Radiotherapy combined with anlotinib in locoregional recurrent esophageal squamous cell carcinoma after radical surgery: a prospective, Phase II clinical trial.

Background: Chemoradiotherapy is less tolerable for postoperative locoregional recurrent esophageal squamous cell carcinoma (ESCC).

Methods: ESCC patients with three or fewer locoregional recurrent lesions after radical surgery were enrolled. Anlotinib (12 mg, d1-14) was administered with radiotherapy (50.4-59.4 Gy) concurrently for two cycles, followed by sequentially for another two cycles. The primary endpoints were objective response rate (ORR) and toxicity.

Results: Between October 2019 and July 2022, 40 patients were eligible. The ORR was 90.0% (20.0% complete response, 70.0% partial response). The median local failure-free survival, distant metastasis-free survival, progression-free survival, and overall survival were 21.7 (95% CI, 7.839-35.627), 26.4 (95% CI, 17.706-35.028), 12.7 (95% CI, 4.023-21.377), and 29.9 months (95% CI, 18.543-41.323), respectively. Grade 3 adverse events occurred in only two patients (5.0%) who developed hypertension. No grade 4 treatment-related adverse events were observed.

Conclusions: The regimen of radiotherapy combined with anlotinib demonstrated high efficacy with tolerable toxicity in postoperative locoregional recurrent ESCC. This novel regimen provided a selectable treatment strategy for such patients, especially for those who cannot tolerate or refuse chemotherapy. Further randomised controlled trials are warranted.

Clinical trial registration: Chinese Clinical Trial Registry (ChiCTR1900025752).