First-line fadrozole HCI (CGS 16949A) versus tamoxifen in postmenopausal women with advanced breast cancer. Prospective randomised trial of the Swiss Group for Clinical Cancer Research SAKK 20/88
In a phase III randomized trial, we compared the effectiveness and tolerability of fadrozole (CGS 16949A), a non-steroidal aromatase inhibitor, to tamoxifen as first-line endocrine therapy in postmenopausal women with advanced breast cancer. Two hundred twelve eligible patients were randomized to re...
Gespeichert in:
| Veröffentlicht in: | Annals of oncology 1996-07, Vol.7 (5), p.471 |
|---|---|
| Hauptverfasser: | , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | |
|---|---|
| container_issue | 5 |
| container_start_page | 471 |
| container_title | Annals of oncology |
| container_volume | 7 |
| creator | Thürlimann, B Beretta, K Bacchi, M Castiglione-Gertsch, M Goldhirsch, A Jungi, W F Cavalli, F Senn, H J Fey, M Löhnert, T |
| description | In a phase III randomized trial, we compared the effectiveness and tolerability of fadrozole (CGS 16949A), a non-steroidal aromatase inhibitor, to tamoxifen as first-line endocrine therapy in postmenopausal women with advanced breast cancer.
Two hundred twelve eligible patients were randomized to receive tamoxifen 20 mg daily, or fadrozole 1 mg twice daily orally until disease progression or the advent of undue toxicity. The treatments were to be discontinued upon disease progression.
Prognostic factors were well balanced between the treatment groups, except for sites of metastatic disease. Fadrozole-treated patients had significantly more visceral, especially liver, involvement and less bone-dominant disease. Response rates for fadrozole and tamoxifen were similar, 20% and 27% (95% Confidence Limits (CL): 13%-29% and 21%-35%), respectively. Time to treatment failure was longer in patients randomized to tamoxifen (8.5 months for tamoxifen vs. 6.1 months for fadrozole), but did not reach statistical significance after adjustment for prognostic factors (P = 0.09). Fadrozole, for which a significantly lower percentage of clinically relevant toxic effects (WHO toxicity grade > or = 2) was recorded (27% vs. 13%, respectively; P = 0.009), was better tolerated than tamoxifen. Severe cardiovascular events including 3 fatalities were seen only in patients treated with tamoxifen. Eighty-two patients crossed over to tamoxifen and 66 patients to fadrozole. Crossover endocrine therapy led to response or stable disease in 64% of the patients. The overall survival times of the two treatment groups were similar.
Fadrozole and tamoxifen showed similar efficacy as first-line treatments in postmenopausal patients with advanced breast cancer. Fadrozole was significantly better tolerated and may therefore be an appropriate alternative to tamoxifen, especially for patients predisposed to thromboembolic events. |
| format | Article |
| fullrecord | <record><control><sourceid>pubmed</sourceid><recordid>TN_cdi_pubmed_primary_8839901</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>8839901</sourcerecordid><originalsourceid>FETCH-LOGICAL-p138t-e7ec3e93209842f1f05e3c320d02e633433d94b4a5dfb40155418f1afae5e6053</originalsourceid><addsrcrecordid>eNotkMtOwzAQRb0AlVL4BKRZwiLgxE4aL6uIPtRKIArryonHqlESR7bTAr_HjxGgq9HR3Hs0mjMypiJh0TRl_IJcev9OKc1EIkZklOdMCBqPyffcOB-i2rQIWipnv2yNsCxWcFssthBngovZHRzQ-d5DkI39MBpbMC101ocGW9vJ3ssajnYAOJqwB6kOsq1QQelQ-gDVL7l7eHbWd1gFc0BwslW2MX5IBWeGvtUQ9gjbo_EeFs72HWjroBhOM9WwL_4k8IIepav2sJ2t15DQhzy_Iuda1h6vT3NC3uaPr8Uy2jwtVsVsE3Uxy0OEU6wYCpZQkfNEx5qmyKoBFU0wY4wzpgQvuUyVLjmN05THuY6llphiRlM2ITf_3q4vG1S7zplGus_d6ZnsBxp8cLA</addsrcrecordid><sourcetype>Index Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>First-line fadrozole HCI (CGS 16949A) versus tamoxifen in postmenopausal women with advanced breast cancer. Prospective randomised trial of the Swiss Group for Clinical Cancer Research SAKK 20/88</title><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Alma/SFX Local Collection</source><creator>Thürlimann, B ; Beretta, K ; Bacchi, M ; Castiglione-Gertsch, M ; Goldhirsch, A ; Jungi, W F ; Cavalli, F ; Senn, H J ; Fey, M ; Löhnert, T</creator><creatorcontrib>Thürlimann, B ; Beretta, K ; Bacchi, M ; Castiglione-Gertsch, M ; Goldhirsch, A ; Jungi, W F ; Cavalli, F ; Senn, H J ; Fey, M ; Löhnert, T</creatorcontrib><description>In a phase III randomized trial, we compared the effectiveness and tolerability of fadrozole (CGS 16949A), a non-steroidal aromatase inhibitor, to tamoxifen as first-line endocrine therapy in postmenopausal women with advanced breast cancer.
