Data from Apalutamide and Goserelin for Androgen Receptor–Positive Salivary Gland Carcinoma: A Phase II Nonrandomized Clinical Trial, YATAGARASU

• DOI: 10.1158/1078-0432.c.7403487.v1
• Publication Date: 2024-08-15T07:29:10Z
• Authors: Yoshitaka Honma; Nobuya Monden; Keisuke Yamazaki; Satoshi Kano; Hironaga Satake; Shigenori Kadowaki; Yoshitaka Utsumi; Tomohiko Nakatogawa; Ryo Takano; Koji Fujii; Yosuke Koroki; Junya Aoyama; Shohei Ouchi; Tetsuro Ogawa; Sharon McCarthy; Sabine D. Brookma...; Suneel Mundle; Jinhui Li; Daksh Thaper; Toshitaka Nagao; Yuichiro Tada
• Keywords: Clinical endpoint; Goserelin

<div>AbstractPurpose:<p>To assess the efficacy and safety of apalutamide plus goserelin for androgen receptor (AR)–positive unresectable or recurrent/metastatic salivary gland carcinoma.</p>Patients Methods:<p>This trial was an open-label, single-arm, multicenter phase II study. Patients with histologically confirmed carcinoma AR expression were included. The primary endpoint overall response rate (ORR) according to RECIST v1.1 by independent central radiology review in first 24 response-evaluable (RE) patients who had been observed at least weeks from study initiation (primary RE patients). be declared when 8 responded.</p>Results:<p>A total 31 enrolled. In a median follow-up 7.4 months, ORR 25.0% [6/24 patients; 95% confidence interval, 9.8%–46.7%; <i>P</i> = 0.11 (one-sided)], which did not meet predefined criteria efficacy. Clinical benefit (ORR + stable disease weeks) progression-free survival 50.0% respectively. Both duration reached. Exploratory analyses showed better 54.5% (6/11) positivity ≥70% no history prior systemic therapy. Grade 3 higher treatment-emergent adverse events reported 35.5% (11/31), included skin rash, anemia, leukopenia, cancer pain.</p>Conclusions:<p>Although this criteria, clinically meaningful subset AR-positive consistent experience prostate cancer.</p></div>