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Phase II Study of Anlotinib Plus Doxetaxel for Relapsed NSCLC

By: Justine Landin, PhD
Posted: Monday, December 13, 2021

The antiangiogenesis agent anlotinib may improve clinical outcomes for patients with advanced EGFR-negative non–small cell lung cancer (NSCLC) when added to docetaxel, according to the results of the multicenter, randomized, phase II ALTER-L018 study. Specifically, anlotinib plus docetaxel was found to increase progression-free survival (4.26 months) and overall response rates (36.6%) compared with docetaxel alone (1.64 months and 7.3%, respectively). These findings were presented by Lin Wu, MD, of Central South University, Changsha, China, and colleagues during the European Society for Medical Oncology (ESMO) Congress 2021 (Abstract 1220P) and later published in the Annals of Oncology.

“Anlotinib plus docetaxel is a feasible choice for relapsed NSCLC progressing after first-line platinum-based chemotherapy with or without immune checkpoint inhibitors, significantly improving survival and with manageable safety,” stated the study investigators.

Patients with advanced EGFR-negative NSCLC that progressed following first-line chemotherapy with or without immune checkpoint inhibitors were enrolled (n = 75). Patients were randomly assigned to receive either anlotinib plus docetaxel or docetaxel alone.

Anlotinib treatment appeared to increase median progression-free survival (4.3 months) and overall survival (16.2 months), compared with docetaxel alone (P < .001). However, there was no apparent difference between the groups in terms of overall survival (P = .94). Tumor response overall response rates were 36.7% following anlotinib treatment compared with 7.3% with docetaxel alone (P = .002). The disease control rate was also increased with the combination (83.3%) compared with docetaxel alone (53.6%, P = .009). 

The most common adverse events of grade 3 or higher related to treatment were leukopenia, neutropenia, and thrombocytopenia in the combination-therapy group and leukopenia and neutropenia in the doxetaxel-alone group. Adverse events were slightly more common following anlotinib treatment compared with docetaxel alone. However, the safety profiles were reported to be manageable.

Disclosure: The study authors reported no conflicts of interest.



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