Two hundred twelve eligible patients were randomized to receive tamoxifen 20 mg daily, or fadrozole 1 mg twice daily orally until disease progression or the advent of undue toxicity. The treatments were to be discontinued upon disease progression.
Prognostic factors were well balanced between the treatment groups, except for sites of metastatic disease. Fadrozole-treated patients had significantly more visceral, especially liver, involvement and less bone-dominant disease. Response rates for fadrozole and tamoxifen were similar, 20% and 27% (95% Confidence Limits (CL): 13%-29% and 21%-35%), respectively. Time to treatment failure was longer in patients randomized to tamoxifen (8.5 months for tamoxifen vs. 6.1 months for fadrozole), but did not reach statistical significance after adjustment for prognostic factors (P = 0.09). Fadrozole, for which a significantly lower percentage of clinically relevant toxic effects (WHO toxicity grade > or = 2) was recorded (27% vs. 13%, respectively; P = 0.009), was better tolerated than tamoxifen. Severe cardiovascular events including 3 fatalities were seen only in patients treated with tamoxifen. Eighty-two patients crossed over to tamoxifen and 66 patients to fadrozole. Crossover endocrine therapy led to response or stable disease in 64% of the patients. The overall survival times of the two treatment groups were similar.
Fadrozole and tamoxifen showed similar efficacy as first-line treatments in postmenopausal patients with advanced breast cancer. Fadrozole was significantly better tolerated and may therefore be an appropriate alternative to tamoxifen, especially for patients predisposed to thromboembolic events.</description><identifier>ISSN: 0923-7534</identifier><identifier>PMID: 8839901</identifier><language>eng</language><publisher>England</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents, Hormonal - adverse effects ; Antineoplastic Agents, Hormonal - therapeutic use ; Breast Neoplasms - drug therapy ; Breast Neoplasms - pathology ; Disease-Free Survival ; Enzyme Inhibitors - adverse effects ; Enzyme Inhibitors - therapeutic use ; Fadrozole - adverse effects ; Fadrozole - therapeutic use ; Female ; Humans ; Middle Aged ; Prognosis ; Prospective Studies ; Survival Rate ; Tamoxifen - adverse effects ; Tamoxifen - therapeutic use</subject><ispartof>Annals of oncology, 1996-07, Vol.7 (5), p.471</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/8839901$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Thürlimann, B</creatorcontrib><creatorcontrib>Beretta, K</creatorcontrib><creatorcontrib>Bacchi, M</creatorcontrib><creatorcontrib>Castiglione-Gertsch, M</creatorcontrib><creatorcontrib>Goldhirsch, A</creatorcontrib><creatorcontrib>Jungi, W F</creatorcontrib><creatorcontrib>Cavalli, F</creatorcontrib><creatorcontrib>Senn, H J</creatorcontrib><creatorcontrib>Fey, M</creatorcontrib><creatorcontrib>Löhnert, T</creatorcontrib><title>First-line fadrozole HCI (CGS 16949A) versus tamoxifen in postmenopausal women with advanced breast cancer. Prospective randomised trial of the Swiss Group for Clinical Cancer Research SAKK 20/88</title><title>Annals of oncology</title><addtitle>Ann Oncol</addtitle><description>In a phase III randomized trial, we compared the effectiveness and tolerability of fadrozole (CGS 16949A), a non-steroidal aromatase inhibitor, to tamoxifen as first-line endocrine therapy in postmenopausal women with advanced breast cancer.
Two hundred twelve eligible patients were randomized to receive tamoxifen 20 mg daily, or fadrozole 1 mg twice daily orally until disease progression or the advent of undue toxicity. The treatments were to be discontinued upon disease progression.
