Brentuximab vedotin addition to gemcitabine in relapsed or refractory peripheral T-cell lymphoma: a LYSA phase 2 study

作者：Olivier Tournilhac, Kamal Bouabdallah, Solene Lecolant, Maya Hacini, Kamel Laribi, Sébastien Bailly, Thibaut Belmondo, Marie Maerevoet, Loic Ysebaert, Stéphanie Guidez, Steven Le Gouill, Christophe Bonnet, Marc André, Jehan Dupuis, Catherine Thiéblemont, Emmanuel Bachy, Nicolas Daguindau, Franck Morschhauser, Sabine Tricot, Charline Moulin, Anne Banos, Roch Houot, Adrien Chauchet, Emmanuel Gyan, Guillaume Cartron, H. Farhat, Vincent Camus, Bernard Drénou, Hacène Zerazhi, David Sibon, Emmanuelle Nicolas Virelizier, Caroline Delette, Sylvia Snauwaert, Sarah Bailly, Richard Delarue, Sylvain Carras, Albane Ledoux‐Pilon, Marie Parrens, Samuel Griolet, Philippe Gaulard, Marie‐Hélène Delfau‐Larue, Laurence de Leval, Gandhi Damaj · 发表于：Blood Advances · 年份：2025 · DOI：10.1182/bloodadvances.2024015787 · 被引用次数：5 · 研究领域：Lymphoma Diagnosis and Treatment、Cutaneous lymphoproliferative disorders research、T-cell and Retrovirus Studies

ABSTRACT: We aim to evaluate the efficacy of brentuximab vedotin (BV) combined with gemcitabine (GBV) followed by BV maintenance in relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL). Patients with at least 5% CD30+ cells by immunohistochemistry received 4 GBV induction (28 days) cycles of gemcitabine 1000 mg/m2 (day 1, day 15) plus BV 1.8 mg/kg (day 8) followed, in responding patients, by up to 12 BV maintenance (21 day) cycles. Primary end point was overall response rate (ORR) after 4 induction cycles by computed tomography scan-based Lugano criteria. Of 71 enrolled patients (median age of 66 years), 80.3% had received 1 previous line and 60.6% were refractory. The diagnoses per pathology central review were follicular helper T-cell lymphomas (TFHL; 47.9%), anaplastic large-cell lymphomas (ALCL; anaplastic lymphoma kinase [ALK] negative [19.7%] and ALK+ [7%]), peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS; 12.7%), and other entities (12.7%). In the intention-to-treat analysis, ORR was 46.5%, with 19.7% complete response. Twenty-eight patients received maintenance. Grade 3 to 4 adverse events reported in ≥10% of patients during induction comprised neutropenia (55%), thrombocytopenia (14%), anemia (21%), and infection (14%); during maintenance comprised neutropenia (39%), thrombocytopenia (21%), and peripheral neuropathy (14%). With a median follow-up of 32.6 months, the median duration of response, progression-free, and overall survival were 15.8,...