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A randomized phase III trial of four cisplatin (CIS)- containing doublet combinations in stage IVB, recurrent, or persistent cervical carcinoma: A Gynecologic Oncology Group (GOG) study

Carolyn Vachani, RN, MSN, AOCN
The Abramson Cancer Center of the University of Pennsylvania
Ultima Vez Modificado: 5 de junio del 2008

A randomized phase III trial of four cisplatin (CIS)- containing doublet combinations in stage IVB, recurrent, or persistent cervical carcinoma: A Gynecologic Oncology Group (GOG) study

Several studies have demonstrated varying degrees of benefit to adding a second chemotherapy to cisplatin when treating advanced cervical cancer. This GOG sponsored study compared 4 potential regimens looking to identify the optimal regimen. Participants were randomized to receive cisplatin given in combination with paclitaxel (P) (which is standard therapy), vinorelbine (V), gemcitabine (G) or topotecan (T). Many studies will perform a data analysis at pre-specified time points during the study and close early if one arm appears superior. In this study, interim analysis found that no arm was superior to the already standard P arm.

Tumor response rates were not significantly different across the four arms. Rates of complete response were 29.1%, 25.9%, 22.3%, and 23.4% for PC, VC, GC, and TC, respectively. No significant overall survival benefit was seen in any arm, nor was there any significant difference in quality of life scores. Toxicities were also similar.

The authors conclude paclitaxel/ cisplatin should remain the doublet of choice in the treatment of advanced or recurrent cervical cancer.  An upcoming trial plans to add bevacizumab (an antiangiogenic agent) to the regimen, which will hopefully provide additional benefit as this disease remains very difficult to treat with current therapies.