Inotuzumab Ozogamicin and Low-Intensity Chemotherapy in Older Patients With Newly Diagnosed CD22 + Philadelphia Chromosome–Negative B-Cell Precursor Acute Lymphoblastic Leukemia
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Chevallier, Patrice | Leguay, Thibaut | Delord, Marc | Salek, Cyril | Kim, Rathana | Huguet, Françoise | Hicheri, Yosr | Wartiovaara-Kautto, Ulla | Raffoux, Emmanuel | Cluzeau, Thomas | Balsat, Marie | Roth-Guepin, Gabrielle | Tavernier, Emmanuelle | Lepretre, Stephane | Bilger, Karin | Bergugnat, Hugo | Berceanu, Ana | Alexis, Magda | Doubek, Michael | Brissot, Eolia | Hunault-Berger, Mathilde | Lebon, Delphine | Turlure, Pascal | Chantepie, Sylvain | Belhabri, Amine | Wickenhauser, Stefan | Bastie, Jean-Noel | Cacheux, Victoria | Himberlin, Chantal | Banos, Anne | Gardin, Claude | Bonnet, Sarah | Plantier, Isabelle | Pica, Gian Matteo | Escoffre-Barbe, Martine | Boissel, Nicolas | Dombret, Herve | Clappier, Emmanuelle | Rousselot, Philippe | Charbonnier, Amandine | Assouan, Deborah | Hubert, Amandine | Quint, Marine | Kossi, Fulvia Guenbem | Deruche, Elodie | Hunault, Mathilde | Marie, Céline | Robin, Jean-Baptiste | Gay, Julie | Capdupuy, Claudie | Labarrere, Sévérine | Vincent, Edith | Simonet-Boissard, Marion | Larosa, Fabrice | Desbrosses, Yohan | Boiteux, Guillaume | Dufour, Vinciane | Tissot, Elise | Braun, Thorsten | Gardin, Pr Claude | Vidal, Valérie | Edouart, Geoffrey | Vilque, Jean-Pierre | Johnson Ansah, Hyacinthe | Lebouvier, Angélique | Zapalovicz, Marie Charlotte | Renault, Léa | Gian Matteo, Pica | Courouau, Alix | Prieur, Fabienne | Dupre, Charlene | de Renzis, Benoit | Chaleteix, Carine | Fayard, Amandine | Roy, Gwendoline | Bastie, Jean-Noël | Caillot, Denis | Devaux, Laetitia | Lebourgeois, Amandine | Bonnet, Antoine | Peterlin, Pierre | Lok, Anne | Guilllaume, Thierry | Fontaine, Alexis Morice | Touati, Mohamed | Kennel, Céline | Dmytruck, Natalya | Abraham, Julie | Jaccard, Arnaud | Remenieras, Liliane | Girault, Stéphane | Gourin, Marie Pierre | Penot, Amélie | Moreau, Stéphane | Philipon, Céline | Roche, Delphine | Gilis, Lila | Virelizier, Nicolas | Michalet, Anne-Sophie | Monfray, Jérémy | Thomas, Xavier | Praire, Aline | Guepin, Gabrielle Roth | Bonmati, Caroline | Moulin, Charline | Jacquet, Caroline | Carpodomi, Anne | Bouillet, Hélène | Carpentier, Odile | Montero, Mélanie | Pires, Aude | Gastaud, Lauris | Gama, Anastasia | Coelle, Céline | Karmout, Sonia | Loschi, Michael | Lechardeur, Jessica | Chokri, Hatroubi | Broussot, Loic | Waulthier, Agathe | Jourdan, Eric | Scherman, Elodie | Umuhire, Diane | Damiano, Maria Alessandra | Hicheri, Yors | Saillard, Colombe | d'Incan, Evelyne | Hospital, Marie-Anne | l'Attention, Jean Laurent | Rabah, Mme Nassima | Cesari, Laura Castillo | Gehlkopf, Eve | Vincent, Laure | Navarro, Robert | Quittet, Philippe | Fegueux, Nathalie | Ceballos, Patrice | Marin, Fanny Baguet | Sabadash, Véra | Ochmann, Marlène | Laboure, Nina Akakelyan | Bembrahmi, Omar | Michel, Olivier | Ouahrawi, Brahim | Legrand, Olivier | Vekhoff, Anne | Isnard, Françoise | Sa, Sara | Dombret, Hervé | Lenguine, Etienne | Rabian, Florence | Lebras, Karine Celli | Fauvaux, Catherine | Gros, François-Xavier | Cazaubiel, Titouan | Melot, Cyril | Dematteis, Valentin | Messina, Antonella | Le, Quoc-Hung | Maggi, Lucia | Barre, Martine Escoffre | Moignet, Aline | de Guibert, Sophie | Bernard, Marc | Decaux, Olivier | de la Chapelle, Thierry Lamy | Nimubona, Stanislas | Kadende, Mme Erica | Flavigny, Aloyse | Detourmignies, Laurence | Wemeau, Mathieu | Dervite, Isabelle | Dernivoix, Kathy | Camille, Mme | Denizart, Ingrid | Lepretre, Stéphane | Stamatoullas-Bastard, Aspasia | Fontoura, Marie-Laure | Jardin, Fabrice | Menard, Anne-Lise | Camus, Vincent | Lanic, Helene | Contentin, Nathalie | Cardinael, Nathalie | Lemasle-Hue, Emilie | Alani, Mustafa | Lebreton, Pierre | Atia, Youcef | Ledoux, Marie-Pierre | Sonntag, Cécile | Collin, Camille | Guyotat, Denis | Soglu, Gilbert | Le Jeune, Caroline | Cornillon, Jérôme | Durieux, Coralie | Lavoué, Céline | Miler, Dorante | Tavitian, Suzanne | Soldan, Justine | Rigaudeau, Sophie | Philippe, Laure | Lambert, Juliette | Besson, Caroline | Cabannes, Aurélie | Longval, Thomas | Taksin, Anne-Laure | Bah, Mariama | Beulaygue, Anaïs | Folber, Frantisek | Hrabovsky, Stepan | Brzonova, Jana | Vejsadova, Hana | Novotova, Elena | Mertova, Jolana | Salonen, Minna | Vaalas, Saara
Edité par
CCSD ; American Society of Clinical Oncology -
International audience.
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) rates were 73.2%, 66%, and 25%, respectively. High-risk cytogenetics and lower CD22 expression (<70%) were associated with worse OS, while both high-risk cytogenetics and MRD2 ≥10 −4 were associated with lower RFS and higher CIR. The 10 allotransplanted patients had very favorable outcomes (90% 2-year OS/RFS and no relapse). Only one nonfatal sinusoidal obstructive syndrome was documented during the study. CONCLUSION Our results support InO's use in first-line regimens for older patients with CD22 + Ph– BCP-ALL.
