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Anlotinib combined with induction chemotherapy followed by chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma: A phase II study.

e18071 Background: Necrotic lesion is a negative prognostic factor for nasopharyngeal carcinoma (NPC) while there are few treatment options for it. This study investigated the efficacy and safety of anlotinib (a multi-target tyrosine kinase inhibitor) in combination with induction chemotherapy (IC) followed by concurrent chemoradiotherapy (CCRT) in treatment of liquefactive necrosis of NPC. Methods: This is an open-label, single-arm, phase II trial (NCT05232552). Patients with histologically confirmed stage T3-4N2/T1-4N3M0 NPC (AJCC 8th) who had measurable lesions per RECISTv1.1 and received no previous treatment for cancer were enrolled. Other inclusion criteria included 18-70 years old and ZPS 0-2. All patients received docetaxel (75 mg/m², iv, d1), cisplatin (75 mg/m², iv, d1) and anlotinib (12mg, oral, qd, d1-14) every 3 weeks for 3 cycles before CCRT. Chemoradiotherapy was 2 cycles of cisplatin (100 mg/m², iv, d1) and anlotinib (12mg, oral, qd, d1-14) every 3 weeks, concurrently with intensity-modulated radiotherapy (GTV > 66Gy). The primary endpoint was progression-free survival rate at 3 years. Here we report the results of a preliminary analysis. Results: Between January 2021 and September 2021, 34 patients (28 males and 6 females) were enrolled, and the median age was 54 years old. At the data cutoff date on January 24, 2022, all patients were eligible for the evaluation of tumor response with primary and lymph node lesions. 79.4% of the patients (27 of 34) had a response each for primary and lymph node lesions after IC, while 70.6% (20 of 34) achieved complete response in lymph node lesions compared with 29.4% (10 of 34) in primary lesions. At 6 weeks after CCRT, 100.0% of the patients (34 of 34) had a response in primary lesions and 97.1% (33 of 34) in lymph node lesions. The incidence of liquefactive necrosis was 58.8% (20 of 34) and there were 51 necrotic lesions in all. Among those necrotic lesions, 56.9% (29 of 51) and 80.4% (41 of 51) had complete response after IC and CCRT. The average area shrinkage of necrotic lesion after IC and CCRT was 84.5%±0.25, 97.7%±0.06, respectively. The most common adverse events of grade 3 was leucopenia (17.6%) and mucositis (17.6%), and there was 1 patient (2.9%) occurred neutropenia of grade 4. Conclusions: This preliminary analysis indicated that anlotinib combined with IC and CCRT had promising efficacy and favorable tolerance as treatment of liquefactive necrosis of locoregionally advanced NPC.