title: 131I-tositumomab therapy as initial treatment for follicular lymphoma.
abstract: BACKGROUND
  Advanced-stage follicular B-cell lymphoma is considered incurable. Anti-CD20 radioimmunotherapy is effective in patients who have had a relapse after chemotherapy or who have refractory follicular lymphoma, but it has not been tested in previously untreated patients.
  
  
  METHODS
  Seventy-six patients with stage III or IV follicular lymphoma received as initial therapy a single course of treatment with 131I-tositumomab therapy (registered as Tositumomab and Iodine I 131 Tositumomab [the Bexxar therapeutic regimen]). This consisted of a dosimetric dose of tositumomab and 131I-labeled tositumomab followed one week later by a therapeutic dose, delivering 75 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 polymerase chain reaction (PCR) to detect rearrangement of the BCL2 gene showed molecular responses in 80 percent of assessable patients who had a clinical complete response. After a median follow-up of 5.1 years, the actuarial 5-year progression-free survival for all patients was 59 percent, with a median progression-free survival of 6.1 years. The annualized rate of relapse progressively decreased over time: 25 percent, 13 percent, and 12 percent during the first, second, and third years, respectively, and 4.4 percent per year after three years. Of 57 patients who had a complete response, 40 remained in remission for 4.3 to 7.7 years. Hematologic toxicity was moderate, with no patient requiring transfusions or hematopoietic growth factors. No cases of myelodysplastic syndrome have been observed.
  
  
  CONCLUSIONS
  A single one-week course of 131I-tositumomab therapy as initial treatment can induce prolonged clinical and molecular remissions in patients with advanced follicular lymphoma.
authors.affiliation: Department of Internal Medicine, Division of Hematology and Oncology, University of Michigan Medical Center, Ann Arbor, MI 48109-0936, USA. mkaminsk@umich.edu
authors.forename: Mark S
authors.initials: MS
authors.lastname: Kaminski
authors.forename: Melissa
authors.initials: M
authors.lastname: Tuck
authors.forename: Judith
authors.initials: J
authors.lastname: Estes
authors.forename: Arne
authors.initials: A
authors.lastname: Kolstad
authors.forename: Charles W
authors.initials: CW
authors.lastname: Ross
authors.forename: Kenneth
authors.initials: K
authors.lastname: Zasadny
authors.forename: Denise
authors.initials: D
authors.lastname: Regan
authors.forename: Paul
authors.initials: P
authors.lastname: Kison
authors.forename: Susan
authors.initials: S
authors.lastname: Fisher
authors.forename: Stewart
authors.initials: S
authors.lastname: Kroll
authors.forename: Richard L
authors.initials: RL
authors.lastname: Wahl
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D018951:Antigens, CD20 / Q000276:immunology*; D001402:B-Lymphocytes; D001856:Bone Marrow Examination; D018572:Disease-Free Survival; D005260:Female; D015321:Gene Rearrangement / Q000187:drug effects; D019254:Genes, bcl-2; D006801:Humans; D007958:Leukocyte Count; D008224:Lymphoma, Follicular / Q000235:genetics / Q000276:immunology / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D016499:Radioimmunotherapy / Q000009:adverse effects; D011874:Radiometry; D012074:Remission Induction; D016019:Survival Analysis; D013972:Thyrotropin / Q000097:blood
chemical_list: D000911:Antibodies, Monoclonal; D018951:Antigens, CD20; D013972:Thyrotropin; C119496:tositumomab I-131