KEY TAKEAWAYS
- The study aimed to investigate the antitumor activity and safety of surufatinib in patients with R/M MSGTs of the head and neck.
- The primary endpoint was to determine ORR.
- Researchers noticed promising antitumor activity of surufatinib in patients with R/M MSGTs, with a safety profile requiring continued monitoring, suggesting its potential as a therapeutic option.
Recurrent or metastatic malignant salivary gland tumors (R/M MSGTs) of the head and neck pose significant clinical challenges due to limited therapeutic options and poor prognosis. Sur
.ufatinib, a potent small-molecule tyrosine kinase inhibitor (TKI) targeting VEGF receptors (VEGFR) 1, 2, and 3, FGFR 1, and CSF-1R, holds promise in addressing these challenges. Previous studies have shown the effectiveness of antiangiogenic inhibitors in head and neck cancer.
Rongrong Li and the team aimed to assess the efficacy and safety of surufatinib’s antitumor activity and safety in R/M MSGT patients.
Researchers performed an inclusive analysis, enrolling patients aged 18-75 with incurable and progressive R/M MSGTs who received surufatinib at a daily dose of 300 mg until intolerance or disease progression. Utilizing Simon’s two-stage minimax design, stage 1 enrolled 13 patients, with stage 2 initiated upon observing 1 or more responses, leading to a total sample size of 32 patients.
The primary endpoint, assessed by RECIST 1.1 criteria, was objective response rate (ORR), with secondary endpoints including disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety evaluation. This study was prospectively registered with ClinicalTrials.gov (NCT04910854).
About 12 patients enrolled and received treatment from May 2019 to March 2023. Median age was 45.5 years (range 27-60), with 83.3% females and 41.7% having ECOG performance status of 2. Predominant histological types were adenoid cystic carcinoma (ACC, 41.7%) and mucoepidermoid carcinoma (MEC, 41.7%). Lung metastases were the most common (83.3%). Previous chemotherapy and antiangiogenic therapy were noted in 5 patients (41.7%) and 4 (33.3%) of patients, respectively, while 6 (50.0%) had ≥2 prior lines of treatment.
As of September 2023, 2 patients achieved partial response (PR), 9 had stable disease (SD), resulting in ORR of 16.7% (95% CI: 2.1-48.4%) and DCR of 91.7% (95% CI: 61.5-99.8%). Median PFS was 8.57 months (95% CI 4.76-11.33), with 3-month and 6-month PFS rates of 83.3% (95% CI: 51.6-97.9%) and 41.7% (95% CI 15.2-72.3%), respectively. Median OS was immature.
Most TRAEs were grade 1-2, including hyperuricemia (58.3%) and hypertension (41.7%), while grade ≥3 AEs included hypertension (25.0%), proteinuria (25.0%), and nephrotic syndrome (8.3%). No treatment-related deaths occurred.
The study concluded that surufatinib exhibited promising antitumor activity in patients with R/M MSGTs. The observed safety profile aligned with prior clinical studies, necessitating continued monitoring and management.
The study was sponsored by Shanghai Ninth People’s Hospital affiliated to Shanghai Jiao Tong University.
Source: https://astro.confex.com/astro/hncs2024/meetingapp.cgi/Paper/59549
Clinical Trial: https://clinicaltrials.gov/study/NCT04910854
Li R, Zhu G. (2024). “Efficacy and Safety of Surufatinib for Recurrent or Metastatic Malignant Salivary Gland Tumors: An Open-Label, Single-Arm, Phase II Study.” Presented at MHNCS 2024 – 2024 (Abstract 237).
