Exemestane Is Superior to Megestrol Acetate After Tamoxifen Failure in Postmenopausal Women With Advanced Breast Cancer: Results of a Phase III Randomized Double-Blind Trial

Kaufmann, M.; Bajetta, Emilio; Dirix, Luc; Fein, Luis; Jones, Stephen E.; Zilembo, Nicoletta; Dugardyn, Jean-Louis; Nasurdi, Cristina; Mennel, Robert G.; Červek, Jožica; Fowst, Camilla; Polli, Anna; Salle, E. Di; Arkhipov, Alexei; Piscitelli, G.; Miller, Langdon L.; Massimini, Giorgio

doi:10.1200/jco.2000.18.7.1399

Cited by 497 publications

(214 citation statements)

References 20 publications

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“…All patients taking part in these trials had chemotherapy-resistant EOC and therefore represent a group with a poor prognosis. Similar results were reported in breast cancer patients with visceral metastases who received anastrazole (RR, 7%-14%) or exemestane (RR, 13.5%-25%) [82][83][84][85]. Endocrine treatment in breast cancer is generally more beneficial for patients with soft tissue metastases or low-volume disease.…”

Section: Discussionsupporting

confidence: 72%

Revisiting the Role of Antiandrogen Strategies in Ovarian Cancer

et al. 2011

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After completing this course, the reader will be able to:1. Explain the role of the androgen axis in the development of ovarian cancer.2. Discuss the potential compounds with anti-androgen activity that can be assessed for the treatment of patients with ovarian cancer.This article is available for continuing medical education credit at CME.TheOncologist.com. CME CME ABSTRACTAndrogen receptors are frequently expressed in epithelial ovarian cancer (EOC). Their role in the development of EOC is not fully understood. In the present review we first discuss the epidemiological data linking a hyperandrogen state to a higher risk for ovarian cancer, second describe in vitro studies of the role of androgens in influencing the growth of EOC, and finally review the completed clinical trials with compounds that exploit the androgen axis in patients with ovarian cancer. The therapeutic approaches that inhibit androgen signaling have so far produced only modest response rates. In the light of new data regarding the role of androgen stimulation in the evolution of EOC and the emergence of new compounds used for the treatment of other hormone-driven malignancies, such as prostate and breast cancer, we provide suggestions for new studies of antiandrogen therapeutics in the treatment of EOC. A specific example is the new agent abiraterone. In addition, we propose a panel of molecules that could be assessed as potential biomarkers that may aid patient selection for this approach in the future. The Oncologist

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Section: Discussionsupporting

confidence: 72%

Revisiting the Role of Antiandrogen Strategies in Ovarian Cancer

et al. 2011

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“…Another compassionate-use study in Belgium has reported that 26.4% of patients with VM achieved CB following fulvestrant treatment [15]. With regard to exemestane, a previous Phase III trial evaluating this agent versus megestrol acetate found that CB rates were higher with exemestane (36.3%) than with megestrol acetate (30.0%) in patients with VM, although the difference was not significant [4]. In addition, a recent case series where exemestane was given following several prior therapies, including non-steroidal AIs, described a CB rate of 33.0% for patients with visceral involvement [10].…”

Section: Discussionmentioning

confidence: 99%

“…In a subgroup analysis of combined data from these trials, both agents demonstrated similar activity in patients with VM, with objective response and clinical benefit (CB) endpoints favouring fulvestrant, although the differences between treatments were not statistically significant [6]. In another double-blind, randomised Phase III trial comparing exemestane versus megestrol acetate (Megace TM ) after tamoxifen failure, exemestane demonstrated better activity than megestrol acetate in patients with VM [4].…”

Section: Introductionmentioning

confidence: 99%

“…Phase III clinical trials of endocrine treatments for patients with VM have been mainly limited to patients with visceral disease that is not rapidly progressing or symptomatic [4][5][6]. Analyses of treatment benefit in this subgroup of patients are important, as they provide insights into the usefulness of endocrine therapy as an alternative to chemotherapy in this clinical setting.…”

Section: Introductionmentioning

confidence: 99%

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Activity of fulvestrant versus exemestane in advanced breast cancer patients with or without visceral metastases: data from the EFECT trial

Mauriac

Romieu²,

Bines

2008

Breast Cancer Res Treat

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Purpose Patients with visceral metastases (VM: lung and/or liver metastases) are generally regarded as being less responsive to hormonal therapy, and chemotherapy often becomes the default treatment. This paper reports a subgroup analysis from EFECT (The Evaluation of Faslodex versus Exemestane Clinical Trial) examining the efficacy of fulvestrant and exemestane in patients with or without VM. Methods EFECT is a randomised, doubleblind, multicentre, Phase III trial in postmenopausal women with advanced breast cancer progressing or recurring after prior non-steroidal aromatase inhibitor therapy. Results Overall, approximately 57% of patients in EFECT had visceral involvement. Fulvestrant and exemestane demonstrated clinical benefit in 29.1% and 27.2% of patients with VM, respectively. Median duration of response was 13.5 vs 10.8 months and median duration of clinical benefit was 9.9 vs 8.1 months, respectively. Conclusions These results encourage the use of endocrine agents such as fulvestrant in treating patients with advanced breast cancer and VM.

