FACT: An Open-Label Randomized Phase III Study of Fulvestrant and Anastrozole in Combination Compared With Anastrozole Alone As First-Line Therapy for Patients With Receptor-Positive Postmenopausal Breast Cancer

Bergh, Jonas; Jönsson, Per‐Ebbe; Lidbrink, Elisabet; Trudeau, Maureen; Eiermann, W.; Brattström, Daniel; Lindemann, Justin P.O.; Wiklund, Fredrik; Henriksson, Roger

doi:10.1200/jco.2011.38.1095

Cited by 249 publications

(154 citation statements)

References 19 publications

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“…In one study (FACT), combination endocrine therapy was not superior to single-agent anastrozole (time to progression: HR, 0.99; 95% CI, 0.81-1.20; P=.91). 86 In the second study (S0226) by SWOG, PFS (HR, 0.80; 95% CI, 0.68-0.94; stratified log-rank P=.007) and OS (HR, 0.81; 95% CI, 0.65-1.00; stratified P=.049) were superior with combination anastrozole plus fulvestrant. 87 An unplanned subset analysis in this trial suggested that patients without prior adjuvant tamoxifen experienced the greatest benefit.…”

Section: First-line Endocrine Therapy For Metastatic Hormone Receptormentioning

confidence: 99%

NCCN Guidelines Insights: Breast Cancer, Version 1.2017

Gradishar¹,

Anderson

Balassanian

et al. 2017

J Natl Compr Canc Netw

396

346

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These NCCN Guidelines Insights highlight the important updates/changes to the surgical axillary staging, radiation therapy, and systemic therapy recommendations for hormone receptor-positive disease in the 1.2017 version of the NCCN Guidelines for Breast Cancer. This report summarizes these updates and discusses the rationale behind them. Updates on new drug approvals, not available at press time, can be found in the most recent version of these guidelines at NCCN.org.

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Section: First-line Endocrine Therapy For Metastatic Hormone Receptormentioning

confidence: 99%

NCCN Guidelines Insights: Breast Cancer, Version 1.2017

Gradishar¹,

Anderson

Balassanian

et al. 2017

J Natl Compr Canc Netw

396

346

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“…соответственно (р = 1,0). Причины расхождения результатов прохо-дят аналитическое рассмотрение, но от дальнейших исследований по комбинированному применению эндокринопрепаратов, одновременно воздейству-ющих на путь метаболизма эстрогенов, научное со-общество воздерживается [39].…”

Section: комбинированная терапияunclassified

Aromatase inhibitors of the third generation in endocrine therapy of breast cancer and endometrial cancer: the successes and failures of the combination therapy

Fadeeva

Павловна²,

Lisyanskaya

et al. 2016

Rev Clin Pharm Drug Ther

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Поступила в редакцию 12. 05.2016 Принята к печати 10. 06.2016 Ключевые слова:рак молочной железы; рак тела матки; лечение; ингибиторы ароматазы III поколения; тамоксифен. РезюмеОбзор обобщает современные данные клинических исследо-ваний, посвященных эффективности эндокринной терапии рака молочной железы и рака тела матки, включая эндоме- триальную стромальную саркому, ингибиторами аромата-зы (ИА) III поколения. В обзоре представлены данные кли-нических исследований, сравнивающих эффективность ИА и тамоксифена, а также данные о комбинированной терапии ИА с ингибиторами mTOR-пути (протокол BOLERO-2), с антиэстрогенами (протоколы SWOG S0226, FACT, FIRST), ингибитором CDK4/6 (протокол PALOMA-1) и другими пре-паратами. AROMATASE INHIBITORS OF THE THIRD GENERATION IN ENDOCRINE THERAPY OF BREAST CANCER AND ENDOMETRIAL CANCER: THE SUCCESSES AND FAILURES OF THE COMBINATION THERAPYKeywords:  breast cancer; endometrial cancer; therapy; aromatase inhibitors of III generation; tamoxifen. Abstract. This review provides the current evidence of clinical studies on the effectiveness of endocrine therapy for breast cancer and endometrial cancer, including endometrial stromal sarcoma, by aromatase inhibitor (AI) III generation. The review presents dates from clinical trials comparing the effectiveness of AI and tamoxifen, as well as dates on combination therapy AI with inhibitors of mTOR pathway (BOLERO-2 trial), an antiestrogen (SWOG S0226, FACT, FIRST trials), an inhibitor of CDK4 / 6 (PALOMA -1 trial) and other drugs. ВВЕДЕНИЕРак эндометрия (РЭ) представляет собой не толь-ко клиническую, но и социально-экономическую про-блему, так как инцидентность данного заболевания вместе с другими гормонально зависимыми опу-холями в Российской Федерации за последние не-сколько десятков лет увеличилась более чем в 2 раза, причем результаты лечения во многих регионах яв-ляются неудовлетворительными [1]. Новые техники хирургического лечения -активное тиражирование эндовидеохирургии -не улучшили отдаленные ре-зультаты лечения. В недавно выполненном под кон-тролем Gynecologic Oncology Group (GOG) проспек-

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“…18,19 The open-label, randomised, phase III Fulvestrant and Anastrozole Combination Therapy (FACT) trial found no clinical advantage with the combination of fulvestrant 250 mg plus anastrozole versus anastrozole alone. 21 In contrast, the Southwest Oncology Group (SWOG), in another open-label, randomised, phase III trial, reported results favouring this combination approach over anastrozole alone ( Table 2). 22 In this study, among women who had not received prior tamoxifen therapy, the median PFS was 12. greater antitumour activity than the 250 mg regimen.…”

Section: Fulvestrantmentioning

confidence: 99%

Endocrine Therapeutic Strategies for Patients with Hormone Receptor-positive Advanced Breast Cancer

Schmid¹

2017

European Oncology &Amp; Haematology

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Endocrine treatment constitutes the therapeutic backbone for patients with oestrogen and/or progesterone receptor-positive breast cancer unless there is visceral crisis or suspected or known endocrine resistance. Whether all patients who are suitable for endocrine therapy should receive combination therapy or whether there remains a role for single-agent endocrine therapy is yet to be determined. Cancer biology (ESR1 mutational status) and disease pattern determine the choice of single-agent endocrine treatment. Possibly, patients with low disease burden, slow progression and presumed endocrine sensitivity might still be considered for single-agent endocrine therapy, whereas patients with more aggressive disease including visceral metastases might benefit from combination therapy. Improved guidance on selection and sequencing of treatments should become available once overall survival (OS) and progression-free survival (PFS) data have been reported from the ongoing trials in breast cancer, principally, FALCON (NCT01602380), PALOMA-2 (NCT01740427) and MONALEESA-2 (NCT01958021), which include different patient groups and, probably, different endocrine sensitivity.

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FACT: An Open-Label Randomized Phase III Study of Fulvestrant and Anastrozole in Combination Compared With Anastrozole Alone As First-Line Therapy for Patients With Receptor-Positive Postmenopausal Breast Cancer

Abstract: Fulvestrant (250 mg + LD regimen) in combination with anastrozole offered no clinical efficacy advantage over anastrozole monotherapy in this population of individuals with a relatively high proportion of previous adjuvant antiestrogen exposure.

Cited by 249 publications

References 19 publications

NCCN Guidelines Insights: Breast Cancer, Version 1.2017

NCCN Guidelines Insights: Breast Cancer, Version 1.2017

Aromatase inhibitors of the third generation in endocrine therapy of breast cancer and endometrial cancer: the successes and failures of the combination therapy

Endocrine Therapeutic Strategies for Patients with Hormone Receptor-positive Advanced Breast Cancer

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