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http://hdl.handle.net/2445/173305
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DC Field | Value | Language |
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dc.contributor.author | Antonarakis, Emmanuel S. | - |
dc.contributor.author | Piulats, Josep M. | - |
dc.contributor.author | Gross-Goupil, Marine | - |
dc.contributor.author | Goh, Jeffrey | - |
dc.contributor.author | Ojamaa, Kristiina | - |
dc.contributor.author | Hoimes, Christopher J. | - |
dc.contributor.author | Vaishampayan, Ulka | - |
dc.contributor.author | Berger, Raanan | - |
dc.contributor.author | Sezer, Ahmet | - |
dc.contributor.author | Alanko, Tuomo | - |
dc.contributor.author | Wit, Ronald de | - |
dc.contributor.author | Li, Chunde | - |
dc.contributor.author | Omlin, Aurelius | - |
dc.contributor.author | Procopio, Giuseppe | - |
dc.contributor.author | Fukasawa, Satoshi | - |
dc.contributor.author | Tabata, Ken-ichi | - |
dc.contributor.author | Park, Se Hoon | - |
dc.contributor.author | Feyerabend, Susan | - |
dc.contributor.author | Drake, Charles G. | - |
dc.contributor.author | Wu, Haiyan | - |
dc.contributor.author | Qiu, Ping | - |
dc.contributor.author | Kim, Jeri | - |
dc.contributor.author | Poehlein, Christian | - |
dc.contributor.author | Bono, Johann Sebastian de | - |
dc.date.accessioned | 2021-01-22T16:00:26Z | - |
dc.date.available | 2021-01-22T16:00:26Z | - |
dc.date.issued | 2020-02-10 | - |
dc.identifier.uri | http://hdl.handle.net/2445/173305 | - |
dc.description.abstract | PURPOSE: Pembrolizumab has previously shown antitumor activity against programmed death ligand 1 (PD-L1)-positive metastatic castration-resistant prostate cancer (mCRPC). Here, we assessed the antitumor activity and safety of pembrolizumab in three parallel cohorts of a larger mCRPC population. METHODS: The phase II KEYNOTE-199 study included three cohorts of patients with mCRPC treated with docetaxel and one or more targeted endocrine therapies. Cohorts 1 and 2 enrolled patients with RECIST-measurable PD-L1-positive and PD-L1-negative disease, respectively. Cohort 3 enrolled patients with bone-predominant disease, regardless of PD-L1 expression. All patients received pembrolizumab 200 mg every 3 weeks for up to 35 cycles. The primary end point was objective response rate per RECIST v1.1 assessed by central review in cohorts 1 and 2. Secondary end points included disease control rate, duration of response, overall survival (OS), and safety. RESULTS: Two hundred fifty-eight patients were enrolled: 133 in cohort 1, 66 in cohort 2, and 59 in cohort 3. Objective response rate was 5% (95% CI, 2% to 11%) in cohort 1 and 3% (95% CI, < 1% to 11%) in cohort 2. Median duration of response was not reached (range, 1.9 to >= 21.8 months) and 10.6 months (range, 4.4 to 16.8 months), respectively. Disease control rate was 10% in cohort 1, 9% in cohort 2, and 22% in cohort 3. Median OS was 9.5 months in cohort 1, 7.9 months in cohort 2, and 14.1 months in cohort 3. Treatment-related adverse events occurred in 60% of patients, were of grade 3 to 5 severity in 15%, and led to discontinuation of treatment in 5%. CONCLUSION: Pembrolizumab monotherapy shows antitumor activity with an acceptable safety profile in a subset of patients with RECIST-measurable and bone-predominant mCRPC previously treated with docetaxel and targeted endocrine therapy. Observed responses seem to be durable, and OS estimates are encouraging. | - |
dc.format.extent | 10 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1200/JCO.19.01638 | - |
dc.relation.ispartof | Journal of Clinical Oncology, 2020, vol. 38, num. 5, p. 395-405 | - |
dc.relation.uri | https://doi.org/10.1200/JCO.19.01638 | - |
dc.rights | (c) American Society of Clinical Oncology, 2020 | - |
dc.source | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) | - |
dc.subject.classification | Càncer de pròstata | - |
dc.subject.classification | Metàstasi | - |
dc.subject.other | Prostate cancer | - |
dc.subject.other | Metastasis | - |
dc.title | Pembrolizumab for Treatment-Refractory Metastatic Castration-Resistant Prostate Cancer: Multicohort, Open-Label Phase II KEYNOTE-199 Study | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.date.updated | 2020-12-21T13:14:53Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 31774688 | - |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
Files in This Item:
File | Description | Size | Format | |
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AntonarakisES.pdf | 892.14 kB | Adobe PDF | View/Open |
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