Poster Presentation COSA 2015 ASM

PARAGON- An ANZGOG Phase 2 study of anastrazole in asymptomatic women with estrogen (ER)/ progesterone (PR) positive ovarian cancer with a CA125 progression after first line treatment. (#186)

Philip Beale 1 , Rachel O'Connell 2 , Katrin Sjoquist 2 , Julie Martyn 2 , David Cannon 2 , Tony Bonaventura 3 , Peter Grant 4 , Jeffrey Goh 5 , Yoland Antill 6 , Michael Friedlander 7 8 , Jim Scurry 9
  1. Chris O'Brien Lifehouse, Sydney, Australia
  2. NHMRC Clinical Trials Centre, Camperdown, NSW, Australia
  3. Calvary Mater Newcastle, Newcastle, NSW, Australia
  4. Mercy Hospital for Women, Melbourne, Victoria, Australia
  5. Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia
  6. Franston Hospital, Melbourne, Victoria, Australia
  7. Prince of Wales Hospital, Sydney, NSW, Australia
  8. ANZGOG- Australia New Zealand Gynaecological Oncology Group, Sydney, NSW, Australia
  9. JHH, Stockton, NSW

Background The aim of PARAGON is to investigate the activity of anastrozole, in patients with ER/ PR positive metastatic gynaecological cancers in a series of 7 individual phase 2 studies embedded in an “umbrella” protocol. The primary end point is clinical benefit at 3 months- complete response (CR), partial response (PR) and stable disease (SD). Secondary endpoints include time to progression, quality of life and toxicity. Hormonal therapy is a well-tolerated and an attractive option when the objective of treatment is to delay time to symptomatic progression.

Methods We recruited 54 asymptomatic postmenopausal women with ER/ PR positive ovarian cancer with GCIG defined CA125 progression and small volume disease after completion of first line treatment. Patients received anastrozole until progression or unacceptable toxicity.

Results 53 patients were evaluable .The clinical benefit (CR/ PR/ SD) at 3 months was 33.3% (95% CI, 22- 47%). 7.8% of patients had symptomatic progression. Progression was based on RECIST/ GCIG CA125 criteria. The median PFS was 2.7 months. Median duration of clinical benefit was 6.5 months. 6 patients remain progression free on treatment and 7 patients have received treatment for more than 6 months. Two patients stopped treatment due to arthralgia.

Conclusion A subset of patients with a rising CA125 after completion of first line treatment derived clinical benefit with anastrozole with acceptable toxicity. The PFS is similar to that reported in similarly designed studies. TRANS-PARAGON will investigate predictors of response.