Safety and efficacy of radiotherapy combined with anlotinib in locally advanced non-small cell lung cancer patients intolerant to concurrent chemoradiotherapy: Preliminary result of a phase II clinical trial
Abstract
8043
Background:
Concurrent chemoradiotherapy (cCRT) is the standard treatment for patients with unresectable locally advanced non-small cell lung cancer (LA-NSCLC). However, parts of patients only receive sequential chemoradiotherapy (sCRT) due to various reasons. This phase II study aimed to improve the outcomes of patients receiving sCRT by combining anti-angiogenesis therapy (anlotinib) during radiotherapy course.
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 patients were prescribed oral 12 mg anlotinib up for 3 cycles during radiotherapy. The primary endpoint is 2-year overall survival (OS). 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…
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