RT Journal Article
SR Electronic
T1 Paragon (ANZGOG-0903): Phase 2 Study of Anastrozole in Women With Estrogen or Progesterone Receptor–Positive Platinum-Resistant or -Refractory Recurrent Ovarian Cancer
JF International Journal of Gynecologic Cancer
JO Int J Gynecol Cancer
FD BMJ Publishing Group Ltd
SP 900
OP 906
DO 10.1097/IGC.0000000000000978
VO 27
IS 5
A1 Bonaventura, Anthony
A1 O'Connell, Rachel L.
A1 Mapagu, Cristina
A1 Beale, Philip J.
A1 McNally, Orla M.
A1 Mileshkin, Linda R.
A1 Grant, Peter T.
A1 Hadley, Alison M.
A1 Goh, Jeffery C.H.
A1 Sjoquist, Katrin M.
A1 Martyn, Julie
A1 DeFazio, Anna
A1 Scurry, James
A1 Friedlander, Michael L.
YR 2017
UL http://ijgc.bmj.com/content/27/5/900.abstract
AB 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.