Atezolizumab in Patients with Metastatic Urothelial Carcinoma Who Have Progressed After First-line Chemotherapy: Results of Real-life Experiences

Atezolizumab (ATZ) has demonstrated antitumor activity and manageable safety in previous studies in patients with locally advanced or metastatic platinum-resistant urothelial carcinoma. To compare the real-life experience and data of clinical trials on ATZ treatment in metastatic urothelial carcinom...

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Veröffentlicht in:European urology focus 2021-09, Vol.7 (5), p.1061-1066
Hauptverfasser: Tural, Deniz, Ölmez, Ömer Fatih, Sümbül, Ahmet Taner, Artaç, Mehmet, Özhan, Nail, Akar, Emre, Çakar, Burcu, Köstek, Osman, Ekenel, Meltem, Erman, Mustafa, Coşkun, Hasan Şenol, Selçukbiricik, Fatih, Keskin, Özge, Türköz, Fatma Paksoy, Oruç, Kerem, Bayram, Selami, Yılmaz, Uğur, Bilgetekin, İrem, Yıldız, Birol, Şendur, Mehmet Ali Nahit, Paksoy, Nail, Dirican, Ahmet, Erdem, Dilek, Selam, Meltem, Tanrıverdi, Özgür, Paydaş, Semra, Urakçı, Zuhat, Atağ, Elif, Güncan, Sabri, Ürün, Yüksel, Alkan, Ali, Kaya, Ali Osman, Özyükseler, Deniz Tataroğlu, Taşkaynatan, Halil, Yıldırım, Mustafa, Sönmez, Müge, Başoğlu, Tuğba, Gündüz, Şeyda, Kılıçkap, Saadettin
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container_end_page 1066
container_issue 5
container_start_page 1061
container_title European urology focus
container_volume 7
creator Tural, Deniz
Ölmez, Ömer Fatih
Sümbül, Ahmet Taner
Artaç, Mehmet
Özhan, Nail
Akar, Emre
Çakar, Burcu
Köstek, Osman
Ekenel, Meltem
Erman, Mustafa
Coşkun, Hasan Şenol
Selçukbiricik, Fatih
Keskin, Özge
Türköz, Fatma Paksoy
Oruç, Kerem
Bayram, Selami
Yılmaz, Uğur
Bilgetekin, İrem
Yıldız, Birol
Şendur, Mehmet Ali Nahit
Paksoy, Nail
Dirican, Ahmet
Erdem, Dilek
Selam, Meltem
Tanrıverdi, Özgür
Paydaş, Semra
Urakçı, Zuhat
Atağ, Elif
Güncan, Sabri
Ürün, Yüksel
Alkan, Ali
Kaya, Ali Osman
Özyükseler, Deniz Tataroğlu
Taşkaynatan, Halil
Yıldırım, Mustafa
Sönmez, Müge
Başoğlu, Tuğba
Gündüz, Şeyda
Kılıçkap, Saadettin
description Atezolizumab (ATZ) has demonstrated antitumor activity and manageable safety in previous studies in patients with locally advanced or metastatic platinum-resistant urothelial carcinoma. To compare the real-life experience and data of clinical trials on ATZ treatment in metastatic urothelial carcinoma. Patients with urothelial cancer treated with ATZ after progression on first-line chemotherapy from an expanded access program were retrospectively studied. Data of patients were obtained from their files and hospital records. Safety was evaluated for patients treated with at least one cycle of ATZ. The primary endpoint was objective response rate (ORR). The secondary endpoints are overall survival (OS), progression-free survival (PFS), duration of response, and safety profile of patients. Kaplan-Meier methods were used to calculate median follow-up and estimate PFS and OS. Data of 115 enrolled patients were analyzed. Most of the patients (92.3%, n = 106) had received chemotherapy regimen only once prior to ATZ. The median follow-up duration was 23.5 mo. The complete response rate, partial response rate, and ORR were 8.7% (n = 10), 20.0% (n = 23), and 28.7% (n = 33), respectively. The median duration of response was 20.4 mo (95% confidence interval [CI], 6.47–28.8). Of the 33 patients who responded to treatment, 60% (n = 20) had an ongoing response at the time of the analysis. PFS and OS with ATZ were 3.8 mo (95% CI, 2.25–5.49) and 9.8 mo (95% CI, 6.7–12.9), respectively. All-cause and any-grade adverse events were observed in 113 (98%) patients. Of the patients, 64% experienced a