AustralieFrV1, Main, Exploration, bibRecord, 00CD52

Third-line hormonal treatment with exemestane in postmenopausal patients with advanced breast cancer progressing on aminoglutethimide: a phase ii multicentre multinational study

Identifieur interne : 00CD52 ( Main/Exploration ); précédent : 00CD51; suivant : 00CD53

Third-line hormonal treatment with exemestane in postmenopausal patients with advanced breast cancer progressing on aminoglutethimide: a phase ii multicentre multinational study

Auteurs : B. Thürlimann [Suisse] ; R. Paridaens [Belgique] ; D. Serin [France] ; J. Bonneterre [France] ; H. Roché [France] ; R. Murray [Australie] ; E. Di Salle [Italie] ; S. Lanzalone [Italie] ; M. G. Zurlo [Italie] ; G. Piscitelli [Italie]

Source :

European Journal of Cancer [ 0959-8049 ] ; 1997.

RBID : ISTEX:5A724169E2CFF379B40F69C855C0DBFCFEA235B6

Descripteurs français

Pascal (Inist)
- Aminoglutéthimide, Androstane dérivé, Anticancéreux, Carcinome, Essai clinique phase II, Estrogen synthase, Exémestane, Glande mammaire, Homme, Inhibiteur enzyme, Métastase, Postménopause, Stade avancé, Traitement.
Wicri :
- topic : Homme.

English descriptors

Abstract

Abstract: In a European multicentre phase II study, 80 postmenopausal patients (pts) with advanced breast cancer progressing on aminoglutethimide (AG) at daily doses of ≥ 500 mg were enrolled. Seventy-eight received exemestane (200mg daily orally), including 33pts resistant to prior AG, 39pts who had progressed after an initial response to AG, and 6 pts whose response to AG was either unavailable or not evaluable. Three pts were pretreated with AG only, 69 with tamoxifen and AG, and 6 with tamoxifen, AG and other hormone therapies; 55% had also previously received chemotherapy. The predominant site of disease was visceral in 34 cases, bone in 27 and soft tissue in 17. Based on Peer Review assessment, the overall objective response rate (CRs plus PRs) was 26% (12% in pts resistant to AG and 33% in AG-responsive pts). Disease stabilisation ≥ 24 weeks was achieved in an additional 13% of patients (15% of those resistant to AG and 13% of those AG-responsive), resulting in an overall success rate of 39% (28–50, 95% confidence interval). The median duration of objective response, overall success and median TTP were 59, 48 and 21 weeks, respectively. Toxicities were usually mild to moderate in severity, with hot flushes (21%), nausea (19%), dizziness (12%), weakness (12%), increased sweating (12%), androgenic symptoms (10%) and peripheral oedema (9%) as the most common side-effects. Only 2 pts (3%) discontinued treatment due to adverse events. These results are very promising considering that exemestane was administered as third- or fourth-line hormonal treatment in most cases and confirm previous observations about the lack of cross-resistance when steroidal aromatase inhibitors are sequenced with the non-steroidal aromatase inhibitor AG.

Url:

https://api.istex.fr/document/5A724169E2CFF379B40F69C855C0DBFCFEA235B6/fulltext/pdf

DOI: 10.1016/S0959-8049(97)00283-9

Affiliations:

Le document en format XML

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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Advanced stage</term>
<term>Adverse events</term>
<term>Aminoglutethimide</term>
<term>Androgenic symptoms</term>
<term>Androstane derivatives</term>
<term>Antineoplastic agent</term>
<term>Aromatase</term>
<term>Aromatase activity</term>
<term>Aromatase enzyme</term>
<term>Aromatase inhibition</term>
<term>Aromatase inhibitor</term>
<term>Aromatase inhibitors</term>
<term>Austria investigators</term>
<term>Baseline</term>
<term>Baseline characteristics</term>
<term>Baseline levels</term>
<term>Baseline values</term>
<term>Belgium investigators</term>
<term>Bone scan</term>
<term>Brain metastasis</term>
<term>Breast</term>
<term>Breast cancer</term>
<term>Breast cancer patients</term>
<term>Carcinoma</term>
<term>Daily dose</term>
<term>Daily doses</term>
<term>Detection limit</term>
<term>Disease stabilisation</term>
<term>Ecog performance status</term>
<term>Elsevier science</term>
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<term>Endocrine therapies</term>
<term>Endocrine therapy</term>
<term>Endocrine treatment</term>
<term>Enzyme inhibitor</term>
<term>Estrogen synthase</term>
<term>Evaluable</term>
<term>Exemestane</term>
<term>Exemestane treatment</term>
<term>Formestane</term>
<term>France investigators</term>
<term>Haem group</term>
<term>Hormonal</term>
<term>Hormonal therapy</term>
<term>Hormonal treatment</term>
<term>Human</term>
<term>Inhibitor</term>
<term>Inhibitory effect</term>
<term>Initial response</term>
<term>Investigator</term>
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<term>Median</term>
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<term>Median time</term>
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<term>Overall success rate</term>
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<term>Carcinome</term>
<term>Essai clinique phase II</term>
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<front><div type="abstract" xml:lang="en">Abstract: In a European multicentre phase II study, 80 postmenopausal patients (pts) with advanced breast cancer progressing on aminoglutethimide (AG) at daily doses of ≥ 500 mg were enrolled. Seventy-eight received exemestane (200mg daily orally), including 33pts resistant to prior AG, 39pts who had progressed after an initial response to AG, and 6 pts whose response to AG was either unavailable or not evaluable. Three pts were pretreated with AG only, 69 with tamoxifen and AG, and 6 with tamoxifen, AG and other hormone therapies; 55% had also previously received chemotherapy. The predominant site of disease was visceral in 34 cases, bone in 27 and soft tissue in 17. Based on Peer Review assessment, the overall objective response rate (CRs plus PRs) was 26% (12% in pts resistant to AG and 33% in AG-responsive pts). Disease stabilisation ≥ 24 weeks was achieved in an additional 13% of patients (15% of those resistant to AG and 13% of those AG-responsive), resulting in an overall success rate of 39% (28–50, 95% confidence interval). The median duration of objective response, overall success and median TTP were 59, 48 and 21 weeks, respectively. Toxicities were usually mild to moderate in severity, with hot flushes (21%), nausea (19%), dizziness (12%), weakness (12%), increased sweating (12%), androgenic symptoms (10%) and peripheral oedema (9%) as the most common side-effects. Only 2 pts (3%) discontinued treatment due to adverse events. These results are very promising considering that exemestane was administered as third- or fourth-line hormonal treatment in most cases and confirm previous observations about the lack of cross-resistance when steroidal aromatase inhibitors are sequenced with the non-steroidal aromatase inhibitor AG.</div>
</front>
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Third-line hormonal treatment with exemestane in postmenopausal patients with advanced breast cancer progressing on aminoglutethimide: a phase ii multicentre multinational study

Third-line hormonal treatment with exemestane in postmenopausal patients with advanced breast cancer progressing on aminoglutethimide: a phase ii multicentre multinational study

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Abstract

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