A phase 2 study of anastrozole in patients with oestrogen receptor and/progesterone receptor positive recurrent/metastatic granulosa cell tumours/sex-cord stromal tumours of the ovary: The PARAGON/ANZGOG 0903 trial
Hormonal therapies are commonly prescribed to patients with metastatic granulosa cell tumours (GCT), based on high response rates in small retrospective studies. Aromatase inhibitors (AIs) are reported to have high response rates and an accepted treatment option. We report the results of a phase 2 t...
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| Veröffentlicht in: | Gynecologic oncology 2021-10, Vol.163 (1), p.72-78 |
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| creator | Banerjee, Susana N. Tang, Monica O'Connell, Rachel L. Sjoquist, Katrin Clamp, Andrew R. Millan, David Nottley, Steven Lord, Rosemary Mullassery, Vinod Menon Hall, Marcia Gourley, Charlie Bonaventura, Tony Goh, Jeffrey C. Sykes, Peter Grant, Peter T. McNally, Orla Alexander, Laura Kelly, Caroline Carty, Karen Divers, Laura Bradshaw, N. Edmondson, Richard J. Friedlander, Michael |
| description | Hormonal therapies are commonly prescribed to patients with metastatic granulosa cell tumours (GCT), based on high response rates in small retrospective studies. Aromatase inhibitors (AIs) are reported to have high response rates and an accepted treatment option. We report the results of a phase 2 trial of an AI in recurrent/metastatic GCTs.
41 patients with recurrent ER/PR + ve GCT received anastrozole 1 mg daily until progression or unacceptable toxicity. The primary endpoint was clinical benefit rate (CBR) at 12 weeks, evaluated by RECIST1.1 criteria. Secondary endpoints included progression-free survival (PFS), CBR duration, quality of life and toxicity.
The CBR at 12 weeks in 38 evaluable patients was 78.9%, which included one (2.6%; 95% CI: 0.5–13.5%) partial response and 76.3% stable disease. Two additional patients without measurable disease were stable, based on inhibin. Median PFS was 8.6 m (95% CI 5.5–13.5 m). There were delayed responses observed after 12 weeks with a total of 4 pts. (10.5%; 95% CI 4.2%–24.1%) with a RECIST partial response; 23 (59%) patients were progression-free at 6 months. The adverse effects were predominantly low grade.
This is the first prospective trial of hormonal therapy in GCTs. Although there was a high CBR, the objective response rate to anastrozole was much lower than the pooled response rates of >70% to AIs reported in most retrospective series and case reports. PARAGON demonstrates the importance of prospective trials in rare cancers and the need to reconsider the role of AIs as single agents in GCTs.
•Granulosa cell tumours are rare and there are no prospective trials of hormonal therapies.•High response rates have been reported with aromatase inhibitors in case reports.•PARAGON is a prospective study of anastrozole in granulosa cell tumours.•The objective response rate was 10.5%, which is lower than reported in the literature. |
| doi_str_mv | 10.1016/j.ygyno.2021.07.024 |
| format | Article |
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41 patients with recurrent ER/PR + ve GCT received anastrozole 1 mg daily until progression or unacceptable toxicity. The primary endpoint was clinical benefit rate (CBR) at 12 weeks, evaluated by RECIST1.1 criteria. Secondary endpoints included progression-free survival (PFS), CBR duration, quality of life and toxicity.
The CBR at 12 weeks in 38 evaluable patients was 78.9%, which included one (2.6%; 95% CI: 0.5–13.5%) partial response and 76.3% stable disease. Two additional patients without measurable disease were stable, based on inhibin. Median PFS was 8.6 m (95% CI 5.5–13.5 m). There were delayed responses observed after 12 weeks with a total of 4 pts. (10.5%; 95% CI 4.2%–24.1%) with a RECIST partial response; 23 (59%) patients were progression-free at 6 months. The adverse effects were predominantly low grade.
This is the first prospective trial of hormonal therapy in GCTs. Although there was a high CBR, the objective response rate to anastrozole was much lower than the pooled response rates of >70% to AIs reported in most retrospective series and case reports. PARAGON demonstrates the importance of prospective trials in rare cancers and the need to reconsider the role of AIs as single agents in GCTs.