treatment-related adverse event of any grade and 24 (21.2%) had a grade 3–4 treatment-related adverse event. Limitations of the study included its retrospective design, and determination of treatment response based on clinical notes and local radiographic studies. In these real-life data, ATZ was effective and well tolerated in patients with metastatic urothelial carcinoma who have progressed with platinum-based first-line chemotherapy. ATZ is an effective and tolerable treatment for patients with locally advanced or metastatic platinum-resistant urothelial carcinoma in our study, similar to previously reported trials. Atezolizumab is effective and well-tolerated in patients with metastatic urothelial cancer who progressed with first-line chemotherapy, consistent with the outcomes of the previous clinical trials in this setting. Atezolizumab is an effective and tolerable treatment op
doi_str_mv 10.1016/j.euf.2020.09.010
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To compare the real-life experience and data of clinical trials on ATZ treatment in metastatic urothelial carcinoma. Patients with urothelial cancer treated with ATZ after progression on first-line chemotherapy from an expanded access program were retrospectively studied. Data of patients were obtained from their files and hospital records. Safety was evaluated for patients treated with at least one cycle of ATZ. The primary endpoint was objective response rate (ORR). The secondary endpoints are overall survival (OS), progression-free survival (PFS), duration of response, and safety profile of patients. Kaplan-Meier methods were used to calculate median follow-up and estimate PFS and OS. Data of 115 enrolled patients were analyzed. Most of the patients (92.3%, n = 106) had received chemotherapy regimen only once prior to ATZ. The median follow-up duration was 23.5 mo. The complete response rate, partial response rate, and ORR were 8.7% (n = 10), 20.0% (n = 23), and 28.7% (n = 33), respectively. The median duration of response was 20.4 mo (95% confidence interval [CI], 6.47–28.8). Of the 33 patients who responded to treatment, 60% (n = 20) had an ongoing response at the time of the analysis. PFS and OS with ATZ were 3.8 mo (95% CI, 2.25–5.49) and 9.8 mo (95% CI, 6.7–12.9), respectively. All-cause and any-grade adverse events were observed in 113 (98%) patients. Of the patients, 64% experienced a treatment-related adverse event of any grade and 24 (21.2%) had a grade 3–4 treatment-related adverse event. Limitations of the study included its retrospective design, and determination of treatment response based on clinical notes and local radiographic studies. In these real-life data, ATZ was effective and well tolerated in patients with metastatic urothelial carcinoma who have progressed with platinum-based first-line chemotherapy. ATZ is an effective and tolerable treatment for patients with locally advanced or metastatic platinum-resistant urothelial carcinoma in our study, similar to previously reported trials. Atezolizumab is effective and well-tolerated in patients with metastatic urothelial cancer who progressed with first-line chemotherapy, consistent with the outcomes of the previous clinical trials in this setting. Atezolizumab is an effective and tolerable treatment option for patients with urothelial cancer after progression by the chemotherapy. Clinical activity and safety of atezolizumab treatment in real-life patients were consistent with the outcomes of the previous clinical trials in this setting</description><identifier>ISSN: 2405-4569</identifier><identifier>EISSN: 2405-4569</identifier><identifier>DOI: 