A phase I/II trial of TAC-101, an oral synthetic retinoid, in patients with advanced hepatocellular carcinoma |
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Authors: | Kimberly B. Higginbotham Richard Lozano Thomas Brown Yehuda Z. Patt Takashi Arima James L. Abbruzzese Melanie B. Thomas |
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Affiliation: | (1) Department of Gastrointestinal Medical Oncology Unit 426, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA;(2) University of New Mexico Cancer Research and Treatment Center, Albuquerque, NM, USA;(3) Taiho Pharmaceutical Co., Ltd, Tokyo, Japan |
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Abstract: | Purpose Preclinical models showed TAC-101 (4-[3,5-bis(trimethylsilyl) benzamide] benzoic acid), an oral synthetic retinoid, has anti-tumor activity in hepatocellular carcinoma (HCC). A phase I/II study was performed in advanced HCC patients (pts). Patients and methods Thirty-three patients were enrolled. During Phase I, pts received 40 mg daily for 14 days q3 weeks; 2 of 5 patients developed DLT so dose was reduced to 20 mg/day. Twenty-eight patients received 20 mg/day. Results No pt had a CR or PR, but 12 of 21 (57%) had SD. Two pts (9.5%) had late PR after discontinuing TAC-101. Median survival (MS) for all 28 pts treated with 20 mg/day was 12.7 months (95% CI 8.8–22.7); MS for 21 evaluable pts was 19.2 months (95% CI 10.4–27.6). Conclusions 20 mg of TAC- was well tolerated. Significant disease stabilization (12/21 pts, 57%), 2 late PRs, and prolonged MS (19.2 months) suggest that TAC-101 provides meaningful patient benefit. |
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Keywords: | Hepatocellular carcinoma Clinical trial Retinoids TAC-101 Survival |
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