To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ICML: Campath-1H and Rituximab for the Treatment of Hematological Malignancies URL: http://www.pslgroup.com/dg/215C46.htm Doctor's Guide June 16, 2002
By Claudia Orellana LUGANO, SWITZERLAND -- June 16, 2002 -- The combination of the monoclonal antibodies campath-1H and rituximab is safe and effective in patients with relapsed and/or refractory hematological malignancies, according to the results of an exploratory study. Stefan Faderl, MD, of M.D. Anderson Cancer Center, University of Texas, Houston, Texas, United States, presented the findings here Wednesday at the 8th International Conference of Malignant Lymphoma (ICML). The combination shows promise for a wide variety of patients with poor prognosis. Both antibodies (R anti CD20 and C anti CD52) were given intravenously. Rituximab was given at a dose of 375 mg/m2 once weekly for four weeks. In week 1, campath-1H was given at a dose of 3 mg/m2 on day 3, 10 mg/m2 on day 4, and 30 mg/m2 on day 5. During weeks 2, 3, and 4, campath-1H was given at a dose of 30 mg/m2 on days 3 and 5 of each week. Trimethoprim/sulfamethoxazole and valacyclovir were given for infection prophylaxis. Thirty-one patients were treated: 18 with chronic lymphocytic leukaemia (CLL), eight with CLL and prolymphocytic leukaemia (PLL), two with Richter's syndrome, and three with mantle cell lymphoma (MCL). Median age was 60 years (range 42 to 79). The median number of previous treatments was four, ranging from one to eight. Seventeen of 29 patients (59 percent) were refractory to fludarabine, 18 of 28 (64 percent) to alkylators, and 14 of 27 (52 percent) to both. "This was an exploratory study to get an idea what kind of patients it would be feasible to treat with this antibody combination, so that's why there was a very broad eligibility for patients. Treatment or pretreatment history is very different, and obviously the histologies were very heterogeneous," said Dr. Faderl. The overall response rate of 45 percent (14 patients). Three patients achieved a complete response (two CLL and one CLL/PLL), 10 had partial response (7 CLL, 3 CLL/PLL), and one CLL patient had nodal partial response. Among responders, the median time to progression was seven months, (range one to12) and the median survival was nine months (range three to 13). Infections occurred in 15 patients: five cytomegalovirus antigenemia, five pneumonia (one viral, two fungal, and two bacterial), one skin, seven FUO. Toxicities were grade 1 to 2 and mainly infusion-related. The most frequently observed adverse events were fever and rigor (up to 97 percent of patients), dyspnea (52 percent), rash and/or hives (42 percent), fatigue (39 percent), and myalgia (35 percent). "Given these results, where the patients who better responded were those with CLL, I'd prefer to treat patients with CLL with this combination. Hopefully we will perform studies on patients who haven't been so heavily pretreated as this group was," Dr. Faderl said. --------------------------------------------------------------------------------------------- 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.