Selected Abstracts: ASCO Phase 2 study of TLK286 (GST P1-1 activated glutathione analog) as third-line therapy in patients with advanced metastatic breast cancer (MBC) Year: 2003 Abstract No: 61 Author(s): D. Washington, K. Miller, G. T. Budd, C. Taylor, D. D. Von Hoff, G. L. Brown, R. Parra, A. Jameson, J. Mascavage, W. D. Henner; Indiana University Cancer Center, Indianapolis, IN; Cleveland Clinic, Cleveland, OH; Arizona Cancer Ctr, Tucson, AZ; Telik, Inc., South San Francisco, CA Abstract: Introduction: TLK286 is a novel glutathione analog prodrug activated by glutathione S-transferase P1- 1. The purpose of this study is to evaluate the safety and efficacy of TLK286 in the treatment of ³ third-line metastatic breast cancer (MBC). Methods: Advanced MBC patients who had failed prior therapy with anthracyclines and taxanes received TLK286 at 960 mg/m2 IV weekly until tumor progression or unacceptable toxicities. Objective tumor response (ORR) was determined by RECIST, safety by NCI-CTC, and time to tumor progression (TTP) by Kaplan-Meier analysis. Results: Thirty-five patients (median age 52, range 30-80) were enrolled June-December, 2002. 192+ doses (1-20+ per patient) were administered. All patients had failed prior chemotherapy regimens (median 3, range 2-6), and most had failed both anthracyclines (73%) and taxanes (83%). TLK286 was administered at 97% of the specified dose intensity. The most common possibly drug-related toxicities (£ Grade 2) were: fatigue, nausea, and dysuria. There were no Grade 4 toxicities and Grade 3 toxicities were infrequent (n=2). No cumulative toxicities were seen. At interim analysis, 21 of 35 patients were evaluable. One patient has a robust (>90% tumor reduction) partial response (PR) by RECIST and continues on TLK286 > 8 months. Two patients have had minor responses (MRs) that have not yet met PR. Nine patients have durable stable disease (SD). Disease stabilization rate (PR+MR+SD) is 48%. The longest duration of TLK286 therapy is the PR patient, progression-free for 20+ doses (8+ months). Conclusions: TLK286 has significant single-agent antitumor activity in MBC patients as ³ third-line salvage therapy and has been well tolerated. Determination of TTP and final ORR will require further patient follow-up. Abstract No. 886 Abstract 872 Phase I Study of Flavopiridol & Docetaxel Abstract 930 This is a marine product Abstract 2184 Amifostine is a synthetic antioxidant Abstract 2251 Yoga Therapy: Pscyhotherapeutic Intervention (Bca) Abstract 2093 ASCO Abstract #45 Weekly Docetaxel Causes Eye Problems ASCO Abstract #337, 2003 Abstract 47 ASCO, 2003 ASCO Abstract # 54, 2003 ASCO Abstract #375, 2003 Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.