Phase II trial of cisplatin, gemcitabine and pembrolizumab for platinum-resistant ovarian cancer.

<h4>Objective</h4>To evaluate the combination of pembrolizumab, cisplatin and gemcitabine in recurrent platinum-resistant ovarian cancer.<h4>Methods</h4>Patients received six cycles of chemotherapy with gemcitabine and cisplatin on day 1 and day 8 of a 21-day treatment cycle....

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Autores principales:	Christine S Walsh, Mitchell Kamrava, Andre Rogatko, Sungjin Kim, Andrew Li, Ilana Cass, Beth Karlan, Bobbie J Rimel
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/a612667296934eabbd43ceddcb1e41a2
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spelling	oai:doaj.org-article:a612667296934eabbd43ceddcb1e41a22021-12-02T20:11:06ZPhase II trial of cisplatin, gemcitabine and pembrolizumab for platinum-resistant ovarian cancer.1932-620310.1371/journal.pone.0252665https://doaj.org/article/a612667296934eabbd43ceddcb1e41a22021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0252665https://doaj.org/toc/1932-6203<h4>Objective</h4>To evaluate the combination of pembrolizumab, cisplatin and gemcitabine in recurrent platinum-resistant ovarian cancer.<h4>Methods</h4>Patients received six cycles of chemotherapy with gemcitabine and cisplatin on day 1 and day 8 of a 21-day treatment cycle. Pembrolizumab was administered on day 1 of cycles 3-6 and as maintenance monotherapy in cycles 7-34. Palliative radiation to a non-target symptomatic lesion was allowed. The primary objective was overall response rate by RECIST 1.1 criteria. Secondary objectives included safety, progression-free survival, time to progression, duration of response and overall survival.<h4>Results</h4>An interim analysis for futility was performed at 18 evaluable patients. Overall response rate was 60%, duration of response was 4.9 months and time to progression was 5.2 months. Progression-free survival at 6 and 12 months was 43% and 5%. Median progression-free survival was 6.2 months and median overall survival was 11.3 months. In all patients, CA125 levels reflected response and progression. There were no pseudoprogression events. After receiving palliative radiation during pembrolizumab maintenance, a patient with recurrent ovarian clear cell carcinoma had an exceptional and durable response that is ongoing for greater than 2 years. After consultation with the sponsor, based on the modest duration of response observed at the interim analysis for futility, the decision was made to close the trial to further accrual.<h4>Conclusions</h4>The addition of pembrolizumab to cisplatin and gemcitabine did not appear to provide benefit beyond chemotherapy alone in patients with recurrent platinum-resistant ovarian cancer.Christine S WalshMitchell KamravaAndre RogatkoSungjin KimAndrew LiIlana CassBeth KarlanBobbie J RimelPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 6, p e0252665 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Christine S Walsh Mitchell Kamrava Andre Rogatko Sungjin Kim Andrew Li Ilana Cass Beth Karlan Bobbie J Rimel Phase II trial of cisplatin, gemcitabine and pembrolizumab for platinum-resistant ovarian cancer.
description	<h4>Objective</h4>To evaluate the combination of pembrolizumab, cisplatin and gemcitabine in recurrent platinum-resistant ovarian cancer.<h4>Methods</h4>Patients received six cycles of chemotherapy with gemcitabine and cisplatin on day 1 and day 8 of a 21-day treatment cycle. Pembrolizumab was administered on day 1 of cycles 3-6 and as maintenance monotherapy in cycles 7-34. Palliative radiation to a non-target symptomatic lesion was allowed. The primary objective was overall response rate by RECIST 1.1 criteria. Secondary objectives included safety, progression-free survival, time to progression, duration of response and overall survival.<h4>Results</h4>An interim analysis for futility was performed at 18 evaluable patients. Overall response rate was 60%, duration of response was 4.9 months and time to progression was 5.2 months. Progression-free survival at 6 and 12 months was 43% and 5%. Median progression-free survival was 6.2 months and median overall survival was 11.3 months. In all patients, CA125 levels reflected response and progression. There were no pseudoprogression events. After receiving palliative radiation during pembrolizumab maintenance, a patient with recurrent ovarian clear cell carcinoma had an exceptional and durable response that is ongoing for greater than 2 years. After consultation with the sponsor, based on the modest duration of response observed at the interim analysis for futility, the decision was made to close the trial to further accrual.<h4>Conclusions</h4>The addition of pembrolizumab to cisplatin and gemcitabine did not appear to provide benefit beyond chemotherapy alone in patients with recurrent platinum-resistant ovarian cancer.
format	article
author	Christine S Walsh Mitchell Kamrava Andre Rogatko Sungjin Kim Andrew Li Ilana Cass Beth Karlan Bobbie J Rimel
author_facet	Christine S Walsh Mitchell Kamrava Andre Rogatko Sungjin Kim Andrew Li Ilana Cass Beth Karlan Bobbie J Rimel
author_sort	Christine S Walsh
title	Phase II trial of cisplatin, gemcitabine and pembrolizumab for platinum-resistant ovarian cancer.
title_short	Phase II trial of cisplatin, gemcitabine and pembrolizumab for platinum-resistant ovarian cancer.
title_full	Phase II trial of cisplatin, gemcitabine and pembrolizumab for platinum-resistant ovarian cancer.
title_fullStr	Phase II trial of cisplatin, gemcitabine and pembrolizumab for platinum-resistant ovarian cancer.
title_full_unstemmed	Phase II trial of cisplatin, gemcitabine and pembrolizumab for platinum-resistant ovarian cancer.
title_sort	phase ii trial of cisplatin, gemcitabine and pembrolizumab for platinum-resistant ovarian cancer.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/a612667296934eabbd43ceddcb1e41a2
work_keys_str_mv	AT christineswalsh phaseiitrialofcisplatingemcitabineandpembrolizumabforplatinumresistantovariancancer AT mitchellkamrava phaseiitrialofcisplatingemcitabineandpembrolizumabforplatinumresistantovariancancer AT andrerogatko phaseiitrialofcisplatingemcitabineandpembrolizumabforplatinumresistantovariancancer AT sungjinkim phaseiitrialofcisplatingemcitabineandpembrolizumabforplatinumresistantovariancancer AT andrewli phaseiitrialofcisplatingemcitabineandpembrolizumabforplatinumresistantovariancancer AT ilanacass phaseiitrialofcisplatingemcitabineandpembrolizumabforplatinumresistantovariancancer AT bethkarlan phaseiitrialofcisplatingemcitabineandpembrolizumabforplatinumresistantovariancancer AT bobbiejrimel phaseiitrialofcisplatingemcitabineandpembrolizumabforplatinumresistantovariancancer
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Phase II trial of cisplatin, gemcitabine and pembrolizumab for platinum-resistant ovarian cancer.

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