•Granulosa cell tumours are rare and there are no prospective trials of hormonal therapies.•High response rates have been reported with aromatase inhibitors in case reports.•PARAGON is a prospective study of anastrozole in granulosa cell tumours.•The objective response rate was 10.5%, which is lower than reported in the literature.</description><identifier>ISSN: 0090-8258</identifier><identifier>EISSN: 1095-6859</identifier><identifier>DOI: 10.1016/j.ygyno.2021.07.024</identifier><identifier>PMID: 34412908</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; Aged ; Anastrozole - therapeutic use ; Aromatase inhibitors ; Clinical benefit ; Female ; Granulosa Cell Tumor - chemistry ; Granulosa Cell Tumor - drug therapy ; Granulosa Cell Tumor - mortality ; Granulosa cell tumour ovary ; Humans ; Middle Aged ; Neoplasm Recurrence, Local - chemistry ; Neoplasm Recurrence, Local - drug therapy ; Neoplasm Recurrence, Local - mortality ; Ovarian Neoplasms - chemistry ; Ovarian Neoplasms - drug therapy ; Ovarian Neoplasms - mortality ; Quality of Life ; Receptors, Estrogen - analysis ; Receptors, Progesterone - analysis ; Response ; Sex Cord-Gonadal Stromal Tumors - chemistry ; Sex Cord-Gonadal Stromal Tumors - drug therapy ; Sex Cord-Gonadal Stromal Tumors - mortality</subject><ispartof>Gynecologic oncology, 2021-10, Vol.163 (1), p.72-78</ispartof><rights>2021</rights><rights>Copyright © 2021. Published by Elsevier Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c359t-fd4ad81f9672351495ceea4dcf7fbf2508c92953d5cafd92549d32b7caad36dc3</citedby><cites>FETCH-LOGICAL-c359t-fd4ad81f9672351495ceea4dcf7fbf2508c92953d5cafd92549d32b7caad36dc3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ygyno.2021.07.024$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34412908$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Banerjee, Susana N.</creatorcontrib><creatorcontrib>Tang, Monica</creatorcontrib><creatorcontrib>O'Connell, Rachel L.</creatorcontrib><creatorcontrib>Sjoquist, Katrin</creatorcontrib><creatorcontrib>Clamp, Andrew R.</creatorcontrib><creatorcontrib>Millan, David</creatorcontrib><creatorcontrib>Nottley, Steven</creatorcontrib><creatorcontrib>Lord, Rosemary</creatorcontrib><creatorcontrib>Mullassery, Vinod Menon</creatorcontrib><creatorcontrib>Hall, Marcia</creatorcontrib><creatorcontrib>Gourley, Charlie</creatorcontrib><creatorcontrib>Bonaventura, Tony</creatorcontrib><creatorcontrib>Goh, Jeffrey C.</creatorcontrib><creatorcontrib>Sykes, Peter</creatorcontrib><creatorcontrib>Grant, Peter T.</creatorcontrib><creatorcontrib>McNally, Orla</creatorcontrib><creatorcontrib>Alexander, Laura</creatorcontrib><creatorcontrib>Kelly, Caroline</creatorcontrib><creatorcontrib>Carty, Karen</creatorcontrib><creatorcontrib>Divers, Laura</creatorcontrib><creatorcontrib>Bradshaw, N.</creatorcontrib><creatorcontrib>Edmondson, Richard J.</creatorcontrib><creatorcontrib>Friedlander, Michael</creatorcontrib><creatorcontrib>on behalf of PARAGON investigators</creatorcontrib><creatorcontrib>PARAGON investigators</creatorcontrib><title>A phase 2 study of anastrozole in patients with oestrogen receptor and/progesterone receptor positive recurrent/metastatic granulosa cell tumours/sex-cord stromal tumours of the ovary: The PARAGON/ANZGOG 0903 trial</title><title>Gynecologic oncology</title><addtitle>Gynecol Oncol</addtitle><description>Hormonal therapies are commonly prescribed to patients with metastatic granulosa cell tumours (GCT), based on high response rates in small retrospective studies. Aromatase inhibitors (AIs) are reported to have high response rates and an accepted treatment option. We report the results of a phase 2 trial of an AI in recurrent/metastatic GCTs.
41 patients with recurrent ER/PR + ve GCT received anastrozole 1 mg daily until progression or unacceptable toxicity. The primary endpoint was clinical benefit rate (CBR) at 12 weeks, evaluated by RECIST1.1 criteria. Secondary endpoints included progression-free survival (PFS), CBR duration, quality of life and toxicity.
