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Anlotinib plus oral fluoropyrimidine S-1 in refractory or relapsed small-cell lung cancer (SALTER TRIAL): a
Wei Wang1,2, Guixian Wu3, Wujun Luo4
1Department of Radiation Oncology, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, Zhejiang, 317000, China.
Background:
Patients with small-cell lung cancer (SCLC) have few treatment options and dismal overall survival (OS) after failed platinum-based chemotherapy.
Methods:
The eligibility criteria of this phase II clinical trial included patients with measurable disease, age of 18 to 75 years, a confirmed diagnosis of disease progression or recurrence after prior platinum-based chemotherapy with a pathologically proven diagnosis of SCLC. Patients were treated with anlotinib at a dosage of 12 mg once daily (QD) and S-1 at 60 mg twice daily (BID) for 2 weeks, followed by a 1-week treatment-free interval. After six cycles of the above treatment, patients continued the maintenance therapy using S-1 monotherapy at 60 mg/ BID for 2 weeks, followed by a 1-week treatment-free interval until disease progression.
Results:
From March 2019 to June 2020, a total of 71 patients were initially assessed for eligibility in this study. Out of these, 52 patients who met the inclusion criteria were enrolled, and 48 patients received at least two doses of the study drug. The median follow-up time was 25.1 months. The ORR was seen in 21 patients (43.8%). The median PFS was 4.5 months (95% CI, 3.5-5.5 months), and the median OS was 5.9 months (95% CI, 4.6-7.3 months). The most common grade 3-4 treatment-related adverse events were thrombocytopenia (16.7%), anemia (14.6%), neutropenia (14.6%), and hypertension (10.4%). No treatment-related death occurred.
Conclusions:
The combination of anlotinib with oral fluoropyrimidine S-1 demonstrated notable activity in relapsed or refractory SCLC, showing a favorable ORR and an acceptable, manageable safety profile.
Trial Registration:
This trial was registered with ClinicalTrial.gov (NCT03823118) on 3 January 2019.
Insights
This study shows that combining anlotinib with S-1 is an effective treatment for patients with relapsed or refractory small-cell lung cancer (SCLC). The combination therapy demonstrated a notable objective response rate and an acceptable safety profile.
Area of Science:
- Oncology
- Clinical Pharmacology
Background:
- Small-cell lung cancer (SCLC) presents limited therapeutic avenues and poor survival rates post-platinum-based chemotherapy.
- Identifying effective salvage therapies for SCLC is a critical unmet need.
Purpose of the Study:
- To evaluate the efficacy and safety of anlotinib combined with S-1 in patients with relapsed or refractory SCLC.
- To assess the objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) of this combination therapy.
Main Methods:
- A phase II clinical trial enrolled 52 patients with SCLC who progressed after platinum-based chemotherapy.
- Patients received anlotinib (12 mg QD) plus S-1 (60 mg BID) for 2 weeks, followed by a 1-week break, for up to six cycles.
- Maintenance therapy involved S-1 monotherapy until disease progression.
Main Results:
- The objective response rate (ORR) was 43.8% (21 patients).
- Median progression-free survival (PFS) was 4.5 months, and median overall survival (OS) was 5.9 months.
- Common grade 3-4 adverse events included thrombocytopenia (16.7%), anemia (14.6%), neutropenia (14.6%), and hypertension (10.4%); no treatment-related deaths occurred.
Conclusions:
- The combination of anlotinib and S-1 exhibits significant activity in relapsed/refractory SCLC.
- This regimen offers a favorable ORR and a manageable safety profile, representing a potential treatment option.
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