Tisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer.,The New England Journal of Medicine

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Tisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer.
The New England Journal of Medicine ( IF 96.2 ) Pub Date : 2024-07-04 , DOI: 10.1056/nejmoa2313811
Ignace Vergote ₁ , Antonio González-Martín ₁ , Keiichi Fujiwara ₁ , Elsa Kalbacher ₁ , Andrea Bagaméri ₁ , Sharad Ghamande ₁ , Jung-Yun Lee ₁ , Susana Banerjee ₁ , Fernando Cotait Maluf ₁ , Domenica Lorusso ₁ , Kan Yonemori ₁ , Els Van Nieuwenhuysen ₁ , Luis Manso ₁ , Linn Woelber ₁ , Anneke Westermann ₁ , Allan Covens ₁ , Kosei Hasegawa ₁ , Byoung-Gie Kim ₁ , Miriam Raimondo ₁ , Maria Bjurberg ₁ , Felipe Melo Cruz ₁ , Antoine Angelergues ₁ , David Cibula ₁ , Lisa Barraclough ₁ , Ana Oaknin ₁ , Christine Gennigens ₁ , Leo Nicacio ₁ , Melinda Siew Leng Teng ₁ , Elizabeth Whalley ₁ , Ibrahima Soumaoro ₁ , Brian M Slomovitz ₁ ,

Affiliation

From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital Universitario 12 de Octubre (L.M.), and Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M.), Madrid, and Gynecologic Cancer Program, Vall d'Hebron Institute of Oncology, Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.O.) - all in Spain; Saitama Medical School International Medical Center, Saitama (K.F., K.H.), and the National Cancer Center Hospital, Tokyo (K.Y.) - both in Japan; Centre Hospitalier Universitaire de Besançon, Besançon (E.K.), and GINECO (E.K., A.A.) and Groupe Hospitalier Diaconesses Croix Saint-Simon (A.A.), Paris - all in France; Országos Onkológiai Intézet, Budapest, Hungary (A.B.); Georgia Cancer Center, Augusta University, Augusta (S.G.); Yonsei University College of Medicine (J.-Y.L.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (B.-G.K.) - both in Seoul, South Korea; the Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London (S.B.), and the Christie NHS Foundation Trust, Clinical Oncology, Manchester (L.B.) - both in the United Kingdom; Hospital Beneficencia Portuguesa de São Paulo (F.C.M.), Hospital Israelita Albert Einstein de São Paulo (F.C.M.), and Instituto Brasileiro de Controle do Câncer (F.M.C.) - all in Sao Paulo; Fondazione Policlinico Gemelli IRCCS and Catholic University of Sacred Heart, Rome (D.L.); Arbeitsgemeinschaft Gynäkologische Onkologie Study Group and University Medical Center Hamburg-Eppendorf, Hamburg, Germany (L.W.); Amsterdam University Medical Centers, Amsterdam (A.W.); Sunnybrook Research Institute, Toronto (A.C.); Medica Oncólogia Clinica en Grupo Gamma, Rosario, Argentina (M.R.); Skåne University Hospital and Lund University, Lund, Sweden (M.B.); First Faculty of Medicine, Charles University, General University Hospital in Prague, Prague, Czech Republic (D.C.); Pfizer, Bothell, WA (L.N., M.S.L.T., E.W.); Genmab US, Princeton, NJ (I.S.); and Mount Sinai Medical Center, Miami Beach, FL (B.M.S.).

BACKGROUND Recurrent cervical cancer is a life-threatening disease, with limited treatment options available when disease progression occurs after first-line combination therapy. METHODS We conducted a phase 3, multinational, open-label trial of tisotumab vedotin as second- or third-line therapy in patients with recurrent or metastatic cervical cancer. Patients were randomly assigned, in a 1:1 ratio, to receive tisotumab vedotin monotherapy (2.0 mg per kilogram of body weight every 3 weeks) or the investigator's choice of chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed). The primary end point was overall survival. RESULTS A total of 502 patients underwent randomization (253 were assigned to the tisotumab vedotin group and 249 to the chemotherapy group); the groups were similar with respect to demographic and disease characteristics. The median overall survival was significantly longer in the tisotumab vedotin group than in the chemotherapy group (11.5 months [95% confidence interval {CI}, 9.8 to 14.9] vs. 9.5 months [95% CI, 7.9 to 10.7]), results that represented a 30% lower risk of death with tisotumab vedotin than with chemotherapy (hazard ratio, 0.70; 95% CI, 0.54 to 0.89; two-sided P = 0.004). The median progression-free survival was 4.2 months (95% CI, 4.0 to 4.4) with tisotumab vedotin and 2.9 months (95% CI, 2.6 to 3.1) with chemotherapy (hazard ratio, 0.67; 95% CI, 0.54 to 0.82; two-sided P<0.001). The confirmed objective response rate was 17.8% in the tisotumab vedotin group and 5.2% in the chemotherapy group (odds ratio, 4.0; 95% CI, 2.1 to 7.6; two-sided P<0.001). A total of 98.4% of patients in the tisotumab vedotin group and 99.2% in the chemotherapy group had at least one adverse event that occurred during the treatment period (defined as the period from day 1 of dose 1 until 30 days after the last dose); grade 3 or greater events occurred in 52.0% and 62.3%, respectively. A total of 14.8% of patients stopped tisotumab vedotin treatment because of toxic effects. CONCLUSIONS In patients with recurrent cervical cancer, second- or third-line treatment with tisotumab vedotin resulted in significantly greater efficacy than chemotherapy. (Funded by Genmab and Seagen [acquired by Pfizer]; innovaTV 301 ClinicalTrials.gov number, NCT04697628.).

更新日期：2024-07-04

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