Axitinib Monotherapy in Adenoid Cystic Carcinoma

• July 13, 2020
• Reading time: 2 minutes

During the ASCO 2020 Virtual Scientific Program (May 29–31), Dr. Bhumsuk Keam presented the efficacy and safety results of a Phase 2 clinical trial evaluating Axitinib, a tyrosine kinase inhibitor, as a monotherapy for patients with recurrent or metastatic adenoid cystic carcinoma (ACC).

Study Design: This Phase 2 trial enrolled 60 patients with recurrent or metastatic ACC, randomized 1:1 into two groups:

1. Axitinib Group: Axitinib 5mg orally twice daily (N=30).
2. Observation Group: Standard observation (N=30).

The primary endpoint was the 6-month progression-free survival (PFS) rate. Secondary endpoints included objective response rate (ORR), overall survival (OS), and progression-free survival (PFS) duration.

Clinical Context: Patients with recurrent or metastatic ACC often show limited response to conventional cytotoxic chemotherapy. However, previous Phase 2 trials with angiogenesis inhibitors suggested potential anti-tumor activity, leading to this evaluation of Axitinib.

Clinical Outcomes: At a median follow-up of 25.4 months, the results were as follows:

• 6-Month PFS Rate: 73.2% (Axitinib Group) vs. 23.2% (Observation Group).
• Median PFS: 10.8 months (Axitinib Group) vs. 2.8 months (Observation Group).
• Objective Response Rate (ORR): 3.3% (Axitinib Group) vs. 0% (Observation Group).
• Disease Control Rate (DCR): 100% (Axitinib Group) vs. 51.9% (Observation Group).
• Median Overall Survival (OS): Not reached (Axitinib Group) vs. 28.5 months (Observation Group).

Safety Profile: In the Axitinib group, most patients experienced Grade 1–2 adverse events, primarily oral mucositis and fatigue.

Conclusion: Dr. Bhumsuk Keam concluded that Axitinib monotherapy significantly improves the 6-month progression-free survival rate compared to observation in patients with recurrent or metastatic adenoid cystic carcinoma.

Note: Medical Supporter provides translations of international clinical trial data for informational purposes. This content does not constitute medical advice or an endorsement of specific medications. Please consult with healthcare professionals for clinical decision-making.

Source: Randomized phase II study of axitinib versus observation in patients with recurred or metastatic adenoid cystic carcinoma. (2020 ASCO Virtual Scientific Program, Abstract No: 6503)

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