Trastuzumab for treatment of refractory/relapsed HER2-positive adult B-ALL: results of a phase II GRAALL study
Mené sur 15 patients atteints d'une leucémie B lymphoblastique aiguë HER2+ récidivante ou réfractaire (âge médian : 62 ans), cet essai de phase II évalue l'efficacité et la toxicité du trastuzumab
The aim of this Phase II study was to evaluate the efficacy and safety of trastuzumab, a humanized monoclonal antibody targeted against the human epidermal growth factor receptor 2 (HER2), for adult patients with relapsed/refractory HER2-positive B-ALL. Fifteen patients, with a median age of 62 years, received trastuzumab according to the schedule approved for breast cancer patients i.e. 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly. The overall response rate was 13% with two patients achieving partial response and partial remission cytolytic response, respectively. Two other patients were documented with blast clearance. Only one reversible grade 3 cardiac toxic event occurred. This Phase II study showed that trastuzumab monotherapy can allow for some responses in a very high-risk refractory/relapsed HER2-positive adult B-ALL population. Combination of trastuzumab with chemotherapy or other therapeutic monoclonal antibodies should be tested in the future. The trial was registered at http://clinicaltrials.gov/ct no.NCT00724360.