Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial

Placido, Sabino De; Gallo, Ciro; Laurentiis, Michelino De; Bisagni, Giancarlo; Arpino, Grazia; Sarobba, Maria Giuseppa; Riccardi, Ferdinando; Russo, Antonio; Mastro, Lucia Del; Cogoni, Alessio Aligi; Cognetti, Francesco; Gori, Stefania; Foglietta, Jennifer; Frassoldati, Antonio; Amoroso, Domenico; Laudadio, Lucio; Moscetti, Luca; Montemurro, Filippo; Verusio, Claudio; Bernardo, Antônio; Lorusso, Vito; Gravina, Adriano; Moretti, G; Lauria, Rossella; Lai, A.; Mocerino, Carmela; Rizzo, Sérgio; Nuzzo, Francesco; Carlini, Paolo; Perrone, Francesco; Accurso, Antonello; Agostara, Biagio; Aieta, Michele; Alabiso, Oscar; Alicicco, Maria Grazia; Amadori, Dino; Amaducci, Laura; Amiconi, Gianna; Antuzzi, Giustino; Ardine, Mara; Ardizzoia, Antonio; Aversa, Caterina; Badalamenti, Giuseppe; Barni, Sandro; Basurto, C; Berardi, Rossana; Bergamasco, Cinzia; Bidoli, Paolo; Bighin, Claudia; Biondi, Edoardo; Boni, C.; Borgonovo, Karen; Botta, Mario; Bravi, Stefano; Bruzzi, Paolo; Buono, Giuseppe; Butera, Alfredo; Caldara, A.; Candeloro, Giampiero; Cappelletti, C.; Cardalesi, Cinzia; Carfora, E; Cariello, Anna; Carrozza, Francesco; Cartenì, Giacomo; Caruso, Michele; Casadei, Virginia; Casanova, Cláudia; Castori, L.; Cavanna, Luigi; Cavazzini, Giovanna; Cazzaniga, M.; Chilelli, Mario Giovanni; Chiodini, Paolo; Chiorrini, Silvia; Ciardiello, Fortunato; Ciccarese, Mariangela; Cinieri, Saverio; Clerico, Mario; Coccaro, Mariarosa; Comandè, Mario; Corbo, Claudia; Cortino, G.; Cusenza, Stefania; Daniele, Gennaro; D’Arco, Alfonso Maria; D’Auria, G.; Dazzi, Claudio; Angelis, Carmine De; Braud, Filippo de; Feo, Gianfranco De; Matteis, A. De; Tursi, Michele De; Blasio, Anna Di; Lucca, Giuseppe Di; Lullo, Liberato Di; Rella, Francesca Di; Renzo, Gianfranco Di; Stefano, P. Di; Stefano, Aida Di; Diana, Anna; Donati, Sara; Fabbri, Agnese; Fabi, Alessandra; Faedi, Marina; Farina, Gabriella; Farris, A.; Febbraro, Antonio; Fedele, Palma; Federico, Piera; Ferraú, Francesco; Ferretti, Gianluigi; Ferro, Antonella; Floriani, Irene; Forcignanò, R.; Forciniti, Samantha; Forestieri, Valeria; Fornari, Gianni; Frisinghelli, M.; Fusco, Vittorio; Gallizzi, Giulia; Galvano, Antonio; Gambardella, A.; Gambi, Angelo; Gebbia, Vittorio; Gervasi, Erika; Ghilardi, Mara; Giacobino, Alice; Giardina, G; Giotta, Francesco; Giraudi, S.; Giuliano, Mario; Grassadonia, Antonino; Grasso, Donatella; Grosso, Federica; Guizzaro, Lorenzo; Incoronato, Pasquale; Incorvaia, Lorena; Iodice, Giovanni; Verde, Nicla La; Labonia, V.; Landi, G.; Latorre, Agnese; Leonardi, V.; Levaggi, Alessia; Limite, Gennaro; Bascialla, L.; Livi, Lorenzo; Maiello, Evaristo; Mandelli, D; Marcon, Ilaria; Menon, Daniela; Montedoro, Michele; Moraca, Lucia; Moretti, Anna; Morritti, Maria; Morselli, Patrizia; Mura, Antonella; Mura, Silvia; Musacchio, Michela; Muzio, Alberto; Natale, D.; Natoli, Clara; Nigro, Cinzia; Nisticò, Cecilia; Nuzzo, Antonio; Orditura, Michele; Orlando, Laura; Pacilio, Carmen; Palumbo, Giuliano; Palumbo, R.; Pasini, Felice; Paternò, Emanuela; Pazzola, Antonio; Pelliccioni, Silvia; Pensabene, Matilde; Perroni, D.; Gritti, Angela; Petrelli, Fausto; Piccirillo, Maria Carmela; Pinotti, Graziella; Pogliani, C.; Poli, Davide; Prader, Sonia; Recchia, F.; Rizzi, Daniele; Romano, Carmen; Rossello, Rosalba; Rossini, Chiara; Salvucci, G.; Sanna, Valeria; Santini, Alessandra; Saracchini, Silvana; Savastano, Clementina; Scambia, Giovanni; Schettini, Francesco; Schiavone, P.; Schirone, Alessio; Seles, E.; Signoriello, Simona; Signoriello, Giuseppe; Silva, Rosa Rita; Silvestri, Antonia; Simeon, Vittorio; Spagnoletti, Ilaria; Tamberi, Stefano; Teragni, Cristina; Thalmann, Verena; Thomas, R.; Thomas, Guglielmo; Tienghi, A.; Tinari, Nicola; Tinessa, Vincenza; Tomei, Federica; Tonini, Giuseppe; Torri, Valter; Traficante, Divina; Tudini, Marianna; Turazza, Monica; Vignoli, Roberto; Vitale, Maria Giuseppa; Zacchia, Alessandra; Zagarese, Pasquale; Zanni, Alda; Zavallone, Laura; Zavettieri, M.; Zoboli, Alessandra

