Thanx my baddddddddd...how could I have let that slip the radar? esp. 'cuz I'm in the vulnerable age group..
from ASCO '04.
A phase I/II trial of BBR-2778 (pixantrone), methylprednisolone, cisplatin, and cytosine arabinoside (BSHAP) in relapsed/refractory aggressive non-Hodgkin’s lymphoma (NHL).
Abstract No: 6590
Citation: Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 22, No 14S (July 15 Supplement), 2004: 6590
Author(s): G. Camboni, L. Fayad, A. Tulpule, M. Modiano, B. M. Espina, F. Cabanillas, A. M. Levine; Novuspharma, Milan, Italy; M. D. Anderson Cancer Center, Houston, TX; USC Keck School of Medicine, Los Angeles, CA; Arizona Clinical Cancer Research Center, Tucson, AZ
Abstract:
Background: BBR-2778 (Pixantrone) is a novel aza-anthacenedione DNA intercalator with anti-tumor synergy with cisplatin, no delayed cardiotoxicity in animal models, and evidence of anti-tumor activity in vivo. Pixantrone was substituted for etoposide in the ESHAP regimen to define the safety and efficacy profile in patients(pts) with aggressive relapsed or refractory non-Hodgkin's lymphoma (NHL). Methods: All pts received BBR-2778 (pixantrone) 80 mg/m2, IV day 1; methylprednisolone 500 mg IV days 1-5; cisplatin, 25 mg/m2, IV over 30 minutes, days 1-4; and cytosine arabinoside, 2000 mg/m2 IV, day 5. Treatment was given every 21 days as an outpatient, when possible. Results: 21 patients with a median age of 50 years (range 35-75) were studied. Pathologies included diffuse large B-cell or variants in 19 (90%) and follicular grade 3 in 2. 18 (86%) had stage III or IV disease. All received a prior anthracycline-containing regimen. 14 (67%) were refractory to their immediate prior regimen. Initially, 4 dose levels of pixantrone were planned. However after 2 dose limiting toxicities (grade 3 infection; febrile neutropenia), 80 mg/m2 was defined as the maximum tolerated dose. The most common grade 4 side effects were hematologic: neutropenia in 13 (68%), including febrile neutropenia in 5 (26%); thrombocytopenia in 8 (42%), and anemia in 4 (21%). No clinically significant cardiac events or decreases in LVEF > 20% were noted. Non-hematologic side effects were mostly grade1 or 2 in severity. Of 18 pts evaluable for response, complete remission (CR) was documented in 7 (39%) and partial remissions (PR) in 4 (22%) for a major response rate of 61%. Among the 11 responders, 4 had primary refractory disease. Six pts went on to stem cell transplant after remission to BSHAP. The median duration of CR or PR is 195+ days (range 24+ to 290+). Conclusions: The recommended dose of pixantrone in the BSHAP regimen in 80 mg/m2. The primary toxicity is hematologic. The regimen can be given on an outpatient basis, and is associated with major responses in 61% of relapsed and refractory aggressive NHL patients. |
