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Gemcitabine/Paclitaxel Combo Shows Greater Efficacy Than Monotherapy in Metastatic Breast Cancer Patients: Presented at ASCO

By Rabiya S. Tuma

CHICAGO, IL -- June 3, 2003 -- Gemcitabine plus paclitaxel appears to show greater efficacy than paclitaxel alone in treating metastatic breast cancer patients who were pre-treated with anthracyclines.

This finding is according to interim results from a phase III registration trial presented here June 1^st, at the 39^th Annual Meeting of the American Society of Clinical Oncology.

Women treated with the combination therapy had a better overall response rate (39.3%) relative to those treated with paclitaxel alone (25.6%, P = 0.007) and a significantly longer time to progression (P = 0.0013). There was no apparent difference, however, in median response duration, with women on the gemcitabine-paclitaxel arm experiencing 5.4 months of progression-free survival as compared with 3.5 for those on standard paclitaxel.

In addition, "there was a nonsignificant trend towards improved pain and less analgesic use" in the group treated with the combination therapy, said Joyce O'Shaughnessy, MD, from Baylor-Sammons Cancer Center and U.S. Oncology in Dallas, Texas, who reported the results.

Grade IV haematologic toxicities were more common in patients on the combination therapy, including neutropaenia, anaemia, and thrombocytopaenia. The adverse events were not substantial enough to cause numerous patients to withdraw from the trial: 7 patients on the combination therapy withdrew from the trial due to adverse events, versus 5 on monotherapy.

Prior phase II trials have demonstrated 40% to 55% overall response rates with this combination. The final analysis of the current phase III trial, including evaluation of the primary endpoint of overall survival, is expected in late 2004.

To be eligible for the trial, patients had to have unresectable, locally recurrent, or metastatic breast cancer, be at least 18 years of age, and have a Karnofsky score of 70 or greater and at least 1 bidimensionally measurable lesion. No prior therapy for metastatic disease was allowed, but previous anthracycline or hormone therapy was permissible. In fact, nearly 97% of patients enrolled in the trial had been previously treated with either of these modalities.

A total of 529 patients have been randomised into the 2 arms, and 521 have received treatment. In the combination therapy arm, patients receive 175 mg/m² paclitaxel on day 1 and 1250 mg/m² gemcitabine on days 1 and 8 of a 21-day cycle. Those treated with monotherapy paclitaxel receive 175 mg/m² paclitaxel on day 1 of a 21-day cycle. Both groups had standard paclitaxel premedications. Treatment continued until disease progression. Patients were assessed every 8 weeks.

"Because of the favourable risk-benefit profile reported in this controlled clinical trial, gemcitabine plus paclitaxel is a new treatment option for metastatic breast cancer patients who may benefit from combination chemotherapy," concluded Dr. O'Shaughnessy.

This study was supported by Eli Lilly.


[Study title: Gemcitabine Plus Paclitaxel (GT) vs Paclitaxel (T) as First-Line Treatment for Anthracycline Pre-Treated Metastatic Breast Cancer (MBC): Interim Results af a Global Phase III Study. Abstract 25]

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