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1. Biosimilar Versus Originator Pegfilgrastim for Preventing Chemotherapy-Induced Neutropenia: A Phase III Randomized, Multicenter, Evaluator-Blinded, Noninferiority Study

Author

Ruben D. Kowalyszyn, Luis E. Fein, Martin E. Richardet, Mirta S. Varela, Eduardo Ortiz, Cristian Micheri, Juan J. Zarba, Susana Kahl, Ezequiel Klimovsky, Andrea A. Federico, Jorge H. Cassini, Gustavo Cortese, and Nestor Lago

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

PURPOSEThis study evaluated the efficacy, safety, and immunogenicity of biosimilar pegfilgrastim (PegFilBS) and originator pegfilgrastim (PegFilOR) in patients with stage 2-4 breast cancer.METHODSThis phase III randomized, multicenter, evaluator-blinded, noninferiority study recruited women with stage 2-4 breast cancer in Argentina who were scheduled to receive chemotherapy. Stratification was based on the breast cancer stage. The primary end point was the duration of severe neutropenia (DSN, noninferiority margin: 1 day) in the first chemotherapy cycle. Secondary end points assessed were incidence of severe neutropenia, grade 3 neutropenia, febrile neutropenia, infections, postchemotherapy hospitalization and duration, and the incidence of adverse drug reactions (ADRs).RESULTSA total of 120 patients were randomly assigned to receive PegFilBS (58 patients) or PegFilOR (62 patients). Severe neutropenia occurred in 52 of 283 cycles (18.4%) for 27 patients who received PegFilBS and in 48 of 297 cycles (16.2%) for 20 patients who received PegFilOR (P = .48). During the first cycle, severe neutropenia occurred in 16 patients who received PegFilBS (DSN: 0.78 ± 1.53 days) and in 11 patients who received PegFilOR (DSN: 0.53 ± 1.25 days; 95% CI, –0.26 to 0.76 days). In the intention-to-treat analysis, the mean DSN values were 0.90 ± 1.79 days for the PegFilBS group and 0.50 ± 1.21 for the PegFilOR group (95% CI, –0.15 to 0.95 days). No significant differences were observed for the secondary efficacy end points. Three patients experienced seven ADRs in the PegFilBS group while 10 patients experienced 31 ADRs in the PegFilOR group. The most common ADR was myalgia.CONCLUSIONRelative to PegFilOR, PegFilBS provided noninferior efficacy outcomes in Argentinian women with stage 2-4 breast cancer who were treated using myelosuppressive chemotherapy.

Published
2022
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2. Spectrum of BRCA1/2 variants in 940 patients from Argentina including novel, deleterious and recurrent germline mutations: Impact on healthcare and clinical practice

Author

Hector Daniel Vuotto, Francisco Bernardo Santillan, Antonio Lorusso, Reinaldo Chacón, Vanesa Romano, Martín Greco, Silvia Adela Avila, Enrique Diaz Canton, Lina Maria Nunez, José Davalos Michel, Florencia Perazzo, Gonzalo Recondo, Eduardo Abalo, María Laura Barrientos, Florencia Cecilia Cardoso, Ignacio Mc Lean, Cristina Noblía, Eduardo Beccar Varela, Oscar G. Mandó, Angela R. Solano, María Viniegra, Gustavo Cortese, Ernesto J. Podestá, Eduardo Gonzalez, and Carlos Bas

Subjects
0301 basic medicine, Latin Americans, CIENCIAS MÉDICAS Y DE LA SALUD, BRCA1/2 spectrum, Population, hispanic panel, HISPANIC PANEL, Medicina Clínica, 03 medical and health sciences, 0302 clinical medicine, purl.org/becyt/ford/3.2 [https], Personal history, education, Latin American BRCA1/2 mutations, LATIN AMERICAN BRCA1/2 MUTATIONS, education.field_of_study, genetic testing policy, BRCA1/2 SPECTRUM, BRCA1/2 RECURRENT MUTATIONS, BRCA1/2 recurrent mutations, Ovary cancer, Clinical Practice, 030104 developmental biology, Geography, Oncology, 030220 oncology & carcinogenesis, purl.org/becyt/ford/3 [https], Medicina Critica y de Emergencia, Clinical Research Paper, Humanities, GENETIC TESTING POLICY
Abstract

