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| |  SABCS: Weekly Chemotherapy Schedule Safer Than Three-Week Schedule By Robert H. Carlson SAN ANTONIO, TX -- December 5, 2003 -- A weekly schedule of chemotherapy with paclitaxel, carboplatin and trastuzumab (Herceptin) in women with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer was as effective as a 3-week schedule, but far less toxic, researchers from the Mayo Clinic said on December 4th here at the 26th Annual San Antonio Breast Cancer Symposium. The North Central Cancer Treatment Group trial N98-32-52, a randomized phase-II trial, was discussed here by principal investigator Edith Perez, MD, professor of medicine, Mayo Clinic, Jacksonville, Florida, United States. "We reached the goals we were looking for, which was a non-anthracycline regimen with high efficacy and low toxicity," Dr. Perez said. This assessed the efficacy and tolerability of 2 different schedules of paclitaxel, carboplatin and trastuzumab as first-line therapy for HER2-positive metastatic breast cancer. The first schedule, cycled every 3 weeks, included paclitaxel 200mg/m2, carboplatin area under the curve (AUC) 6 and trastuzumab (8 and then 6 mg/kg) administered on Day 1 of the cycle. After 8 cycles, treatment with trastuzumab continued until disease progression. The second regimen, given in 1-week cycles, was paclitaxel 80 mg/m2 given once weekly, carboplatin AUC 2 given for 3 weeks out of 4, and trastuzumab weekly. After 6 cycles, treatment with trastuzumab was continued until disease progression. Dr. Perez said the latest data were on 91 patients eligible for assessment: 43 randomized to the every-3-week schedule and 48 to the weekly schedule. Median age was 56 years and 55 years, respectively. Most patients had visceral dominant disease: 67% in the 3-week schedule and 85% in the weekly group. This generally includes lung and liver metastases, and indicates a population with poor prognosis. The women were mostly postmenopausal (77% in the 3-week schedule group and 79% in the weekly group). Prior adjuvant chemotherapy was given in 51% and 62% respectively. Prior adjuvant anthracycline was given in 28% and 30%, respectively. Forty-nine percent in each group were HER2-positive. Efficacy data showed that a response lasting more than 4 weeks was achieved by 65% of the every-3-week group versus 71% in the weekly arm, and median response duration was 9.9 months versus 12.5 months. For the 3-week group versus the once-weekly group, the rates of grade-3 neurosensory effects were 19% versus 2%; febrile neutropenia 14% versus 2%; and arthralgia 13% versus 2%. "Toxicity profiles significantly favored the weekly schedule," Dr. Perez said. "These differences in toxicity were remarkable, [achieved] by changing the schedule of the chemotherapy drugs." Dr. Perez was also able to report no congestive heart failure in either of the treatment groups -- a concern ever since trastuzumab's pivotal trial.
[Study title: N98-32-52: Efficacy and Tolerability of Two Schedules of Paclitaxel, Carboplatin and Trastuzumab in Women with HER2 Positive Metastatic Breast Cancer: a North Central Cancer Treatment Group Randomized Phase II Trial. Abstract 216]
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