131I-Tositumomab Therapy as Initial Treatment for Follicular Lymphoma

doi:10.1056/NEJMoa041511

Volume 352:441-449		February 3, 2005		Number 5

¹³¹I-Tositumomab Therapy as Initial Treatment for Follicular Lymphoma

Mark S. Kaminski, M.D., Melissa Tuck, M.A., Judith Estes, M.S.N., N.P., Arne Kolstad, M.D., Ph.D., Charles W. Ross, M.D., Kenneth Zasadny, Ph.D., Denise Regan, B.S., Paul Kison, B.S., Susan Fisher, B.A., Stewart Kroll, M.A., and Richard L. Wahl, M.D.

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Editorial
by Connors, J. M.

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ABSTRACT

Background Advanced-stage follicular B-cell lymphoma is consideredincurable. Anti-CD20 radioimmunotherapy is effective in patientswho have had a relapse after chemotherapy or who have refractoryfollicular lymphoma, but it has not been tested in previouslyuntreated patients.

Methods Seventy-six patients with stage III or IV follicularlymphoma received as initial therapy a single course of treatmentwith ¹³¹I-tositumomab therapy (registered as Tositumomab andIodine I 131 Tositumomab [the Bexxar therapeutic regimen]).This consisted of a dosimetric dose of tositumomab and ¹³¹I-labeledtositumomab followed one week later by a therapeutic dose, delivering75 cGy of radiation to the total body.

Results Ninety-five percent of the patients had any response,and 75 percent had a complete response. The use of polymerasechain reaction (PCR) to detect rearrangement of the BCL2 geneshowed molecular responses in 80 percent of assessable patientswho had a clinical complete response. After a median follow-upof 5.1 years, the actuarial 5-year progression-free survivalfor all patients was 59 percent, with a median progression-freesurvival of 6.1 years. The annualized rate of relapse progressivelydecreased over time: 25 percent, 13 percent, and 12 percentduring the first, second, and third years, respectively, and4.4 percent per year after three years. Of 57 patients who hada complete response, 40 remained in remission for 4.3 to 7.7years. Hematologic toxicity was moderate, with no patient requiringtransfusions or hematopoietic growth factors. No cases of myelodysplasticsyndrome have been observed.

Conclusions A single one-week course of ¹³¹I-tositumomab therapyas initial treatment can induce prolonged clinical and molecularremissions in patients with advanced follicular lymphoma.

Source Information

From the Department of Internal Medicine, Division of Hematology and Oncology (M.S.K., M.T., J.E.), the Department of Pathology (C.W.R.), and the Department of Radiology, Division of Nuclear Medicine (K.Z., D.R., P.K., S.F.), University of Michigan Medical Center, Ann Arbor; the Department of Oncology, Norwegian Radium Hospital, Oslo (A.K.); Corixa, Seattle (S.K.); and the Department of Radiology and Radiological Sciences, Division of Nuclear Medicine, Johns Hopkins University School of Medicine, Baltimore (R.L.W.).

Address reprint requests to Dr. Kaminski at the Division of Hematology and Oncology, Department of Internal Medicine, University of Michigan Cancer Center and Geriatrics Center, Rm. 4316, 1500 E. Medical Center Dr., Ann Arbor, MI 48109-0936, or at mkaminsk{at}umich.edu.

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