Principal results of the cancer of the ovary abiraterone trial (CORAL): A phase II study of abiraterone in patients with recurrent epithelial ovarian cancer (CRUKE/12/052)

Date

07 Oct 2016

Session

Gynaecological cancers

Presenters

Susana Banerjee

Citation

Annals of Oncology (2016) 27 (6): 1-36. 10.1093/annonc/mdw435

Authors

S. Banerjee1, L. Kilburn2, R. Bowen3, H. Tovey2, M. Hall4, S. Kaye1, G. Rustin4, M. Gore1, J. McLachlan1, A. Attygalle5, N. Tunariu6, J.P. Lima1, P. Chatfield2, L. Jeffs2, E. Folkerd7, M. Hills8, S. Perry2, G. Attard9, M. Dowsett10, J. Bliss2

Author affiliations

  • 1 Gynaecology Unit, The Royal Marsden NHS Foundation Trust, SM2 5PT - Sutton/GB
  • 2 Clinical Trials And Statistics Unit, Institute of Cancer Research ICR, SM2 5NG - London/GB
  • 3 Department Of Oncology, Royal United Hospitals Bath NHS Foundation Trust, Bath/GB
  • 4 Medical Oncology, Mount Vernon Cancer Centre, HA6 2RN - Northwood/GB
  • 5 Histopathology, Royal Marsden Hospital NHS Foundation Trust, London/GB
  • 6 Radiology, Royal Marsden Hospital NHS Foundation Trust, SW36JJ - London/GB
  • 7 The Ralph Lauren Centre For Breast Cancer Research, Institute of Cancer Research ICR, SW36JJ - London/GB
  • 8 The Ralph Lauren Centre For Breast Cancer Research, Royal Marsden Hospital NHS Foundation Trust, London/GB
  • 9 Centre For Molecular Pathology, Royal Marsden Hospital Institute of Cancer Research, SH2 5NG - Sutton/GB
  • 10 Centre For Molecular Pathology, The Royal Marsden NHS Foundation Trust, SM2 5PT - Sutton/GB
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Background

There is a need for more therapy options in recurrent epithelial ovarian cancer (EOC). Androgens bind to the androgen receptor (AR) which is commonly expressed in EOC. Abiraterone, a CYP17 inhibitor, irreversibly inhibits androgen biosynthesis and is widely used in prostate cancer. CORAL was designed to evaluate the clinical activity of abiraterone in EOC.

Methods

CORAL is a prospective, multi-centre, open-label, non-randomised, 2-stage phase II clinical trial. Eligible patients had disease progression within 12 months of last systemic therapy and no prior hormonal anti-cancer agents. Patients received abiraterone 1000mg daily plus 5 mg prednisone continuously until disease progression. The primary endpoint is objective response rate (ORR) according to combined RECIST/GCIG criteria at 12 weeks. Secondary endpoints include clinical benefit rate (CBR = ORR + stable) at 12 weeks. Tissue and blood samples were collected to explore the AR signalling pathway in EOC and identify patients most likely to benefit from abiraterone.

Results

42 patients were recruited (median age 65 (range 34-85) years; 83% high grade serous; median time since initial diagnosis 2.8 years (IQR 2-5) and 47% had ≥3 prior lines of therapy). Using a 10% cut-off, 29 (69%) patients were AR+. 10% had ≥ grade 3 hypokalaemia; 24% had dose delays and 0% dose reductions. ORR was 1/42 (2%). This 1 response was in an AR + , low grade serous EOC patient and lasted 47 weeks. CBR was 11/42 (26%) and 8/29 (28%) in AR+ patients; in 4 of these 29 (14%), disease control was prolonged ≥ 6 months. 1 patient continues on abiraterone.

Conclusions

CORAL is the first trial of a CYP17 inhibitor targeting the AR pathway in ovarian cancer patients. While ORR was low, a subset of patients achieved sustained clinical benefit and detailed characterisation of these patients is underway. Targeting AR in EOC including low grade serous cancer warrants further investigation.

Clinical trial identification

EudraCT Number: 2013-000293-29 (17-01-2013)

Legal entity responsible for the study

The Institute of Cancer Research/The Royal Marsden Hospital NHS Foundation Trust

Funding

Janssen Cilag Ltd

Disclosure

G. Attard: On the ICR "rewards to inventors" list for abiraterone acetate. Has received consulting fees and travel support from Janssen-Cilag and speakers' fees and grant support from Janssen. M. Dowsett: On the ICR "rewards to inventors" list for abiraterone acetate. All other authors have declared no conflicts of interest.

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