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1. S130: PRELIMINARY RESULTS OF QUIWI: A DOUBLE BLINDED, RANDOMIZED CLINICAL TRIAL COMPARING STANDARD CHEMOTHERAPY PLUS QUIZARTINIB VERSUS PLACEBO IN ADULT PATIENTS WITH NEWLY DIAGNOSED FLT3-ITD WILD-TYPE AML

Author

Pau Montesinos, Rebeca Rodríguez-Veiga, Juan Miguel Bergua Burgues, Lorenzo Algarra, Carmen Botella, Perez Simon Josè Antonio, Teresa Bernal, Mar Tormo, Maria Calbacho Robles, Olga Salamero, Josefina Serrano, Victor Noriega, Juan Antonio López-López, Susana Vives Polo, Mercedes Colorado, Jose Luis Lopez Lorenzo, María Belén Vidriales, Raimundo Garcia Boyero, Mayte Olave, Pilar Herrera-Puente, Olga Arce, Manuel Barrios Garcia, Maria Jose Sayas Lloris, Marta Polo, Maria Isabel Gomez Roncero, Eva Barragan, Rosa Ayala Diaz, Maria Carmen Chillon, Maria Jose Calasanz, Blanca Boluda, David Martinez-Cuadrón, and Jorge Labrador

Subjects
Diseases of the blood and blood-forming organs, RC633-647.5
Published
2023
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2. P504: UPDATED DATA FOR ZIFTOMENIB IN PATIENTS WITH NPM1-MUTATED RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA

Author

Amir Fathi, Eunice Wang, Ghayas Issa, Jessica Altman, Pau Montesinos, Stéphane de Botton, Roland Walter, Kirsten Pettit, Mrinal Patnaik, Marina Kremyanskaya, Maria Baer, James M Foran, Gary Schiller, Lionel Ades, Maël Heiblig, Pierre Peterlin, Olga Salamero Garcia, Cristina Papayannidis, Kun Nie, Julie Ahsan Mackey, Marilyn Tabachri, Daniel Corum, Mollie Leoni, Stephen Dale, and Harry Erba

Subjects
Diseases of the blood and blood-forming organs, RC633-647.5
Published
2023
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3. P498: INCIDENCE, RISK FACTORS AND OUTCOMES OF SECOND NEOPLASMS IN PATIENTS WITH ACUTE PROMYELOCYTIC LEUKEMIA: THE PETHEMA-PALG EXPERIENCE.

Author

Marta Sobas, Wanda Knopinska-Posluszny, Beata Piątkowska-Jakubas, Gert Ossenkoppele, Flor García-Álvarez, María Elena Amutio Díez, Mar Caballero, David Martinez-Cuadrón, Eliana Aguiar, Jose Gonzalez Campos, Ana Garrido Diaz, Lorenzo Algarra, Olga Salamero, Javier de la Serna, Maria Jose Sayas Lloris, Manuel Mateo Perez Encinas, Susana Vives Polo, Veronica Gonzalez DE LA Calle, Jorge Labrador, Ana Inés Prado, Lucía Celebrin, Jiri Mayer, Graca Luiza O P Neto Vasconcelos Esteves, Almudena de Laiglesia, Juan Miguel Bergua Burgues, Maria Luz Amigo, Carlos Rodriguez Medina, Marta Polo, Agnieszka Pluta, Edyta Cichocka, Marek Skarupski, Miguel A Sanz, and Pau Montesinos

Subjects
Diseases of the blood and blood-forming organs, RC633-647.5
Published
2023
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4. Adjunctive Volasertib in Patients With Acute Myeloid Leukemia not Eligible for Standard Induction Therapy: A Randomized, Phase 3 Trial

