Journal of Clinical Oncology, Vol 18, Issue 6
(March), 2000: 1316-1323
© 2000 American Society for Clinical Oncology
Multicenter Phase II Study of Iodine-131 Tositumomab for Chemotherapy-Relapsed/Refractory Low-Grade and Transformed Low-Grade B-Cell Non-Hodgkin’s Lymphomas
By Julie M. Vose,
Richard L. Wahl,
Mansoor Saleh,
Ama Z. Rohatiner,
Susan J. Knox,
John A. Radford,
Andrew D. Zelenetz,
George F. Tidmarsh,
Robert J. Stagg,
Mark S. Kaminski
From the University of Nebraska Medical Center, Omaha, NE; University of Michigan Medical Center, Ann Arbor, MI; University of Alabama-Birmingham, Birmingham, AL; St Bartholomew’s Hospital, London; Christie Hospital National Health Service Trust, Manchester, England; Stanford University Medical Center, Palo Alto; Coulter Pharmaceutical, South San Francisco, CA; and Memorial Sloan-Kettering Cancer Center, New York, NY.
Address reprint requests to Julie M. Vose, MD, Department of Internal Medicine, 987680 Nebraska Medical Center, Omaha, NE 68198-7680.
PURPOSE: This multicenter phase II study evaluated the efficacy, dosimetry methodology, and safety of iodine-131 tositumomab in patients with chemotherapy-relapsed/refractory low-grade or transformed low-grade non-Hodgkin’s lymphoma (NHL).
PATIENTS AND METHODS: Patients received a dosimetric dose that consisted of 450 mg of anti-B1 antibody followed by 35 mg (5 mCi) of iodine-131 tositumomab. Serial total-body gamma counts were then obtained to calculate the patient-specific millicurie activity required to deliver the therapeutic dose. A therapeutic dose of 75 cGy total-body dose (attenuated to 65 cGy in patients with platelet counts of 101,000 to 149,000 cells/mm3) was given 7 to 14 days after the dosimetric dose.
RESULTS: Forty-five of 47 patients were treated with a single dosimetric and therapeutic dose. Twenty-seven patients (57%) had a response. The response rate was similar in patients with low-grade (57%) or transformed low-grade (60%) NHL. The median duration of response was 9.9 months. Fifteen patients (32%) achieved a complete response (CR; 10 CRs and five clinical CRs), including five patients (50%) with transformed low-grade NHL. The median duration of CR was 19.9 months, and six patients have an ongoing CR. Treatment was well tolerated, with the principal toxicity being hematologic. The most common nonhematologic toxicities that were considered to be possibly related to the treatment included mild to moderate fatigue (32%), nausea (30%), fever (26%), vomiting (15%), infection (13%), pruritus (13%), and rash (13%). Additionally, one patient developed human-antimouse antibodies.
CONCLUSION: Iodine-131 tositumomab produced a high overall response rate, and approximately one third of patients had a CR despite having chemotherapy-relapsed or refractory low-grade or transformed low-grade NHL.
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