2532 - A Phase II Trial of Safety and Efficacy of Radiotherapy Combined with Anlotinib in Locally Advanced Non-Small Cell Lung Cancer Patients Intolerable to Concurrent Chemoradiotherapy: Preliminary Survival Analysis
Presenter(s)
Y. Yuan1, J. Wang2, H. Li2, T. Zhang2, L. Deng2, W. Liu Jr2, W. Q. Wang3, X. Wang2, J. LV2, Z. Zhou4, Q. Feng1, Z. Xiao2, and N. Bi5; 1Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China, 2Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China, 3Cancer Hospital Chinese Academy of Medical Sciences, beijing, China, 4Department of Radiation Oncology, National Cancer Center / Cancer Institute & Hospital, Chinese Academic of Medical Sciences, Beijing, China, 5State Key Laboratory of Molecular Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
Purpose/Objective(s): Concurrent chemoradiotherapy (cCRT) is the standard treatment for patients (pts) with unresectable locally advanced non-small cell lung cancer (LA-NSCLC). However, parts of pts only receive sequential chemoradiotherapy (sCRT) due to various reasons. This phase II study aimed to improve the outcomes of pts receiving sCRT by combining anti-angiogenesis therapy (anlotinib) during radiotherapy course.
Materials/Methods: Patients with unresectable LA-NSCLC intolerable to cCRT were prospectively enrolled. Induction chemotherapy with or without immunotherapy were given for 4-6 cycles. Then pts were prescribed oral 12 mg anlotinib up for 3 cycles during radiotherapy. The accrual target was 38 pts, aiming to improve the 2-year overall survival (OS) rate from 34% with sCRT to 55% with cCRT The primary endpoint is 2-year. Acute adverse events (AEs) were defined as any treatment related events from the start of radiotherapy until 3 months post-radiotherapy. The trial has been registered in ChiCTR.org as ChiCTR2200060712.
Results: From October 2020 to January 2024, 41 patients with stage II-III NSCLC were enrolled. 11 (26.8%) patients received induction chemotherapy and 30 (73.2%) patients received induction chemotherapy combined with immunotherapy. The rate of grade 3–4 acute hematological AEs was 29.3% (12 cases). The rates of grade 3 hemoptysis were 2.4% (1 case), with no grade 4 hemoptysis reported. The incidence of grade 3–4 radiation pneumonitis was 9.8% (4/41). No grade 5 AEs occurred in all patients. The median follow-up was 16.8 (range: 7.0–50.7) months. 22 (53.7%) patients experienced recurrence, including 5 patients (12.2%) with primary-site recurrence and 7 patients (17.1%) with regional-node recurrence, 12 patients (29.3%) had distant metastases. The median progression-free survival (PFS) was 18.9 months (95%CI 14.6-23.2 months) and 1-year PFS was 77.2%. 9 patients (22.0%) died, including 3 patients who died of covid-19 pneumonia during the follow-up period, 1 patient who died of hydatid pneumonia due to long-term bed rest after cerebral infarction, and 4 patients who died of tumor-related diseases. The 1-year overall survival was 89.9%.
Conclusion: Our data first showed the combination of thoracic radiotherapy and anti-angiogenesis therapy (anlotinib) is of safety, well controlled toxicity, and efficacy for inoperable LA-NSCNC patients who cannot tolerate cCRT.