doi:10.1016/s1470-2045(18)30116-5

Cited by 66 publications

(47 citation statements)

References 26 publications

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“…Approximately 40% of women with newly diagnosed breast cancer are Asians [1] but the evidence regarding the occurrence of AI-associated musculoskeletal problems among Asians is scarce. The majority of the clinical trials [3,4,10] recruited a few or small proportions of Asian participants. Three small, single-group observational studies (n < 400) from Japan found that 35% to 72% of AI users reported joint pain [9,11,12].…”

Section: Introductionmentioning

confidence: 99%

“…Compared to women with breast cancer in Western countries, Asian women with breast cancer have different characteristics (e.g., younger-onset age) [13], responses, and tolerability to the treatment [14]. The First Adjuvant Trial on All Aromatase Inhibitors (FATA-GIM3 trial) [10] found that the use of AIs for five years was not superior to the use of tamoxifen for two years followed by three years of AI use, and the three AIs had similar efficacy in 5-year disease-free survival and overall survival. Larger studies examining the safety of AI therapy in Asian populations are needed to inform and improve patient care for individuals with breast cancer.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Aromatase Inhibitors and Risk of Arthritis and Carpal Tunnel Syndrome among Taiwanese Women with Breast Cancer: A Nationwide Claims Data Analysis

Chien

Yang

Kwoh

et al. 2020

JCM

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Tamoxifen or aromatase inhibitor (AI) therapy may prevent breast cancer recurrence, however, adverse effects may lead to treatment discontinuation. Evidence regarding the occurrence of AI-associated musculoskeletal problems among Asians is scarce. We identified women with breast cancer-initiating tamoxifen or AIs from the Taiwan National Health Insurance Research Database (2007–2012). Using multivariable cause-specific hazard models, we examined the association between endocrine therapy and the risk of any arthritis and carpal tunnel syndrome, adjusting for age, prior cancer treatment, and other health status factors. Among 32,055 eligible women with breast cancer (mean age = 52.6 ± 11.5 years), 87.4% initiated tamoxifen, 3.9% initiated anastrozole, 8.0% initiated letrozole, and 0.7% initiated exemestane. AI users had a higher 1-year cumulative incidence for any arthritis (13.0% vs. 8.2%, p < 0.0001) and carpal tunnel syndrome (1.4% vs. 0.8%, p = 0.008). Compared to tamoxifen users, AI users had a higher risk of any arthritis [adjusted hazard ratio (aHR) = 1.21, 95%CI = 1.09–1.34] and carpal tunnel syndrome (aHR = 1.68, 95%CI = 1.22–2.32). No significant difference was observed in the risks of any arthritis and carpal tunnel syndrome across different AIs. Taxane use was not associated with any arthritis (aHR = 0.92, 95%CI = 0.81–1.05) or carpal tunnel syndrome (aHR = 0.97, 95%CI = 0.67–1.40) compared to other chemotherapies. Taiwanese women with breast cancer-initiating AIs had an increased risk of arthritis and carpal tunnel syndrome compared to those who initiated tamoxifen.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Aromatase Inhibitors and Risk of Arthritis and Carpal Tunnel Syndrome among Taiwanese Women with Breast Cancer: A Nationwide Claims Data Analysis