The CBR at 12 weeks in 38 evaluable patients was 78.9%, which included one (2.6%; 95% CI: 0.5–13.5%) partial response and 76.3% stable disease. Two additional patients without measurable disease were stable, based on inhibin. Median PFS was 8.6 m (95% CI 5.5–13.5 m). There were delayed responses observed after 12 weeks with a total of 4 pts. (10.5%; 95% CI 4.2%–24.1%) with a RECIST partial response; 23 (59%) patients were progression-free at 6 months. The adverse effects were predominantly low grade.
This is the first prospective trial of hormonal therapy in GCTs. Although there was a high CBR, the objective response rate to anastrozole was much lower than the pooled response rates of >70% to AIs reported in most retrospective series and case reports. PARAGON demonstrates the importance of prospective trials in rare cancers and the need to reconsider the role of AIs as single agents in GCTs.
•Granulosa cell tumours are rare and there are no prospective trials of hormonal therapies.•High response rates have been reported with aromatase inhibitors in case reports.•PARAGON is a prospective study of anastrozole in granulosa cell tumours.•The objective response rate was 10.5%, which is lower than reported in the literature.</description><subject>Adult</subject><subject>Aged</subject><subject>Anastrozole - therapeutic use</subject><subject>Aromatase inhibitors</subject><subject>Clinical benefit</subject><subject>Female</subject><subject>Granulosa Cell Tumor - chemistry</subject><subject>Granulosa Cell Tumor - drug therapy</subject><subject>Granulosa Cell Tumor - mortality</subject><subject>Granulosa cell tumour ovary</subject><subject>Humans</subject><subject>Middle Aged</subject><subject>Neoplasm Recurrence, Local - chemistry</subject><subject>Neoplasm Recurrence, Local - drug therapy</subject><subject>Neoplasm Recurrence, Local - mortality</subject><subject>Ovarian Neoplasms - chemistry</subject><subject>Ovarian Neoplasms - drug therapy</subject><subject>Ovarian Neoplasms - mortality</subject><subject>Quality of Life</subject><subject>Receptors, Estrogen - analysis</subject><subject>Receptors, Progesterone - analysis</subject><subject>Response</subject><subject>Sex Cord-Gonadal Stromal Tumors - chemistry</subject><subject>Sex Cord-Gonadal Stromal Tumors - drug therapy</subject><subject>Sex Cord-Gonadal Stromal Tumors - mortality</subject><issn>0090-8258</issn><issn>1095-6859</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9UcGO0zAQjRCILQtfgIR85JLEseMkRuIQrZaCtNoitFy4WK49aV0lcbCdQvlQvgdnuyw3TrZm3rw3b16SvC5wVuCiyg_ZaXcabUYwKTJcZ5iUT5JVgTlLq4bxp8kKY47ThrDmInnh_QFjTHFBnicXtCwLwnGzSn63aNpLD4ggH2Z9QrZDcpQ-OPvL9oDMiCYZDIzBox8m7JGFpbeDETlQMAXrIl7n01LzAZwd4V9nst4Ec7yvzM5FlnyAENkjpUI7J8e5t14iBX2PwjzY2fncw89UWafRIjTIx8ayWtgDskfpTu_QXfx-br-0681t3t5-W2_WKNqlKDgj-5fJs072Hl49vJfJ1w_Xd1cf05vN-tNVe5MqynhIO11K3RQdr2pCWVFypgBkqVVXd9uOMNwoTjijminZaU5YyTUl21pJqWmlFb1M3p55o__vczyAGIxf3MgR7OwFYRUtSUUIjlB6hipnvXfQicmZIVoRBRZLoOIg7gMVS6AC1yIGGqfePAjM2wH048zfBCPg_RkA0ebRgBNexbgUaBOPHoS25r8CfwCFWLif</recordid><startdate>202110</startdate><enddate>202110</enddate><creator>Banerjee, Susana N.</creator><creator>Tang, Monica</creator><creator>O'Connell, Rachel L.</creator><creator>Sjoquist, Katrin</creator><creator>Clamp, Andrew R.</creator><creator>Millan, David</creator><creator>Nottley, Steven</creator><creator>Lord, Rosemary</creator><creator>Mullassery, Vinod Menon</creator><creator>Hall, Marcia</creator><creator>Gourley, Charlie</creator><creator>Bonaventura, Tony</creator><creator>Goh, Jeffrey C.</creator><creator>Sykes, Peter</creator><creator>Grant, Peter T.</creator><creator>McNally, Orla</creator><creator>Alexander, Laura</creator><creator>Kelly, Caroline</creator><creator>Carty, Karen</creator><creator>Divers, Laura</creator><creator>Bradshaw, N.</creator><creator>Edmondson, Richard J.