دورية أكاديمية
Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial
| العنوان: | Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial |
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| المؤلفون: | Powles T., van der Heijden M. S., Castellano D., Galsky M. D., Loriot Y., Petrylak D. P., Ogawa O., Park S. H., Lee J. -L., De Giorgi U., Bogemann M., Bamias A., Eigl B. J., Gurney H., Mukherjee S. D., Fradet Y., Skoneczna I., Tsiatas M., Novikov A., Suarez C., Fay A. P., Duran I., Necchi A., Wildsmith S., He P., Angra N., Gupta A. K., Levin W., Bellmunt J., Lee J. L., Westgeest H., Flechon A., Ou Y. -C., Park I., Matveev V., Perez-Valderrama B., Cheng S., Frank S., Anido U., Hamzaj A., Retz M., Sridhar S., Scagliotti G. V., Voortman J., Alekseev B., Alyasova A., Komyakov B., Dumez H., Pavic M., Kimura G., Mizokami A., Osanto S., Arranz J. A., Piersma D., Shin S. J., Karyakin O., Delgado I., Gonzalez J. L., Pang S. -T., Tran A., Lipatov O., Su W. -P., Flaig T., Alva A., Park Kyong H., Kopyltsov E., Almagro E., Domenech M., Chang Y. -H., Sautois B., Ravaux A., Aravantinos G., Georgoulias V., Mulder S., Kim Y. J., Kater F., Chevreau C., Tagawa S., Zalewski P., Joly F., Hatiboglu G., Gianni L., Morelli F., Tambaro R., Hashimoto Y., Nosov A., Font A., Rodriguez-Vida A. M., Jones R., Vasudev N., Srinivas S., Zhang J., Gil T., Finch D., Grimm M. -O., Su Y. -L., Chowdhury S., Hocking C., Plas E., North S., Jensen N. V., Theodore C., Imkamp F., Peer A., Kobayashi T., Sakai H., Sassa N., Yoshimura K., Aarts M., Ferreira Castro A., Topuzov M., Rodriguez J. F., Vazquez F. J., Tsai Y. -C., Crabb S., Hussain S., Bendell J., Gross-Goupil M., Gwenaelle G., Berger R., Statsenko G., Evans L., Drakaki A., Somer B., Davis I., Lynam J., Borges G., Dettino A., Martins G., Zucca L. E., Agerbaek M., Kalofonos H., Rosenbaum E., Enokida H., Kikukawa H., Nishimura K., Tamada S., Uemura M., Lopez Y., Gietema J., Slojewski M., Fernandes I., Smolin A., Mazhar D., Kalebasty A. R., Carthon B., Loidl W., Franke F., Girotto G., Alimohamed N., Macfarlane R., Pappot H., Niegisch G., Mavroudis D., Sella A., Porta C., Ebara S., Nakamura M., Obara W., Okuno N., Shinohara N., Sugimoto M., Suzuki A., Tokuda N., Uemura H., Yamaguchi A., Ramirez F., Rozanowski P., Wiechno P., Keam B., Kislov N., Plaksin D., Cicin I., Kumar S., Rosales J., Vaishampayan U., Culine S., Papandreou C., Nara T., Erman M., Kreiger L., Janoski J., Rosa D., Siqueira M., Canil C., Sengelov L., Tourani J. -M., Arai G., Hashine K., Kawakita M., Nakaigawa N., Nomi H., Shiina H., Suzuki H., Yonese J., Kuri R., Macedo E., Rivera S., Villalobos Prieto A., Polakiewicz-Gilowska A., Zaucha R., Lopes F., Ponomarev R., Pomerantz M., Shariat S., Luk C., Lesniewski-Kmak K. |
| المساهمون: | Powles, T., van der Heijden, M. S., Castellano, D., Galsky, M. D., Loriot, Y., Petrylak, D. P., Ogawa, O., Park, S. H., Lee, J. -L., De Giorgi, U., Bogemann, M., Bamias, A., Eigl, B. J., Gurney, H., Mukherjee, S. D., Fradet, Y., Skoneczna, I., Tsiatas, M., Novikov, A., Suarez, C., Fay, A. P., Duran, I., Necchi, A., Wildsmith, S., He, P., Angra, N., Gupta, A. K., Levin, W., Bellmunt, J., Lee, J. L., Westgeest, H., Flechon, A., Ou, Y. -C., Park, I., Matveev, V., Perez-Valderrama, B., Cheng, S., Frank, S., Anido, U., Hamzaj, A., Retz, M., Sridhar, S., Scagliotti, G. V., Voortman, J., Alekseev, B., Alyasova, A., Komyakov, B., Dumez, H., Pavic, M., Kimura, G., Mizokami, A., Osanto, S., Arranz, J. A., Piersma, D., Shin, S. J., Karyakin, O., Delgado, I., Gonzalez, J. L., Pang, S. -T., Tran, A., Lipatov, O., Su, W. -P., Flaig, T., Alva, A., Park