Author

Hartmut Döhner, Argiris Symeonidis, Dries Deeren, Judit Demeter, Miguel A. Sanz, Achilles Anagnostopoulos, Jordi Esteve, Walter Fiedler, Kimmo Porkka, Hee-Je Kim, Je-Hwan Lee, Kensuke Usuki, Stefano D'Ardia, Chul Won Jung, Olga Salamero, Heinz-August Horst, Christian Recher, Philippe Rousselot, Irwindeep Sandhu, Koen Theunissen, Felicitas Thol, Konstanze Döhner, Veronica Teleanu, Daniel J. DeAngelo, Tomoki Naoe, Mikkael A. Sekeres, Valerie Belsack, Miaomiao Ge, Tillmann Taube, and Oliver G. Ottmann

Subjects
Diseases of the blood and blood-forming organs, RC633-647.5
Abstract

In this phase 3 trial, older patients with acute myeloid leukemia ineligible for intensive chemotherapy were randomized 2:1 to receive the polo-like kinase inhibitor, volasertib (V; 350 mg intravenous on days 1 and 15 in 4-wk cycles), combined with low-dose cytarabine (LDAC; 20 mg subcutaneous, twice daily, days 1–10; n = 444), or LDAC plus placebo (P; n = 222). Primary endpoint was objective response rate (ORR); key secondary endpoint was overall survival (OS). Primary ORR analysis at recruitment completion included patients randomized ≥5 months beforehand; ORR was 25.2% for V+LDAC and 16.8% for P+LDAC (n = 371; odds ratio 1.66 [95% confidence interval (CI), 0.95–2.89]; P = 0.071). At final analysis (≥574 OS events), median OS was 5.6 months for V+LDAC and 6.5 months for P+LDAC (n = 666; hazard ratio 0.97 [95% CI, 0.8–1.2]; P = 0.757). The most common adverse events (AEs) were infections/infestations (grouped term; V+LDAC, 81.3%; P+LDAC, 63.5%) and febrile neutropenia (V+LDAC, 60.4%; P+LDAC, 29.3%). Fatal AEs occurred in 31.2% with V+LDAC versus 18.0% with P+LDAC, most commonly infections/infestations (V+LDAC, 17.1%; P+LDAC, 6.3%). Lack of OS benefit with V+LDAC versus P+LDAC may reflect increased early mortality with V+LDAC from myelosuppression and infections.

Published
2021
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5. Adjunctive Volasertib in Patients With Acute Myeloid Leukemia not Eligible for Standard Induction Therapy: A Randomized, Phase 3 Trial

Author

Philippe Rousselot, Veronica Teleanu, Kimmo Porkka, Christian Recher, Achilles Anagnostopoulos, Oliver G. Ottmann, Miguel A. Sanz, Daniel J. DeAngelo, Mikkael A. Sekeres, Felicitas Thol, Hartmut Döhner, Kensuke Usuki, Konstanze Döhner, Dries Deeren, Miaomiao Ge, Stefano D'Ardia, Olga Salamero, Irwindeep Sandhu, Chul Won Jung, Tillmann Taube, Je-Hwan Lee, Tomoki Naoe, Koen Theunissen, Jordi Esteve, Heinz-August Horst, Judit Demeter, Walter Fiedler, Valerie Belsack, Argiris Symeonidis, Hee-Je Kim, Institut Català de la Salut, [Döhner H] Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany. [Symeonidis A] Hematology Division, University Hospital, University of Patras Medical School, Patras, Greece. [Deeren D] AZ Delta, Roeselare, Belgium. [Demeter J] Semmelweis University, Budapest, Hungary. [Sanz MA] Department of Hematology, University Hospital La Fe, Valencia, Spain. [Anagnostopoulos A] Hematology Department, General Hospital G. Papanikolaou, Thessaloniki, Greece. [Salamero O] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain, Vall d'Hebron Barcelona Hospital Campus, HUS Comprehensive Cancer Center, Department of Medicine, Hematologian yksikkö, and Helsinki University Hospital Area