</creator><creator>Friedlander, Michael</creator><general>Elsevier Inc</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></search><sort><creationdate>202110</creationdate><title>A phase 2 study of anastrozole in patients with oestrogen receptor and/progesterone receptor positive recurrent/metastatic granulosa cell tumours/sex-cord stromal tumours of the ovary: The PARAGON/ANZGOG 0903 trial</title><author>Banerjee, Susana N. ; Tang, Monica ; O'Connell, Rachel L. ; Sjoquist, Katrin ; Clamp, Andrew R. ; Millan, David ; Nottley, Steven ; Lord, Rosemary ; Mullassery, Vinod Menon ; Hall, Marcia ; Gourley, Charlie ; Bonaventura, Tony ; Goh, Jeffrey C. ; Sykes, Peter ; Grant, Peter T. ; McNally, Orla ; Alexander, Laura ; Kelly, Caroline ; Carty, Karen ; Divers, Laura ; Bradshaw, N. ; Edmondson, Richard J. ; Friedlander, Michael</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c359t-fd4ad81f9672351495ceea4dcf7fbf2508c92953d5cafd92549d32b7caad36dc3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Anastrozole - therapeutic use</topic><topic>Aromatase inhibitors</topic><topic>Clinical benefit</topic><topic>Female</topic><topic>Granulosa Cell Tumor - chemistry</topic><topic>Granulosa Cell Tumor - drug therapy</topic><topic>Granulosa Cell Tumor - mortality</topic><topic>Granulosa cell tumour ovary</topic><topic>Humans</topic><topic>Middle Aged</topic><topic>Neoplasm Recurrence, Local - chemistry</topic><topic>Neoplasm Recurrence, Local - drug therapy</topic><topic>Neoplasm Recurrence, Local - mortality</topic><topic>Ovarian Neoplasms - chemistry</topic><topic>Ovarian Neoplasms - drug therapy</topic><topic>Ovarian Neoplasms - mortality</topic><topic>Quality of Life</topic><topic>Receptors, Estrogen - analysis</topic><topic>Receptors, Progesterone - analysis</topic><topic>Response</topic><topic>Sex Cord-Gonadal Stromal Tumors - chemistry</topic><topic>Sex Cord-Gonadal Stromal Tumors - drug therapy</topic><topic>Sex Cord-Gonadal Stromal Tumors - mortality</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Banerjee, Susana N.</creatorcontrib><creatorcontrib>Tang, Monica</creatorcontrib><creatorcontrib>O'Connell, Rachel L.</creatorcontrib><creatorcontrib>Sjoquist, Katrin</creatorcontrib><creatorcontrib>Clamp, Andrew R.</creatorcontrib><creatorcontrib>Millan, David</creatorcontrib><creatorcontrib>Nottley, Steven</creatorcontrib><creatorcontrib>Lord, Rosemary</creatorcontrib><creatorcontrib>Mullassery, Vinod Menon</creatorcontrib><creatorcontrib>Hall, Marcia</creatorcontrib><creatorcontrib>Gourley, Charlie</creatorcontrib><creatorcontrib>Bonaventura, Tony</creatorcontrib><creatorcontrib>Goh, Jeffrey C.</creatorcontrib><creatorcontrib>Sykes, Peter</creatorcontrib><creatorcontrib>Grant, Peter T.</creatorcontrib><creatorcontrib>McNally, Orla</creatorcontrib><creatorcontrib>Alexander, Laura</creatorcontrib><creatorcontrib>Kelly, Caroline</creatorcontrib><creatorcontrib>Carty, Karen</creatorcontrib><creatorcontrib>Divers, Laura</creatorcontrib><creatorcontrib>Bradshaw, N.</creatorcontrib><creatorcontrib>Edmondson, Richard J.</creatorcontrib><creatorcontrib>Friedlander, Michael</creatorcontrib><creatorcontrib>on behalf of PARAGON investigators</creatorcontrib><creatorcontrib>PARAGON investigators</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Gynecologic oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Banerjee, Susana N.</au><au>Tang, Monica</au><au>O'Connell, Rachel L.</au><au>Sjoquist, Katrin</au><au>Clamp, Andrew R.</au><au>Millan, David</au><au>Nottley, Steven</au><au>Lord, Rosemary</au><au>Mullassery, Vinod Menon</au><au>Hall, Marcia</au><au>Gourley, Charlie</au><au>Bonaventura, Tony</au><au>Goh, Jeffrey C.</au><au>Sykes, Peter</au><au>Grant, Peter T.</au><au>McNally, Orla</au><au>Alexander, Laura</au><au>Kelly, Caroline</au><au>Carty, Karen</au><au>Divers, Laura</au><au>Bradshaw, N.