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Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer.
Powles, Thomas; Valderrama, Begoña P; Gupta, Shilpa; Bedke, Jens; Kikuchi, Eiji; Hoffman-Censits, Jean; Iyer, Gopa; Vulsteke, Christof; Park, Se Hoon; Shin, Sang Joon; Castellano, Daniel; Fornarini, Giuseppe; Li, Jian-Ri; Gümüs, Mahmut; Mar, Nataliya; Loriot, Yohann; Fléchon, Aude; Duran, Ignacio; Drakaki, Alexandra; Narayanan, Sujata; Yu, Xuesong; Gorla, Seema; Homet Moreno, Blanca; van der Heijden, Michiel S.
Afiliação
  • Powles T; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • Valderrama BP; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • Gupta S; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • Bedke J; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • Kikuchi E; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • Hoffman-Censits J; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • Iyer G; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • Vulsteke C; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • Park SH; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • Shin SJ; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • Castellano D; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • Fornarini G; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • Li JR; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • Gümüs M; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • Mar N; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • Loriot Y; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • Fléchon A; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • Duran I; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • Drakaki A; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • Narayanan S; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • Yu X; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • Gorla S; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • Homet Moreno B; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
  • van der Heijden MS; From Barts Cancer Institute Biomedical Research Centre, Queen Mary University of London, London (T.P.); Hospital Universitario Virgen del Rocio, Seville (B.P.V.), Hospital Universitario 12 de Octubre, Madrid (D.C.), and Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitar
N Engl J Med ; 390(10): 875-888, 2024 Mar 07.
Article em En | MEDLINE | ID: mdl-38446675
ABSTRACT

BACKGROUND:

No treatment has surpassed platinum-based chemotherapy in improving overall survival in patients with previously untreated locally advanced or metastatic urothelial carcinoma.

METHODS:

We conducted a phase 3, global, open-label, randomized trial to compare the efficacy and safety of enfortumab vedotin and pembrolizumab with the efficacy and safety of platinum-based chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma. Patients were randomly assigned in a 11 ratio to receive 3-week cycles of enfortumab vedotin (at a dose of 1.25 mg per kilogram of body weight intravenously on days 1 and 8) and pembrolizumab (at a dose of 200 mg intravenously on day 1) (enfortumab vedotin-pembrolizumab group) or gemcitabine and either cisplatin or carboplatin (determined on the basis of eligibility to receive cisplatin) (chemotherapy group). The primary end points were progression-free survival as assessed by blinded independent central review and overall survival.

RESULTS:

A total of 886 patients underwent randomization 442 to the enfortumab vedotin-pembrolizumab group and 444 to the chemotherapy group. As of August 8, 2023, the median duration of follow-up for survival was 17.2 months. Progression-free survival was longer in the enfortumab vedotin-pembrolizumab group than in the chemotherapy group (median, 12.5 months vs. 6.3 months; hazard ratio for disease progression or death, 0.45; 95% confidence interval [CI], 0.38 to 0.54; P<0.001), as was overall survival (median, 31.5 months vs. 16.1 months; hazard ratio for death, 0.47; 95% CI, 0.38 to 0.58; P<0.001). The median number of cycles was 12 (range, 1 to 46) in the enfortumab vedotin-pembrolizumab group and 6 (range, 1 to 6) in the chemotherapy group. Treatment-related adverse events of grade 3 or higher occurred in 55.9% of the patients in the enfortumab vedotin-pembrolizumab group and in 69.5% of those in the chemotherapy group.

CONCLUSIONS:

Treatment with enfortumab vedotin and pembrolizumab resulted in significantly better outcomes than chemotherapy in patients with untreated locally advanced or metastatic urothelial carcinoma, with a safety profile consistent with that in previous reports. (Funded by Astellas Pharma US and others; EV-302 ClinicalTrials.gov number, NCT04223856.).
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Carcinoma de Células de Transição / Neoplasias Urológicas / Anticorpos Monoclonais / Antineoplásicos Limite: Humans Idioma: En Ano de publicação: 2024 Tipo de documento: Article
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Carcinoma de Células de Transição / Neoplasias Urológicas / Anticorpos Monoclonais / Antineoplásicos Limite: Humans Idioma: En Ano de publicação: 2024 Tipo de documento: Article