Inotuzumab Ozogamicin and Low-Intensity Chemotherapy in Older Patients With Newly Diagnosed CD22 + Philadelphia Chromosome–Negative B-Cell Precursor Acute Lymphoblastic Leukemia

作者：Patrice Chevallier, Thibaut Leguay, Marc Delord, Cyril Šálek, Rathana Kim, Françoise Huguet, Yosr Hicheri, Ulla Wartiovaara‐Kautto, Emmanuel Raffoux, Thomas Cluzeau, Marie Balsat, Gabrielle Roth-Guépin, Emmanuelle Tavernier, Stéphane Leprêtre, Karin Bilger, Hugo Bergugnat, Ana Berceanu, Magda Alexis, Michael Doubek, Éolia Brissot, Mathilde Hunault, Delphine Lebon, Pascal Turlure, Sylvain Chantepie, Amine Belhabri, Stefan Wickenhauser, Jean Bastié, Victoria Cacheux, Chantal Himberlin, Anne Banos, Claude Gardin, Sarah Bonnet, Isabelle Plantier, Gian Matteo Pica, Martine Escoffre‐Barbe, Nicolas Boissel, Hervé Dombret, Emmanuelle Clappier, Philippe Rousselot, Delphine Lebon, Amandine Charbonnier, Déborah Assouan, Amandine Hubert, Marine Quint, Fulvia Guenbem Kossi, Elodie Deruche, Mathilde Hunault, Céline Marie, Anne Banos, Jean‐Baptiste Robin, Julie Gay, C. Capdupuy, Sévérine Labarrere, Edith Vincent, Marion Simonet‐Boissard, Ana Berceanu, Fabrice Larosa, Yohan Desbrosses, Guillaume Boiteux, Vinciane Dufour, Elise Tissot, Thorsten Braun, P Gardin, Valérie Vidal, Geoffrey Edouart, Sylvain Chantepie, Jean‐Pierre Vilque, Hyacinthe Johnson Ansah, Angélique Lebouvier, Marie Charlotte Zapalovicz, Léa Renault, Pica Gian Matteo, Alix Courouau, Fabienne Prieur, Charlene Dupre, Victoria Cacheux, Benoît De Renzis, Carine Chaleteix, Amandine Fayard, Gwendoline Roy, Jean Bastié, Denis Caillot, Laetitia Devaux, Patrice Chevallier, Amandine Lebourgeois, Antoine Bonnet, Pierre Péterlin, Anne Lok, Thierry Guilllaume, Alexis Morice Fontaine, Pascal Turlure, Mohamed Touati, Céline Kennel, Natalya Dmytruck, Julie Abraham, Arnaud Jaccard, Liliane Réménieras, Stéphane Girault, Marie Pierre Gourin, Amélie Penot, Stéphane Moreau, Céline Philipon, Delphine Roche, Amine Belhabri, Lila Gilis, Nicolas Virelizier, Anne-Sophie Michalet, Jérémy Monfray, Marie Balsat, Xavier Thomas, Aline Praire, Gabrielle Roth Guépin, Caroline Bonmati, Charline Moulin, Caroline Jacquet, Anne Carpodomi, Hélène Bouillet, O. Carpentier, Mélanie Montero, Aude Pires, Lauris Gastaud, Angelita Habr Gama, Céline Coëlle, Sonia Karmout, Thomas Cluzeau, Michaël Loschi, Jessica Lechardeur, Hatroubi Chokri, Loic Broussot, Stefan Wickenhauser, Agathe Waulthier, Éric Jourdan, Elodie Scherman, Diane Umuhire, Mario Atilio Damiano, Yors Hicheri, Colombe Saillard, Evelyne D'Incan, Jean Laurent L'Attention, Mme Nassima Rabah, L Cesari, Eve Gehlkopf, Laure Vincent, Robert Navarro, Philippe Quittet, Nathalie Fegueux, Patrice Céballos, Fanny Baguet Marin, V. Sabadash, Magda Alexis, Marlène Ochmann, Nina Akakelyan Laboure, Omar Bembrahmi, Olivier Michel, Brahim Ouahrawi, Éolia Brissot, Olivier Legrand, Anne Vekhoff, Françoise Isnard, E. Sara, Hervé Dombret, Emmanuel Raffoux, Etienne Lenguine, Florence Rabian, Karine Celli