Anlotinib plus oral fluoropyrimidine S-1 in refractory or relapsed small-cell lung cancer (SALTER TRIAL): a multicenter, single-arm, phase II trial

• Published in: BMC cancer Vol. 24; no. 1; pp. 1182 - 9
• Main Authors: Wang, Wei, Wu, Guixian, Luo, Wujun, Lin, Ling, Zhou, Chao, Yao, Guifei, Chen, Meifang, Wu, Xiaomai, Chen, Ziran, Ye, Junhui, Yang, Haihua, Lv, Dongqing
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 27.09.2024; BioMed Central; BMC
• Subjects: Administration, Oral; Adult; Aged; Anemia; Angiogenesis; Antiangiogenic TKIs; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cancer; Cancer therapies; Care and treatment; Cell growth; Chemotherapy; Clinical trials; Diagnosis; Disease; Diseases; Drug Combinations; Drug therapy; Drug therapy, Combination; Female; Fluorouracil; Humans; Hypertension; Hypotheses; Indoles - administration & dosage; Indoles - adverse effects; Indoles - therapeutic use; Liver; Lung cancer; Lung cancer, Small cell; Lung Neoplasms - drug therapy; Lung Neoplasms - mortality; Lung Neoplasms - pathology; Male; Medical research; Medicine, Experimental; Metastasis; Middle Aged; Neoplasm Recurrence, Local - drug therapy; Neutropenia; Oral fluoropyrimidine S-1; Oxonic Acid - administration & dosage; Oxonic Acid - adverse effects; Patients; Physiological aspects; Platinum; Quinolines - administration & dosage; Quinolines - adverse effects; Quinolines - therapeutic use; Relapse; Small cell lung carcinoma; Small Cell Lung Carcinoma - drug therapy; Small Cell Lung Carcinoma - mortality; Small Cell Lung Carcinoma - pathology; Small-cell lung cancer; Software; Tegafur - administration & dosage; Tegafur - adverse effects; Testing; Thrombocytopenia; Treatment outcome; Tumors; Young Adult; China; Treatment outcome; Relapse; Oral fluoropyrimidine S-1; Small-cell lung cancer; Antiangiogenic TKIs
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-024-12954-8

Patients with small-cell lung cancer (SCLC) have few treatment options and dismal overall survival (OS) after failed platinum-based chemotherapy. 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. 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. 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. This trial was registered with ClinicalTrial.gov (NCT03823118) on 3 January 2019.