title: Obinutuzumab (GA101) in relapsed/refractory chronic lymphocytic leukemia: final data from the phase 1/2 GAUGUIN study.
abstract: GAUGUIN evaluated the safety and efficacy of obinutuzumab (GA101) monotherapy in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). In phase 1 (dose escalation), 13 patients received obinutuzumab 400 to 1200 mg (days 1 and 8 of cycle 1; day 1 of cycles 2-8). In phase 2, 20 patients received a fixed dose of 1000 mg (days 1, 8, and 15 of cycle 1; day 1 of cycles 2-8). Infusion-related reactions occurred in nearly all patients, but few were grade 3/4. Grade 3/4 neutropenia occurred in 7 patients in phase 1 (but was not dose-related) and in 4 patients in phase 2. Overall end-of-treatment response (all partial responses) was 62% (phase 1) and 15% (phase 2); best overall response was 62% and 30%, respectively. Phase 2 median progression-free survival was 10.7 months and median duration of response was 8.9 months. In summary, obinutuzumab monotherapy is active in patients with heavily pretreated relapsed/refractory CLL.
authors.affiliation: Département d'Hématologie, Unités Mixtes de Recherche-Centre National de la Recherche Scientifique 5235, Centre Hospitalier Universitaire de Montpellier, Montpellier, France;
authors.forename: Guillaume
authors.initials: G
authors.lastname: Cartron
authors.affiliation: Service d'Hematologie Clinique, Unité d'Investigation Clinique, Institut National de la Santé et de la Recherche Médicale 1414, Centre Hospitalier Universitaire Pontchaillou, Rennes, France;
authors.forename: Sophie
authors.initials: S
authors.lastname: de Guibert
authors.affiliation: Service d'Hématologie Clinique et Thérapie Cellulaire, Hôpital du Haut-Lévèque, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France;
authors.forename: Marie-Sarah
authors.initials: MS
authors.lastname: Dilhuydy
authors.affiliation: Service d'Hématologie, Centre Hospitalier Universitaire de Lille, Lille, France;
authors.forename: Franck
authors.initials: F
authors.lastname: Morschhauser
authors.affiliation: Service d'Hématologie, Groupe Hospitalier Pitié-Salpêtrière, Paris, France;
authors.forename: Veronique
authors.initials: V
authors.lastname: Leblond
authors.affiliation: Unité Hémopathies Lymphoïdes, Centre Hospitalier Universitaire Henri Mondor, Creteil, France;
authors.forename: Jehan
authors.initials: J
authors.lastname: Dupuis
authors.affiliation: Département d'Hématologie, Centre Hospitalier Universitaire Nantes, Nantes, France;
authors.forename: Beatrice
authors.initials: B
authors.lastname: Mahe
authors.affiliation: Centre de Lutte Contre le Cancer Paoli-Calmettes, Marseille, France;
authors.forename: Reda
authors.initials: R
authors.lastname: Bouabdallah
authors.affiliation: Pharma Development Biostatistics, Roche Products, Welwyn Garden City, United Kingdom;
authors.forename: Guiyuan
authors.initials: G
authors.lastname: Lei
authors.affiliation: Department of Medical Oncology and.
authors.forename: Michael
authors.initials: M
authors.lastname: Wenger
authors.affiliation: Pharma Development Oncology, F. Hoffmann-La Roche, Basel, Switzerland; and.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Wassner-Fritsch
authors.affiliation: First Department of Internal Medicine, University of Cologne, Cologne, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Hallek
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; D005260:Female; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; C543332:obinutuzumab