Subjects
Other subheadings::Other subheadings::/drug therapy [Other subheadings], Otros calificadores::Otros calificadores::/efectos adversos [Otros calificadores], Gastroenterology, RECOMMENDATIONS, Persones grans, chemistry.chemical_compound, 0302 clinical medicine, DECITABINE, Clinical endpoint, VENETOCLAX, 0303 health sciences, Hazard ratio, terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Neoplasms::Neoplasms by Histologic Type::Leukemia::Leukemia, Myeloid::Leukemia, Myeloid, Acute [DISEASES], Volasertib, Hematology, OPEN-LABEL, 3. Good health, 030220 oncology & carcinogenesis, Leucèmia mieloide aguda - Quimioteràpia - Complicacions, medicine.drug, medicine.medical_specialty, 3122 Cancers, Decitabine, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], KINASE INHIBITOR VOLASERTIB, DIAGNOSIS, Placebo, BI 6727, Article, neoplasias::neoplasias por tipo histológico::leucemia::leucemia mieloide::leucemia mieloide aguda [ENFERMEDADES], 03 medical and health sciences, Internal medicine, Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], MANAGEMENT, medicine, Other subheadings::Other subheadings::/adverse effects [Other subheadings], Diseases of the blood and blood-forming organs, Adverse effect, AZACITIDINE, 030304 developmental biology, business.industry, medicine.disease, LOW-DOSE CYTARABINE, chemistry, Cytarabine, RC633-647.5, business, Febrile neutropenia
Abstract

Terapia de inducción estándar; Volasertib adyuvante; Leucemia mieloide aguda Standard Induction Therapy; Adjunctive Volasertib; Acute Myeloid Leukemia Teràpia d'inducció estàndard; Volasertib adjuvant; Leucèmia mieloide aguda In this phase 3 trial, older patients with acute myeloid leukemia ineligible for intensive chemotherapy were randomized 2:1 to receive the polo-like kinase inhibitor, volasertib (V; 350 mg intravenous on days 1 and 15 in 4-wk cycles), combined with low-dose cytarabine (LDAC; 20 mg subcutaneous, twice daily, days 1–10; n = 444), or LDAC plus placebo (P; n = 222). Primary endpoint was objective response rate (ORR); key secondary endpoint was overall survival (OS). Primary ORR analysis at recruitment completion included patients randomized ≥5 months beforehand; ORR was 25.2% for V+LDAC and 16.8% for P+LDAC (n = 371; odds ratio 1.66 [95% confidence interval (CI), 0.95–2.89]; P = 0.071). At final analysis (≥574 OS events), median OS was 5.6 months for V+LDAC and 6.5 months for P+LDAC (n = 666; hazard ratio 0.97 [95% CI, 0.8–1.2]; P = 0.757). The most common adverse events (AEs) were infections/infestations (grouped term; V+LDAC, 81.3%; P+LDAC, 63.5%) and febrile neutropenia (V+LDAC, 60.4%; P+LDAC, 29.3%). Fatal AEs occurred in 31.2% with V+LDAC versus 18.0% with P+LDAC, most commonly infections/infestations (V+LDAC, 17.1%; P+LDAC, 6.3%). Lack of OS benefit with V+LDAC versus P+LDAC may reflect increased early mortality with V+LDAC from myelosuppression and infections. This study was funded by Boehringer Ingelheim.

Published
2021
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6. PF255 INCIDENCE AND RISK FACTORS FOR EARLY DEATH AMONG 2421 APL PATIENTS: THE PETHEMA REGISTRY EXPERIENCE

Author

David Martínez-Cuadrón, Edo Vellenga, Lourdes Escoda, Raimundo García-Boyero, E. de Lisa, Teresa Bernal, Bob Löwenberg, Josefina Serrano, Olga Salamero, Mar Tormo, J. de la Serna, Cristiane Damas Gil, Miguel-Angel Sanz, Montserrat Arnan, José González-Campos, J. Arias, Andrzej Pluta, C. Sossa, Manuel Pérez-Encinas, Marta Sobas, Isolda Fernández, Susana Vives, M.E. Amutio, Salut Brunet, Marta Polo, and Pau Montesinos