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“…[9,10]. Kituose veikaluose [11,12] aprašyta, kad, šios grupės pacientams skyrus hormonų terapiją AI, periodas iki progresavimo buvo ilgas.…”

Section: Svarstymasunclassified

Metastazavusio Krūties Vėžio Gydymas Tik Geriamaisiais Chemoterapijos Ir Hormonų Terapijos Preparatais

Timovskaja¹,

Zotovas²,

Anikusko³

2017

Medicinos Teorija Ir Praktika

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SANTRAUKAReikšminiai žodžiai: metastazavęs krūties vėžys, paliatyvi citostatinė terapija, chemoterapija ir hormonų terapija, periodo be progresavimo trukmė, tegafuras, anastrozolas. Tyrimo tikslas. Palyginti įvairių paliatyvios terapijos schemų efektyvumą, tablečių formos preparatų skyrus hormonų receptorių teigiamam, HER-2/neu neigiamam metastazavusiam krūties vėžiui (MKV) gydyti. Objektas ir metodai. Veikale pateikti 81 MKV sergančios pacientės gydymo rezultatai. Atsitiktinės atrankos būdu tiriamosios buvo suskirstytos į tris grupes ir joms buvo skirta tik tablečių formos preparatų. Pirmosios grupės (A) pacientėms buvo skirta paliatyvi hormonų terapija -aromatazės inhibitoriaus (AI) anastrozolo po 1 mg kasdien. Vieną šios grupės terapijos kursą sudarė 21 diena. Antrosios grupės (C+Ca) pacientėms buvo skirta kapecitabino (2 500 mg/m 2 per parą nuo 8 iki 21 dienos) ir ciklofosfamido (100 mg kasdien nuo 1 iki 14 dienos), esant 21 dienos terapijos ciklui. Trečiosios grupės (T+A) pacientėms buvo skirta tegafuro (1 200-1 600 mg/parą (3-4 kapsulės per parą)) nuo 1 iki 14 dienos (esant 21 dienos terapijos ciklui), derinant su kasdien po 1 mg vartojamu anastrozolu. Buvo nustatoma periodo trukmė be ligos progresavimo -laikas nuo tyrime taikomo gydymo pradžios iki navikinio proceso progresavimo požymių atsiradimo gydant (pagal Kaplano-Mejerio metodą) -ir tiriamos toksinės paskirtos terapijos apraiškos. Rezultatai. Vidutinė periodo be ligos progresavimo trukmė, kartu skyrus chemoterapijos ir hormonų terapijos preparatų tegafuro ir anastrozolo, buvo ilgesnė (15,3 ± 2,1 mėn.) nei skyrus vien tik hormonų terapijos preparato anastrozolo (9,4 ± 1,1 mėn.) arba citostatiko kapecitabino ir ciklofosfamido tablečių derinio (10,0 ± 1,2 mėn.). Pagal Kaplano-Mejerio metodą nustatytas išgyvenamumas be recidyvo buvo geresnis kartu skyrus chemoterapijos ir hormonų terapijos preparatų tegafuro ir anastrozolo nei skyrus tik anastrozolo arba ciklofosfamido ir kapecitabino derinio (p ≤ 0,005). Nepageidaujamų reiškinių dažnis vartojant įvairių paliatyvios terapijos tablečių formos preparatų buvo beveik toks pat. Pasireiškė I-II laipsnio toksinio poveikio nepageidaujamų reiškinių. Išvados. Paliatyvi tablečių formos chemoterapija ir hormonų terapija yra efektyvus hormonų receptorių teigiamo, HER-2/ neu neigiamo MKV gydymo būdas dėl pakankamo efektyvumo, priimtino toksinio poveikio profilio ir galimybės ilgai vartoti preparatus ambulatorinėmis sąlygomis. ABSTRACTKey words: recurrent breast cancer, palliative therapy, cytostatic therapy, chemoendocrine therapy, therapy with tegafur, anastrozole. Aim of the study was to compare the effectiveness of different regimes of palliative therapy using tablet forms of drugs in patients with hormon-dependant Her-2/neu negative recurrent breast cancer who were randomised to three groups and treated exclusively with tablet forms of drugs form of drugs. The first group (A) of patients got palliative endocrine therapy with aromatase inhibitor anastrozole 1 mg daily. For one course of the therapy in this group o...

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Exemestane Is Superior to Megestrol Acetate After Tamoxifen Failure in Postmenopausal Women With Advanced Breast Cancer: Results of a Phase III Randomized Double-Blind Trial

Abstract: EXE prolongs survival time, time to tumor progression, and time to treatment failure compared with MA and offers a well-tolerated treatment option for postmenopausal women with progressive advanced breast cancer who experienced failure of tamoxifen.

Cited by 497 publications

References 20 publications

Revisiting the Role of Antiandrogen Strategies in Ovarian Cancer

Revisiting the Role of Antiandrogen Strategies in Ovarian Cancer

Activity of fulvestrant versus exemestane in advanced breast cancer patients with or without visceral metastases: data from the EFECT trial

Metastazavusio Krūties Vėžio Gydymas Tik Geriamaisiais Chemoterapijos Ir Hormonų Terapijos Preparatais

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