title: Impact of post-brentuximab vedotin consolidation on relapsed/refractory CD30+ Hodgkin lymphomas: a large retrospective study on 240 patients enrolled in the French Named-Patient Program.
abstract: Brentuximab vedotin was reported to be effective and safe against refractory/relapsed Hodgkin lymphoma in cohorts of between 12 to 102 patients. Herein we report our retrospective analysis of the French experience with brentuximab vedotin used alone to treat 240 refractory/relapsed Hodgkin lymphoma patients enrolled in a named patient program between 2011 and 2013. All patients had histologically documented CD30+ Hodgkin lymphoma; 74% had refractory disease or early relapses. After a median of 3 lines of chemotherapy, brentuximab vedotin was infused intravenously (1.8 mg/kg every 3 weeks). The primary endpoint was best response. Response at the end of treatment, its duration, survival data and toxicity profile were secondary endpoints. Patients received a median of 6 cycles; 68 underwent a consolidation thereafter. The best response was observed after a median of 4 cycles in 145 (60.4%) patients: 33.8% complete response/unconfirmed complete response, 26.7% partial response. Objective responses were observed as decreased (39.3%) in the 28 patients >60 years. The median response duration was 8.4 months. With median follow-up at 16.1 months, median progression-free survival was 6.8 months and this was significantly longer for patients transplanted after brentuximab vedotin (a median of 18,8 months); median overall survival was not reached. No death has been linked to brentuximab vedotin toxicity. The most common adverse events were peripheral sensory neuropathy (29.3%) and hematological toxicity. The results of this analysis support the previously reported brentuximab vedotin efficacy with manageable toxicity. Because of the short-term responses in most patients, a high-dose therapy with stem cell transplantation for responders should be considered as quickly as possible.
authors.affiliation: Service d'Hématologie, CHU de Nancy, Université de Lorraine, Vandoeuvre les Nancy, France au.perrot@chu-nancy.fr.
authors.forename: Aurore
authors.initials: A
authors.lastname: Perrot
authors.affiliation: Hôpital Saint Louis AP-HP, Université Diderot, Paris, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Monjanel
authors.affiliation: Département d'Hématologie, CLCC Institut Paoli Calmettes, Marseille, France.
authors.forename: Réda
authors.initials: R
authors.lastname: Bouabdallah
authors.affiliation: Département d'Hématologie Clinique, CHRU Hôpital Lapeyronie, Montpellier, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Quittet
authors.affiliation: Service Hématologie, Hospices Civils de Lyon, Université Claude Bernard, Pierre-Bénite, France.
authors.forename: Clémentine
authors.initials: C
authors.lastname: Sarkozy
authors.affiliation: Service d'Hématologie, Hôpital Pontchaillou, Rennes, France.
authors.forename: Marc
authors.initials: M
authors.lastname: Bernard
authors.affiliation: Département d'Hématologie, Centre Henri Becquerel, Rouen, France.
authors.forename: Aspasia
authors.initials: A
authors.lastname: Stamatoullas
authors.affiliation: Fédération d'Hématologie, Institut Universitaire du Cancer, Toulouse, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Borel
authors.affiliation: Service d'Hématologie, CHU de Bordeaux, Hôpital Haut-Lévèque, Pessac, France.
authors.forename: Krimo
authors.initials: K
authors.lastname: Bouabdallah
authors.affiliation: Service de Cancérologie Médicale, CLCC Léon Bérard, Lyon, France.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Nicolas-Virelizier
authors.affiliation: The Lymphoma Academic Research Organisation (LYSARC), Centre Hospitalier Lyon Sud, Pierre-Bénite, France.
authors.forename: Marion
authors.initials: M
authors.lastname: Fournier
authors.affiliation: Service d'Hématologie, Hôpital Claude Huriez, Unité GRITA, Université de Lille, Lille, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Morschhauser
authors.affiliation: Hôpital Saint Louis AP-HP, Université Diderot, Paris, France.
authors.forename: Pauline
authors.initials: P
authors.lastname: Brice
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D014408:Biomarkers, Tumor / Q000235:genetics*; D000079963:Brentuximab Vedotin; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005260:Female; D005602:France; D015870:Gene Expression; D006689:Hodgkin Disease / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000473:pathology; D006801:Humans; D018796:Immunoconjugates / Q000008:administration & dosage* / Q000009:adverse effects; D007275:Injections, Intravenous; D017730:Ki-1 Antigen / Q000235:genetics; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000175:diagnosis / Q000209:etiology / Q000473:pathology; D009367:Neoplasm Staging; D010523:Peripheral Nervous System Diseases / Q000175:diagnosis / Q000209:etiology / Q000473:pathology; D012008:Recurrence; D012074:Remission Induction; D012189:Retrospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D014408:Biomarkers, Tumor; D018796:Immunoconjugates; D017730:Ki-1 Antigen; D000079963:Brentuximab Vedotin