Lv Xiao-Ming, Liu Yang, Feng Yan, Liang Hong-Liang, Zhi Wei-Wei
Department of Thoracic Surgery, Linfen Central Hospital, Linfen, Shanxi, 041000, China.
Department of Cardiovascular Surgery, Xijing Hospital, Air Force Military Medical, University, Xincheng, Xi'an, 710032, China.
J Cancer. 2024 May 5;15(11):3539-3546. doi: 10.7150/jca.91701. eCollection 2024.
The primary aim of this phase II clinical study was to assess the safety and efficacy of combining anlotinib, etoposide, and platinum-based drugs as a first-line treatment for ES-SCLC. Patients underwent the standard chemotherapeutic regimen, consisting of four courses of etoposide plus cisplatin/carboplatin. Additionally, each patient received a 2-week intervention with anlotinib (12 mg/day, once daily). Anlotinib was continued until disease progression, occurrence of unbearable adverse events (AEs), or withdrawal from the research. Progression-free survival (PFS) served as the primary prognostic measure. Secondary measures included the disease control rate (DCR), objective response rate (ORR), overall survival time (OS), and the incidence of AEs. The DCR and ORR were 97.6% and 91.0%, respectively. Estimated PFS and OS were 5.0 months (95% CI: 1.0-10.8 months) and 13.0 months (95% CI: 8.4-18.6 months), respectively. No unexpected adverse effects were reported during the trial. The most common adverse reactions included anemia (42.22%), hypertension (53.33%), alopecia (40.00%), elevated transaminase (24.40%), and elevated alkaline phosphatase (24.44%). Sixteen cases (35.56%) were classified as AEs of grades 3-5. No deaths attributed to treatment-related causes occurred in any patient during the trial. Combination chemotherapy is currently the first-line therapy for extensive small-cell lung cancer (ES-SCLC). Combining anlotinib with conventional platinum-based chemotherapy demonstrated promising therapeutic outcomes and prognosis in the management of ES-SCLC.
这项II期临床研究的主要目的是评估安罗替尼、依托泊苷和铂类药物联合作为广泛期小细胞肺癌（ES-SCLC）一线治疗的安全性和有效性。患者接受了标准化疗方案，包括四个疗程的依托泊苷加顺铂/卡铂。此外，每位患者接受为期2周的安罗替尼干预（12毫克/天，每日一次）。安罗替尼持续使用直至疾病进展、出现无法耐受的不良事件（AE）或退出研究。无进展生存期（PFS）作为主要的预后指标。次要指标包括疾病控制率（DCR）、客观缓解率（ORR）、总生存时间（OS）和不良事件的发生率。DCR和ORR分别为97.6%和91.0%。估计的PFS和OS分别为5.0个月（95%CI：1.0 - 10.8个月）和13.0个月（95%CI：8.4 - 18.6个月）。试验期间未报告意外不良反应。最常见的不良反应包括贫血（42.22%）、高血压（53.33%）、脱发（40.00%）、转氨酶升高（24.40%）和碱性磷酸酶升高（24.44%）。16例（35.56%）被归类为3 - 5级AE。试验期间任何患者均未发生与治疗相关原因导致的死亡。联合化疗目前是广泛期小细胞肺癌（ES-SCLC）的一线治疗方法。安罗替尼与传统铂类化疗联合在ES-SCLC的治疗中显示出有前景的治疗效果和预后。
