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Trial Confirms Efficacy of Weekly Paclitaxel for Metastatic Breast Cancer: Presented at ASCO

By M. M. Pennell

NEW ORLEANS, LA -- June 10, 2004 -- Results of a randomized trial that compared weekly paclitaxel to an every-3-week regimen for treatment of metastatic breast cancer "confirm what oncologists have known and are doing in practice -- weekly paclitaxel is superior," said lead investigator Andrew Seidman, MD, Memorial Sloan Kettering Cancer Center in New York, New York.

The trial results also confirmed that adding trastuzumab to chemotherapy is not effective in women with breast cancer that is not overexpressing the HER-2 gene. Dr. Seidman presented the late-breaking results of the Cancer and Leukemia Group B (CALCB) 9840 trial on June 5th at the American Society of Clinical Oncology 40th Annual Meeting.

The analysis was based on 580 women recruited for the study and 120 women enrolled in CALGB 9342, a somewhat controversial approach but one that was approved by the National Cancer Institute, Dr. Seidman said. The 9342 patients were taking paclitaxel at the standard dose. He said this unique protocol allowed the investigators to answer the dosing frequency question more quickly, while "conserving patient resources."

Dr. Seidman and colleagues stratified the study subjects according to line of therapy (first or second) and HER-2 status, and randomly assigned them to 1 of 4 treatment arms -- standard paclitaxel (every 3 weeks), weekly paclitaxel, standard paclitaxel administered with trastuzumab, or weekly paclitaxel with trastuzumab.

Response rates were 40% in the weekly paclitaxel arm and 28% in the standard regimen arm (P =.017). Weekly paclitaxel was also associated with a significantly longer time to progression, a secondary end point of the study (P =.0008; adjusted hazard ratio, 1.45). Again, the addition of trastuzumab to paclitaxel did not have a significant effect in women with HER-2-negative metastatic breast cancer.

Weekly paclitaxel was associated with less myelosuppression but more neurotoxicity than the standard regimen, Dr. Seidman said in an interview.

"When considered together with the results of CALGB 9342, where an increase in paclitaxel dose did not improve outcome, the present results are consistent with the concept that the frequency of drug administration -- or density -- may account for the improved efficacy that was observed," Dr. Seidman said during his presentation.


[Presentation title: CALGB 9840: Phase III Study of Weekly Paclitaxel Via 1-Hour Infusion Versus Standard 3h Every Third Week in the Treatment of Metastatic Breast Cancer With Trastuzumab for HER2 Positive and Randomized for T in HER2 Normal MBC. Abstract 512]

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