10.1016/j.euf.2020.09.010</identifier><identifier>PMID: 33008789</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Antibodies, Monoclonal, Humanized ; Atezolizumab ; Bladder cancer ; Carcinoma, Transitional Cell - pathology ; Humans ; Immunotherapy ; Retrospective Studies ; Urinary Bladder Neoplasms - drug therapy ; Urologic Neoplasms - pathology ; Urothelial carcinoma</subject><ispartof>European urology focus, 2021-09, Vol.7 (5), p.1061-1066</ispartof><rights>2020 European Association of Urology</rights><rights>Copyright © 2020 European Association of Urology. Published by Elsevier B.V. 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To compare the real-life experience and data of clinical trials on ATZ treatment in metastatic urothelial carcinoma. Patients with urothelial cancer treated with ATZ after progression on first-line chemotherapy from an expanded access program were retrospectively studied. Data of patients were obtained from their files and hospital records. Safety was evaluated for patients treated with at least one cycle of ATZ. The primary endpoint was objective response rate (ORR). The secondary endpoints are overall survival (OS), progression-free survival (PFS), duration of response, and safety profile of patients. Kaplan-Meier methods were used to calculate median follow-up and estimate PFS and OS. Data of 115 enrolled patients were analyzed. Most of the patients (92.3%, n = 106) had received chemotherapy regimen only once prior to ATZ. The median follow-up duration was 23.5 mo. 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ATZ is an effective and tolerable treatment for patients with locally advanced or metastatic platinum-resistant urothelial carcinoma in our study, similar to previously reported trials. Atezolizumab is effective and well-tolerated in patients with metastatic urothelial cancer who progressed with first-line chemotherapy, consistent with the outcomes of the previous clinical trials in this setting. Atezolizumab is an effective and tolerable treatment option for patients with urothelial cancer after progression by the chemotherapy. Clinical activity and safety of atezolizumab treatment in real-life patients were consistent with the outcomes of the previous clinical trials in this setting</description><subject>Antibodies, Monoclonal, Humanized</subject><subject>Atezolizumab</subject><subject>Bladder cancer</subject><subject>Carcinoma, Transitional Cell - pathology</subject><subject>Humans</subject><subject>Immunotherapy</subject><subject>Retrospective Studies</subject><subject>Urinary Bladder Neoplasms - drug therapy</subject><subject>Urologic Neoplasms - pathology</subject><subject>Urothelial carcinoma</subject><issn>2405-4569</issn><issn>2405-4569</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc9u1DAQxi0EolXpA3BBPnJJ6n_ZOHBarVqK1KoVouJoOfaE9cqJF9tpad-ib4y3WypOnGY0-n3faOZD6D0lNSV0cbKpYR5qRhipSVcTSl6hQyZIU4lm0b3-pz9AxyltCCG0ES2X_C064JwQ2cruED0uMzwE7x7mUffYTfhaZwdTTvjO5TW-hKxTLiODb2LIa_BOe7zS0bgpjBr_WAd8rm8BX8fwM0JKYPFyyBDxmYspV95NgFdrGHfaqLf3n_A3SLMv_mEorfYFGQCf_t5CLHsNpHfozaB9guPneoRuzk6_r86ri6svX1fLi8rwhufKtKyXTddZa1vLaMP6dhiYMT2VthGctaYVprGECGs6rcWiobLriSwqY5lg_Ah93PtuY_g1Q8pqdMmA93qCMCfFhJCCciplQekeNTGkFGFQ2-hGHe8VJWoXhtqoEobahaFIp0oYRfPh2X7uR7Avir-vL8DnPQDlyFsHUSXz9AHrIpisbHD_sf8DOa2cLQ</recordid><startdate>202109</startdate><enddate>202109</enddate><creator>Tural, Deniz</creator><creator>Ölmez, Ömer Fatih</creator><creator>Sümbül, Ahmet Taner</creator><creator>Artaç, Mehmet</creator><creator>Özhan, Nail</creator><creator>Akar, Emre</creator><creator>Çakar, Burcu</creator><creator>Köstek, Osman</creator><creator>Ekenel, Meltem</creator><creator>Erman, Mustafa</creator><creator>Coşkun, Hasan