Anlotinib, a multi-targeted tyrosine kinase inhibitor (TKI), demonstrates promising efficacy and safety as a maintenance therapy for patients with extensive-stage small cell lung cancer (ES-SCLC), particularly when combined with immunotherapy. A recent retrospective study published in Frontiers in Oncology evaluated the effectiveness of anlotinib in combination with immunotherapy or chemotherapy in ES-SCLC patients.
The study, conducted at the Second Affiliated Hospital of Chongqing Medical University, included 30 patients with ES-SCLC who received anlotinib as first-line or second-line maintenance therapy. The primary endpoint was progression-free survival (PFS), while secondary endpoints included overall survival (OS), objective remission rate (ORR), disease control rate (DCR), intracranial progression-free time (TTP), and drug safety.
Study Details and Patient Characteristics
The patients received anlotinib at a dose of 12 mg/day for 14 days in a 21-day cycle, combined with either chemotherapy or immunotherapy for 4-6 cycles. Anlotinib maintenance was continued until disease progression or unacceptable adverse events occurred. The median age of the patients was 64 years, with 70% having a history of smoking. 60% of patients received anlotinib in combination with immune checkpoint inhibitors, while 40% received it with chemotherapy.
Significant Improvements in Survival
The study revealed a median PFS of 7.2 months (95% CI: 6.67-7.73 months) for all patients. The median OS was 17.6 months (95% CI: 14.00-21.20 months), with a 1-year OS rate of 76.7%. Notably, patients who received anlotinib with immunotherapy had a significantly longer median PFS of 8.2 months (95% CI: 5.91-10.49 months) compared to 5.6 months (95% CI: 4.92-6.28 months) for those who received it with chemotherapy (p=0.0017). Similarly, the median OS was 20.1 months (95% CI: 14.61-25.59 months) for the immunotherapy group versus 15.1 months (95% CI: 14.76-15.44 months) for the chemotherapy group (p=0.0094).
Impact on Brain Metastases
Brain metastases are a common and detrimental complication in ES-SCLC. The study found that anlotinib maintenance therapy prolonged the time to intracranial progression. For patients who had brain metastases before receiving anlotinib, the median PFS was 6.2 months. For those who developed brain metastases after starting anlotinib, the median time to intracranial progression was 7.2 months.
Manageable Adverse Events
The most common grade 1-2 adverse events associated with anlotinib were anemia (46.7%), hypertension (43.3%), elevated transaminases (36.7%), and leukopenia (36.7%). Grade 3-4 adverse events were reported in 33.3% of patients, including severe anemia, hypertension, transaminase elevation, leukopenia, neutropenia, and severe fatigue. All patients experiencing grade 3-4 adverse events had their anlotinib dosage reduced or temporarily discontinued. No treatment-related deaths occurred.
Clinical Implications
These findings suggest that anlotinib is a valuable maintenance therapy option for ES-SCLC patients, particularly when combined with immunotherapy. The study's authors emphasize the need for larger, prospective, randomized controlled trials to further validate these results and to compare the efficacy of anlotinib in combination with immunotherapy versus other treatment approaches.
"Our study has indicated the good efficacy and safety about the application of anlotinib in the combination therapy and subsequent maintenance therapy in the first-line or second-line treatment of ES-SCLC," the researchers concluded. "We revealed that patients were sensitive to the therapeutic regimen and gained prolonged PFS and OS, especially when patients received the therapy of anlotinib plus immunotherapy."
