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| |  ESMO: Ibandronate Reduces Bone Complications in Colorectal Cancer Patients With Bone Metastases By Charlene Laino VIENNA, AUSTRIA -- November 1, 2004 -- For the first time, researchers have shown that ibandronate provides significant clinical benefit to patients with bone metastases secondary to colorectal cancer. "The results of our 2 ongoing studies show that ibandronate is effective in preventing skeletal events in patients with colorectal cancer as well as metastatic breast cancer," said lead investigator Panagiotis Heras, MD, chief of internal medicine, General Hospital of Nafplio, Nafplio, Greece. "Currently, ibandronate is only indicated for use in patients with metastatic breast cancer and metastatic bone lesions, but the new study suggests the indication should be expanded to colorectal and perhaps other cancers as well," he said here on October 31st at the 29th European Society for Medical Oncology Congress. In the first trial, 102 women with breast cancer and bone metastases were randomised to treatment with 6 mg of ibandronate every 4 weeks for 24 months, or placebo on the same schedule. Thirty-six percent of the women in the ibandronate arm experienced a skeletal event, compared with 48% in the placebo arm (P =.027). Ibandronate was also associated with a significant delay in the time to first event, with a median of 457 days versus 304 days for placebo (P =.007). In the second trial, 152 patients with colorectal, prostate, or lung tumours were randomised to 6 mg of ibandronate or placebo every 4 weeks for 9 months. In the subset of 15 patients with colorectal cancer -- the only group that has been analysed to date -- ibandronate significantly reduced the proportion of patients who experienced a skeletal event, with 39% of patients having an event versus 78% in the placebo arm (P =.019). Ibandronate also delayed the time to the first event to 279 days, compared with 93 days for placebo (P =.009). Ibandronate also significantly reduced the skeletal morbidity rate to a mean of 2.36 versus 3.14 for placebo (P =.018) and prolonged the time to progression of bone lesions, with 214 days for treated patients versus 81 days for placebo patients (P =.018). In both trials, ibandronate was well tolerated, Dr. Heras said.
[Presentation title: Ibandronate Is Effective in Preventing Skeletal Events In Patients With Bone Metastases Secondary to Breast and Colorectal Carcinoma. Poster 53]
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