Şenol</creator><creator>Selçukbiricik, Fatih</creator><creator>Keskin, Özge</creator><creator>Türköz, Fatma Paksoy</creator><creator>Oruç, Kerem</creator><creator>Bayram, Selami</creator><creator>Yılmaz, Uğur</creator><creator>Bilgetekin, İrem</creator><creator>Yıldız, Birol</creator><creator>Şendur, Mehmet Ali Nahit</creator><creator>Paksoy, Nail</creator><creator>Dirican, Ahmet</creator><creator>Erdem, Dilek</creator><creator>Selam, Meltem</creator><creator>Tanrıverdi, Özgür</creator><creator>Paydaş, Semra</creator><creator>Urakçı, Zuhat</creator><creator>Atağ, Elif</creator><creator>Güncan, Sabri</creator><creator>Ürün, Yüksel</creator><creator>Alkan, Ali</creator><creator>Kaya, Ali Osman</creator><creator>Özyükseler, Deniz Tataroğlu</creator><creator>Taşkaynatan, Halil</creator><creator>Yıldırım, Mustafa</creator><creator>Sönmez, Müge</creator><creator>Başoğlu, Tuğba</creator><creator>Gündüz, Şeyda</creator><creator>Kılıçkap, Saadettin</creator><general>Elsevier B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-2144-6469</orcidid></search><sort><creationdate>202109</creationdate><title>Atezolizumab in Patients with Metastatic Urothelial Carcinoma Who Have Progressed After First-line Chemotherapy: Results of Real-life Experiences</title><author>Tural, Deniz ; Ölmez, Ömer Fatih ; Sümbül, Ahmet Taner ; Artaç, Mehmet ; Özhan, Nail ; Akar, Emre ; Çakar, Burcu ; Köstek, Osman ; Ekenel, Meltem ; Erman, Mustafa ; Coşkun, Hasan Şenol ; Selçukbiricik, Fatih ; Keskin, Özge ; Türköz, Fatma Paksoy ; Oruç, Kerem ; Bayram, Selami ; Yılmaz, Uğur ; Bilgetekin, İrem ; Yıldız, Birol ; Şendur, Mehmet Ali Nahit ; Paksoy, Nail ; Dirican, Ahmet ; Erdem, Dilek ; Selam, Meltem ; Tanrıverdi, Özgür ; Paydaş, Semra ; Urakçı, Zuhat ; Atağ, Elif ; Güncan, Sabri ; Ürün, Yüksel ; Alkan, Ali ; Kaya, Ali Osman ; Özyükseler, Deniz Tataroğlu ; Taşkaynatan, Halil ; Yıldırım, Mustafa ; Sönmez, Müge ; Başoğlu, Tuğba ; Gündüz, Şeyda ; Kılıçkap, Saadettin</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c353t-c72b8599ddd7d2152b7ff2ccb18d54327c74c5d004dc9aa465189b082b8cd2423</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Antibodies, Monoclonal, Humanized</topic><topic>Atezolizumab</topic><topic>Bladder cancer</topic><topic>Carcinoma, Transitional Cell - 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Academic</collection><jtitle>European urology focus</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tural, Deniz</au><au>Ölmez, Ömer Fatih</au><au>Sümbül, Ahmet Taner</au><au>Artaç, Mehmet</au><au>Özhan, Nail</au><au>Akar, Emre</au><au>Çakar, Burcu</au><au>Köstek, Osman</au><au>Ekenel, Meltem</au><au>Erman, Mustafa</au><au>Coşkun, Hasan Şenol</au><au>Selçukbiricik, Fatih</au><au>Keskin, Özge</au><au>Türköz, Fatma Paksoy</au><au>Oruç, Kerem</au><au>Bayram, Selami</au><au>Yılmaz, Uğur</au><au>Bilgetekin, İrem</au><au>Yıldız, Birol</au><au>Şendur, Mehmet Ali Nahit</au><au>Paksoy, Nail</au><au>Dirican, Ahmet</au><au>Erdem, Dilek</au><au>Selam, Meltem</au><au>Tanrıverdi, Özgür</au><au>Paydaş, Semra</au><au>Urakçı, Zuhat</au><au>Atağ, Elif</au><au>Güncan, Sabri</au><au>Ürün, Yüksel</au><au>Alkan, Ali</au><au>Kaya, Ali Osman</au><au>Özyükseler, Deniz Tataroğlu</au><au>Taşkaynatan, Halil</au><au>Yıldırım, Mustafa</au><au>Sönmez, Müge</au><au>Başoğlu, Tuğba</au><au>Gündüz, Şeyda</au><au>Kılıçkap, Saadettin</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Atezolizumab in Patients with Metastatic Urothelial Carcinoma Who Have Progressed After First-line Chemotherapy: Results of Real-life Experiences</atitle><jtitle>European urology focus</jtitle><addtitle>Eur