Kyong, H., Kopyltsov, E., Almagro, E., Domenech, M., Chang, Y. -H., Sautois, B., Ravaux, A., Aravantinos, G., Georgoulias, V., Mulder, S., Kim, Y. J., Kater, F., Chevreau, C., Tagawa, S., Zalewski, P., Joly, F., Hatiboglu, G., Gianni, L., Morelli, F., Tambaro, R., Hashimoto, Y., Nosov, A., Font, A., Rodriguez-Vida, A. M., Jones, R., Vasudev, N., Srinivas, S., Zhang, J., Gil, T., Finch, D., Grimm, M. -O., Su, Y. -L. |
| بيانات النشر: | Lancet Publishing Group |
| سنة النشر: | 2020 |
| الوصف: | Background: Survival outcomes are poor for patients with metastatic urothelial carcinoma who receive standard, first-line, platinum-based chemotherapy. We assessed the overall survival of patients who received durvalumab (a PD-L1 inhibitor), with or without tremelimumab (a CTLA-4 inhibitor), as a first-line treatment for metastatic urothelial carcinoma. Methods: DANUBE is an open-label, randomised, controlled, phase 3 trial in patients with untreated, unresectable, locally advanced or metastatic urothelial carcinoma, conducted at 224 academic research centres, hospitals, and oncology clinics in 23 countries. Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0 or 1. We randomly assigned patients (1:1:1) to receive durvalumab monotherapy (1500 mg) administered intravenously every 4 weeks; durvalumab (1500 mg) plus tremelimumab (75 mg) administered intravenously every 4 weeks for up to four doses, followed by durvalumab maintenance (1500 mg) every 4 weeks; or standard-of-care chemotherapy (gemcitabine plus cisplatin or gemcitabine plus carboplatin, depending on cisplatin eligibility) administered intravenously for up to six cycles. Randomisation was done through an interactive voice–web response system, with stratification by cisplatin eligibility, PD-L1 status, and presence or absence of liver metastases, lung metastases, or both. The coprimary endpoints were overall survival compared between the durvalumab monotherapy versus chemotherapy groups in the population of patients with high PD-L1 expression (the high PD-L1 population) and between the durvalumab plus tremelimumab versus chemotherapy groups in the intention-to-treat population (all randomly assigned patients). The study has completed enrolment and the final analysis of overall survival is reported. The trial is registered with ClinicalTrials.gov, NCT02516241, and the EU Clinical Trials Register, EudraCT number 2015-001633-24. Findings: Between Nov 24, 2015, and March 21, 2017, we randomly ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/wos/WOS:000599899200041; volume:21; issue:12; firstpage:1574; lastpage:1588; numberofpages:15; journal:THE LANCET ONCOLOGY; http://hdl.handle.net/20.500.11768/110034Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85091519786 |
| DOI: | 10.1016/S1470-2045(20)30541-6 |
| الإتاحة: | https://doi.org/20.500.11768/110034Test https://doi.org/10.1016/S1470-2045Test(20)30541-6 https://hdl.handle.net/20.500.11768/110034Test |
| رقم الانضمام: | edsbas.2A8AA25B |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/S1470-2045(20)30541-6 |
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