<p>A Trial of the Safety and Efficacy of Chemotherapy Plus Anlotinib vs Chemotherapy Alone as Second- or Third-Line Salvage Treatment for Advanced Non-Small Cell Lung Cancer</p>

Abstract

Purpose: Anlotinib is a newly developed oral multitarget tyrosine kinase inhibitor. We retrospectively evaluated the toxicity and clinical efficacy of chemotherapy combined with anlotinib versus chemotherapy alone for metastatic/advanced non-small cell lung cancer (NSCLC) in patients who failed firstor second-line systemic treatment in China. Patients and Methods: In this retrospective trial, ninety-four advanced NSCLC patients received chemotherapy combined with anlotinib (n = 41) or chemotherapy alone (n = 53) in Henan Cancer Hospital. We recorded the objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and adverse events (AEs). Results: In the anlotinib plus chemotherapy group, eleven patients (27%) achieved a PR (partial response), and twenty-one patients (51%) achieved SD (stable disease), with an ORR of 27% and a DCR of 78%. In the chemotherapy alone group, eight patients (15%) achieved a PR, and nineteen patients (36%) had SD, with an ORR of 15% and a DCR of 51%. The ORR in the combination arm was slightly, but not obviously, higher than that in the chemotherapy arm (27% vs 15%, p > 0.05). In addition, the DCR was significantly higher in the combination arm than in the chemotherapy alone arm (78% vs 51%, p=0.007). At the end of follow-up, patients in the combination arm had a 1.5-month longer median PFS than patients in the chemotherapy arm; this difference was statistically significant (5.0 vs 3.5, p=0.002). The median OS was not achieved at the final analysis. The hematological and nonhematological toxicities were well tolerated and controlled. In general, most toxicity was limited to grade I or II, well tolerated and controlled. Conclusion: Our study suggests that anlotinib combined with chemotherapy may be an effective and well-tolerated treatment for advanced NSCLC in patients who fail firstor second-line therapy.

Anlotinib for refractory advanced non-small-cell lung cancer: A systematic review and meta-analysis

“…Three studies were excluded because they presented single-center data from the ALTER 0303 study [ 27 – 29 ]. Two studies were excluded because they were retrospective studies [ 30 , 31 ]. All studies were conducted in China.…”

Real-World Efficacy and Safety of Anlotinib With and Without Immunotherapy in Advanced Non-Small Cell Lung Cancer

“…The ALTER 0303 study and previous real-world studies showed that anlotinib alone could improve prognosis in NSCLC patients as third or later line treatment. Furthermore, the combination of anlotinib with immunotherapy, target therapy, or chemotherapy has been shown to have synergetic efficacy (22)(23)(24)27). We retrospectively analyzed real-world data to determine the efficacies of these therapeutic strategies in NSCLC, paying special attention to the combination of anlotinib plus immunotherapy.…”

FGFR2-ERC1: A Subtype of FGFR2 Oncogenic Fusion Variant in Lung Adenocarcinoma and the Response to Anlotinib

“… 30 , 31 In addition, anlotinib has been shown to have synergistic effects with chemotherapy and targeted therapies. 32 , 33 Adverse effects of anlotinib monotherapy have been shown to be manageable in previous studies. 34–36 Based on the ALTER0303 study, anlotinib has been approved as an NSCLC standard third-line treatment indication.…”