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[PMID]: | 29224502 |
[Au] Autor: | Connors JM; Jurczak W; Straus DJ; Ansell SM; Kim WS; Gallamini A; Younes A; Alekseev S; Illés Á; Picardi M; Lech-Maranda E; Oki Y; Feldman T; Smolewski P; Savage KJ; Bartlett NL; Walewski J; Chen R; Ramchandren R; Zinzani PL; Cunningham D; Rosta A; Josephson NC; Song E; Sachs J; Liu R; Jolin HA; Huebner D; Radford J; ECHELON-1 Study Group |
[Ad] Endereço: | From the University of British Columbia and the Department of Medical Oncology, British Columbia Cancer Agency Centre for Lymphoid Cancer, Vancouver, Canada (J.M.C., K.J.S.); the Department of Hematology, Jagiellonian University, Krakow (W.J.), the Department of Hematology, Institute of Hematology a |
[Ti] Título: | Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin's Lymphoma. |
[So] Source: | N Engl J Med;378(4):331-344, 2018 01 25. | [Is] ISSN: | 1533-4406 |
[Cp] País de publicação: | United States |
[La] Idioma: | eng |
[Ab] Resumo: | BACKGROUND: Brentuximab vedotin is an anti-CD30 antibody-drug conjugate that has been approved for relapsed and refractory Hodgkin's lymphoma. METHODS: We conducted an open-label, multicenter, randomized phase 3 trial involving patients with previously untreated stage III or IV classic Hodgkin's lymphoma, in which 664 were assigned to receive brentuximab vedotin, doxorubicin, vinblastine, and dacarbazine (A+AVD) and 670 were assigned to receive doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). The primary end point was modified progression-free survival (the time to progression, death, or noncomplete response and use of subsequent anticancer therapy) as adjudicated by an independent review committee. The key secondary end point was overall survival. RESULTS: At a median follow-up of 24.6 months, 2-year modified progression-free survival rates in the A+AVD and ABVD groups were 82.1% (95% confidence interval [CI], 78.8 to 85.0) and 77.2% (95% CI, 73.7 to 80.4), respectively, a difference of 4.9 percentage points (hazard ratio for an event of progression, death, or modified progression, 0.77; 95% CI, 0.60 to 0.98; P=0.04). There were 28 deaths with A+AVD and 39 with ABVD (hazard ratio for interim overall survival, 0.73 [95% CI, 0.45 to 1.18]; P=0.20) [corrected]. All secondary efficacy end points trended in favor of A+AVD. Neutropenia occurred in 58% of the patients receiving A+AVD and in 45% of those receiving ABVD; in the A+AVD group, the rate of febrile neutropenia was lower among the 83 patients who received primary prophylaxis with granulocyte colony-stimulating factor than among those who did not (11% vs. 21%). Peripheral neuropathy occurred in 67% of patients in the A+AVD group and in 43% of patients in the ABVD group; 67% of patients in the A+AVD group who had peripheral neuropathy had resolution or improvement at the last follow-up visit. Pulmonary toxicity of grade 3 or higher was reported in less than 1% of patients receiving A+AVD and in 3% of those receiving ABVD. Among the deaths that occurred during treatment, 7 of 9 in the A+AVD group were associated with neutropenia and 11 of 13 in the ABVD group were associated with pulmonary-related toxicity. CONCLUSIONS: A+AVD had superior efficacy to ABVD in the treatment of patients with advanced-stage Hodgkin's lymphoma, with a 4.9 percentage-point lower combined risk of progression, death, or noncomplete response and use of subsequent anticancer therapy at 2 years. (Funded by Millennium Pharmaceuticals and Seattle Genetics; ECHELON-1 ClinicalTrials.gov number, NCT01712490 ; EudraCT number, 2011-005450-60 .). |
[Mh] Termos MeSH primário: |
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico Doença de Hodgkin/tratamento farmacológico Imunoconjugados/administração & dosagem Fatores Imunológicos/administração & dosagem
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[Mh] Termos MeSH secundário: |
Adolescente Adulto Idoso Idoso de 80 Anos ou mais Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos Bleomicina/administração & dosagem Dacarbazina/administração & dosagem Intervalo Livre de Doença Doxorrubicina/administração & dosagem Feminino Seguimentos Doença de Hodgkin/mortalidade Seres Humanos Imunoconjugados/efeitos adversos Fatores Imunológicos/efeitos adversos Masculino Meia-Idade Estadiamento de Neoplasias Neutropenia/induzido quimicamente Taxa de Sobrevida Vimblastina/administração & dosagem Adulto Jovem
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[Pt] Tipo de publicação: | CLINICAL TRIAL, PHASE III; COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; RESEARCH SUPPORT, NON-U.S. GOV'T |
[Nm] Nome de substância:
| 0 (Immunoconjugates); 0 (Immunologic Factors); 11056-06-7 (Bleomycin); 5V9KLZ54CY (Vinblastine); 7GR28W0FJI (Dacarbazine); 7XL5ISS668 (brentuximab vedotin); 80168379AG (Doxorubicin) |
[Em] Mês de entrada: | 1802 |
[Cu] Atualização por classe: | 180305 |
[Lr] Data última revisão:
| 180305 |
[Sb] Subgrupo de revista: | AIM; IM |
[Da] Data de entrada para processamento: | 171212 |
[Cl] Clinical Trial: | ClinicalTrial
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[St] Status: | MEDLINE |
[do] DOI: | 10.1056/NEJMoa1708984 |
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