Prognostic outcomes and safety in patients treated with pembrolizumab for advanced urothelial carcinoma: experience in real-world clinical practice

Background Prognostic outcomes and safety following treatment with pembrolizumab in patients with advanced urothelial carcinoma (UC) have not been fully elucidated in clinical practice. The aim of this study was to evaluate the oncological efficacy and safety of pembrolizumab after failure of platin...

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Veröffentlicht in:International journal of clinical oncology 2020-05, Vol.25 (5), p.899-905
Hauptverfasser: Tamura, Daichi, Jinnouchi, Noriaki, Abe, Masakazu, Ikarashi, Daiki, Matsuura, Tomohiko, Kato, Renpei, Maekawa, Shigekatsu, Kato, Yoichiro, Kanehira, Mitsugu, Takata, Ryo, Obara, Wataru
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container_issue 5
container_start_page 899
container_title International journal of clinical oncology
container_volume 25
creator Tamura, Daichi
Jinnouchi, Noriaki
Abe, Masakazu
Ikarashi, Daiki
Matsuura, Tomohiko
Kato, Renpei
Maekawa, Shigekatsu
Kato, Yoichiro
Kanehira, Mitsugu
Takata, Ryo
Obara, Wataru
description Background Prognostic outcomes and safety following treatment with pembrolizumab in patients with advanced urothelial carcinoma (UC) have not been fully elucidated in clinical practice. The aim of this study was to evaluate the oncological efficacy and safety of pembrolizumab after failure of platinum-based chemotherapy in Japanese patients with advanced UC in a routine clinical setting. Methods This retrospective study included 41 consecutive Japanese patients with advanced UC treated with pembrolizumab as second-line or greater therapy at Iwate Medical University Hospital from January 2018 to April 2019. Results The mean follow-up period was 6.2 months. The objective response rate, median progression-free survival, and median overall survival were 15%, 2.5 months, and 11.9 months, respectively. Univariate analysis identified poor performance status (> 1), liver metastasis, two or more metastatic organs, low hemoglobin levels, two or more prior regimens, high baseline C-reactive protein levels, higher relative C-reactive protein level change after 6 weeks, and higher relative neutrophil-to-lymphocyte ratio change after 6 weeks as significant predictors of overall survival. Among these factors, poor performance status (> 1), two or more metastatic organs, and higher relative neutrophil-to-lymphocyte ratio change after 6 weeks were identified as independent predictors of overall survival in multivariate analysis. Conclusions The introduction of pembrolizumab can result in favorable cancer control outcomes in Japanese patients with advanced UC, and the prognosis of these patients can be stratified according to three potential parameters, including poor performance status, high number of metastatic organs, and higher relative neutrophil-to-lymphocyte ratio change.
doi_str_mv 10.1007/s10147-019-01613-9
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The aim of this study was to evaluate the oncological efficacy and safety of pembrolizumab after failure of platinum-based chemotherapy in Japanese patients with advanced UC in a routine clinical setting. Methods This retrospective study included 41 consecutive Japanese patients with advanced UC treated with pembrolizumab as second-line or greater therapy at Iwate Medical University Hospital from January 2018 to April 2019. Results The mean follow-up period was 6.2 months. The objective response rate, median progression-free survival, and median overall survival were 15%, 2.5 months, and 11.9 months, respectively. Univariate analysis identified poor performance status (&gt; 1), liver metastasis, two or more metastatic organs, low hemoglobin levels, two or more prior regimens, high baseline C-reactive protein levels, higher relative C-reactive protein level change after 6 weeks, and higher relative neutrophil-to-lymphocyte ratio change after 6 weeks as significant predictors of overall survival. Among these factors, poor performance status (&gt; 1), two or more metastatic organs, and higher relative neutrophil-to-lymphocyte ratio change after 6 weeks were identified as independent predictors of overall survival in multivariate analysis. Conclusions The introduction of pembrolizumab can result in favorable cancer control outcomes in Japanese patients with advanced UC, and the prognosis of these patients can be stratified according to three potential parameters, including poor performance status, high number of metastatic organs, and higher relative neutrophil-to-lymphocyte ratio change.</description><identifier>ISSN: 1341-9625</identifier><identifier>EISSN: 1437-7772</identifier><identifier>DOI: 10.1007/s10147-019-01613-9</identifier><identifier>PMID: 31907720</identifier><language>eng</language><publisher>Singapore: Springer Singapore</publisher><subject>Bladder cancer ; C-reactive protein ; Cancer Research ; Chemotherapy ; Clinical medicine ; Hemoglobin ; Immunotherapy ; Lymphocytes ; Medical prognosis ; Medicine ; Medicine &amp; Public Health ; Metastases ; Metastasis ; Monoclonal antibodies ; Multivariate analysis ; Neutrophils ; Oncology ; Original Article ; Patients ; Pembrolizumab ; Platinum ; Safety ; Surgical Oncology ; Targeted cancer therapy ; Urothelial carcinoma</subject><ispartof>International journal of clinical oncology, 2020-05, Vol.25 (5), p.899-905</ispartof><rights>Japan Society of Clinical Oncology 2020</rights><rights>Japan Society of Clinical Oncology 2020.