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Tisotumab Vedotin a...
Tisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer
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- Vergote, Ignace (författare)
- University Hospitals Leuven
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- Gonzalez-Martin, Antonio (författare)
- University of Navarra
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Fujiwara, Keiichi (författare)
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- Kalbacher, Elsa (författare)
- Centre Hospitalier Universitaire de Besancon
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- Bagameri, Andrea (författare)
- National Institute of Oncology, Budapest
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- Ghamande, Sharad (författare)
- Medical College of Georgia
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- Lee, Jung Yun (författare)
- Yonsei University
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- Banerjee, Susana (författare)
- Royal Marsden NHS Foundation Trust
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- Maluf, Fernando Cotait (författare)
- Hospital Beneficencia Portuguesa de São Paulo,Albert Einstein Israelite Hospital
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- Lorusso, Domenica (författare)
- Policlinico Universitario Agostino Gemelli
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- Yonemori, Kan (författare)
- National Cancer Center Hospital, Japan
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- Van Nieuwenhuysen, Els (författare)
- University Hospitals Leuven
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- Manso, Luis (författare)
- 12 de Octubre University Hospital
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- Woelber, Linn (författare)
- University Medical Center Hamburg-Eppendorf
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- Westermann, Anneke (författare)
- Academic Medical Center of University of Amsterdam (AMC)
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Covens, Allan (författare)
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Hasegawa, Kosei (författare)
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- Kim, Byoung Gie (författare)
- Kangbuk Samsung Hospital
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Raimondo, Miriam (författare)
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- Bjurberg, Maria (författare)
- Lund University,Lunds universitet,LUCC: Lunds universitets cancercentrum,Övriga starka forskningsmiljöer,Bröst/ovarialcancer,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,LUCC: Lund University Cancer Centre,Other Strong Research Environments,Breast/ovarian cancer,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital
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Cruz, Felipe Melo (författare)
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- Angelergues, Antoine (författare)
- Groupe Hospitalier Diaconesses Croix Saint-Simon
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- Cibula, David (författare)
- General University Hospital in Prague
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- Barraclough, Lisa (författare)
- Christie NHS Foundation Trust
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- Oaknin, Ana (författare)
- Vall d’Hebron Institute of Oncology
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- Gennigens, Christine (författare)
- University of Liège Hospital
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- Nicacio, Leo (författare)
- Pfizer Inc. US
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- Teng, Melinda Siew Leng (författare)
- Pfizer Inc. US
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- Whalley, Elizabeth (författare)
- Pfizer Inc. US
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Soumaoro, Ibrahima (författare)
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- Slomovitz, Brian M. (författare)
- Mount Sinai Medical Center, Miami Beach
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(creator_code:org_t)
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- 2024
- 2024
- Engelska 12 s.
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Ingår i: New England Journal of Medicine. - 0028-4793. ; 391:1, s. 44-55
- Relaterad länk:
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http://dx.doi.org/10...
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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Abstract
Ämnesord
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- 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; twosided 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
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Vergote, Ignace
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Gonzalez-Martin, ...
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Fujiwara, Keiich ...
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Kalbacher, Elsa
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Bagameri, Andrea
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Ghamande, Sharad
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visa fler...
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Lee, Jung Yun
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Banerjee, Susana
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Maluf, Fernando ...
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Lorusso, Domenic ...
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Yonemori, Kan
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Van Nieuwenhuyse ...
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Manso, Luis
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Woelber, Linn
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Westermann, Anne ...
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Covens, Allan
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Hasegawa, Kosei
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Kim, Byoung Gie
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Raimondo, Miriam
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Bjurberg, Maria
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Cruz, Felipe Mel ...
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Angelergues, Ant ...
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Cibula, David
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Barraclough, Lis ...
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Oaknin, Ana
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Gennigens, Chris ...
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Nicacio, Leo
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Teng, Melinda Si ...
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Whalley, Elizabe ...
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Soumaoro, Ibrahi ...
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Slomovitz, Brian ...
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