BRCA1/2 mutations in Latin America are scarcely documented and in serious need of knowledge about the spectrum of BRCA pathogenic variants, information which may alter clinical practice and subsequently improve patient outcome. In addition, the search for data on testing policies in different regions constitutes a fundamental strength for the present study, which analyzes BRCA1/2 gene sequences and large rearrangements in 940 probands with familial and/or personal history of breast/ovary cancer (BOC). In non-mutated DNA samples, Multiplex Ligation-dependent Probe Amplification assays (MLPA) were used for the analysis of large rearrangements. Our studies detected 179 deleterious mutations out of 940 (19.04%) probands, including 5 large rearrangements and 22 novel mutations. The recurrent mutations accounted for 15.08% of the total and only 2.87% of the probands analyzed, very different from a Hispanic panel previously described. In conclusion: a) this first comprehensive description of the spectrum in BRCA1/2 sheds light on the low frequency of recurrent mutations; b) this information is key in clinical practice to select adequate sequencing studies in our population, subsequently improve patient outcome and prevent damage associated to false normal reports resulting from the use of invalid population panels; c) panels of mutations from other populations should be cautiously validated before imported, even those of apparently similar origin, a concept to be considered beyond significance in Argentina. Fil: Solano, Angela Rosario. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET.; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Investigaciones Biomédicas. Universidad de Buenos Aires. Facultad de Medicina. Instituto de Investigaciones Biomédicas; Argentina Fil: Cardoso, Florencia Cecilia. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET.; Argentina Fil: Romano, Vanesa. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET.; Argentina Fil: Perazzo, Florencia. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET.; Argentina Fil: Bas, Carlos. Hospital Aleman; Argentina Fil: Recondo, Gonzalo. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET.; Argentina Fil: Santillan, Francisco Bernardo. Sanatorio Mater Dei; Argentina Fil: Gonzalez, Eduardo. Universidad de Buenos Aires. Facultad de Medicina. Instituto de Oncología "Ángel H. Roffo"; Argentina Fil: Abalo, Eduardo. Instituto Universitario CEMIC; Argentina Fil: Viniegra, Maria. Centro de Estudios de Estado y Sociedad; Argentina Fil: Davalos Michel, José. Universidad de Buenos Aires. Facultad de Medicina; Argentina Fil: Nuñez, Lina Maria. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET.; Argentina Fil: Nobilia, Cristina Maria. Instituto de Oncología “Angel H. Roffo”. Universidad de Buenos Aires; Argentina Fil: Mc Lean, Ignacio. Hospital Universitario Austral; Argentina Fil: Diaz Canton, Enrique. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET.; Argentina Fil: Chacon, Reinaldo Daniel. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Investigaciones Biomédicas. Universidad de Buenos Aires. Facultad de Medicina. Instituto de Investigaciones Biomédicas; Argentina Fil: Cortese, Gustavo. Universidad de Buenos Aires. Facultad de Medicina. Hospital de Clínicas General San Martín; Argentina Fil: Beccar Varela, Eduardo. Hospital Universitario Austral; Argentina Fil: Greco, Martin Rodolfo. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET.; Argentina Fil: Barrientos, Maria Laura. Hospital Regional Victor M. Sanguinetti; Argentina Fil: Avila, Silvia Adela. Hospital Provincial de Neuquén; Argentina Fil: Vuotto, Hector Daniel. Sanatorio Mater Dei; Argentina Fil: Lorusso, Antonio. Liga Argentina de Lucha contra el Cancer; Argentina Fil: Podesta, Ernesto Jorge. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Investigaciones Biomédicas. Universidad de Buenos Aires. Facultad de Medicina. Instituto de Investigaciones Biomédicas; Argentina Fil: Mando, Oscar Gaspar. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; Argentina

Published
2017

3. A randomized, multicenter clinical trial to determine the efficacy and safety of pegfilgrastim (GEMA BIOTECH) compared to pegfilgrastim (Roche) for prevention of chemotherapy induced neutropenia in patients with breast cancer

Author

Cristian Micheri, Luis Fein, Martin Eduardo Richardet, Ezequiel Klimovsky, E. H. Ortiz, Florencia Visintini Jaime, Mirta Susana Varela, Lucas Cordeiro, Andrea Federico, Nestor Lago, Susana Kahl, Ruben Dario Kowalyszyn, Gustavo Cortese, Jorge Horacio Cassini, and J. J. Zarba

Subjects
Cancer Research, business.industry, technology, industry, and agriculture, Biosimilar, macromolecular substances, Neutropenia, medicine.disease, Biotechnology, Clinical trial, Breast cancer, Oncology, Chemotherapy induced, Medicine, In patient, business, Febrile neutropenia, Pegfilgrastim, medicine.drug
Abstract

3113 Background: Peg-Neutropine, GEMA BIOTECH SAU biosimilar Peg-Filgrastim, is the first Peg-Filgrastim approved in LATAM for prevention of febrile neutropenia in patients treated with myelosuppressive chemotherapy. Methods: Study population: women with stage 2, 3 or 4 of breast cancer scheduled to receive 4 or 6 cycles of chemotherapy (with Taxane) at 3 weeks interval. Stratification was based on breast cancer stage. Study drug was administered subcutaneously in a 6 mg dose. The study was blind to the assessors. The primary endpoint was Duration of Severe Neutropenia (DSN, Absolute Neutrophil Count-ANC < 500/mm3) in the first cycle of chemotherapy. Secondary endpoints were incidence of severe neutropenia (SN), other efficacy measures, and incidence of ADRs. The non-inferiority margin for DSN was estimated in less than 1 day. Results: A total of 120 subjects were randomized 1:1, 58 were treated with Peg-Neutropine and 62 with Peg-Filgrastim (Roche). Efficacy: SN was developed in 52/283 (18,4%) cycles with Peg-Neutropine in 27 patients and 48/297 (16,2%) cycles with Peg-Filgrastim (Roche) in 20 patients (p=0,4836). In the first cycle, 16 patients with Peg-Neutropine and 11 patients with Peg-Filgrastim (Roche) developed SN. In per protocol analysis mean DNS in the first cycle was 0,78 ± 1,53 days for Peg-Neutropine group and 0,53±1,25 for Peg-Filgrastim (Roche) group (95% IC for the difference -0,26; 0,76). Per ITT analysis the mean DSN was 0,90±1,79 for Peg- Neutropine group and 0,50±1,21 for Peg-Filgrastim (Roche) group , (95% IC for the difference -0,15; 0,95). For all the efficacy secondary endpoints the differences were not statistically significant. Safety: 7 ADRs were developed by 3 subjects with Peg-Neutropine and 31 ADRs were developed by 10 subjects with Peg-Filgrastim (Roche). The most common reaction was myalgia, and other ADRs were arthralgia, asthenia, bone pain and acid sensitive syndrome. Conclusions: Based on the non-inferiority margin established we conclude that Peg-Neutropine is biosimilar to Peg-Filgrastim (Roche). Clinical trial information: NCT03404752.

Published
2019
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