Prognostic factors were well balanced between the treatment groups, except for sites of metastatic disease. Fadrozole-treated patients had significantly more visceral, especially liver, involvement and less bone-dominant disease. Response rates for fadrozole and tamoxifen were similar, 20% and 27% (95% Confidence Limits (CL): 13%-29% and 21%-35%), respectively. Time to treatment failure was longer in patients randomized to tamoxifen (8.5 months for tamoxifen vs. 6.1 months for fadrozole), but did not reach statistical significance after adjustment for prognostic factors (P = 0.09). Fadrozole, for which a significantly lower percentage of clinically relevant toxic effects (WHO toxicity grade > or = 2) was recorded (27% vs. 13%, respectively; P = 0.009), was better tolerated than tamoxifen. Severe cardiovascular events including 3 fatalities were seen only in patients treated with tamoxifen. Eighty-two patients crossed over to tamoxifen and 66 patients to fadrozole. Crossover endocrine therapy led to response or stable disease in 64% of the patients. The overall survival times of the two treatment groups were similar.
Fadrozole and tamoxifen showed similar efficacy as first-line treatments in postmenopausal patients with advanced breast cancer. Fadrozole was significantly better tolerated and may therefore be an appropriate alternative to tamoxifen, especially for patients predisposed to thromboembolic events.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antineoplastic Agents, Hormonal - adverse effects</subject><subject>Antineoplastic Agents, Hormonal - therapeutic use</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Breast Neoplasms - pathology</subject><subject>Disease-Free Survival</subject><subject>Enzyme Inhibitors - adverse effects</subject><subject>Enzyme Inhibitors - therapeutic use</subject><subject>Fadrozole - adverse effects</subject><subject>Fadrozole - therapeutic use</subject><subject>Female</subject><subject>Humans</subject><subject>Middle Aged</subject><subject>Prognosis</subject><subject>Prospective Studies</subject><subject>Survival Rate</subject><subject>Tamoxifen - adverse effects</subject><subject>Tamoxifen - therapeutic use</subject><issn>0923-7534</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1996</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNotkMtOwzAQRb0AlVL4BKRZwiLgxE4aL6uIPtRKIArryonHqlESR7bTAr_HjxGgq9HR3Hs0mjMypiJh0TRl_IJcev9OKc1EIkZklOdMCBqPyffcOB-i2rQIWipnv2yNsCxWcFssthBngovZHRzQ-d5DkI39MBpbMC101ocGW9vJ3ssajnYAOJqwB6kOsq1QQelQ-gDVL7l7eHbWd1gFc0BwslW2MX5IBWeGvtUQ9gjbo_EeFs72HWjroBhOM9WwL_4k8IIepav2sJ2t15DQhzy_Iuda1h6vT3NC3uaPr8Uy2jwtVsVsE3Uxy0OEU6wYCpZQkfNEx5qmyKoBFU0wY4wzpgQvuUyVLjmN05THuY6llphiRlM2ITf_3q4vG1S7zplGus_d6ZnsBxp8cLA</recordid><startdate>199607</startdate><enddate>199607</enddate><creator>Thürlimann, B</creator><creator>Beretta, K</creator><creator>Bacchi, M</creator><creator>Castiglione-Gertsch, M</creator><creator>Goldhirsch, A</creator><creator>Jungi, W F</creator><creator>Cavalli, F</creator><creator>Senn, H J</creator><creator>Fey, M</creator><creator>Löhnert, T</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope></search><sort><creationdate>199607</creationdate><title>First-line fadrozole HCI (CGS 16949A) versus tamoxifen in postmenopausal women with advanced breast cancer. Prospective randomised trial of the Swiss Group for Clinical Cancer Research SAKK 20/88</title><author>Thürlimann, B ; Beretta, K ; Bacchi, M ; Castiglione-Gertsch, M ; Goldhirsch, A ; Jungi, W F ; Cavalli, F ; Senn, H J ; Fey, M ; Löhnert, T</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p138t-e7ec3e93209842f1f05e3c320d02e633433d94b4a5dfb40155418f1afae5e6053</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1996</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antineoplastic Agents, Hormonal - adverse effects</topic><topic>Antineoplastic Agents, Hormonal - therapeutic use</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Breast Neoplasms - pathology</topic><topic>Disease-Free Survival</topic><topic>Enzyme Inhibitors - adverse effects</topic><topic>Enzyme Inhibitors - therapeutic use</topic><topic>Fadrozole - adverse effects</topic><topic>Fadrozole - therapeutic use</topic><topic>Female</topic><topic>Humans</topic><topic>Middle Aged</topic><topic>Prognosis</topic><topic>Prospective Studies</topic><topic>Survival Rate</topic><topic>Tamoxifen - adverse effects</topic><topic>Tamoxifen - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Thürlimann, B</creatorcontrib><creatorcontrib>Beretta, K</creatorcontrib><creatorcontrib>Bacchi, M</creatorcontrib><creatorcontrib>Castiglione-Gertsch, M</creatorcontrib><creatorcontrib>Goldhirsch, A</creatorcontrib><creatorcontrib>Jungi, W F</creatorcontrib><creatorcontrib>Cavalli, F</creatorcontrib><creatorcontrib>Senn, H J</creatorcontrib><creatorcontrib>Fey, M</creatorcontrib><creatorcontrib>Löhnert, T</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><jtitle>Annals of oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Thürlimann, B</au><au>Beretta, K</au><au>Bacchi, M</au><au>Castiglione-Gertsch, M</au><au>Goldhirsch, A</au><au>Jungi, W F</au><au>Cavalli, F</au><au>Senn, H J</au><au>Fey, M</au><au>Löhnert, T</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>First-line fadrozole HCI (CGS 16949A) versus tamoxifen in postmenopausal women with advanced breast cancer. Prospective randomised trial of the Swiss Group for Clinical Cancer Research SAKK 20/88</atitle><jtitle>Annals of oncology</jtitle><addtitle>Ann Oncol</addtitle><date>1996-07</date><risdate>1996</risdate><volume>7</volume><issue>5</issue><spage>471</spage><pages>471-</pages><issn>0923-7534</issn><abstract>In a phase III randomized trial, we compared the effectiveness and tolerability of fadrozole (CGS 16949A), a non-steroidal aromatase inhibitor, to tamoxifen as first-line endocrine therapy in postmenopausal women with advanced breast cancer.
