GEMTUZUMAB OZOGAMICINE-BASED SALVAGE THERAPIES IN REFRACTORY/RELAPSED ACUTE MYELOID LEUKEMIA PATIENTS
Author(s): ,
Sonia Jaramillo Segura
Affiliations:
Innere Medizin V,Universitätsklinikum Heidelberg,Heidelberg,Germany
,
Pau Montesinos
Affiliations:
Hematology Department,Hospital Universitario i Politècnic La Fe CIBERONC, Instituto Carlos III,Madrid,Spain
,
Adriano Venditti
Affiliations:
Hematology, Department of Biomedicine and Prevention,University Tor Vergata,Rome,Italy
,
Cristina Papayannidis
Affiliations:
Dipartamento di Medicina especialistica, Diagnostica e Sperimentale,Università di Bologna,Forlì,Italy
,
Sabine Kayser
Affiliations:
Innere Medizin V,Universitätsklinikum Heidelberg,Heidelberg,Germany
,
David Martinez-cuadrón
Affiliations:
Hospital Universitario i Politècnic La Fe CIBERONC, Instituto Carlos III,Madrid,Spain
,
Giovangiacinto Paterno
Affiliations:
5Hematology, Department of Biomedicine and Prevention, University Tor Vergata,Rome,Italy
,
Josefina Serrano
Affiliations:
Hospital Reina Sofía, Córdoba, PETHEMA group,Córdoba,Spain
,
Marta Polo
Affiliations:
Hospital Clínico San Carlos, PETHEMA group,Madrid,Spain
,
Raimundo García-Boyero
Affiliations:
Hospital General Universitario, PETHEMA group,Castellón,Spain
,
Carsten Müller-Tidow
Affiliations:
Innere V,Universitätsklinikum Heidelberg,Heidelberg,Germany
Richard F. Schlenk
Affiliations:
Innere Medizin V,Universitätsklinikum Heidelberg,Heidelberg,Germany;National Center of Tumor Diseases,Heidelberg,Germany
EHA Library. Jaramillo Segura S. Jun 15, 2019; 266652; PS1035
Dr. Sonia Jaramillo Segura
Dr. Sonia Jaramillo Segura
Contributions
Abstract

Abstract: PS1035

Type: Poster Presentation

Presentation during EHA24: On Saturday, June 15, 2019 from 17:30 - 19:00

Location: Poster area

Background
The prognosis of patients with refractory/early relapsed acute myeloid leukemia (AML) remains poor. Between 10% and 40% of newly diagnosed patients are categorized as resistant to intensive induction therapy. Moreover, there are no current standard treatments in this situation. Significant improvements in survival are described in patients achieving complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) followed by allogeneic hematopoietic cell transplantation (allo-HCT). Recently, a combination of gemtuzumab ozogamicin (GO) with all-trans retinoic acid, high-dose cytarabine, and mitoxantrone (GO-A-HAM) was reported as a promising regimen compared to others in this clinical situation (Wattad et al. Leukemia 2017;31(6):1306-1313.). 

Aims
To assess gemtuzumab ozogamicine (GO)-based salvage therapy regimens with respect to response (CR/CRi), overall survival (OS) and survival after allo-HCT in adult patients with refractory/early relapsed AML.

Methods
Patients (18 to 71 years) with refractory/relapsed AML in need of salvage therapy were accrued between 2007 and 2016 in three European countries. Salvage therapy consisted either of one cycle of fludarabine 30 mg/m² days 1-4, idarubicin 10 mg/m2 days 1-3, high dose Ara-C (HDAC) 2g/m² days1-4 and GO 3 mg/m² on day 1 (FLAGOIDA regimen) or HDAC 2 g/m² on days 1-5, fludarabine 30 mg/m² days 1-5 and GO 6 mg/m² on day 6 (FLU-HDAC-GO regimen) or Ara-C ± etoposide ± fludarabine and GO 3mg/m² on day 1 (GO-Ara-C regimens). We compared the three therapy regimens in terms of response rate, OS, and OS after HCT and compared the results with the ones obtained in a published (Hütter-Krönke et al. Haematologica. 2016 Jul;101(7):839-45.) phase II study of the GO-A-HAM regimen (GO 3 mg/m² on day 1, all-trans retinoic acid (45 mg/m² orally on days 4-6, 15 mg/m² orally on days 7-28, HDAC 3 g/m² on days 1-3 and mitoxantrone 12 mg/m² on days 2-3).

Results
Overall, 81 patients receiving salvage therapy with GO were included into the study. The median age at inclusion was 53 years with significant heterogeneity between the cohorts (p=0.04), 48% of the patients were male and 85% had de novo AML. Response (CR/CRi) to salvage therapy were 63% with FLAGOIDA, 41% with FLU-HDAC-GO and 58% with GO-Ara-C group. Response-rates achieved were not different between groups and in comparison with the GO-A-HAM regimen with 51% (p=0.25). The only factor significantly associated with response in multivariable analysis was unfavorable genetic risk group according to ELN risk classification (OR: 0.48 p=0.03). Overall 68% of the patients after salvage therapy with FLAGOIDA, 26% after FLU-HDAC-GO, and 50% after GO-Ara-C proceeded to allo-HCT, compared to 76% in the GO-A-HAM cohort. There was a significant difference with regard to OS between the different cohorts (p<0.0001) with an OS of the total cohort of 28% after 3 years. However, when we focused on patients proceeding to an allo-HCT outcome was comparable between the different cohorts (p=0.52) with 39% after 3 years.

Conclusion
Data from our study on real-world compared to clinical-study data on GO in refractory AML-patients confirmed that GO-based salvage regimens are associated with a high response rate irrespective of the different chemotherapy regimens combined with GO. Furthermore, salvage therapy including GO followed by allo-HCT emerges as effective strategy in AML patients with refractory disease after standard induction therapy.

Session topic: 4. Acute myeloid leukemia - Clinical

Keyword(s): Refractory, Relapsed acute myeloid leukemia

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