Inotuzumab ozogamicin as induction therapy for patients older than 55 years with Philadelphia chromosome-negative B-precursor ALL

• Verfasst von: Stelljes, Matthias [VerfasserIn]
• Verfasst von: Raffel, Simon [VerfasserIn]
• Verfasst von: Alakel, Nael [VerfasserIn]
• Verfasst von: Wäsch, Ralph [VerfasserIn]
• Verfasst von: Kondakci, Mustafa [VerfasserIn]
• Verfasst von: Scholl, Sebastian [VerfasserIn]
• Verfasst von: Rank, Andreas [VerfasserIn]
• Verfasst von: Hänel, Mathias [VerfasserIn]
• Verfasst von: Spriewald, Bernd [VerfasserIn]
• Verfasst von: Hanoun, Maher [VerfasserIn]
• Verfasst von: Martin, Sonja [VerfasserIn]
• Verfasst von: Schwab, Katjana [VerfasserIn]
• Verfasst von: Serve, Hubert [VerfasserIn]
• Verfasst von: Reiser, Lena [VerfasserIn]
• Verfasst von: Knaden, Julian [VerfasserIn]
• Verfasst von: Pfeifer, Heike [VerfasserIn]
• Verfasst von: Marx, Julia [VerfasserIn]
• Verfasst von: Sauer, Tim [VerfasserIn]
• Verfasst von: Berdel, Wolfgang E. [VerfasserIn]
• Verfasst von: Lenz, Georg [VerfasserIn]
• Verfasst von: Brüggemann, Monika [VerfasserIn]
• Verfasst von: Gökbuget, Nicola [VerfasserIn]
• Verfasst von: Wethmar, Klaus [VerfasserIn]
• Titel: Inotuzumab ozogamicin as induction therapy for patients older than 55 years with Philadelphia chromosome-negative B-precursor ALL
• Verf.angabe: Matthias Stelljes (MD), Simon Raffel (MD), Nael Alakel (MD), Ralph Wäsch (MD), Mustafa Kondakci (MD), Sebastian Scholl (MD), Andreas Rank (MD), Mathias Hänel (MD), Bernd Spriewald (MD), Maher Hanoun (MD), Sonja Martin (MD), Katjana Schwab (MD), Hubert Serve (MD), Lena Reiser (MD), Julian Knaden (BSc), Heike Pfeifer (MD), Julia Marx (MD), Tim Sauer (MD), Wolfgang E. Berdel (MD), Georg Lenz (MD), Monika Brüggemann (MD), Nicola Gökbuget (MD), and Klaus Wethmar (MD, PhD)
• E-Jahr: 2024
• Jahr: January 2024
• Umfang: 10 S.
• Illustrationen: Diagramme
• Fussnoten: Online veröffentlicht: October 26, 2023 ; Gesehen am 11.02.2025
• Titel Quelle: Enthalten in: Journal of clinical oncology
• Ort Quelle: Alexandria, Va. : American Society of Clinical Oncology, 1983
• Jahr Quelle: 2024
• Band/Heft Quelle: 42(2024), 3 vom: Jan., Seite 273-282
• ISSN Quelle: 1527-7755
• DOI: doi:10.1200/JCO.23.00546
• Datenträger: Online-Ressource
• Sprache: eng
• K10plus-PPN: 1916974627

Abstract

Purpose - Despite recent advances in adapting the intensity of treatment for older patients with ALL, current protocols are associated with high rates of early deaths, treatment-related toxicity, and dismal prognosis. We evaluated inotuzumab ozogamicin and dexamethasone (Dex) as induction therapy in older patients with ALL within the German Multicenter Study Group for Adult ALL (GMALL). - Patients and Methods - The open-label, multicenter, phase II, INITIAL-1 trial enrolled 45 patients older than 55 years with newly diagnosed, CD22-positive, BCR::ABL-negative B-precursor ALL (B-ALL). Patients received up to three cycles of inotuzumab ozogamicin/Dex and up to six cycles of age-adapted GMALL consolidation and maintenance therapy. - Results - Forty-three evaluable patients with common/pre-B (n = 38) and pro-B ALL (n = 5), with a median age of 64 years (range, 56-80), received at least two cycles of inotuzumab ozogamicin induction therapy. All patients achieved complete remission (CR/CR with incomplete hematologic recovery). Twenty-three (53%) and 30 (71%) patients had no evidence of molecularly assessed measurable residual disease (minimum 10e−4 threshold) after the second and third inductions, respectively. After a median follow-up of 2.7 years, event-free survival at one (primary end point) and 3 years was 88% (95% CI, 79 to 98) and 55% (95% CI, 40 to 71), while overall survival (OS) was 91% (95% CI, 82 to 99) and 73% (95% CI, 59 to 87), respectively. None of the patients died during 6 months after the start of induction. Most common adverse events having common toxicity criteria grade ≥3 during induction were leukocytopenia, neutropenia, thrombocytopenia, anemia, and elevated liver enzymes. One patient developed nonfatal veno-occlusive disease after induction II. - Conclusion - Inotuzumab ozogamicin-based induction followed by age-adapted chemotherapy was well tolerated and resulted in high rates of remission and OS. These data provide a rationale for integrating inotuzumab ozogamicin into first-line regimens for older patients with B-ALL.