</au><au>Edmondson, Richard J.</au><au>Friedlander, Michael</au><aucorp>on behalf of PARAGON investigators</aucorp><aucorp>PARAGON investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A phase 2 study of anastrozole in patients with oestrogen receptor and/progesterone receptor positive recurrent/metastatic granulosa cell tumours/sex-cord stromal tumours of the ovary: The PARAGON/ANZGOG 0903 trial</atitle><jtitle>Gynecologic oncology</jtitle><addtitle>Gynecol Oncol</addtitle><date>2021-10</date><risdate>2021</risdate><volume>163</volume><issue>1</issue><spage>72</spage><epage>78</epage><pages>72-78</pages><issn>0090-8258</issn><eissn>1095-6859</eissn><abstract>Hormonal therapies are commonly prescribed to patients with metastatic granulosa cell tumours (GCT), based on high response rates in small retrospective studies. Aromatase inhibitors (AIs) are reported to have high response rates and an accepted treatment option. We report the results of a phase 2 trial of an AI in recurrent/metastatic GCTs.
41 patients with recurrent ER/PR + ve GCT received anastrozole 1 mg daily until progression or unacceptable toxicity. The primary endpoint was clinical benefit rate (CBR) at 12 weeks, evaluated by RECIST1.1 criteria. Secondary endpoints included progression-free survival (PFS), CBR duration, quality of life and toxicity.
The CBR at 12 weeks in 38 evaluable patients was 78.9%, which included one (2.6%; 95% CI: 0.5–13.5%) partial response and 76.3% stable disease. Two additional patients without measurable disease were stable, based on inhibin. Median PFS was 8.6 m (95% CI 5.5–13.5 m). There were delayed responses observed after 12 weeks with a total of 4 pts. (10.5%; 95% CI 4.2%–24.1%) with a RECIST partial response; 23 (59%) patients were progression-free at 6 months. The adverse effects were predominantly low grade.
This is the first prospective trial of hormonal therapy in GCTs. Although there was a high CBR, the objective response rate to anastrozole was much lower than the pooled response rates of >70% to AIs reported in most retrospective series and case reports. PARAGON demonstrates the importance of prospective trials in rare cancers and the need to reconsider the role of AIs as single agents in GCTs.
•Granulosa cell tumours are rare and there are no prospective trials of hormonal therapies.•High response rates have been reported with aromatase inhibitors in case reports.•PARAGON is a prospective study of anastrozole in granulosa cell tumours.•The objective response rate was 10.5%, which is lower than reported in the literature.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>34412908</pmid><doi>10.1016/j.ygyno.2021.07.024</doi><tpages>7</tpages></addata></record> |
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| ispartof | Gynecologic oncology, 2021-10, Vol.163 (1), p.72-78 |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adult Aged Anastrozole - therapeutic use Aromatase inhibitors Clinical benefit Female Granulosa Cell Tumor - chemistry Granulosa Cell Tumor - drug therapy Granulosa Cell Tumor - mortality Granulosa cell tumour ovary Humans Middle Aged Neoplasm Recurrence, Local - chemistry Neoplasm Recurrence, Local - drug therapy Neoplasm Recurrence, Local - mortality Ovarian Neoplasms - chemistry Ovarian Neoplasms - drug therapy Ovarian Neoplasms - mortality Quality of Life Receptors, Estrogen - analysis Receptors, Progesterone - analysis Response Sex Cord-Gonadal Stromal Tumors - chemistry Sex Cord-Gonadal Stromal Tumors - drug therapy Sex Cord-Gonadal Stromal Tumors - mortality |
| title | A phase 2 study of anastrozole in patients with oestrogen receptor and/progesterone receptor positive recurrent/metastatic granulosa cell tumours/sex-cord stromal tumours of the ovary: The PARAGON/ANZGOG 0903 trial |
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