Urol Focus</addtitle><date>2021-09</date><risdate>2021</risdate><volume>7</volume><issue>5</issue><spage>1061</spage><epage>1066</epage><pages>1061-1066</pages><issn>2405-4569</issn><eissn>2405-4569</eissn><abstract>Atezolizumab (ATZ) has demonstrated antitumor activity and manageable safety in previous studies in patients with locally advanced or metastatic platinum-resistant urothelial carcinoma. To compare the real-life experience and data of clinical trials on ATZ treatment in metastatic urothelial carcinoma. Patients with urothelial cancer treated with ATZ after progression on first-line chemotherapy from an expanded access program were retrospectively studied. Data of patients were obtained from their files and hospital records. Safety was evaluated for patients treated with at least one cycle of ATZ. The primary endpoint was objective response rate (ORR). The secondary endpoints are overall survival (OS), progression-free survival (PFS), duration of response, and safety profile of patients. Kaplan-Meier methods were used to calculate median follow-up and estimate PFS and OS. Data of 115 enrolled patients were analyzed. Most of the patients (92.3%, n = 106) had received chemotherapy regimen only once prior to ATZ. The median follow-up duration was 23.5 mo. The complete response rate, partial response rate, and ORR were 8.7% (n = 10), 20.0% (n = 23), and 28.7% (n = 33), respectively. The median duration of response was 20.4 mo (95% confidence interval [CI], 6.47–28.8). Of the 33 patients who responded to treatment, 60% (n = 20) had an ongoing response at the time of the analysis. PFS and OS with ATZ were 3.8 mo (95% CI, 2.25–5.49) and 9.8 mo (95% CI, 6.7–12.9), respectively. All-cause and any-grade adverse events were observed in 113 (98%) patients. Of the patients, 64% experienced a treatment-related adverse event of any grade and 24 (21.2%) had a grade 3–4 treatment-related adverse event. Limitations of the study included its retrospective design, and determination of treatment response based on clinical notes and local radiographic studies. In these real-life data, ATZ was effective and well tolerated in patients with metastatic urothelial carcinoma who have progressed with platinum-based first-line chemotherapy. ATZ is an effective and tolerable treatment for patients with locally advanced or metastatic platinum-resistant urothelial carcinoma in our study, similar to previously reported trials. Atezolizumab is effective and well-tolerated in patients with metastatic urothelial cancer who progressed with first-line chemotherapy, consistent with the outcomes of the previous clinical trials in this setting. Atezolizumab is an effective and tolerable treatment option for patients with urothelial cancer after progression by the chemotherapy. Clinical activity and safety of atezolizumab treatment in real-life patients were consistent with the outcomes of the previous clinical trials in this setting</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>33008789</pmid><doi>10.1016/j.euf.2020.09.010</doi><tpages>6</tpages><orcidid>https://orcid.org/0000-0003-2144-6469</orcidid></addata></record>
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subjects Antibodies, Monoclonal, Humanized
Atezolizumab
Bladder cancer
Carcinoma, Transitional Cell - pathology
Humans
Immunotherapy
Retrospective Studies
Urinary Bladder Neoplasms - drug therapy
Urologic Neoplasms - pathology
Urothelial carcinoma
title Atezolizumab in Patients with Metastatic Urothelial Carcinoma Who Have Progressed After First-line Chemotherapy: Results of Real-life Experiences
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