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c399t-a3733ac3e09c2d9060b80442bd40b151328c5a7803d86144ed3d9b544d69b01d3</citedby><cites>FETCH-LOGICAL-c399t-a3733ac3e09c2d9060b80442bd40b151328c5a7803d86144ed3d9b544d69b01d3</cites><orcidid>0000-0001-9498-9996</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10147-019-01613-9$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10147-019-01613-9$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31907720$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tamura, Daichi</creatorcontrib><creatorcontrib>Jinnouchi, Noriaki</creatorcontrib><creatorcontrib>Abe, Masakazu</creatorcontrib><creatorcontrib>Ikarashi, Daiki</creatorcontrib><creatorcontrib>Matsuura, Tomohiko</creatorcontrib><creatorcontrib>Kato, Renpei</creatorcontrib><creatorcontrib>Maekawa, Shigekatsu</creatorcontrib><creatorcontrib>Kato, Yoichiro</creatorcontrib><creatorcontrib>Kanehira, Mitsugu</creatorcontrib><creatorcontrib>Takata, Ryo</creatorcontrib><creatorcontrib>Obara, Wataru</creatorcontrib><title>Prognostic outcomes and safety in patients treated with pembrolizumab for advanced urothelial carcinoma: experience in real-world clinical practice</title><title>International journal of clinical oncology</title><addtitle>Int J Clin Oncol</addtitle><addtitle>Int J Clin Oncol</addtitle><description>Background Prognostic outcomes and safety following treatment with pembrolizumab in patients with advanced urothelial carcinoma (UC) have not been fully elucidated in clinical practice. The aim of this study was to evaluate the oncological efficacy and safety of pembrolizumab after failure of platinum-based chemotherapy in Japanese patients with advanced UC in a routine clinical setting. Methods This retrospective study included 41 consecutive Japanese patients with advanced UC treated with pembrolizumab as second-line or greater therapy at Iwate Medical University Hospital from January 2018 to April 2019. Results The mean follow-up period was 6.2 months. The objective response rate, median progression-free survival, and median overall survival were 15%, 2.5 months, and 11.9 months, respectively. Univariate analysis identified poor performance status (&gt; 1), liver metastasis, two or more metastatic organs, low hemoglobin levels, two or more prior regimens, high baseline C-reactive protein levels, higher relative C-reactive protein level change after 6 weeks, and higher relative neutrophil-to-lymphocyte ratio change after 6 weeks as significant predictors of overall survival. Among these factors, poor performance status (&gt; 1), two or more metastatic organs, and higher relative neutrophil-to-lymphocyte ratio change after 6 weeks were identified as independent predictors of overall survival in multivariate analysis. 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The aim of this study was to evaluate the oncological efficacy and safety of pembrolizumab after failure of platinum-based chemotherapy in Japanese patients with advanced UC in a routine clinical setting. Methods This retrospective study included 41 consecutive Japanese patients with advanced UC treated with pembrolizumab as second-line or greater therapy at Iwate Medical University Hospital from January 2018 to April 2019. Results The mean follow-up period was 6.2 months. The objective response rate, median progression-free survival, and median overall survival were 15%, 2.5 months, and 11.9 months, respectively. Univariate analysis identified poor performance status (&gt; 1), liver metastasis, two or more metastatic organs, low hemoglobin levels, two or more prior regimens, high baseline C-reactive protein levels, higher relative C-reactive protein level change after 6 weeks, and higher relative neutrophil-to-lymphocyte ratio change after 6 weeks as significant predictors of overall survival. Among these factors, poor performance status (&gt; 1), two or more metastatic organs, and higher relative neutrophil-to-lymphocyte ratio change after 6 weeks were identified as independent predictors of overall survival in multivariate analysis. Conclusions The introduction of pembrolizumab can result in favorable cancer control outcomes in Japanese patients with advanced UC, and the prognosis of these patients can be stratified according to three potential parameters, including poor performance status, high number of metastatic organs, and higher relative neutrophil-to-lymphocyte ratio change.</abstract><cop>Singapore</cop><pub>Springer Singapore</pub><pmid>31907720</pmid><doi>10.1007/s10147-019-01613-9</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0001-9498-9996</orcidid></addata></record>
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subjects Bladder cancer
C-reactive protein
Cancer Research
Chemotherapy
Clinical medicine
Hemoglobin
Immunotherapy
Lymphocytes
Medical prognosis
Medicine
Medicine & Public Health
Metastases
Metastasis
Monoclonal antibodies
Multivariate analysis
Neutrophils
Oncology
Original Article
Patients
Pembrolizumab
Platinum
Safety
Surgical Oncology
Targeted cancer therapy
Urothelial carcinoma
title Prognostic outcomes and safety in patients treated with pembrolizumab for advanced urothelial carcinoma: experience in real-world clinical practice
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