Anlotinib Plus Irinotecan or Docetaxel Shows Promising Efficacy in SCLC

Patients with small cell lung cancer who failed first-line treatment within 6 months were examined for efficacy of anlotinib plus chemotherapy in a phase 2 trial whose results were presented at the 2021 ESMO Congress.

Patients with small cell lung cancer (SCLC) for whom first-line therapy failed within 6 months and who subsequently received treatment with anlotinib plus irinotecan or docetaxel showed antitumor activity and a manageable toxicity profile, according to data from a phase 2 study (NCT0457779).

The median progression-free survival was 4.0 months (95% CI, 3.16-4.84) and the median overall survival was 7.5 months (95% CI, 3.01-11.99) with the anlotinib combination. The overall response rate (ORR) in 21 patients was 47.6% and the disease control rate was 90.5%.

“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,” Bing Xia, PhD, from Rutgers Cancer Institute, and colleagues wrote in a presentation of the data.

This single-arm study enrolled 26 participants, and 24 were eligible for the efficacy analysis. The median age was 61.9 years, with most (79.2%) being male and half (50%) being former. The median follow-up time was 8.4 months (95% CI, 2.58-14.22). At enrollment, 45.8% of patients (n = 11) had brain metastases and 41.7% (n = 10) had liver metastases.

Patients were eligible for this study if they were between the ages of 18 to 75 years, had cytologically or histologically confirmed SCLC, had relapsed within 6 months of receiving first-line treatment, and had an ECOG performance score of 0 to 1.

Patients were given 12 mg of anlotinib every day on day 1 to 14 of a 21-day cycle. For chemotherapy, patients were administered either irinotecan at 65 mg/m2 on days 1 and 8 once every 3 weeks for up to 4 cycles or docetaxel at 60 mg/m2 once every 3 weeks up to every 4 cycles.

The primary end point was ORR, with secondary end points of progression-free survival, disease control rate, overall survival, and safety.

A total of 21 patients were evaluable for responses, with 1 (4.76%) reaching a complete response, and 9 (42.86%) reaching a partial response.

The most reported all-grade treatment-related adverse effects were anemia (37.5%), weakness (37.5%), anorexia (33.3%), leukopenia (20.8%), and hypertension (20.8%). Patients also had grade 3 or higher adverse effects such as thrombocytopenia (8.4%), leukopenia (8.4%), and anemia (4.2%).

These data were previously made available in a poster at the 2021 European Society of Medical Oncology Congress.


Xia B, Chen X, Jiang H, et al. Anlotinib plus irinotecan or docetaxel in small-cell lung cancer (SCLC) relapsed within six months: Updated results from a single-arm phase II study. Ann Oncol. 2021;32(suppl 5):1657P. doi:10.1016/j.annonc.2021.08.241

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