Abiraterone Acetate in Patients With Castration-Resistant, Androgen Receptor-Expressing Salivary Gland Cancer: A Phase II Trial
PURPOSE The activity of androgen-deprivation therapy (ADT) in androgen receptor-positive (AR+) salivary gland carcinomas (SGCs) has been established in the past few years. Second-line treatment in castration-resistant patients is still unknown. We investigated the activity of abiraterone acetate as...
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| Veröffentlicht in: | Journal of clinical oncology 2021-12, Vol.39 (36), p.4061-4068 |
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| creator | Locati, Laura D. Cavalieri, Stefano Bergamini, Cristiana Resteghini, Carlo Colombo, Elena Calareso, Giuseppina Mariani, Luigi Quattrone, Pasquale Alfieri, Salvatore Bossi, Paolo Platini, Francesca Capone, Iolanda Licitra, Lisa |
| description | PURPOSE The activity of androgen-deprivation therapy (ADT) in androgen receptor-positive (AR+) salivary gland carcinomas (SGCs) has been established in the past few years. Second-line treatment in castration-resistant patients is still unknown. We investigated the activity of abiraterone acetate as second-line treatment in ADT-resistant, AR+ patients with SGC.
METHODS This was a single-institution phase II trial. A two-stage Simon's design was applied. The primary end point was confirmed objective response rate. Secondary end points were disease control rate, safety, progression-free survival, and overall survival. Patients were eligible when the following criteria were met: histologic diagnosis of AR-overexpressing SGC, measurable disease according to RECIST 1.1, clinical and/or radiologic progression on ADT, suppressed serum testosterone, and no limits for the number of previous chemotherapy lines. All patients received abiraterone 1 g daily plus prednisone 10 mg and luteinizing hormone-releasing hormone agonist until progression or unacceptable toxicities.
RESULTS From 2015 to 2019, 24 AR+ patients with SGC (23 men; median age 65.8 years) were treated within the study. The overall response rate was 21% (5 partial responses), with a disease control rate of 62.5%. The median duration of response was 5.82 months. Median progression-free survival was 3.65 months (95% CI, 1.94 to 5.89), and median overall survival was 22.47 months (95% CI, 6.74 to not reached). Objective response to previous ADT did not correlate with the activity of abiraterone. Adverse events (AEs) were recorded in 22 cases (92%) with grade 3 AEs in six patients (25%): fatigue (two), flushing (one), supraventricular tachycardia (one), and two non-drug-related AEs. No drug-related grade 4 or 5 AEs were recorded.
CONCLUSION Abiraterone plus luteinizing hormone-releasing hormone agonist is active and safe as a second-line option in AR-expressing, castration-resistant SGC. (C) 2021 by American Society of Clinical Oncology |
| doi_str_mv | 10.1200/JCO.21.00468 |
| format | Article |
| fullrecord | <record><control><sourceid>pubmed_cross</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8677956</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>34597119</sourcerecordid><originalsourceid>FETCH-LOGICAL-c384t-7ddcdc8ec2361e384a224aeb336ff0cd5c41f4456b018baf9ddd4c34522904163</originalsourceid><addsrcrecordid>eNqNkc1v1DAQxS0Eokvhxhn5TrP4K4nDASmKSllUqVUpgpvl2JNdo9Re2W4Lp_7rdbuwghsnj-zfvPG8h9BrSpaUEfLu83C2ZHRJiGjkE7SgNWurtq3rp2hBWs4qKvn3A_QipR-EUCF5_RwdcFF3LaXdAt31o4s6QwwecG8glxo7j891duBzwt9c3uBBp1woF3x1AcmlrH0-wr23MazB4wswsM0hVsc_txFScn6Nv-jZ3ej4C5_M2tui4A3E97jH5xudAK9W-DI6Pb9EzyY9J3j1-zxEXz8eXw6fqtOzk9XQn1aGS5Gr1lpjjQTDeEOhXGnGhIaR82aaiLG1EXQSom5GQuWop85aK0xZk7GOCNrwQ_Rhp7u9Hq_AmrJb1LPaRndVPqmCdurfF-82ah1ulGzatqsfBI52AiaGlCJM-15K1EMQqgShGFWPQRT8zd_z9vAf5wsgd8AtjGFKprhtYI8RUrKjDRO0VEQOLj-6P4Rrn0vr2_9v5fdIpabw</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Abiraterone