A phase II trial of abiraterone acetate plus prednisone in patients with triple-negative androgen receptor positive locally advanced or metastatic breast cancer (UCBG 12-1)
2016; Elsevier BV; Volume: 27; Issue: 5 Linguagem: Inglês
10.1093/annonc/mdw067
ISSN1569-8041
AutoresHervé Bonnefoi, Thomas Grellety, Olivier Trédan, Mahasti Saghatchian, Florence Dalenc, Audrey Mailliez, T. L'Haridon, Paul Cottu, Sophie Abadie‐Lacourtoisie, Benoît You, M Mousseau, Jérôme Dauba, Francesco Del Piano, Isabelle Desmoulins, Florence Coussy, Nicolas Madranges, Julien Grenier, François‐Clément Bidard, Charlotte Proudhon, Gaëtan MacGrogan, C. Orsini, M. Pulido, Anthony Gonçalves,
Tópico(s)Breast Cancer Treatment Studies
ResumoSeveral 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 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.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.AA plus prednisone treatment is beneficial for some patients with molecular apocrine tumours and five patients are still on treatment.NCT01842321.
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