovarian cancer includes Taxol and Paraplatin, and while the cancer initially responds to these agents, it eventually develops a resistance to the drugs. A great deal of research has been conducted to evaluate the benefit of adding a third drug to this regimen, and thus far none have shown a benefit.
The Gynecologic Oncology Group (GOG) conducted a multiarm Phase III study to evaluate four different experimental arms against a single reference arm of Taxol and Paraplatin. The study included 4,312 women who were randomly allocated to one of five arms. The four experimental arms incorporated Gemzar® (gemcitabine), Hycamtin® (topotecan), or methoxypolyethylene glycosylated liposomal doxorubicin into the regimen. The objective was to determine whether the addition of the third agent improved progression-free survival (PFS) or overall survival (OS) compared to the standard double regimen.
Each arm included eight cycles of therapy, which were delivered either as triplet therapy or sequential doublet therapy. A minimum of four cycles of the standard Taxol/Paraplatin therapy and four cycles of the experimental therapy were delivered in each of the four experimental arms.
The results indicated that there were no improvements in PFS or OS associated with any of the experimental regimens. The researchers concluded that the addition of a third cytotoxic agent did not provide benefit in PFS or OS for women with advanced-stage ovarian cancer. At this point the combination of Taxol and Paraplatin remains the standard treatment of choice in this population; however, research is ongoing in an effort to improve treatment and response for these women.
1 Bookman MA, Brady MF, McGuire WP, et al. Evaluation of new platinum-based treatment regimens in advanced-stage ovarian cancer: A phase III trial of the Gynecologic Cancer InterGroup. Journal of Clinical Oncology. 2009; 27: 1419-1425.
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