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Cisplatin plus paclitaxel optimal treatment for cervical carcinoma

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CHICAGO — The combination of cisplatin plus paclitaxel proved to be superior in terms of progression-free survival, overall survival and response rate for the treatment of persistent late-stage cervical carcinoma compared with cisplatin plus vinorelbine, gemcitabine or topotecan.

Bradley J Monk, MD, associate professor in the division of gynecologic oncology at the University of California, Irvine, School of Medicine, presented the results of the Gynecologic Oncology Group study at the 2008 ASCO Annual Meeting.

The researchers enrolled 513 patients between May 2003 and April 2007. Patients were randomly assigned to receive cisplatin plus one of four additional agents: paclitaxel, vinorelbine, gemcitabine or topotecan.

The trial was stopped after an April 2007 interim analysis indicated that none of the experimental treatment arms were likely to have a significant advantage compared with cisplatin plus paclitaxel.

Patients assigned to cisplatin plus paclitaxel had the best response rate (29.1%). Response rates in the experimental arms were worse, but the difference was not statistically significant.

Cisplatin plus paclitaxel was also superior to the other treatment arms in both progression-free and overall survival (see table). Although these differences were not statistically significantly, they may be clinically important, according to Monk.

“At these doses and schedules, toxicities appeared similar between treatment arms except for less marrow suppression with cislpatin plus gemcitabine and more alopecia with cisplatin plus paclitaxel,” Monk said. “Trends favoring quality of life, response rate, progression-free survival and overall survival for cisplatin plus paclitaxel should make this the control arm for future phase-3 trials.” – by Leah Lawrence

B.J. Monk. #LBA5504. Presented at: 2008 ASCO Annual Meeting; May 30-June 2, 2008; Chicago.

This is a strong study. It is one of the GOG systematic explorations of conventional antineoplastic agents. I think given the probable lack of difference in outcomes in the arms, incorporation of toxicity and quality of life endpoints was important. The response rates to single agents and doublets in phase-2 trials are deceiving. They do not translate into clinically significant improvements in progression-free survival. Declining response rates and unimproved survival are probably due to increasing use of prior cisplatin during concurrent chemotherapy and radiation therapy. These patients should be entered into trials of innovative targeting agents.

– Gillian Thomas, MD

Toronto Odette Sunnybrook Cancer Center