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Title: Paclitaxel Fails to Improve Outcomes in Advanced Endometrial Cancer Patients Treated With Surgery, Radiation, Cisplatin, and Doxorubicin: Presented at SGO

"Paclitaxel Fails to Improve Outcomes in Advanced Endometrial Cancer Patients Treated With Surgery, Radiation, Cisplatin, and Doxorubicin: Presented at SGO"

By Ed Susman TAMPA, Fla -- March 12, 2008 -- The addition of paclitaxel to the regimen for treatment of advanced endometrial cancer failed to improve clinical outcomes significantly but increased patient morbidity, according to a phase 3 study presented here at the Society of Gynaecologic Oncologists (SGO) 2008 Annual Meeting on Women's Cancer. After 3 years, 62% of patients maintained progression-free survival without paclitaxel compared with 64% of patients treated with paclitaxel, the researchers reported. "The study hypothesis was based on the idea that adding paclitaxel to the regimen would not improve outcomes," said Howard D. Homesley, MD, Clinical Professor of Medicine, and Chief of Gynaecological Services, Leo W. Jenkins Cancer Centre, East Carolina University, Greenville, North Carolina. "We also wanted to determine if these patients who were being treated with surgery and radiation could tolerate chemotherapy as well," Dr. Homesley said in his plenary discussion on March 9. Dr. Homesley and colleagues randomised 552 patients with advanced endometrial cancer who had undergone surgery and radiation therapy. Women were eligible for the study if they were diagnosed with stage 3 or stage 4 endometrial cancers and had undergone total abdominal hysterectomy and bilateral salpingo-oophorectomy, and had less than 2 cm of residual tumour. After volume-directed radiation, patients were randomly assigned to receive cisplatin 45 mg/m[² plus doxorubicin 50 mg/m² every 3 weeks for 6 cycles or to this regimen combined with paclitaxel 160 mg/m². Patients also received filgrastim or pegfilgrastim.

"Both groups of patients were able to tolerate the treatment, with 82.6% of the 270 patients in the 2-drug arm completing all 6 cycles and 78.4% of the 282 patients in the 3-drug arm completing the treatment protocol," Dr. Homesley said.

A quality-of-life analysis found a greater incidence of neurotoxicity among the patients taking paclitaxel, he said. The neurotoxicity scale score was 5.2 points lower for the paclitaxel patients (P < .001) at the end of chemotherapy and persisted even at 6 months post-treatment although the difference had narrowed to 1.6 points (P = .014).

Overall, however, Dr. Homesley suggested that both groups of patients "tolerated well full doses of both the 2- and 3-chemotherapy-drug combinations."

[Presentation title: Randomized Phase III Trial in Advanced Endometrial Carcinoma of Surgery and Volume-Directed Radiation Followed by Cisplatin and Doxorubicin With or Without Paclitaxel: A Gynecologic Oncology Group Study. Abstract 1]

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