Abstract 1657P
Background
There is still no unsatisfactory treatment strategy for patients (pts) with advanced SCLC relapsed within six months after first-line treatment, although chemotherapy alone is the standard treatment. Anlotinib, an oral multitarget tyrosine kinase inhibitor, effectively inhibits angiogenesis and enhances tumor cell response to chemotherapy. In the ALTER 1202 trial, anlotinib had significantly improved progression-free survival (PFS) and overall survival (OS) of advanced SCLC pts who received at least two lines chemotherapy. Therefore, we presented the updated efficacy and safety of anlotinib plus irinotecan or docetaxel in SCLC relapsed within six months after first-line treatment.
Methods
Eligible pts with advanced SCLC who have relapsed within six months after first-line platinum-based treatment received anlotinib (12mg, QD from day 1 to 14 of a 21-day cycle) and irinotecan (65mg/m2, day 1,8, q3w, up to 4 cycles) or docetaxel (60mg/m2, q3w, up to 4 cycles) until progression or intolerable toxicity. The primary endpoint was the objective response rate (ORR). Secondary endpoints included PFS, the disease control rate (DCR), OS and safety.
Results
As of April 28, 2021, we recruited 26 pts, among which 24 pts (median age: 61.9 years, male: 79.2%, ECOG PS 1: 75.0%, brain metastasis: 50%, liver metastasis: 41.7%) were eligible for efficacy analysis. Median follow-up time was 9.2 months (95% Cl, 1.63-16.77). Median PFS was 4.0 months (95%Cl: 3.16-4.84). The median OS was 7.5 months (95%Cl: 3.01-11.99). Of 21 evaluable pts, 1 pts had complete response (CR) and 9 pts reached partial response (PR). The ORR was 47.6% (10/21) and the DCR was 90.5% (19/21), respectively. Most common grade 1-2 treatment-related adverse events (TRAEs) included weakness (37.5%), anorexia (33.3%), anemia (33.3%) and hypertension (20.8%). 3 pts (12.5%) suffered from grade 3 AEs, which were leukopenia, thrombocytopenia, and anemia.
Conclusions
Anlotinib plus irinotecan or docetaxel continued to show promising efficacy and manageable toxicities in SCLC relapsed within six months after first-line treatment. It may become a novel therapeutic strategy for the population.
Clinical trial identification
NCT04757779.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.