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Published on: March 6, 2018
Abiraterone Acetate in Patients With Castration-Resistant, Androgen Receptor-Expressing Salivary Gland Cancer: A
Laura D Locati1, Stefano Cavalieri1, Cristiana Bergamini1
1Head and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Purpose:
The activity of androgen-deprivation therapy (ADT) in androgen receptor-positive (AR+) salivary gland carcinomas (SGCs) has been established in the past few years. Second-line treatment in castration-resistant patients is still unknown. We investigated the activity of abiraterone acetate as second-line treatment in ADT-resistant, AR+ patients with SGC.
Methods:
This was a single-institution phase II trial. A two-stage Simon's design was applied. The primary end point was confirmed objective response rate. Secondary end points were disease control rate, safety, progression-free survival, and overall survival. Patients were eligible when the following criteria were met: histologic diagnosis of AR-overexpressing SGC, measurable disease according to RECIST 1.1, clinical and/or radiologic progression on ADT, suppressed serum testosterone, and no limits for the number of previous chemotherapy lines. All patients received abiraterone 1 g daily plus prednisone 10 mg and luteinizing hormone-releasing hormone agonist until progression or unacceptable toxicities.
Results:
From 2015 to 2019, 24 AR+ patients with SGC (23 men; median age 65.8 years) were treated within the study. The overall response rate was 21% (5 partial responses), with a disease control rate of 62.5%. The median duration of response was 5.82 months. Median progression-free survival was 3.65 months (95% CI, 1.94 to 5.89), and median overall survival was 22.47 months (95% CI, 6.74 to not reached). Objective response to previous ADT did not correlate with the activity of abiraterone. Adverse events (AEs) were recorded in 22 cases (92%) with grade 3 AEs in six patients (25%): fatigue (two), flushing (one), supraventricular tachycardia (one), and two non-drug-related AEs. No drug-related grade 4 or 5 AEs were recorded.
Conclusion:
Abiraterone plus luteinizing hormone-releasing hormone agonist is active and safe as a second-line option in AR-expressing, castration-resistant SGC.
Insights
Abiraterone acetate shows activity as a second-line treatment for androgen receptor-positive salivary gland carcinomas resistant to androgen-deprivation therapy. This study found it to be a safe and effective option for patients with advanced disease.
Area of Science:
- Oncology
- Medical Research
- Clinical Trials
Background:
- Androgen-deprivation therapy (ADT) is established for androgen receptor-positive (AR+) salivary gland carcinomas (SGCs).
- The efficacy of second-line treatments in castration-resistant SGC patients remains largely unknown.
Purpose of the Study:
- To investigate the activity of abiraterone acetate as a second-line treatment in AR+ SGC patients who are resistant to ADT.
- To evaluate the safety and efficacy of this treatment approach.
Main Methods:
- A single-institution phase II trial utilizing a two-stage Simon's design.
- Patients with AR-overexpressing SGC, measurable disease, and progression on ADT were enrolled.
- Treatment involved daily abiraterone acetate, prednisone, and a luteinizing hormone-releasing hormone agonist.
Main Results:
- The overall response rate was 21% with a disease control rate of 62.5% in 24 treated patients.
- Median progression-free survival was 3.65 months, and median overall survival was 22.47 months.
- Adverse events were common (92%), but grade 3 events were limited to 25%, with no drug-related grade 4 or 5 events.
Conclusions:
- Abiraterone acetate plus a luteinizing hormone-releasing hormone agonist is an active and safe second-line treatment option.
- This combination therapy demonstrates efficacy in AR-expressing, castration-resistant SGC.
- The findings support the use of abiraterone in this patient population.
