Source: Lancet  |  Posted 11 years ago

SAN ANTONIO, TX -- December 13, 2000 -- The use of weekly Taxol (paclitaxel) and Paraplatin (carboplatin) is effective and well-tolerated as a first-line treatment for advanced breast cancer patients, according to a study released at the 23rd annual San Antonio Breast Cancer Symposium.

"When treating women with advanced breast cancer, we try to increase their quality of life while prolonging survival," according to David Loesch, MD, of Oncology and Hematology Associates, Indianapolis, IN, and US Oncology, Inc., and lead investigator of this study. "Our study results showed that weekly Taxol and Paraplatin produces a response rate comparable to the best achieved by standard front-line chemotherapy in the multi-institution setting. Our goal of identifying an active regimen that does not cause damage to the heart was met."

The study was led by the research group within US Oncology, Inc. and enrolled 100 patients with advanced breast cancer between November 1998 and August 1999. Over 60 percent of these patients had received prior adjuvant chemotherapy. The results showed a 60 percent response rate, with 8 percent of patients achieving complete disappearance of disease. There were relatively low side effects in patients treated with weekly Taxol and Paraplatin.

"We feel that our results are particularly reliable given the large number of patients enrolled and the general lack of selection bias that frequently occurs in smaller, single-institution studies. With this high response rate and lack of cardiotoxicity," said Dr. Loesch, "the weekly Taxol and Paraplatin regimen should be considered an option for patients with newly diagnosed metastatic breast cancer. In addition, this regimen should be strongly considered for evaluation in the adjuvant setting."

The purpose of the study was to determine the activity of weekly Taxol and Paraplatin as a first-line therapy for advanced breast cancer patients. Since weekly chemotherapy is administered more frequently than the traditional regimens, it is effective in treating advanced disease because the tumor receives a more sustained dose of chemotherapy, which may prevent the tumor from growing or developing resistance. Group one (20 patients) received three weeks of Taxol (135 mg/m2) and Paraplatin (AUC=2); however due to increased toxicity, the weekly dose of Taxol was reduced for the rest of the patients (100mg/m2) (group 2, 80 patients).

Fifty-eight patients experienced either a complete or partial response to treatment with a median time to response of 1.8 months; there were no differences in response rates between the two groups. Estimated median time to progression was 4.8 months and estimated time to survival for all patients was 13 months; death was mainly due to disease. Side effects were generally modest, with low white blood cells being the most significant. Other side effects experienced were nerve pain and numbness in the extremities and infections.

More than 180,000 new cases of breast cancer will be diagnosed and more than 40,000 women will die in 2000, according to the American Cancer Society. Breast cancer is the second leading cause of cancer-related death in women. Advanced or metastatic disease is cancer that has spread beyond the original tumor site. Treatment for metastatic disease remains a challenge for the oncology community with an average survival rate of two years. Therefore, the goal of treatment for advanced breast cancer is usually to palliate (reduce symptoms of the disease) and to prolong survival.