Two hundred twelve eligible patients were randomized to receive tamoxifen 20 mg daily, or fadrozole 1 mg twice daily orally until disease progression or the advent of undue toxicity. The treatments were to be discontinued upon disease progression.
Prognostic factors were well balanced between the treatment groups, except for sites of metastatic disease. Fadrozole-treated patients had significantly more visceral, especially liver, involvement and less bone-dominant disease. Response rates for fadrozole and tamoxifen were similar, 20% and 27% (95% Confidence Limits (CL): 13%-29% and 21%-35%), respectively. Time to treatment failure was longer in patients randomized to tamoxifen (8.5 months for tamoxifen vs. 6.1 months for fadrozole), but did not reach statistical significance after adjustment for prognostic factors (P = 0.09). Fadrozole, for which a significantly lower percentage of clinically relevant toxic effects (WHO toxicity grade > or = 2) was recorded (27% vs. 13%, respectively; P = 0.009), was better tolerated than tamoxifen. Severe cardiovascular events including 3 fatalities were seen only in patients treated with tamoxifen. Eighty-two patients crossed over to tamoxifen and 66 patients to fadrozole. Crossover endocrine therapy led to response or stable disease in 64% of the patients. The overall survival times of the two treatment groups were similar.
Fadrozole and tamoxifen showed similar efficacy as first-line treatments in postmenopausal patients with advanced breast cancer. Fadrozole was significantly better tolerated and may therefore be an appropriate alternative to tamoxifen, especially for patients predisposed to thromboembolic events.</abstract><cop>England</cop><pmid>8839901</pmid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0923-7534 |
| ispartof | Annals of oncology, 1996-07, Vol.7 (5), p.471 |
| issn | 0923-7534 |
| language | eng |
| recordid | cdi_pubmed_primary_8839901 |
| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Adult Aged Aged, 80 and over Antineoplastic Agents, Hormonal - adverse effects Antineoplastic Agents, Hormonal - therapeutic use Breast Neoplasms - drug therapy Breast Neoplasms - pathology Disease-Free Survival Enzyme Inhibitors - adverse effects Enzyme Inhibitors - therapeutic use Fadrozole - adverse effects Fadrozole - therapeutic use Female Humans Middle Aged Prognosis Prospective Studies Survival Rate Tamoxifen - adverse effects Tamoxifen - therapeutic use |
| title | First-line fadrozole HCI (CGS 16949A) versus tamoxifen in postmenopausal women with advanced breast cancer. Prospective randomised trial of the Swiss Group for Clinical Cancer Research SAKK 20/88 |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-02T03%3A55%3A51IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-pubmed&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=First-line%20fadrozole%20HCI%20(CGS%2016949A)%20versus%20tamoxifen%20in%20postmenopausal%20women%20with%20advanced%20breast%20cancer.%20Prospective%20randomised%20trial%20of%20the%20Swiss%20Group%20for%20Clinical%20Cancer%20Research%20SAKK%2020/88&rft.jtitle=Annals%20of%20oncology&rft.au=Th%C3%BCrlimann,%20B&rft.date=1996-07&rft.volume=7&rft.issue=5&rft.spage=471&rft.pages=471-&rft.issn=0923-7534&rft_id=info:doi/&rft_dat=%3Cpubmed%3E8839901%3C/pubmed%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_id=info:pmid/8839901&rfr_iscdi=true |