H Bonnefoi1, T Grellety2, O Tredan3, M Saghatchian4, F Dalenc5, A Mailliez6, T L'Haridon7, P Cottu8, S Abadie-Lacourtoisie9, B You10, M Mousseau11, J Dauba12, F Del Piano13, I Desmoulins14, F Coussy15, N Madranges2, J Grenier16, F C Bidard8, C Proudhon8, G MacGrogan17, C Orsini18, M Pulido19, A Gonçalves20. 1. Department of Medical Oncology, Institut Bergonié Unicancer, Univ. Bordeaux, INSERM U916, INSERM CIC1401, Bordeaux h.bonnefoi@bordeaux.unicancer.fr. 2. Department of Medical Oncology, Institut Bergonié Unicancer, Univ. Bordeaux, INSERM U916, INSERM CIC1401, Bordeaux. 3. Department of Medical Oncology, Centre Léon Bérard, Lyon. 4. Department of Medical Oncology, Breast Cancer Unit, Gustave Roussy, Villejuif. 5. Department of Medical Oncology, Institut Claudius Regaud, IUCT-Oncopole, Toulouse. 6. Department of Breast Cancer, Centre Oscar Lambret, Lille. 7. Department of Medical Oncology, Centre Hospitalier Départemental Vendée, La Roche sur Yon. 8. Department of Medical Oncology, Institut Curie, PSL Research University, Paris. 9. Department of Medical Oncology, Centre Paul Papin, Angers. 10. Department of Medical Oncology, Teaching Hospital, Lyon-Sud University, Lyon. 11. Department of Medical Oncology, CHU Grenoble, Grenoble. 12. Department of Medical Oncology, Centre Hospitalier Layné, Mont-de-Marsan. 13. Department of Gynecologic Surgery, Hôpital du Leman, Thonon-Les-Bains. 14. Department of Medical Oncology, Centre GF Leclerc, Dijon. 15. Department of Medical Oncology, Institut Curie, St Cloud. 16. Department of Medical Oncology, Institut Sainte-Catherine, Avignon. 17. Department of Pathology, Institut Bergonié, INSERM U916, Bordeaux. 18. UNICANCER R&D, Paris. 19. Clinical and Epidemiological Research Unit, Institut Bergonié, INSERM CIC1401, Bordeaux. 20. Department of Medical Oncology, Institut Paoli-Calmettes, Cancer Research Center of Marseille, INSERM U7258, CNRS U1068, Aix-Marseille Université, Marseille, France.
Abstract
BACKGROUND: Several expression array studies identified molecular apocrine breast cancer (BC) as a subtype that expresses androgen receptor (AR) but not estrogen receptor α. We carried out a multicentre single-arm phase II trial in women with AR-positive, estrogen, progesterone receptor and HER2-negative (triple-negative) metastatic or inoperable locally advanced BC to assess the efficacy and safety of abiraterone acetate (AA) plus prednisone. PATIENTS AND METHODS: Patients with a metastatic or locally advanced, centrally reviewed, triple-negative and AR-positive (≥10% by immunohistochemistry, IHC) BC were eligible. Any number of previous lines of chemotherapy was allowed. AA (1000 mg) was administered once a day with prednisone (5 mg) twice a day until disease progression or intolerance. The primary end point was clinical benefit rate (CBR) at 6 months defined as the proportion of patients presenting a complete response (CR), partial response (PR) or stable disease (SD) ≥6 months. Secondary end points were objective response rate (ORR), progression-free survival (PFS) and safety. RESULTS: One hundred and forty-six patients from 27 centres consented for IHC central review. Of the 138 patients with sufficient tissue available, 53 (37.6%) were AR-positive and triple-negative, and 34 of them were included from July 2013 to December 2014. Thirty patients were eligible and evaluable for the primary end point. The 6-month CBR was 20.0% [95% confidence interval (CI) 7.7%-38.6%], including 1 CR and 5 SD ≥6 months, 5 of them still being under treatment at the time of analysis (6.4+, 9.2+, 14.5+, 17.6+, 23.4+ months). The ORR was 6.7% (95% CI 0.8%-22.1%). The median PFS was 2.8 months (95% CI 1.7%-5.4%). Fatigue, hypertension, hypokalaemia and nausea were the most common drug-related adverse events; the majority of them being grade 1 or 2. CONCLUSIONS: AA plus prednisone treatment is beneficial for some patients with molecular apocrine tumours and five patients are still on treatment. CLINICALTRIALSGOV: NCT01842321.
BACKGROUND: Several expression array studies identified molecular apocrine breast cancer (BC) as a subtype that expresses androgen receptor (AR) but not estrogen receptor α. We carried out a multicentre single-arm phase II trial in women with AR-positive, estrogen, progesterone receptor and HER2-negative (triple-negative) metastatic or inoperable locally advanced BC to assess the efficacy and safety of abiraterone acetate (AA) plus prednisone. PATIENTS AND METHODS: Patients with a metastatic or locally advanced, centrally reviewed, triple-negative and AR-positive (≥10% by immunohistochemistry, IHC) BC were eligible. Any number of previous lines of chemotherapy was allowed. AA (1000 mg) was administered once a day with prednisone (5 mg) twice a day until disease progression or intolerance. The primary end point was clinical benefit rate (CBR) at 6 months defined as the proportion of patients presenting a complete response (CR), partial response (PR) or stable disease (SD) ≥6 months. Secondary end points were objective response rate (ORR), progression-free survival (PFS) and safety. RESULTS: One hundred and forty-six patients from 27 centres consented for IHC central review. Of the 138 patients with sufficient tissue available, 53 (37.6%) were AR-positive and triple-negative, and 34 of them were included from July 2013 to December 2014. Thirty patients were eligible and evaluable for the primary end point. The 6-month CBR was 20.0% [95% confidence interval (CI) 7.7%-38.6%], including 1 CR and 5 SD ≥6 months, 5 of them still being under treatment at the time of analysis (6.4+, 9.2+, 14.5+, 17.6+, 23.4+ months). The ORR was 6.7% (95% CI 0.8%-22.1%). The median PFS was 2.8 months (95% CI 1.7%-5.4%). Fatigue, hypertension, hypokalaemia and nausea were the most common drug-related adverse events; the majority of them being grade 1 or 2. CONCLUSIONS: AA plus prednisone treatment is beneficial for some patients with molecular apocrine tumours and five patients are still on treatment. CLINICALTRIALSGOV: NCT01842321.
Authors: Cody J Peer; Keith T Schmidt; Jessica D Kindrick; Joel R Eisner; Victoria V Brown; Edwina Baskin-Bey; Ravi Madan; William D Figg Journal: Cancer Chemother Pharmacol Date: 2019-07-31 Impact factor: 3.333
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