The next few posts will contain ASH abstracts. If not interested, skip any messages I post here today.
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The Role of Targeted and Nontraditional Therapeutic Approaches in Hematologic Malignancies
Friday, December 3, 2004, 06:00 PM
Emerging clinical data on the use of combination strategies and nontraditional cytotoxic agents for the treatment of hematologic malignancies suggest that traditional cytotoxic chemotherapy use may be avoided or reduced in certain regimens. This symposium will provide an overview of the current treatment trends that incorporate novel targeted agents and nontraditional agents for patients with acute promyelocytic leukemia, multiple myeloma, myelodysplastic syndromes, and lymphoma.
For more information, contact Stefanie Barrans, PharmD, Apothecom Associates, LLC.
Phone: 215-550-8152
Fax: 215-550-8152
E-mail: stefanie.barrans@apothecom.com
This program is sponsored by the Postgraduate Institute for Medicine and supported by Cell Therapeutics, Inc.
Corporate Friday Symposia: The Role of Targeted and Nontraditional Therapeutic Approaches in Hematologic Malignancies (6:00 PM - 10:00 PM)
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Saturday, December 4, 2004, 06:00 PM
[1324] Preliminary Results of a Phase I/II Trial of BBR-2778 (Pixantrone) in Combination with Fludarabine, Dexamethasone, and Rituximab (FPD-R) in the Treatment of Patients with Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (NHL).
Session Type: Poster Session 478-I
Luis Fayad, James Liebmann, Manuel Modiano, Gary I. Cohen, Barbara Pro, Jorge Romaguera, Cristina Davite, Margarita Lymboura, Silvia Comis, Bernard L. Laffranchi. Lymphoma/Myeloma Department, MD Anderson Cancer Center, Houston, TX, USA; NMOHC Research Department, New Mexico Onc/Hem Consultants, Inc., Albuquerque, NM, USA; Arizona Clinical Research Center, Tucson, AZ, USA; Cancer Center, Greater Baltimore Medical Center, Baltimore, MD, USA; Clinical Department, Cell Therapeutics Inc., Milan, Italy
Background: Fludarabine-mitoxantrone-dexamethasone-rituximab (FND-R) is a combination chemotherapy with significant activity in untreated and relapsed indolent B-cell lymphoma patients (pts). Pixantrone is a novel aza-anthracenedione that has no delayed cardiotoxicity in animal models and has single agent activity in NHL. We conducted an outpatient phase I/II trial, to define the recommended dose (RD) of pixantrone when substituting for mitoxantrone in the FND-R regimen, and the safety and efficacy of this regimen in pts with relapsed or refractory indolent NHL.
Methods: Pts received pixantrone with fludarabine (25mg/m2/day, days 1-3), dexamethasone (20mg/day, days 1-5), and rituximab (375mg/m2/day on day 1) in a 28 day regimen (FPD-R). Based on previous single agent clinical studies, the starting dose of pixantrone was defined as 80mg/m². The RD was established to be 120mg/m2 and the protocol was amended to treat patients in the phase II part.
Results: 9 pts (6 males) with a median age of 65 years (range 41-78) were included in the dose-finding part of the study. Following the protocol amendment, 23 pts (11 males) of WHO performance status 0-1, median age 61 (range 32-78) have been enrolled in the currently ongoing phase II part. Pathology included SLL/CLL, follicular grade I, follicular grade II, MALT, marginal cell, and other indolent B-cell lymphomas. All pts had received a prior anthracycline-containing regimen (median number 1, range 1-4). The study regimen was well tolerated; median number of courses received was 5 (range 2-8). Grade 4 toxicities were neutropenia in 10 pts, leukopenia in 5 pts, and thrombocytopenia in 1 pt. No clinically significant cardiac events or decreases in LVEF =20% were noted. However 4 pts went below 50% LVEF including 1 pt who was below 50% at baseline. Non-hematologic adverse events were primarily grade 1 or 2 in severity. Response rate was 75% for the 20 pts evaluable for response, with 11 (55%) complete remission [7 confirmed (CR), 4 unconfirmed (CRu)], and 4 (20%) partial remission (PR). Two responders went onto bone marrow transplant (BMT): one had a CRu and one a PR. A third patient was pending BMT after CR. At a median follow-up of 345 days, the median duration of response has not been reached, as only two pts have progressed: the first progression occurred at 113 days, and the second pt progressed at 699 days. The remaining pts are still in remission. Conclusions: The RD of pixantrone in the FPD-R regimen is 120mg/m2. The primary toxicity is hematologic. The regimen can be given on an outpatient basis, is associated with major responses, and is very well tolerated in relapsed and refractory indolent NHL pts.
Abstract #1324 appears in Blood, Volume 104, issue 11, November 16, 2004
Keywords: Mitoxantrone|Anthracycline|Chemotherapy
Poster Session: Hodgkin's Lymphoma - Chemotherapy and Rituximab Combinations for Non-Hodgkin's Lymphomas (6:00 PM-7:30 PM) |
