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Sub-category:
Adult Lymphoma
Category:
Leukemia/Lymphoma (Adult)
Meeting:
2001 ASCO Annual Meeting
Abstract No:
1136
Citation:
Proc Am Soc Clin Oncol 20: 2001 (abstr 1136)
Author(s):
Stephanie A. Gregory, Andrew Zelenetz, Susan Knox, Julie Vose, David Magnuson, Mark Kaminski, Rush Presbyterian-St. Luke's Medical Center, Chicago, IL; Memorial Sloan-Kettering Cancer Center, New York, NY; Stanford Univ. Medical Center, Stanford, CA; University of Nebraska Medical Center, Omaka, NE; Coulter Pharmaceutical, Inc., South San Francisco, CA; University of Michigan, Ann Arbor, MI.
Abstract:
NHL is a disease of the elderly. This population often has co-morbid conditions which limit the use of aggressive combination chemotherapies. Bexxar™ (tositumomab and iodine I 131 tositumomab) is a radioimmunotherapeutic in development for patients (pts) with low-grade (LG) or transformed LG NHL. We have retrospectively analyzed the safety and efficacy of Bexxar in the 70 pts older than 60 yrs of age in Phase I-III trials from 1990-1999. PATIENTS: Median age 69 yrs (range:61û82yrs); median time from initial diagnosis to study entry 45 mo; median number prior chemotherapies 3 (range:0û13); 48%-elevated LDH; 43%-(+) bone marrow involvement at study entry; 31%-bulky disease (500g); 60%-LG NHL, 34%-transformed LG NHL, and 6%-de novo intermediate or high grade at entry. Pts received Bexxar as previously described (Blood 2000;90:1259; J Clin Oncol 2000;18:1316). Pt-optimized dosing calculates a specific therapeutic dose based on individual pt clearance. The pts were administered a patient specific total body absorbed radiation dose (TBD) of usually 65 or 75 cGy. The median follow-up was 15 mo (range: 1.5û78 mo). RESULTS: An overall response rate (ORR) was 60% (42 pts) and complete response (CR) was 20% (14 pts). The median duration of ORR was 9 mo (95% CI: 5û12 mo), and median duration of CR has not been reached (95% CI: 12 mo-NR). AEs 10% were fever 41%, asthenia 36%, nausea 31%, anorexia 20%, diarrhea 20%, pain 19%, cough increased 19%, rash 16%, and chills 16%. These were generally mild and transient. Only 4% of dosimetric and therapeutic infusions required rate adjustments. Grade 4 ANC (<500 cells/mm3) was 19% (13 pts), Grade 4 platelet (<10,000 cells/mm3) was 4% (3 pts). Nine pts (13%) were hospitalized for an infection. Safety in elderly pts was similar to pts [less than or equal to]60 yrs. CONCLUSION: Bexxar was efficacious and well tolerated in this population of elderly patients with NHL. Due to physiologic changes in the elderly, conventional chemotherapy may require dose-attenuation; however, Bexxar therapy provides pt-optimized dosing so that the same TBD is given for all age groups. This novel therapy provides a therapeutic choice for pts who may have limited therapeutic options.
 Associated Presentation(s):
Other Abstracts in this Sub-Category:
Abstracts by Stephanie A. Gregory:
Presentations by Stephanie A. Gregory:
Educational Book Manuscripts by Stephanie A. Gregory:
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