• Reproductive Cancers Clinical Trials
• Reproductive Cancers

The results of several Gynecologic Oncology Group (GOG) trials have established doublet chemotherapy with standard-dose cisplatin and paclitaxel as the preferred treatment for advanced or recurrent cervical cancer. The GOG 204 trial (NCT00064077) was conducted to evaluate 3 experimental cisplatin-containing doublet chemotherapy regimens against the standard of cisplatin and paclitaxel. The findings indicated that none of the doublet regimens was superior to cisplatin plus paclitaxel in terms of response rate, progression-free survival (PFS), or overall survival (OS).

The experimental arms in the phase 3 trial consisted of chemotherapy with cisplatin in combination with vinorelbine, topotecan, or gemcitabine. Bradley J. Monk, MD, University of California, Irvine, CA, presenting on behalf of the GOG investigators, noted that the study began as a 2-arm trial that was designed to compare cisplatin and vinorelbine against cisplatin and paclitaxel. The other arms of the trial were added when other studies suggested benefit of topotecan and gemcitabine. The trial was stopped prematurely in April 2007 after a planned interim futility analysis indicated that the 3 experimental arms were not likely to be superior to the standard arm by the end of the study, said Dr. Monk. At the time that the study was closed, 513 of a planned 600 patients had enrolled. Data on response and survival were available for 434 patients. The primary endpoint was OS.

OS was not significantly better for any of the experimental doublet regimens, with the relative hazard ratios (HRs) for all 3 regimens favoring cisplatin and paclitaxel (Table 1). Similarly, the HRs favored cisplatin plus paclitaxel with respect to PFS (a secondary endpoint). Dr. Monk reported that the median PFS for cisplatin plus paclitaxel was 12.9 months, compared with 10 to 10.3 months for the 3 other doublet regimens.

The overall objective response rate (complete plus partial) according to RECIST criteria was 25%. The response rate was highest for cisplatin plus paclitaxel (29.1%) and lowest for cisplatin plus gemcitabine (22.3%). “This difference was not statistically significant but might be clinically important,” said Dr. Monk. The rate was 25.9% for cisplatin plus vinorelbine and 23.4% for cisplatin plus topotecan.

Dr. Monk noted that the toxicities of the regimens were similar, except for a lower frequency of leukopenia and neutropenia in the cisplatin plus gemcitabine arm and a higher frequency of alopecia in the cisplatin plus paclitaxel arm.

• © 2008 MD Conference Express