title: Trastuzumab for treatment of refractory/relapsed HER2-positive adult B-ALL: results of a phase 2 GRAALL study.
abstract: The aim of this phase 2 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 (ie, 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly). The overall response rate was 13% with 2 patients achieving partial response and partial remission cytolytic response, respectively. Two other patients were documented with blast clearance. Only 1 reversible grade 3 cardiac toxic event occurred. This phase 2 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.
authors.affiliation: Service d'Hématologie Clinique, Centre Hospitalier Universitaire (CHU) Hôtel Dieu, Université de Nantes, Centre d'Investigation Clinique en Cancerologie (CI2C) and Inserm U892, Nantes, France. patrice.chevallier@chu-nantes.fr
authors.forename: Patrice
authors.initials: P
authors.lastname: Chevallier
authors.forename: Nelly
authors.initials: N
authors.lastname: Robillard
authors.forename: Aude
authors.initials: A
authors.lastname: Charbonnier
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Raffoux
authors.forename: Sebastien
authors.initials: S
authors.lastname: Maury
authors.forename: Sylvain
authors.initials: S
authors.lastname: Carras
authors.forename: Cecile
authors.initials: C
authors.lastname: Chabrot
authors.forename: Cecile
authors.initials: C
authors.lastname: Fohrer
authors.forename: Marc
authors.initials: M
authors.lastname: Bernard
authors.forename: Jean-Sebastien
authors.initials: JS
authors.lastname: Blade
authors.forename: Anne
authors.initials: A
authors.lastname: Etienne
authors.forename: Pascaline
authors.initials: P
authors.lastname: Talmant
authors.forename: Jacques
authors.initials: J
authors.lastname: Delaunay
authors.forename: Thierry
authors.initials: T
authors.lastname: Guillaume
authors.forename: Mohamad
authors.initials: M
authors.lastname: Mohty
authors.forename: Marie-Christine
authors.initials: MC
authors.lastname: Bene
authors.forename: Norbert
authors.initials: N
authors.lastname: Ifrah
authors.forename: Herve
authors.initials: H
authors.lastname: Dombret
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D019008:Drug Resistance, Neoplasm / Q000187:drug effects*; D005260:Female; D005434:Flow Cytometry; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D015452:Precursor B-Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D000068878:Trastuzumab; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab