SNUS San Antonio Abstract
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[1070] A phase 2b multicenter evaluation of the safety and efficacy of TOCOSOL paclitaxel (TOC- P) as initial treatment of patients with metastatic breast cancer (MBC).
Bogdanova N, Tjulandin S, Ognerubov N, Semiglazov V, Afanasjev B, Makhson A, Krasnozhon D, Manikhas G, Vtoraya O, Mitashok I, Astakhov V, Byakhov M, Luciano G, Moore E, Pratt J, Bolton MG. The 1074 TOCOSOL Paclitaxel Working Group, Russian Federation; Sonus Pharmaceuticals, Bothell, WA
TOC-P is a novel Cremophor-free vitamin E-based paclitaxel formulation that does not need reconstitution or dilution, is given over 15 minutes i.v. push, may result in reduced incidence and severity of infusion reactions and better patient tolerance (in particular, less neuropathy), thus enabling higher single doses and/or a higher cumulative paclitaxel dose, and, potentially, improved anti-tumor efficacy. Pre-medication with steroids is not required. 47 patients (pts) with previously untreated MBC were assigned to receive weekly TOC-P 120 mg/m2 until PD or intolerable toxicity. Median age: 57 (21 74). ECOG PS 0 = 26 pts, PS 1 = 21 pts. Chemotherapy nave: 19 pts; prior adjuvant chemotherapy: 28 pts; prior anthracycline: 18 pts. ER+: 12 pts, ER-: 4 pts, ER status ND: 31 pts. Prior hormone therapy: 14 pts. Pts were required to have measurable disease by RECIST, thus defining a population with a high tumor burden; visceral metastases: 43 pts, 3 sites of disease: 21 pts. One pt was ineligible and is not included in the efficacy analysis. Safety and Efficacy data for the first 16 weeks of treatment are available for 47 and 44 pts respectively. The mean dose delivered was 95 mg/m2/week. 27 pts remain on therapy after an average 17 weeks; 20 pts have discontinued: PD=11, toxicity =7, withdrawal not due to toxicity =2. Investigator reported RR: 22 pts (48%) confirmed PR (confirmatory CT 4 weeks after OR determination); an additional 4 pts (9%) have unconfirmed PR; 8 pts have SD at 16 wks; 9 have PD. The median TTP has not yet been reached. The most frequent toxicity reported was neutropenia (87%). Grade 3/4 neutropenia: 66% of pts, 60% of pts required a dose reduction by wk 4. Dose re-escalation was permitted. The time to return to full dose was 1 wk in >70% of pts. Grade 3 neuropathy: 11% (no grade 4). Arthralgias and myalgias: 34% (2% grade 3, no grade 4). 24 pts (51 %) had an adverse event related to infusion (event occurred within 30 minutes of end of dose). One grade 4 event (sacral pain) was reported and resulted in discontinuation of study drug after 3 occurrences. In all other pts, infusion reactions were easily managed and did not result in discontinuation of therapy. Final data will be presented. TOCOSOL paclitaxel is an active agent in the treatment of MBC. The recommended dose for Phase 3 study is 100 mg/m2 weekly.
Thursday, December 8, 2005 5:00 PM
Poster Session I: Treatment: Chemotherapy - New Drugs and Formulations (5:00 PM-7:00 PM)
AI