Acetate in Patients With Castration-Resistant, Androgen Receptor-Expressing Salivary Gland Cancer: A Phase II Trial</title><source>MEDLINE</source><source>American Society of Clinical Oncology Online Journals</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Web of Science - Science Citation Index Expanded - 2021<img src="https://exlibris-pub.s3.amazonaws.com/fromwos-v2.jpg" /></source><source>Alma/SFX Local Collection</source><creator>Locati, Laura D. ; Cavalieri, Stefano ; Bergamini, Cristiana ; Resteghini, Carlo ; Colombo, Elena ; Calareso, Giuseppina ; Mariani, Luigi ; Quattrone, Pasquale ; Alfieri, Salvatore ; Bossi, Paolo ; Platini, Francesca ; Capone, Iolanda ; Licitra, Lisa</creator><creatorcontrib>Locati, Laura D. ; Cavalieri, Stefano ; Bergamini, Cristiana ; Resteghini, Carlo ; Colombo, Elena ; Calareso, Giuseppina ; Mariani, Luigi ; Quattrone, Pasquale ; Alfieri, Salvatore ; Bossi, Paolo ; Platini, Francesca ; Capone, Iolanda ; Licitra, Lisa</creatorcontrib><description>PURPOSE The activity of androgen-deprivation therapy (ADT) in androgen receptor-positive (AR+) salivary gland carcinomas (SGCs) has been established in the past few years. Second-line treatment in castration-resistant patients is still unknown. We investigated the activity of abiraterone acetate as second-line treatment in ADT-resistant, AR+ patients with SGC.
METHODS This was a single-institution phase II trial. A two-stage Simon's design was applied. The primary end point was confirmed objective response rate. Secondary end points were disease control rate, safety, progression-free survival, and overall survival. Patients were eligible when the following criteria were met: histologic diagnosis of AR-overexpressing SGC, measurable disease according to RECIST 1.1, clinical and/or radiologic progression on ADT, suppressed serum testosterone, and no limits for the number of previous chemotherapy lines. All patients received abiraterone 1 g daily plus prednisone 10 mg and luteinizing hormone-releasing hormone agonist until progression or unacceptable toxicities.
RESULTS From 2015 to 2019, 24 AR+ patients with SGC (23 men; median age 65.8 years) were treated within the study. The overall response rate was 21% (5 partial responses), with a disease control rate of 62.5%. The median duration of response was 5.82 months. Median progression-free survival was 3.65 months (95% CI, 1.94 to 5.89), and median overall survival was 22.47 months (95% CI, 6.74 to not reached). Objective response to previous ADT did not correlate with the activity of abiraterone. Adverse events (AEs) were recorded in 22 cases (92%) with grade 3 AEs in six patients (25%): fatigue (two), flushing (one), supraventricular tachycardia (one), and two non-drug-related AEs. No drug-related grade 4 or 5 AEs were recorded.
CONCLUSION Abiraterone plus luteinizing hormone-releasing hormone agonist is active and safe as a second-line option in AR-expressing, castration-resistant SGC. (C) 2021 by American Society of Clinical Oncology</description><identifier>ISSN: 0732-183X</identifier><identifier>EISSN: 1527-7755</identifier><identifier>DOI: 10.1200/JCO.21.00468</identifier><identifier>PMID: 34597119</identifier><language>eng</language><publisher>PHILADELPHIA: Lippincott Williams & Wilkins</publisher><subject>Abiraterone Acetate - pharmacology ; Abiraterone Acetate - therapeutic use ; Adult ; Aged ; Antineoplastic Agents - pharmacology ; Antineoplastic Agents - therapeutic use ; Female ; Humans ; Life Sciences & Biomedicine ; Male ; Middle Aged ; Oncology ; ORIGINAL REPORTS ; Salivary Gland Neoplasms - drug therapy ; Salivary Gland Neoplasms - pathology ; Science & Technology</subject><ispartof>Journal of clinical oncology, 2021-12, Vol.39 (36), p.4061-4068</ispartof><rights>2021 by American Society of Clinical Oncology 2021 American Society of Clinical Oncology</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>true</woscitedreferencessubscribed><woscitedreferencescount>26</woscitedreferencescount><woscitedreferencesoriginalsourcerecordid>wos000731624100008</woscitedreferencesoriginalsourcerecordid><citedby>FETCH-LOGICAL-c384t-7ddcdc8ec2361e384a224aeb336ff0cd5c41f4456b018baf9ddd4c34522904163</citedby><cites>FETCH-LOGICAL-c384t-7ddcdc8ec2361e384a224aeb336ff0cd5c41f4456b018baf9ddd4c34522904163</cites><orcidid>0000-0001-8485-2275 ; 0000-0003-1294-6859 ; 0000-0003-0623-4118 ; 0000-0003-3315-2580 ; 0000-0003-0135-0224 ; 0000-0001-6208-4084 ; 0000-0003-3132-844X ; 0000-0002-0188-9759</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,315,781,785,886,3730,27929,27930,39263</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34597119$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Locati, Laura D.</creatorcontrib><creatorcontrib>Cavalieri, Stefano</creatorcontrib><creatorcontrib>Bergamini, Cristiana</creatorcontrib><creatorcontrib>Resteghini, Carlo</creatorcontrib><creatorcontrib>Colombo, Elena</creatorcontrib><creatorcontrib>Calareso, Giuseppina</creatorcontrib><creatorcontrib>Mariani, Luigi</creatorcontrib><creatorcontrib>Quattrone, Pasquale</creatorcontrib><creatorcontrib>Alfieri, Salvatore</creatorcontrib><creatorcontrib>Bossi, Paolo</creatorcontrib><creatorcontrib>Platini, Francesca</creatorcontrib><creatorcontrib>Capone, Iolanda</creatorcontrib><creatorcontrib>Licitra, Lisa</creatorcontrib><title>Abiraterone Acetate in Patients With Castration-Resistant, Androgen Receptor-Expressing Salivary Gland Cancer: A Phase II Trial</title><title>Journal of clinical oncology</title><addtitle>J CLIN ONCOL</addtitle><addtitle>J Clin Oncol</addtitle><description>PURPOSE The activity of androgen-deprivation therapy (ADT) in androgen receptor-positive (AR+) salivary gland carcinomas (SGCs) has been established in the past few years. Second-line treatment in castration-resistant patients is still unknown. We investigated the activity of abiraterone acetate as second-line treatment in ADT-resistant, AR+ patients with SGC.
METHODS This was a single-institution phase II trial. A two-stage Simon's design was applied. The primary end point was confirmed objective response rate. Secondary end points were disease control rate, safety, progression-free survival, and overall survival. Patients were eligible when the following criteria were met: histologic diagnosis of AR-overexpressing SGC, measurable disease according to RECIST 1.1, clinical and/or radiologic progression on ADT, suppressed serum testosterone, and no limits for the number of previous chemotherapy lines. All patients received abiraterone 1 g daily plus prednisone 10 mg and luteinizing hormone-releasing hormone agonist until progression or unacceptable toxicities.
RESULTS From 2015 to 2019, 24 AR+ patients with SGC (23 men; median age 65.8 years) were treated within the study. The overall response rate was 21% (5 partial responses), with a disease control rate of 62.5%. The median duration of response was 5.82 months. Median progression-free survival was 3.65 months (95% CI, 1.94 to 5.89), and median overall survival was 22.47 months (95% CI, 6.74 to not reached). Objective response to previous ADT did not correlate with the activity of abiraterone. Adverse events (AEs) were recorded in 22 cases (92%) with grade 3 AEs in six patients (25%): fatigue (two), flushing (one), supraventricular tachycardia (one), and two non-drug-related AEs. No drug-related grade 4 or 5 AEs were recorded.
