Tositumomab and iodine I 131 tositumomab for recurrent indolent and transformed B-cell non-Hodgkin's lymphoma

TY - JOUR

T1 - Tositumomab and iodine I 131 tositumomab for recurrent indolent and transformed B-cell non-Hodgkin's lymphoma

AU - Davies, A J

AU - Rohatiner, A Z S

AU - Howell, S

AU - Britton, K E

AU - Owens, S E

AU - Micallef, I N

AU - Deakin, D P

AU - Carrington, B M

AU - Lawrance, J A

AU - Vinnicombe, S

AU - Mather, S J

AU - Clayton, J

AU - Foley, R

AU - Jan, H

AU - Kroll, S

AU - Harris, M

AU - Amess, J

AU - Norton, A J

AU - Lister, T A

AU - Radford, J A

PY - 2004/4/15

Y1 - 2004/4/15

N2 - PURPOSE: 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.PATIENTS AND 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.CONCLUSION: 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.

AB - PURPOSE: 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.PATIENTS AND 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.CONCLUSION: 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.

KW - Adult

KW - Aged

KW - Antibodies, Monoclonal

KW - Antigens, CD20

KW - Antineoplastic Agents

KW - Humans

KW - Immunoconjugates

KW - Iodine Radioisotopes

KW - Lymphoma, B-Cell

KW - Middle Aged

KW - Neoplasm Recurrence, Local

KW - Radioimmunotherapy

KW - Survival Rate

KW - Clinical Trial

KW - Clinical Trial, Phase II

KW - Journal Article

KW - Multicenter Study

KW - Research Support, Non-U.S. Gov't

UR - http://ascopubs.org/doi/full/10.1200/JCO.2004.06.055

U2 - 10.1200/JCO.2004.06.055

DO - 10.1200/JCO.2004.06.055

M3 - Article

C2 - 15084620

SN - 0732-183X

VL - 22

SP - 1469

EP - 1479

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

IS - 8

ER -