Department of Radiation Oncology, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, Zhejiang, 317000, China.
Department of Radiation Oncology, Key Laboratory of Radiation Oncology of Taizhou, Radiation Oncology Institute of Enze Medical Health Academy, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, Zhejiang, 317000, China.
BMC Cancer. 2024 Sep 27;24(1):1182. 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.
小细胞肺癌（SCLC）患者在铂类化疗失败后，治疗选择有限，总生存期（OS）较差。
这项 II 期临床试验的纳入标准包括：可测量疾病、年龄 18-75 岁、经病理证实的 SCLC 诊断且先前铂类化疗后疾病进展或复发的患者。患者接受安罗替尼 12mg 每日一次（QD）和替吉奥 60mg 每日两次（BID）治疗 2 周，随后 1 周无治疗间歇期。完成 6 个周期上述治疗后，患者继续替吉奥单药治疗 60mg/ BID 2 周，随后 1 周无治疗间歇期，直至疾病进展。
2019 年 3 月至 2020 年 6 月，共有 71 例患者初步评估符合该研究入组条件。其中，52 例符合纳入标准的患者被纳入研究，48 例患者接受了至少 2 个周期的研究药物治疗。中位随访时间为 25.1 个月。21 例患者（43.8%）获得了客观缓解。中位无进展生存期（PFS）为 4.5 个月（95%CI：3.5-5.5 个月），中位总生存期（OS）为 5.9 个月（95%CI：4.6-7.3 个月）。最常见的 3-4 级治疗相关不良事件是血小板减少症（16.7%）、贫血（14.6%）、中性粒细胞减少症（14.6%）和高血压（10.4%）。无治疗相关死亡。
安罗替尼联合口服氟嘧啶替吉奥在复发性或难治性 SCLC 中表现出显著的活性，具有良好的客观缓解率和可接受的、可控的安全性特征。
该试验于 2019 年 1 月 3 日在 ClinicalTrials.gov（NCT03823118）注册。