CONCLUSION Abiraterone plus luteinizing hormone-releasing hormone agonist is active and safe as a second-line option in AR-expressing, castration-resistant SGC. (C) 2021 by American Society of Clinical Oncology</description><subject>Abiraterone Acetate - pharmacology</subject><subject>Abiraterone Acetate - therapeutic use</subject><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic Agents - pharmacology</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Female</subject><subject>Humans</subject><subject>Life Sciences & Biomedicine</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Oncology</subject><subject>ORIGINAL REPORTS</subject><subject>Salivary Gland Neoplasms - drug therapy</subject><subject>Salivary Gland Neoplasms - pathology</subject><subject>Science & Technology</subject><issn>0732-183X</issn><issn>1527-7755</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>HGBXW</sourceid><sourceid>EIF</sourceid><recordid>eNqNkc1v1DAQxS0Eokvhxhn5TrP4K4nDASmKSllUqVUpgpvl2JNdo9Re2W4Lp_7rdbuwghsnj-zfvPG8h9BrSpaUEfLu83C2ZHRJiGjkE7SgNWurtq3rp2hBWs4qKvn3A_QipR-EUCF5_RwdcFF3LaXdAt31o4s6QwwecG8glxo7j891duBzwt9c3uBBp1woF3x1AcmlrH0-wr23MazB4wswsM0hVsc_txFScn6Nv-jZ3ej4C5_M2tui4A3E97jH5xudAK9W-DI6Pb9EzyY9J3j1-zxEXz8eXw6fqtOzk9XQn1aGS5Gr1lpjjQTDeEOhXGnGhIaR82aaiLG1EXQSom5GQuWop85aK0xZk7GOCNrwQ_Rhp7u9Hq_AmrJb1LPaRndVPqmCdurfF-82ah1ulGzatqsfBI52AiaGlCJM-15K1EMQqgShGFWPQRT8zd_z9vAf5wsgd8AtjGFKprhtYI8RUrKjDRO0VEQOLj-6P4Rrn0vr2_9v5fdIpabw</recordid><startdate>20211220</startdate><enddate>20211220</enddate><creator>Locati, Laura D.</creator><creator>Cavalieri, Stefano</creator><creator>Bergamini, Cristiana</creator><creator>Resteghini, Carlo</creator><creator>Colombo, Elena</creator><creator>Calareso, Giuseppina</creator><creator>Mariani, Luigi</creator><creator>Quattrone, Pasquale</creator><creator>Alfieri, Salvatore</creator><creator>Bossi, Paolo</creator><creator>Platini, Francesca</creator><creator>Capone, Iolanda</creator><creator>Licitra, Lisa</creator><general>Lippincott Williams & Wilkins</general><general>Wolters Kluwer Health</general><scope>BLEPL</scope><scope>DTL</scope><scope>HGBXW</scope><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>5PM</scope><orcidid>https://orcid.org/0000-0001-8485-2275</orcidid><orcidid>https://orcid.org/0000-0003-1294-6859</orcidid><orcidid>https://orcid.org/0000-0003-0623-4118</orcidid><orcidid>https://orcid.org/0000-0003-3315-2580</orcidid><orcidid>https://orcid.org/0000-0003-0135-0224</orcidid><orcidid>https://orcid.org/0000-0001-6208-4084</orcidid><orcidid>https://orcid.org/0000-0003-3132-844X</orcidid><orcidid>https://orcid.org/0000-0002-0188-9759</orcidid></search><sort><creationdate>20211220</creationdate><title>Abiraterone Acetate in Patients With Castration-Resistant, Androgen Receptor-Expressing Salivary Gland Cancer: A Phase II Trial</title><author>Locati, Laura D. ; Cavalieri, Stefano ; Bergamini, Cristiana ; Resteghini, Carlo ; Colombo, Elena ; Calareso, Giuseppina ; Mariani, Luigi ; Quattrone, Pasquale ; Alfieri, Salvatore ; Bossi, Paolo ; Platini, Francesca ; Capone, Iolanda ; Licitra, Lisa</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c384t-7ddcdc8ec2361e384a224aeb336ff0cd5c41f4456b018baf9ddd4c34522904163</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Abiraterone Acetate - pharmacology</topic><topic>Abiraterone Acetate - therapeutic use</topic><topic>Adult</topic><topic>Aged</topic><topic>Antineoplastic Agents - pharmacology</topic><topic>Antineoplastic Agents - therapeutic use</topic><topic>Female</topic><topic>Humans</topic><topic>Life Sciences & Biomedicine</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Oncology</topic><topic>ORIGINAL REPORTS</topic><topic>Salivary Gland Neoplasms - drug therapy</topic><topic>Salivary Gland Neoplasms - pathology</topic><topic>Science & Technology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Locati, Laura D.</creatorcontrib><creatorcontrib>Cavalieri, Stefano</creatorcontrib><creatorcontrib>Bergamini, Cristiana</creatorcontrib><creatorcontrib>Resteghini, Carlo</creatorcontrib><creatorcontrib>Colombo, Elena</creatorcontrib><creatorcontrib>Calareso, Giuseppina</creatorcontrib><creatorcontrib>Mariani, Luigi</creatorcontrib><creatorcontrib>Quattrone, Pasquale</creatorcontrib><creatorcontrib>Alfieri, Salvatore</creatorcontrib><creatorcontrib>Bossi, Paolo</creatorcontrib><creatorcontrib>Platini, Francesca</creatorcontrib><creatorcontrib>Capone, Iolanda</creatorcontrib><creatorcontrib>Licitra, Lisa</creatorcontrib><collection>Web of Science Core Collection</collection><collection>Science Citation Index Expanded</collection><collection>Web of Science - Science Citation Index Expanded - 2021</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of clinical oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Locati, Laura D.