- Title
- Paragon (ANZGOG-0903): phase 2 study of Anastrozole in women with estrogen or progesterone receptor-positive platinum-resistant or -refractory recurrent ovarian cancer
- Creator
- Bonaventura, Anthony; O'Connell, Rachel L.; Martyn, Julie; DeFazio, Anna; Scurry, James; Friedlander, Michael L.; Mapagu, Cristina; Beale, Philip J.; McNally, Orla M.; Mileshkin, Linda R.; Grant, Peter T.; Hadley, Alison M.; Goh, Jeffery C. H.; Sjoquist, Katrin M.
- Relation
- International Journal of Gynecological Cancer Vol. 27, Issue 5, p. 900-906
- Publisher Link
- http://dx.doi.org/10.1097/IGC.0000000000000978
- Publisher
- Lippincott Williams & Wilkins
- Resource Type
- journal article
- Date
- 2017
- Description
- 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.
- Subject
- Anastrozole; epithelial ovarian cancer; hormone-responsive; platinum-resistant; ovarian cancer
- Identifier
- http://hdl.handle.net/1959.13/1397395
- Identifier
- uon:34256
- Identifier
- ISSN:1048-891X
- Language
- eng
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