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Executive Summary

TAXOL/G-CSF COMBINATION REDUCED OVARIAN TUMORS BY 50% IN HALF OF PATIENTS with recurrent ovarian cancer in a Phase II National Cancer Institute study. Speaking at a National Institutes of Health Grand Rounds meeting April 15, NCI researcher Eddie Reed reviewed results of 38 evaluable patients treated with taxol in combination with granulocyte colony stimulating factor (G-CSF, Amgen's Neupogen). Nineteen of the patients have "objective responses," defined as a tumor reduction of at least 50%, four had minor responses and 15 did not respond, he said. In the study, taxol was administered in doses ranging from 56.3 to 93.8 mg/m/wk and G-CSF was given in doses up to 20 ug/kg/day. Reed concluded that taxol can be safely increased from 45 mg/m/wk to 83 mg/m/wk with G-CSF support and that dose intensification is associated with an enhanced rate of disease response. The study will be presented at the annual meeting of the American Society of Clinical Oncology in May. Bristol-Myers Squibb is planning to file an NDA by mid-1992 for taxol use for refractory ovarian cancer ("The Pink Sheet" March 9, p. 14). Reed said the NCI study has used a higher dose intensification and has produced the highest objective response rate compared to studies conducted elsewhere. He said a Phase I trial at Johns Hopkins showed a 32% response rate, and two other Phase II trials at outside institutions showed 21% and 36% response rates, respectively. Results of the Phase I trial will be published in the July issue of the Journal of Clinical Oncology. An NCI Phase I trial involving 15 patients with recurrent ovarian cancer found that taxol given in combination with G-CSF reduced tumor size by more than 50% in more than one-third of patients, Reed reported. Minor responses, defined as a 30% to 45% tumor reduction rate, occurred in another 36% of patients. He said these patients also experienced a "dramatic" improvement in clinical status. Reed and his colleagues treated patients with a 24-hour continuous intravenous infusion of taxol for 3 weeks, with doses ranging from 170 to 300 mg/m/cycle. Subjects also received daily subcutaneous injections of G-CSF at 10 ug/kg/day. Reed noted that severe dose-limiting peripheral neuropathy was seen in two of three patients treated with taxol at 300 mg/m, and in one of six treated at 250 mg/m. He added that when given with G-CSF, myelosuppression and mucositis were not dose-limiting features of taxol therapy.

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