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Title: Weekly Paclitaxel and Carboplatin Shows Effect, Favourable Toxicity for Salvage Treatment in Cervical and Endometrial Cancer: Presented at SGO

"Weekly Paclitaxel and Carboplatin Shows Effect, Favourable Toxicity for Salvage Treatment in Cervical and Endometrial Cancer: Presented at SGO"

By Karla Harby MIAMI BEACH, FL -- March 21, 2005 -- A small prospective study of weekly paclitaxel and carboplatin for salvage therapy in recurrent cervical and endometrial cancer has found both effectiveness -- more pronounced in endometrial cancer -- and a favorable toxicity profile. Laura J. Havrilesky, MD, Staff Physician in the Department of Obstetrics/Gynecology, Duke University Medical Center, Durham, North Carolina, United States, reported the study's findings during a presentation here on March 20[^th at the 2005 Annual Meeting on Women's Cancer of the Society of Gynecologic Oncologists.

The regimen had an overall response rate of 38%, with two complete and nine partial responses in a group of 29 patients with advanced or recurrent cervical and endometrial cancer. For the 15 patients with cervical cancer, the overall response rate was 20%, while the 14 patients with endometrial cancer experienced an overall response rate of 57%.

Patients received paclitaxel at a dose of 80 mg/m² and carboplatin at an area under the curve of 2 on days 1, 8, and 15 on a 28-day cycle. One of these patients had disease confined to the pelvis, while the remainder had distant disease, or distant plus local disease, Dr. Havrilesky said. The median number of prior chemotherapy regimens was 1, and 62% of patients had prior radiation.

The investigators removed two patients from the study because of toxicity, and 14% of patients experienced hypersensitivity, three to the carboplatin, and one to the paclitaxel, Dr. Havrilesky said.

The researchers also observed grade 3 anemia in 20% of patients, and grade 3 or 4 neutropenia in 20%. Toxicities were managed successfully by delaying treatment, reducing the dose of paclitaxel, discontinuing the carboplatin, and administering erythropoietic support.

Overall survival in this group of patients was 15.4 months, Dr. Havrilesky said, with the cervical cancer patients experiencing an overall survival of 6.5 months.

In response to a question about whether such frequent chemotherapy had an adverse effect on the quality of life in these patients, Dr. Havrilesky said, "We did not use a quality of life construct, and that of course would have been very useful."

She noted that this study was designed in 1999. "Any trial being designed now would have that [type of quality of life measurement]." She added that previous studies have suggested that the weekly regimen of paclitaxel is less toxic and better tolerated than the monthly regimen.

[Presentation title: A Phase II Study of Weekly Low Dose Paclitaxel and Carboplatin in the Treatment of Advanced or Recurrent Cervical and Endometrial Cancer. Abstract 10]

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