Miniatura

Fitxers

AntonarakisES.pdf (892.14 KB)

Tipus de document

Article

Versió

Versió publicada

Data de publicació

2020-02-10

Tots els drets reservats

Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/173305

Pembrolizumab for Treatment-Refractory Metastatic Castration-Resistant Prostate Cancer: Multicohort, Open-Label Phase II KEYNOTE-199 Study

Títol de la revista

Autors

Director/Tutor

ISSN de la revista

Títol del volum

Recurs relacionat

https://doi.org/10.1200/JCO.19.01638

Resum

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.

Matèries

Càncer de pròstata, Metàstasi

Matèries (anglès)

Prostate cancer, Metastasis

Citació

Col·leccions

Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

Citació

ANTONARAKIS, Emmanuel s., PIULATS, Josep m., GROSS-GOUPIL, Marine, GOH, Jeffrey, OJAMAA, Kristiina, HOIMES, Christopher j., VAISHAMPAYAN, Ulka, BERGER, Raanan, SEZER, Ahmet, ALANKO, Tuomo, WIT, Ronald de, LI, Chunde, OMLIN, Aurelius, PROCOPIO, Giuseppe, FUKASAWA, Satoshi, TABATA, Ken-ichi, PARK, Se hoon, FEYERABEND, Susan, DRAKE, Charles g., WU, Haiyan, QIU, Ping, KIM, Jeri, POEHLEIN, Christian, BONO, Johann sebastian de. Pembrolizumab for Treatment-Refractory Metastatic Castration-Resistant Prostate Cancer: Multicohort, Open-Label Phase II KEYNOTE-199 Study. _Journal of Clinical Oncology_. 2020. Vol. 38, núm. 5, pàgs. 395-405. [consulta: 22 de gener de 2026]. [Disponible a: https://hdl.handle.net/2445/173305]

Exportar metadades

JSON - METS

Compartir registre