Update on real-world efficacy of anlotinib in non-small cell lung cancer.

Abstract

e21173 Background: Anlotinib is a novel oral small molecule TKI with anti-tumor vascular generation and growth inhibition effects, targeting VEGFR, PDGFR, FGFR, and c-kit. It has been shown to be highly effective and low toxicity in the ALTER 0303 study and was approved by NMPA in 2018 for the treatment of NSCLC(non-small cell lung cancer)as third-line and above. Previous studies have shown that anlotinib can benefit patients with advanced NSCLC, especially those in the front-line(first-/second-line). This real-world study aims to update the efficacy of anlotinib in treating NSCLC and to screen the advantage population for anlotinib treatment from front-line/back-line (third-/above-line) treatment, pathological subtype, metastasis site, gene mutation, to provide more effective anlotinib treatment strategies. Methods: This is a multicenter, retrospective, real-world study. Patients with NSCLC who have received anlotinib are included, and subgroup analysis is performed based on pathological subtypes, clinical stages, gene mutations (EGFR mutant/wildtype), front-line/back-line treatments, exploring the impact of different factors on the PFS and OS of NSCLC patients using anlotinib. Results: As of September 2022, a total of 478 patients diagnosed with NSCLC were enrolled in the study, of which 434 were evaluable, with a median age of 63 years, 263 (60.6%) were male, adenocarcinoma in 292 (67.3%), squamous cell carcinoma in 75 (17.3%). At baseline, 59 patients (13.6%) had brain metastasis, 39 (9.0%) had liver metastasis, 127 (29.3%) had bone metastasis, 194 cases (44.7%) had genetic mutations, including 135 cases (31.1%) carrying EGFR mutations. 198 patients (45.6%) received anlotinib as front-line treatment, and 236 patients (54.4%) as back-line treatment. The median follow-up time was 5.09 months (95% Cl, 2.86-7.16), with a mPFS of 4.37 months (95% Cl: 3.78-5.45) in the overall population and a mOS of 20.34 months (95% Cl: 14.88-NA). Among the 138 patients who were evaluable for efficacy, 0 cases achieved complete response (CR), 6 cases partial response (PR), and 57 cases stable disease (SD). ORR was 4.3%, and DCR was 44.9%. The mPFS of front-line was longer than the back-line (5.45 vs 3.52 months), and front-line group had a longer mOS than back-line (NR vs 16.03 months). Subgroup analysis did not find any correlations between pathological subtype or EGFR mutations and patient PFS and OS. However, it was found that the presence of liver and bone metastasis at baseline was related to a shorter OS with anlotinib in the back-line (8.28 vs 16.23 months, p = 0.0253; 7.89 months vs NR, p < 0.001). Conclusions: Anlotinib shows well efficacy in NSCLC patients, prolonging progression-free survival (PFS) and overall survival (OS), especially for front-line patients, suggesting that these patients may be a preferred population for using anlotinib, providing effective evidence for the use of anlotinib treatment for NSCLC patients.