</au><au>Cavalieri, Stefano</au><au>Bergamini, Cristiana</au><au>Resteghini, Carlo</au><au>Colombo, Elena</au><au>Calareso, Giuseppina</au><au>Mariani, Luigi</au><au>Quattrone, Pasquale</au><au>Alfieri, Salvatore</au><au>Bossi, Paolo</au><au>Platini, Francesca</au><au>Capone, Iolanda</au><au>Licitra, Lisa</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Abiraterone Acetate in Patients With Castration-Resistant, Androgen Receptor-Expressing Salivary Gland Cancer: A Phase II Trial</atitle><jtitle>Journal of clinical oncology</jtitle><stitle>J CLIN ONCOL</stitle><addtitle>J Clin Oncol</addtitle><date>2021-12-20</date><risdate>2021</risdate><volume>39</volume><issue>36</issue><spage>4061</spage><epage>4068</epage><pages>4061-4068</pages><issn>0732-183X</issn><eissn>1527-7755</eissn><abstract>PURPOSE The activity of androgen-deprivation therapy (ADT) in androgen receptor-positive (AR+) salivary gland carcinomas (SGCs) has been established in the past few years. Second-line treatment in castration-resistant patients is still unknown. We investigated the activity of abiraterone acetate as second-line treatment in ADT-resistant, AR+ patients with SGC.
METHODS This was a single-institution phase II trial. A two-stage Simon's design was applied. The primary end point was confirmed objective response rate. Secondary end points were disease control rate, safety, progression-free survival, and overall survival. Patients were eligible when the following criteria were met: histologic diagnosis of AR-overexpressing SGC, measurable disease according to RECIST 1.1, clinical and/or radiologic progression on ADT, suppressed serum testosterone, and no limits for the number of previous chemotherapy lines. All patients received abiraterone 1 g daily plus prednisone 10 mg and luteinizing hormone-releasing hormone agonist until progression or unacceptable toxicities.
RESULTS From 2015 to 2019, 24 AR+ patients with SGC (23 men; median age 65.8 years) were treated within the study. The overall response rate was 21% (5 partial responses), with a disease control rate of 62.5%. The median duration of response was 5.82 months. Median progression-free survival was 3.65 months (95% CI, 1.94 to 5.89), and median overall survival was 22.47 months (95% CI, 6.74 to not reached). Objective response to previous ADT did not correlate with the activity of abiraterone. Adverse events (AEs) were recorded in 22 cases (92%) with grade 3 AEs in six patients (25%): fatigue (two), flushing (one), supraventricular tachycardia (one), and two non-drug-related AEs. No drug-related grade 4 or 5 AEs were recorded.
CONCLUSION Abiraterone plus luteinizing hormone-releasing hormone agonist is active and safe as a second-line option in AR-expressing, castration-resistant SGC. (C) 2021 by American Society of Clinical Oncology</abstract><cop>PHILADELPHIA</cop><pub>Lippincott Williams & Wilkins</pub><pmid>34597119</pmid><doi>10.1200/JCO.21.00468</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0001-8485-2275</orcidid><orcidid>https://orcid.org/0000-0003-1294-6859</orcidid><orcidid>https://orcid.org/0000-0003-0623-4118</orcidid><orcidid>https://orcid.org/0000-0003-3315-2580</orcidid><orcidid>https://orcid.org/0000-0003-0135-0224</orcidid><orcidid>https://orcid.org/0000-0001-6208-4084</orcidid><orcidid>https://orcid.org/0000-0003-3132-844X</orcidid><orcidid>https://orcid.org/0000-0002-0188-9759</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Abiraterone Acetate - pharmacology Abiraterone Acetate - therapeutic use Adult Aged Antineoplastic Agents - pharmacology Antineoplastic Agents - therapeutic use Female Humans Life Sciences & Biomedicine Male Middle Aged Oncology ORIGINAL REPORTS Salivary Gland Neoplasms - drug therapy Salivary Gland Neoplasms - pathology Science & Technology |
| title | Abiraterone Acetate in Patients With Castration-Resistant, Androgen Receptor-Expressing Salivary Gland Cancer: A Phase II Trial |
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