PARAGON: Phase II study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic gynecologic neoplasms: ANZGOG 0903.

Gynecologic Cancer
Session Type and Session Title: 
General Poster Session, Gynecologic Cancer
Abstract Number: 
J Clin Oncol 31, 2013 (suppl; abstr TPS5614)
Michael Friedlander, Katrin Marie Sjoquist, Dirkje Willemien Sommeijer, Lisa Bailey, Julie Martyn, Kim Gillies, Linda R. Mileshkin, Rachel O'Connel, Val Gebski, Michelle Margaret Vaughan, Penny Blomfield, Philip James Beale, Michael Quinn, Martin R. Stockler, Janine Margaret Lombard, Alison Maree Hadley, Frederic Amant, Richard J Edmondson, Australia New Zealand Gynaecological Oncology Group; Prince of Wales Hospital, Sydney, Australia; NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia; NHMRC Clinical Trials Centre, Sydney, Australia; NHMRC Clinical Trials Centre, University of Sydney, Camperdown, Australia; Peter MacCallum Cancer Center, Melbourne, Australia; Christchurch Hospital, Christchurch, New Zealand; Royal Hobart Hospital, Hobart, Australia; Sydney Cancer Centre, Sydney, Australia; Royal Women's Hospital, Melbourne, Australia; Calvery Mater Hospital, New Castle, Australia; Royal Brisbane and Women's Hospital, Brisbane, Australia; University Hospitals Leuven, Leuven, Belgium; Northern Institute for Cancer Research, Newcastle Upon Tyne, United Kingdom

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Abstract Disclosures


Background: Many gynaecological cancers of different pathological type express estrogen and/or progesterone hormone receptors (ER/PR). Reports of tumour response and clinical benefit with hormonal therapies show variable rates of activity. There is a need to prospectively study the role of aromatase inhibitors in women with potentially hormone responsive recurrent gynaecological cancers to establish response rates, clinical benefit, quality of life (QoL) and identify predictors of response. Methods: PARAGON is phase II Gynecologic Cancer InterGroup trial lead by the Australia New Zealand Gynaecological Oncology Group, Cancer Research UK and the Belgian Gynaecological Oncology Group. The study is designed to facilitate research in rare tumours. The protocol allows postmenopausal women with recurrent gynaecological cancers to enrol into one of 7 subgroups; epithelial ovarian cancer (EOC) with only rising CA125 after first line chemotherapy, platinum resistant/refractory EOC, low grade EOC, endometrial carcinomas, endometrial stromal sarcomas, miscellaneous sarcomas and granulosa cell tumours and other sex cord stromal tumours. ER/PR positivity must be confirmed by immunohistochemistry. Each subgroup will enrol 25-50 patients with defined stopping rules based on response and reviewed by independent data monitoring committee (IDMC). Eligible patients receive 1 mg anastrozole daily until disease progression or unacceptable toxicity. Primary objective: clinical benefit (partial or complete response or stable disease). Secondary objectives: progression free survival, response duration, QoL, toxicity. Blood and tumour samples are being collected for translational studies and confirmation of ER/PR positivity. Recruitment commenced in 2011 in Australia, New Zealand and the United Kingdom. One hundred and fourteen of 350 planned patients have been enrolled to January 2013. In November 2012 IDMC recommended continuing recruitment to the EOC with rising Ca125 only and resistant/refractory subgroups based on review of activity outcomes for the first 25 patients. The trial will open in Belgium in April 2013. ACTRN12610000796088 Clinical trial information: 12610000796088.