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Paragon (ANZGOG-0903): Phase 2 Study of Anastrozole in Women With Estrogen or Progesterone Receptor–Positive Platinum-Resistant or -Refractory Recurrent Ovarian Cancer
  1. Anthony Bonaventura, FRACP*,
  2. Rachel L. O'Connell, PhD,
  3. Cristina Mapagu, MB BS,§,
  4. Philip J. Beale, PhD,#,
  5. Orla M. McNally, FRCSI**,††,
  6. Linda R. Mileshkin, MD‡‡,
  7. Peter T. Grant, FRANZCOG§§,
  8. Alison M. Hadley, FRACP∥∥,¶¶,
  9. Jeffery C.H. Goh, FRACP∥∥,¶¶,
  10. Katrin M. Sjoquist, FRACP,
  11. Julie Martyn, PhD,
  12. Anna DeFazio, PhD,§,
  13. James Scurry, FRCPA##,*** and
  14. Michael L. Friedlander, AM, FRACP†††
  1. *Calvary Mater Newcastle, Newcastle;
  2. National Health and Medical Research Council Clinical Trials Centre and
  3. Westmead Institute for Medical Research, University of Sydney, Sydney;
  4. §Department of Gynaecological Oncology, Westmead Hospital, Westmead; and
  5. School of Medicine, Western Sydney University;
  6. Chris O’Brien Lifehouse; and
  7. #School of Medicine, University of Sydney, Sydney, New South Wales;
  8. **Royal Women’s Hospital;
  9. ††University of Melbourne;
  10. ‡‡Division of Cancer Medicine, Peter MacCallum Cancer Centre; and
  11. §§Mercy Hospital for Women, Melbourne, Victoria;
  12. ∥∥Royal Brisbane and Women’s Hospital and
  13. ¶¶School of Medicine, University of Queensland, Brisbane, Queensland; and
  14. ##Pathology North and
  15. ***Faculty of Health and Medicine, University of Newcastle, Newcastle; and
  16. †††Department of Medical Oncology, Prince of Wales Hospital, Sydney, New South Wales, Australia.
  1. Address correspondence and reprint requests to Michael L. Friedlander, AM, FRACP, Paragon Trial, NHMRC Clinical Trials Centre, Locked Bag 77, Camperdown, New South Wales 1450, Australia. E-mail: m.friedlander@unsw.edu.au.

Abstract

Background There is some evidence that a subset of patients with recurrent ovarian cancer may benefit from antiestrogen therapy. The Paragon study is a basket protocol that includes a series of phase 2 trials investigating the activity of anastrozole in patients with estrogen or progesterone receptor–positive recurrent gynecological cancers. We report the results of treatment in patients with platinum-resistant or -refractory recurrent epithelial ovarian cancer.

Methods Postmenopausal women who had estrogen and/or progesterone receptor–positive platinum-resistant or platinum-refractory recurrent ovarian cancer and disease measurable by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or GCIG (Gynecologic Cancer InterGroup) CA-125 criteria were eligible. Patients received anastrozole 1 mg daily until progression or unacceptable toxicity. The study was prospectively registered (ACTRN12610000796088).

Results There were 49 evaluable patients, and clinical benefit was observed in 13 (27%; 95% confidence interval [CI], 16%–40%). There were no complete or partial RECIST version 1.1 responses. Clinical benefit was associated with higher global quality-of-life scores. Median progression-free survival was 2.7 months (95% CI, 2.0–2.8 months). The median duration of clinical benefit was 2.8 months (95% CI, 2.6–5.7 months). Most patients (83%) progressed within 6 months. Seven patients continued on treatment for longer than 6 months. Anastrozole was well tolerated in most patients. Subgroup analysis suggested greater clinical benefit in patients with tumors with estrogen-receptor histoscore of more than 200, but this difference was not statistically significant.

Conclusions A subset of patients with estrogen- or progesterone-positive platinum-resistant or platinum-refractory recurrent epithelial ovarian cancers derives clinical benefit from anastrozole, with acceptable toxicity. The challenge remains how to identify them.

  • Anastrozole
  • Epithelial ovarian cancer
  • Hormone-responsive ovarian cancer
  • Platinum-resistant ovarian cancer

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Footnotes

  • The authors declare no conflicts of interest.

  • The study was funded by grants from Cancer Australia (grant 632740) and Priority-driven Collaborative Cancer Research (scheme 1063014). Anastrozole was provided by AstraZeneca.

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