TY - JOUR
T1 - Tositumomab and iodine-131 tositumomab produces durable complete remissions in a subset of heavily pretreated patients with low-grade and transformed non-Hodgkin's lymphomas
AU - Fisher, Richard I.
AU - Kaminski, Mark S.
AU - Wahl, Richard L.
AU - Knox, Susan J.
AU - Zelenetz, Andrew D.
AU - Vose, Julie M.
AU - Leonard, John P.
AU - Kroll, Stewart
AU - Goldsmith, Stanley J.
AU - Coleman, Morton
PY - 2005
Y1 - 2005
N2 - Purpose: This study is an integrated efficacy analysis of the five clinical trials of tositumomab and iodine-131 tositumomab in patients with relapsed or refractory low-grade, follicular, or transformed low-grade non-Hodgkin's lymphoma (NHL) that resulted in the regulatory approval of the iodine-131 tositumomab by the US Food and Drug Administration. Patients and Methods: This integrated analysis included 250 patients. Patients received a single course of iodine-131 tositumomab. Responses were assessed by an independent panel of radiologists and oncologists. Results: Response rates in the five trials ranged from 47% to 68%; complete response rates ranged from 20% to 38%. With a median follow-up of 5.3 years, the 5-year progression-free survival was 17%. Eighty-one (32%) of 250 patients had a time to progression of ≥ 1 year (termed durable response population). For the durable response population, 44% had not progressed at ≥ 2.5 to ≥ 9.5 years and had a median duration of response of 45.8 months. The median duration of complete response was not reached. The durable response population had many poor prognostic characteristics, including bone marrow involvement (41%), bulky disease ≥ 5 cm (49%), and transformed histology (23%). Forty-three percent of the patients had been treated with more than four prior therapies and 36% had not responded to their most recent therapy. Conclusion: The tositumomab and iodine-131 tositumomab therapeutic regimen produces high response rates in patients with relapsed or refractory low-grade, follicular, and transformed low-grade NHL, with a sizable subgroup of patients achieving long-term durable responses.
AB - Purpose: This study is an integrated efficacy analysis of the five clinical trials of tositumomab and iodine-131 tositumomab in patients with relapsed or refractory low-grade, follicular, or transformed low-grade non-Hodgkin's lymphoma (NHL) that resulted in the regulatory approval of the iodine-131 tositumomab by the US Food and Drug Administration. Patients and Methods: This integrated analysis included 250 patients. Patients received a single course of iodine-131 tositumomab. Responses were assessed by an independent panel of radiologists and oncologists. Results: Response rates in the five trials ranged from 47% to 68%; complete response rates ranged from 20% to 38%. With a median follow-up of 5.3 years, the 5-year progression-free survival was 17%. Eighty-one (32%) of 250 patients had a time to progression of ≥ 1 year (termed durable response population). For the durable response population, 44% had not progressed at ≥ 2.5 to ≥ 9.5 years and had a median duration of response of 45.8 months. The median duration of complete response was not reached. The durable response population had many poor prognostic characteristics, including bone marrow involvement (41%), bulky disease ≥ 5 cm (49%), and transformed histology (23%). Forty-three percent of the patients had been treated with more than four prior therapies and 36% had not responded to their most recent therapy. Conclusion: The tositumomab and iodine-131 tositumomab therapeutic regimen produces high response rates in patients with relapsed or refractory low-grade, follicular, and transformed low-grade NHL, with a sizable subgroup of patients achieving long-term durable responses.
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U2 - 10.1200/JCO.2004.00.9217
DO - 10.1200/JCO.2004.00.9217
M3 - Article
C2 - 16186600
AN - SCOPUS:32944476224
SN - 0732-183X
VL - 23
SP - 7565
EP - 7573
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 30
ER -