To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: SABCS: Aptosyn (Exisulind) Plus Xeloda (Capecitabine) Shows Promise in Metastatic Breast Cancer Treatment URL: http://www.pslgroup.com/dg/21001E.htm Doctor's Guide December 13, 2001
By Robert H. Carlson SAN ANTONIO, TX -- December 13, 2001 -- Researchers are combining Aptosyn (exisulind) with Xeloda (capecitabine) for treatment of patients with metastatic breast cancer, and the early reports are that it is safe in heavily pre-treated patients.
Lajos Pusztai, MD, PhD, an assistant professor in the Breast Medical Oncology Department, The University of Texas M. D. Anderson Cancer Center, in Houston, Texas, presented data from a phase-I/II trial at the 24th Annual San Antonio Breast Cancer Symposium, in San Antonio, Texas.
The study is evaluating the safety and efficacy of the combination.
Dr. Pusztai said exisulind selectively induces apoptosis in neoplastic cells and potentiates the cytotoxic activity of chemotherapeutic drugs in preclinical models.
The primary objective of the phase I part of this study was to determine a safe dose for combination therapy with capecitabine and exisulind in patients with metastatic breast cancer who failed both anthracycline and taxane chemotherapy.
Two dose levels were tested. In level 1, patients received oral capecitabine 1,000 mg/m² twice daily for 14 days and oral exisulind 125 mg twice daily. In level 2, the capecitabine dose remained at 1,000 mg/m² twice daily for 14 days, while the exisulind dose increased to 250 mg twice daily in 21-day cycles.
Thirteen patients were accrued and 22 treatment cycles were administered -- seven cycles at dose level 1 and 15 cycles at dose level 2.
Six (54 percent) of the 11 patients who received dose level 2 required dose reduction, Dr. Pusztai said -- three because of reversible liver enzyme elevations assumed to be related to the exisulind, and six for capecitabine-related toxicity. Two patients had toxicity from both drugs.
Dr. Pusztai said the dose-limiting toxicities in this trial were grade 3 palmar-plantar erythrodysthesia (hand-foot syndrome) and diarrhea. Grade 2 fatigue, nausea, and myalgia were also reported. But there was no hematological toxicity greater than grade 3, he added.
Of the nine patients who completed two cycles of therapy, four had stable disease and five had disease progression, Dr. Pusztai reported.
"No unexpected toxicity was seen, and although treatment at dose level 2 resulted in significant toxicity, all symptomatic adverse events were consistent with toxicity from capecitabine," Dr. Pusztai concluded. He said additional patients are now being accrued at level 1 to further explore toxicity and efficacy of this combination. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.