Subjects
Pediatrics, medicine.medical_specialty, business.industry, Incidence (epidemiology), medicine, Early death, Hematology, business
Published
2019
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7. PS995 IMPACT OF DNMT3A MUTATIONAL STATUS IN MOLECULAR MEASURABLE RESIDUAL DISEASE CLEARANCE IN ACUTE MYELOID LEUKEMIA WITH MUTATED NPM1

Author

Jordi Esteve, Montserrat Arnan, Salut Brunet, Marta Pratcorona, Susana Vives, Olga Salamero, Rosa Coll, M.P. Queipo de Llano, Antoni Garcia, Alba Aljarilla, Guadalupe Oñate, Alex Bataller, J. Nomdedeu, Jordi Sierra, and Ana Garrido

Subjects
business.industry, Cancer research, Mutational status, Medicine, Hematology, Disease, Acute Myeloid Leukemia with Mutated NPM1, business
Published
2019
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8. PF216 ROLE OF MEASURABLE RESIDUAL DISEASE (MRD) IN REDEFINING COMPLETE RESPONSE (CR) IN ELDERLY PATIENTS WITH ACUTE MYELOID LEUKEMIA (AML): RESULTS FROM THE PETHEMA-FLUGAZA PHASE III CLINICAL TRIAL

Author

M B Vidriales, Fernando Ramos, Olga Salamero, Bruno Paiva, María-José Sayas, Josefina Serrano, Jorge Labrador, Pilar Alejandra Saiz Martínez, David Martínez-Cuadrón, J.F. Falantes, J. San Miguel, Juana Merino, Esperanza Lavilla, Lorenzo Algarra, Miguel-Angel Sanz, Cristiane Damas Gil, Pau Montesinos, Felipe Prosper, Juan Bergua, J.L. Lopez, S. Vives, Mar Tormo, Ana Alfonso, and Pilar Herrera

Subjects
Oncology, Clinical trial, medicine.medical_specialty, business.industry, Internal medicine, medicine, Myeloid leukemia, Hematology, Disease, business, Complete response
Published
2019
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9. PF272 GLASDEGIB WITH LDAC IN NEWLY DIAGNOSED PATIENTS WITH ACUTE MYELOID LEUKEMIA (AML) UNSUITABLE FOR INTENSIVE CHEMOTHERAPY: EFFECTS ON TRANSFUSIONS AND MARROW RECOVERY VS LDAC ALONE

Author

Michael Heuser, C. Pedro Olive, Jorge E. Cortes, Caroline J. Hoang, Akil Merchant, Mikkael A. Sekeres, W.D. Ma, Geoffrey Chan, James K. McCloskey, Olga Salamero, Mirjana Zeremski, Ashleigh O'Connell, Pau Montesinos, and Eunice S. Wang

Subjects
Oncology, medicine.medical_specialty, business.industry, Internal medicine, Medicine, Myeloid leukemia, Hematology, Newly diagnosed, Intensive chemotherapy, business
Published
2019
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10. PS1065 OPEN-LABEL STUDY OF GILTERITINIB, GILTERITINIB PLUS AZACITIDINE, OR AZACITIDINE ALONE IN NEWLY DIAGNOSED FLT3-MUTATED AML PATIENTS INELIGIBLE FOR INTENSIVE CHEMOTHERAPY: RESULTS FROM THE SAFETY COHORT

Author

Je-Hwan Lee, Jorge Sierra, Shira Dinner, Kamel Laribi, Eunice S. Wang, Goichi Yoshimoto, T. Bernal Del Castillo, Olga Salamero, Shufang Liu, Pau Montesinos, Jordi Esteve, Rik Schots, Janusz Hałka, Mark D. Minden, Erkut Bahceci, and Elizabeth Shima Rich

Subjects
Oncology, medicine.medical_specialty, business.industry, Azacitidine, Gilteritinib, Hematology, Newly diagnosed, Intensive chemotherapy, Open label study, Internal medicine, Cohort, medicine, business, medicine.drug
Published
2019
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