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Apalutamide and Goserelin for Androgen Receptor-Positive Salivary Gland Carcinoma: A Phase II Nonrandomized Clinical
Yoshitaka Honma1, Nobuya Monden2, Keisuke Yamazaki3
1Department of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Purpose:
To assess the efficacy and safety of apalutamide plus goserelin for androgen receptor (AR)-positive unresectable or recurrent/metastatic salivary gland carcinoma.
Patients And Methods:
This trial was an open-label, single-arm, multicenter phase II study. Patients with histologically confirmed unresectable or recurrent/metastatic salivary gland carcinoma with AR expression were included. The primary endpoint was the overall response rate (ORR) according to RECIST v1.1 by an independent central radiology review in the first 24 response-evaluable (RE) patients who had been observed at least 24 weeks from study initiation (primary RE patients). The efficacy was to be declared when at least 8 of the 24 primary RE patients responded.
Results:
A total of 31 patients were enrolled. In the first 24 primary RE patients with a median follow-up of 7.4 months, confirmed ORR by independent central radiology review was 25.0% [6/24 patients; 95% confidence interval, 9.8%-46.7%; P = 0.11 (one-sided)], which did not meet the predefined criteria of efficacy. Clinical benefit rate (ORR + rate of stable disease for at least 24 weeks) and median progression-free survival were 50.0% and 7.4 months, respectively. Both median duration of response and overall survival were not reached. Exploratory analyses showed a better ORR of 54.5% (6/11) in patients with AR positivity ≥70% and no history of prior systemic therapy. Grade 3 or higher treatment-emergent adverse events were reported in 35.5% (11/31), which included skin rash, anemia, leukopenia, and cancer pain.
Conclusions:
Although this study did not meet the predefined efficacy criteria, apalutamide plus goserelin showed clinically meaningful efficacy in a subset of patients with AR-positive salivary gland carcinoma and safety consistent with prior experience in prostate cancer.
Insights
Apalutamide plus goserelin did not meet primary efficacy goals for advanced salivary gland cancer. However, the combination showed potential benefit in a subgroup of patients with high androgen receptor expression and manageable safety.
Area of Science:
- Oncology
- Medical Research
Background:
- Salivary gland carcinoma (SGC) is a rare cancer with limited treatment options.
- Androgen receptor (AR) expression is observed in a subset of SGC, suggesting potential for targeted therapies.
Purpose of the Study:
- To evaluate the efficacy and safety of apalutamide plus goserelin in patients with AR-positive unresectable or recurrent/metastatic salivary gland carcinoma.
- To determine the overall response rate (ORR) as the primary endpoint.
Main Methods:
- An open-label, single-arm, multicenter phase II study.
- 31 patients with confirmed AR-positive SGC were enrolled.
- Primary endpoint: ORR in the first 24 response-evaluable patients, assessed by independent central radiology review.
Main Results:
- The confirmed ORR was 25.0% (6/24 patients), not meeting the predefined efficacy threshold.
- Clinical benefit rate (ORR + stable disease ≥24 weeks) was 50.0%, with a median progression-free survival of 7.4 months.
- Exploratory analysis indicated a higher ORR (54.5%) in patients with AR positivity ≥70% and no prior systemic therapy. Grade 3+ adverse events occurred in 35.5% of patients.
Conclusions:
- Apalutamide plus goserelin did not meet the primary efficacy endpoint for AR-positive SGC.
- The combination demonstrated clinically meaningful activity in a subset of patients, particularly those with high AR expression and no prior treatment.
- Safety profile was consistent with previous studies, primarily in prostate cancer.
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