Abstract 929P
Background
The prognosis of patients (pts) with recurrent or metastatic nasopharyngeal carcinoma(NPC) is very poor, especially those who have failed at least two lines of prior systemic therapy. No well-established therapy is available for those pts. Anlotinib is a novel tyrosine kinase inhibitor that can bind VEGFR-2,-3 with high selectivity and inhibit the angiogenesis to control the growth of tumors. This phase II trial aims to assess the safety and efficacy of anlotinib for recurrent or metastatic NPC.
Methods
Pts with recurrent or metastatic NPC after failure of at least two lines of prior chemotherapy or targeted therapy were eligible. Pts were treated with anlotinib (12mg qd, 2-week on/1-week off) until disease progression or intolerable toxicity. The primary endpoints were confirmed disease control rate (DCR) and overall response rate (ORR). The secondary objectives were to assess progression-free survival (PFS) and incidence of treatment-related adverse events (AEs). The efficacy was evaluated using RECIST 1.1 criteria. The safety was assessed via NCI-CTCAE v5.0.
Results
From April 2019 to April 2020,18 pts were enrolled. The Median age was 49 years, and 2(11.1%) were female. The numbers of treatment lines prior to Anlotinib were 2 (13/18, 72.2%), 3 (4/18, 22.2%) and 4 (1/18, 5.6%) respectively, and 7 pts (38.9%) had received anti-PD-1 immunotherapy before. Among the 17 pts who had completed at least once response evaluation, DCR was 76.5% (13/17, 3 PR, 10 SD), and ORR was 17.6% (3/17). Ten pts were still on treatment as of April 31, 2020. After a median follow-up of 5.4 months, the median PFS was 3.3 months (95% confidence interval [CI] 2.5-5.6m). The most common (≥20%) AEs occurred in the 18 pts were mucositis (61.1%, 11/18), hypertension (55.6%, 10/18), hand-foot syndrome (50.0%, 9/18), proteinuria (50.0%, 9/18), hypothyroidism (50.0%, 9/18) and hyperlipidemia (22.2%, 4/18). Grade 3/4 AEs were reported in 5 pts (hand-foot syndrome, n=2; mucositis, n=3). Nasopharyngeal necrosis and a grade 2 epistaxis were seen in 1 patient each. Dose reductions (reduce to 10mg) occurred in 7 pts due to AEs.
Conclusions
Anlotinib seems to be a promising therapeutic option for recurrent or metastatic NPC with acceptable toxicity profiles.
Clinical trial identification
NCT03906058; April 5th 2019.
Editorial acknowledgement
Legal entity responsible for the study
Sun Yat-sen University Cancer Center.
Funding
National Natural Science Foundation of China (Grant No. 81672686).
Disclosure
All authors have declared no conflicts of interest.