title: Tositumomab and iodine I 131 tositumomab for recurrent indolent and transformed B-cell non-Hodgkin's lymphoma.
abstract: OBJECTIVE
  An open-label phase II study was conducted at two centers to establish the efficacy and safety of tositumomab and iodine I 131 tositumomab at first or second recurrence of indolent or transformed indolent B-cell lymphoma.
  
  
  METHODS
  A single dosimetric dose was followed at 7 to 14 days by the patient-specific administered radioactivity required to deliver a total body dose of 0.75 Gy (reduced to 0.65 Gy for patients with platelets counts of 100 to 149 x 10(9)/L). Forty of 41 patients received both infusions.
  
  
  RESULTS
  Thirty-one of 41 patients (76%) responded, with 20 patients (49%) achieving either a complete (CR) or unconfirmed complete remission [CR(u)] and 11 patients (27%) achieving a partial remission. Response rates were similar in both indolent (76%) and transformed disease (71%). The overall median duration of remission was 1.3 years. The median duration of remission has not yet been reached for those patients who achieved a CR or CR(u). Eleven patients continue in CR or CR(u) between 2.6+ and 5.2+ years after therapy. Therapy was well tolerated; hematologic toxicity was the principal adverse event. Grade 3 or 4 anemia, neutropenia, and thrombocytopenia were observed in 5%, 45%, and 32% of patients, respectively. Secondary myelodysplasia has occurred in one patient. Four patients developed human antimouse antibodies after therapy. Five of 38 assessable patients have developed an elevated thyroid-stimulating hormone; treatment with thyroxine has been initiated in one patient.
  
  
  CONCLUSIONS
  High overall and CR rates were observed after a single dose of tositumomab and iodine I 131 tositumomab in this patient group. Toxicity was modest and easily managed.
authors.affiliation: Cancer Research UK Medical Oncology Unit, Department of Medical Oncology, 45 Little Britain, St Bartholomew's Hospital, London EC1A 7BE, United Kingdom. Andrew.J.Davies@cancer.org.uk
authors.forename: A J
authors.initials: AJ
authors.lastname: Davies
authors.forename: A Z S
authors.initials: AZ
authors.lastname: Rohatiner
authors.forename: S
authors.initials: S
authors.lastname: Howell
authors.forename: K E
authors.initials: KE
authors.lastname: Britton
authors.forename: S E
authors.initials: SE
authors.lastname: Owens
authors.forename: I N
authors.initials: IN
authors.lastname: Micallef
authors.forename: D P
authors.initials: DP
authors.lastname: Deakin
authors.forename: B M
authors.initials: BM
authors.lastname: Carrington
authors.forename: J A
authors.initials: JA
authors.lastname: Lawrance
authors.forename: S
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authors.lastname: Vinnicombe
authors.forename: S J
authors.initials: SJ
authors.lastname: Mather
authors.forename: J
authors.initials: J
authors.lastname: Clayton
authors.forename: R
authors.initials: R
authors.lastname: Foley
authors.forename: H
authors.initials: H
authors.lastname: Jan
authors.forename: S
authors.initials: S
authors.lastname: Kroll
authors.forename: M
authors.initials: M
authors.lastname: Harris
authors.forename: J
authors.initials: J
authors.lastname: Amess
authors.forename: A J
authors.initials: AJ
authors.lastname: Norton
authors.forename: T A
authors.initials: TA
authors.lastname: Lister
authors.forename: J A
authors.initials: JA
authors.lastname: Radford
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018951:Antigens, CD20 / Q000276:immunology*; D000970:Antineoplastic Agents; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use*; D007457:Iodine Radioisotopes / Q000627:therapeutic use; D016393:Lymphoma, B-Cell / Q000188:drug therapy*; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D016499:Radioimmunotherapy; D015996:Survival Rate
chemical_list: D000911:Antibodies, Monoclonal; D018951:Antigens, CD20; D000970:Antineoplastic Agents; D018796:Immunoconjugates; D007457:Iodine Radioisotopes; C119496:tositumomab I-131