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      Older Women With Breast Cancer Respond to Treatment With Capecitabine and Vinorelbine: Presented at SABCS

      By Ed Susman

      SAN ANTONIO, TX -- December 18, 2006 -- More than three quarters of 26 evaluable women over age 60 who are diagnosed with metastatic breast cancer respond to treatment with capecitabine and vinorelbine, researchers reported here at the 29th San Antonio Breast Cancer Symposium (SABCS).

      "The promising response rate of 77% justifies further evaluation of this combination regimen," said Uwe Kohler, MD, PhD, professor of medicine, clinic for obstetrics and gynecology, University of Leipzig, Leipzig, Germany.

      "Half of all women with breast cancer are 58 years old or older," Dr. Kohler said in a poster presentation on December 17th. "In older patients, comorbidity and impaired organ function limit the use of taxane- or anthracycline-containing regimens. However, undertreatment in elderly patients results in poorer survival."

      In the pilot study, Dr. Kohler enrolled 30 women with a median age of 68, aiming to continue to enroll up to 77 women if the initial results showed at least a 46% response rate.

      The researchers treated these women with capecitabine 1000 mg/m2 daily on days 1 through 14, in addition to vinorelbine 25 mg/m2 on days 1 and 8, on a 21-day cycle. The treatment continued until best response, disease progression, or unacceptable toxicity occurred.

      Of the 26 evaluable patients, 3 achieved a complete response and 17 achieved a partial response; 1 patient achieved disease stabilization.

      Although the regimen contained a high dose of capecitabine, it appears to have been well tolerated, Dr. Kohler said. He said there were no cases of grade 3 hand-foot syndrome and an 8% rate of grade 3/4 diarrhea.

      "These preliminary results indicate that this combination regimen of capecitabine and vinorelbine is highly active and well tolerated as first-line therapy in patients over age 60," he said.

      Dr. Kohler presented the findings on behalf of the Northeast German Society for Gynecologic Oncology (NOGGO) breast cancer study group.


      [Presentation title: Capecitabine (C) and Vinorelbine (V) in Elderly Patients (pts.) With Metastatic Breast Cancer (MBC) as 1st Line Treatment: a Prospective Multicentre Phase II Study of the NOGGO Breast Cancer Study Group. Abstract 6089]



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