Chien

Yang

Kwoh

et al. 2020

JCM

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“…Aromatase inhibitors (AI) are another therapeutic option for patients with endometriosis. Third‐generation AIs, such as anastrozole, letrozole and exemestane, are currently used widely for postmenopausal patients with hormone‐dependent breast cancers . Side‐effects of the AI include vaginal dryness, hot flushes, headache, numbness in lower extremities and arthralgia.…”

Section: Aromatase‐targeting Treatment In Endometriosismentioning

confidence: 99%

“…Thirdgeneration AIs, such as anastrozole, letrozole and exemestane, are currently used widely for postmenopausal patients with hormone-dependent breast cancers. 56 Side-effects of the AI include vaginal dryness, hot flushes, headache, numbness in lower extremities and arthralgia. It is considered that AI are likely to maintain low estrogen levels in extraovarian sites during the treatment.…”

Section: Aromatase-targeting Treatment In Endometriosismentioning

confidence: 99%

Aromatase as a target for treating endometriosis

Mori

Ito

Koshiba

et al. 2018

J of Obstet and Gynaecol

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Endometriosis is a common gynecological disease that causes various clinical symptoms, such as chronic pelvic pain, dysmenorrhea and infertility, seriously affecting women's health and their quality of life. The symptoms and endometriotic lesions are relieved, in many cases, after menopause, when estrogen levels are lowered. Therefore, endometriosis is considered to be estrogen-dependent. Aromatase, the enzyme responsible for the last step of estrogen biosynthesis converting testosterone and androgen to estrogen, was previously reported to be more abundant in endometriotic tissues than in the normal endometrium, leading to an increased local estrogen concentration. Therefore, aromatase is considered a key therapeutic target for regulating local estrogen biosynthesis in endometriosis. A more complete understanding of the mechanisms that modulate aromatase and its activity is required to develop novel estrogen-targeted therapies for endometriosis. In this review article, we outline the current understanding of the pathological processes involved in estrogen production in endometriosis and propose novel strategies to treat this disorder.

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“…Several studies indicate that breast cancer is a risk factor to produce death in worldwide [1][2][3]; there are several drugs for the treatment of some of this disease such as tamoxifen (estrogen antagonist) [4], anastrozole, letrozole or exemetane (aromatase inhibitors) [5][6][7], fisetin or methyl paraben (17β-hydroxysteroid dehydrogenase type 1 inhibitors) [8,9]; however some these drugs can produce secondary effects such as secondary endometrial cancer [10] and bone loss [11]. In the search a new therapeutic alternative, several compounds have been developed for treatment of breast cancer.…”

Section: Introductionmentioning

confidence: 99%

Synthesis and theoretical activity of three steroid-derivatives on both aromatase and 17β-hydroxysteroid dehydrogenase Type 1 enzymes

2019

Biointerface Res Appl Chem

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Breast cancer is the most common malignancy in the worldwide. It is noteworthy, that several drugs are used for cancer breast; nevertheless, some these drugs can produce secondary effects such as changes in blood pressure, bone loss and others. The objective of this investigation was synthesizing three steroid derivatives (compounds 4, 5 and 6) to evaluate their theoretical activity against both aromatase (2W3D) and 17β-Hydroxysteroid dehydrogenase Type 1 (3BH4) enzymes using fisetin and exemestane as control in a docking model. The data found indicate that compound 5 could exert a greater interaction with the 2WD4 and 3BH4 proteins in comparison with fisetin, exemestane and compounds 4 or 6. In conclusion, this compound could be a good candidate as both aromatase and 17β-hydroxysteroid dehydrogenase enzymes inhibitor.

show abstract

Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial

Cited by 66 publications

References 26 publications

Aromatase Inhibitors and Risk of Arthritis and Carpal Tunnel Syndrome among Taiwanese Women with Breast Cancer: A Nationwide Claims Data Analysis

Aromatase Inhibitors and Risk of Arthritis and Carpal Tunnel Syndrome among Taiwanese Women with Breast Cancer: A Nationwide Claims Data Analysis

Aromatase as a target for treating endometriosis

Synthesis and theoretical activity of three steroid-derivatives on both aromatase and 17β-hydroxysteroid dehydrogenase Type 1 enzymes

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