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Title: Microtubule Inhibitor Less Toxic than Standard Therapy in Patients with Refractory Ovarian Cancer: Presented at EORTC-NCI-AACR

"Microtubule Inhibitor Less Toxic than Standard Therapy in Patients with Refractory Ovarian Cancer: Presented at EORTC-NCI-AACR"

By Paula Moyer Special to DG News FRANKFURT, GERMANY -- November 21, 2002 -- A new microtubule-inhibiting agent may be a less agent than established second-line agents, and it appears to have similar efficacy for treating patients with refractory ovarian cancer. Dr. Stanley B. Kaye, head of the section of medicine at The Institute of Cancer Research and professor of medical oncology at Royal Marsden Hospital, in London, England, presented the findings during the joint meeting of the European Organisation for the Research and Treatment of Cancer, the National Cancer Institute, and the American Association for Cancer Research. The agent, known as EPO906, is an epothilone agent, a class of investigative treatments that impede the proliferation of malignant cells by inhibiting cell division at the microtubule level. Since mitosis cannot be completed, apoptosis follows. In several Phase I studies, EPO906 was shown to be active in patients with colon, ovarian, breast and carcinoid tumours, as well as non-small cell lung cancer. "This agent may be better tolerated than platinum and paclitaxel [Taxol] and has equivalent results," said Dr. Kaye, referring to established second-line therapy for unresponsive ovarian cancer. In an open-label multicentre phase II study, he and colleagues evaluated the efficacy and safety of EPO906 in 53 patients who had advanced ovarian cancer that had progressed during or within six months after completing first-line therapy consisting of a combination of carboplatin and docetaxel (Taxane). Patients received the treatment at a dose of 2.5 mg/m2 intravenously as a 5-minute bolus infusion. Treatment continued weekly for three weeks, at which point the patients had a one-week rest period from treatment. The patients continued this treatment regimen until the investigators documented a progression in their disease, or until an unacceptable toxicity had developed. Of the 43 evaluable patients, a partial response was observed in three patients (6.1 percent), and stabilisation of disease was observed in another three (6.1 percent). They documented 18 patients (41.9 percent) whose disease progressed and therefore discontinued the study. The remaining 12 (27.9 percent) had not been followed long enough to have data available on their response, Dr. Kaye said. Of the six patients who had either a partial response or stable disease, falling CA-125 values were observed in four, along with varying degrees of radiologic response to treatment. The toxicity documented by the investigators was at a modest level, they reported. Four patients had grade 3 diarrhoea, one had grade 4 nausea, and one patient had grade 4 vomiting. Lower-level adverse effects attributed to the study drug included diarrhoea, nausea, vomiting, anorexia and fatigue. "Our findings suggest that this agent is well-tolerated and has activity in patients with advanced refractory ovarian cancer," said Dr. Kaye. At the next stage of research, he and colleagues plan to determine the best dosing schedule for EPO906 in this group of patients.

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