important (negative) study for those with metastatic breast cancer

[Lani]

Since not everyone in every country of those who read this site has access to Herceptin and since it is not efficacious in all, I thought this negative study might be helpful:

Paclitaxel Maintenance Not Recommended for Stable Metastatic Breast Cancer

NEW YORK (Reuters Health) Aug 30 - Women with metastatic breast cancer who achieve disease control after six to eight courses of first-line anthracycline plus paclitaxel combination chemotherapy do not benefit from additional courses of paclitaxel.

In a randomized study, published in the August 20th issue of the Journal of Clinical of Oncology, Italian researchers evaluated the outcome of 255 women with stable metastatic breast cancer after first-line chemotherapy with epirubicin or doxorubicin plus paclitaxel. The patients were randomized to eight courses of maintenance therapy with paclitaxel or no additional treatment (controls).

Dr. Alessandra Gennari, of the National Cancer Research Institute, Genoa, and colleagues evaluated disease status every 3 months until progression. The study was prematurely stopped after a futility analysis of 109 patients on paclitaxel maintenance and 106 controls indicated there were no differences between the two groups.

Eighty-four patients assigned to maintenance paclitaxel experienced disease progression, as did 80 of the controls. The median time to disease progression was 8 months and 9 months in the paclitaxel and control groups, respectively. Fifty-two deaths occurred in the paclitaxel group, compared with 46 in the control group. The median survival time was 28 months in the maintenance paclitaxel group and 29 months in the control group.

Patient compliance with maintenance paclitaxel was good. Hematologic toxicity was mild.

Further analysis showed "there was only an 8.6% chance of observing a 3-month improvement in median progression-free survival in the group receiving maintenance paclitaxel," Dr. Gennari's team reports.

"The results provide strong evidence against the hypothesis that maintenance paclitaxel is associated with a clinically worthwhile effect on progression-free survival," the investigators conclude.

J Clin Oncol 2006;24:3912-3918.