Lebras, Catherine Fauvaux, Thibaut Leguay, François‐Xavier Gros, Debus, Titouan Cazaubiel, Cyril Melot, Valentin Dematteis, A. Messina, Chantal Himberlin, Quoc‐Hung Le, Lucia Maggi, Martine Escoffre Barre, Aline Moignet, Sophie de Guibert, Bernard Marc, Olivier Decaux, T. Lamy de la Chapelle, Stanislas Nimubona, Mme Erica Kadende, Aloyse Flavigny, Isabelle Plantier, Laurence Detourmignies, Mathieu Wémeau, Isabelle Dervite, Kathy Dernivoix, Mme Camille, Ingrid Denizart, Stéphane Leprêtre, Aspasia Stamatoullas, Marie‐Laure Fontoura, Fabrice Jardin, Anne‐Lise Ménard, Vincent Camus, Hélène Lanic, Nathalie Contentin, Nathalie Cardinael, Emilie Lemasle-Hue, Mustafa Alani, Pierre Lebreton, Youcef Atia, Karin Bilger, Marie‐Pierre Ledoux, Cécile Sonntag, Camille Collin, Emmanuelle Tavernier, Denis Guyotat, Gilbert Soglu, Caroline Le Jeune, Jérôme Cornillon, C Durieux, Céline Lavoué, Dorante Miler, Françoise Huguet, Suzanne Tavitian, J Soldan, Philippe Rousselot, Sophie Rigaudeau, Laure Philippe, Juliette Lambert, Caroline Besson, Aurélie Cabannes, Thomas Longval, Anne‐Laure Taksin, Mariama Bah, Anaïs Beulaygue, Michael Doubek, František Folber, Štěpán Hrabovský, Jana Brzoňová, Hana Vejsadova, Cyril Šálek, E Novotová, Jolana Mertová, Jana Brzoňová, Hana Vejsadova, Ulla Wartiovaara‐Kautto, Minna K. Salonen, Saara Vaalas · 发表于：Journal of Clinical Oncology · 年份：2024 · 被引用次数：43 · 研究领域：Acute Lymphoblastic Leukemia research、CAR-T cell therapy research、Lymphoma Diagnosis and Treatment

PURPOSE The use of inotuzumab ozogamicin (InO), a conjugated anti-CD22 monoclonal antibody, is becoming a promising frontline treatment for older patients with ALL. PATIENTS AND METHODS EWALL-INO is an open-label prospective multicenter phase II trial (ClinicalTrials.gov identifier: NCT03249870 ). Patients age 55 years and older with newly diagnosed CD22 + Philadelphia chromosome–negative (Ph–) B-cell precursor (BCP) ALL were eligible. After a prephase, a first induction consisting of vincristine, dexamethasone, and three injections of InO (0.8 mg/m 2 day 1, 0.5 mg/m 2 day 8/day 15) was followed by a second induction combining cyclophosphamide, dexamethasone, and two injections of InO (0.5 mg/m 2 day 1/day 8). Responders received up to six cycles of chemotherapy consolidation and 18-month chemotherapy maintenance. Allotransplant was allowed after three consolidations. The primary end point was 1-year overall survival (OS). RESULTS Between December 2017 and March 2022, 131 patients (median age 68 years) were included. Three patients died during induction 1 (n = 130), two from multiple organ failure and one from hemorrhage, and none during induction 2 (n = 120). After induction 2, 90% of the patients achieved complete remission (CR) or CR with incomplete platelet recovery (CRp) and 80% had measurable residual disease (MRD2) <10 −4 . Among responders (n = 119), 47 relapsed and 14 died in CR/CRp. One-year OS, relapse-free survival (RFS), and cumulative incidence of relapse (CIR) ...