Anlotinib plus EGFR-TKIs continuation was a potential treatment strategy in selected advanced non-small cell lung cancer (NSCLC) after disease progression in first-line EGFR-TKIs. This study aimed to evaluate the efficacy and safety of combined EGFR-TKIs and anlotinib.
The trial aimed to enroll 120 patients after gradual or local progression in EGFR-TKIs treatment. All patients were treated with oral anlotinib 12 mg daily for 14 days every three weeks until disease progression or intolerable toxicity. The primary end-point was progression-free survival (PFS). The secondary end-points were 6 months and 12 months PFS rate, Overall response rate (ORR), disease control rate (DCR), overall survival (OS) and safety.
From July 08, 2019 to December 15, 2022 the enrollment was completed, including 109 patients with gradual progression. Up to December 31, 2022, 114 patients were available for efficacy assessment (105 patients had confirmed evaluation). Median PFS of combined anlotinib and EGFR-TKIs treatment was 9.2 months (95% CI, 6.6–11.6). Confirmed ORR was 5.7% and DCR was 92.4%. The PFS rate at 6 and 12 months was 66.3% and 36.7% respectively. Safety assessment was available in 116 patients, 94% (109/116) patients were reported treatment related adverse events (TRAEs). The incidence of grade 3 or 4 TRAEs was 36.2% (42/116) and the treatment-related serious adverse event (SAE) was 7.8% (9/116). The common TRAEs were diarrhea (47.4%), hypertension (42.2%), proteinuria (39.7%), and hypertriglyceridemia (24.1%). 22.4% (26/116) of patients experienced anlotinib dose reduction.
EGFR-TKIs plus anlotinib demonstrated meaningful clinical control in advanced NSCLC after gradual or local progression in first-line EGFR-TKIs. And the toxicity was clinically manageable.
NCT04007835.
Guangdong Association of Clinical Trials.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
All authors have declared no conflicts of interest.