Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2013
Radioimmunotherapy with 177Lu-DOTA-rituximab: final results of a phase I/II Study in 31 patients with relapsing follicular, mantle cell, and other indolent B-cell lymphomas.
Клиническое исследование I фазыКлиническое исследование II фазыСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Forrer Flavio, Oechslin-Oberholzer Catharina, Campana Benedetta, Herrmann Richard, Maecke Helmut R, Mueller-Brand Jan, Lohri Andreas
Аннотация
UNLABELLED: The aim of this study was to determine the maximum tolerated dose (MTD) and to explore the clinical response to (177)Lu-DOTA-rituximab in the treatment of patients with relapsed follicular, mantle cell, or other indolent lymphomas such as marginal zone lymphoma.
METHODS: To evaluate the MTD, we adjusted the dosage of the radiopharmaceutical according to body surface area (BSA).
RESULTS: The MTD using (177)Lu-DOTA-rituximab was 1,665 MBq/m(2) of BSA. Thrombocytopenia and leukopenia were the dose-limiting toxicities. Significant anemia occurred only at dose level 7 (1,850 MBq/m(2) of BSA). We observed the nadir of platelets after a median of 36 d from treatment and the nadir of granulocytes after a median of 50 d. Median time to recovery to the next lower grade of toxicity was 7 d. Nonhematologic toxicity was negligible. We observed clinical responses at all dose levels and for all lymphoma entities. Some of the responses were durable; the longest follow-up is currently over 8 y. At present, 11 patients are alive and 8 patients are disease-free.
CONCLUSION: Our results demonstrate the safety and feasibility of (177)Lu-DOTA-rituximab treatment for the lymphoma entities tested in this study.
METHODS: To evaluate the MTD, we adjusted the dosage of the radiopharmaceutical according to body surface area (BSA).
RESULTS: The MTD using (177)Lu-DOTA-rituximab was 1,665 MBq/m(2) of BSA. Thrombocytopenia and leukopenia were the dose-limiting toxicities. Significant anemia occurred only at dose level 7 (1,850 MBq/m(2) of BSA). We observed the nadir of platelets after a median of 36 d from treatment and the nadir of granulocytes after a median of 50 d. Median time to recovery to the next lower grade of toxicity was 7 d. Nonhematologic toxicity was negligible. We observed clinical responses at all dose levels and for all lymphoma entities. Some of the responses were durable; the longest follow-up is currently over 8 y. At present, 11 patients are alive and 8 patients are disease-free.
CONCLUSION: Our results demonstrate the safety and feasibility of (177)Lu-DOTA-rituximab treatment for the lymphoma entities tested in this study.
Предметные рубрики MeSH
AdultAgedAged, 80 and overAntibodies, Monoclonal, Murine-DerivedAntineoplastic AgentsDose-Response Relationship, RadiationFemaleHumansLymphoma, B-CellLymphoma, FollicularLymphoma, Mantle-CellMaleMiddle AgedOrganometallic CompoundsRadiation InjuriesRadioimmunotherapyRadionuclide ImagingRadiopharmaceuticalsRecurrenceRituximabTreatment Outcome