Minna Zhang , Yi Tang , Jiafeng Liang , Lucheng Zhu , Bing Wang , Kaicheng Pan , Xiao Xu , Xueqin Chen , Bing Xia
{"title":"anlotinib和伊立替康联合作为二线治疗6个月内复发的广泛期小细胞肺癌:一项单臂期Ⅱ研究","authors":"Minna Zhang , Yi Tang , Jiafeng Liang , Lucheng Zhu , Bing Wang , Kaicheng Pan , Xiao Xu , Xueqin Chen , Bing Xia","doi":"10.1016/j.lungcan.2025.108630","DOIUrl":null,"url":null,"abstract":"<div><h3>Purpose</h3><div>There is still no satisfactory treatment strategy for patients with extensive-stage small-cell lung cancer (ES-SCLC) relapsed within 6 months after first-line treatment.</div></div><div><h3>Patients and Methods</h3><div>Subjects received 12 mg oral anlotinib on days 1–14 and irinotecan (65 mg/m<sup>2</sup>) on day 1 and 8 every 3 weeks (up to 4 cycles), followed by anlotinib maintainance therapy with anlotinib alone. The primary endpoint was objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), disease control rate (DCR), overall survival (OS) and safety.</div></div><div><h3>Results</h3><div>Thirty-seven patients were evaluable for efficacy and safety profile. ORR was 62.2 % (23/37) and DCR was 91.9 % (34/37). Median PFS and OS for all the patients were 4.5 and 7.2 months. PFS and OS of patients with a 3 < chemothrerapy-free survival (CTFI) ≤ 6 months were better than those of patients with a CTFI ≤ 3 months (PFS 6.5 vs 3.9 months, <em>P</em> = 0.0073; OS 18.5 vs 5.9 months, <em>P</em> < 0.001). Patients who previously received chemotherapy alone or chemotherapy combined with immunotherapy as first-line treatment had similar median PFS and OS (mPFS 4.4 vs 4.9 months, <em>P</em> = 0.38; mOS 7.2 vs 8.3 months, <em>P</em> = 0.79). Only three patients (8.5 %) suffered from Grade 3 adverse effects, which were thrombocytopenia, leukopenia, and anemia.</div></div><div><h3>Conclusion</h3><div>The combination of anlotinib and irinotecan as second-line treatment for ES-SCLC patients who relapsed within 6 months demonstrated promising efficacy and had manageable toxicities. Patients with 3 < CTFI ≤ 6 months had longer PFS and OS than those with CTFI ≤ 3 months. Previous immunotherapy did not affect the efficacy of subsequent anlotinib and irinotecan. It may become a novel therapeutic strategy for this population. The trial was registered with <span><span>www.clinicaltrials.gov</span><svg><path></path></svg></span> (No. NCT04757779).</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"205 ","pages":"Article 108630"},"PeriodicalIF":4.4000,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Combination of anlotinib and irinotecan as second-line therapy in extensive-stage small-cell lung cancer relapsed within six months: a single-arm phase Ⅱ study\",\"authors\":\"Minna Zhang , Yi Tang , Jiafeng Liang , Lucheng Zhu , Bing Wang , Kaicheng Pan , Xiao Xu , Xueqin Chen , Bing Xia\",\"doi\":\"10.1016/j.lungcan.2025.108630\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Purpose</h3><div>There is still no satisfactory treatment strategy for patients with extensive-stage small-cell lung cancer (ES-SCLC) relapsed within 6 months after first-line treatment.</div></div><div><h3>Patients and Methods</h3><div>Subjects received 12 mg oral anlotinib on days 1–14 and irinotecan (65 mg/m<sup>2</sup>) on day 1 and 8 every 3 weeks (up to 4 cycles), followed by anlotinib maintainance therapy with anlotinib alone. The primary endpoint was objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), disease control rate (DCR), overall survival (OS) and safety.</div></div><div><h3>Results</h3><div>Thirty-seven patients were evaluable for efficacy and safety profile. ORR was 62.2 % (23/37) and DCR was 91.9 % (34/37). Median PFS and OS for all the patients were 4.5 and 7.2 months. PFS and OS of patients with a 3 < chemothrerapy-free survival (CTFI) ≤ 6 months were better than those of patients with a CTFI ≤ 3 months (PFS 6.5 vs 3.9 months, <em>P</em> = 0.0073; OS 18.5 vs 5.9 months, <em>P</em> < 0.001). Patients who previously received chemotherapy alone or chemotherapy combined with immunotherapy as first-line treatment had similar median PFS and OS (mPFS 4.4 vs 4.9 months, <em>P</em> = 0.38; mOS 7.2 vs 8.3 months, <em>P</em> = 0.79). Only three patients (8.5 %) suffered from Grade 3 adverse effects, which were thrombocytopenia, leukopenia, and anemia.</div></div><div><h3>Conclusion</h3><div>The combination of anlotinib and irinotecan as second-line treatment for ES-SCLC patients who relapsed within 6 months demonstrated promising efficacy and had manageable toxicities. Patients with 3 < CTFI ≤ 6 months had longer PFS and OS than those with CTFI ≤ 3 months. Previous immunotherapy did not affect the efficacy of subsequent anlotinib and irinotecan. It may become a novel therapeutic strategy for this population. 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引用次数: 0
摘要
目的广泛期小细胞肺癌(ES-SCLC)在一线治疗后6个月内复发,目前仍没有令人满意的治疗策略。患者和方法:受试者在第1 - 14天口服安洛替尼12 mg,每3周(最多4个周期)第1天和第8天口服伊立替康(65 mg/m2),随后单独安洛替尼维持治疗。主要终点为客观缓解率(ORR)。次要终点包括无进展生存期(PFS)、疾病控制率(DCR)、总生存期(OS)和安全性。结果37例患者的疗效和安全性可评价。ORR为62.2% (23/37),DCR为91.9%(34/37)。所有患者的中位PFS和OS分别为4.5和7.2个月。3 <患者的PFS和OS;无化疗生存期(CTFI)≤6个月优于CTFI≤3个月的患者(PFS 6.5 vs 3.9个月,P = 0.0073;OS 18.5 vs 5.9个月,P <;0.001)。先前单独接受化疗或化疗联合免疫治疗作为一线治疗的患者的中位PFS和OS相似(mPFS 4.4 vs 4.9个月,P = 0.38;生存期7.2 vs 8.3个月,P = 0.79)。只有3名患者(8.5%)出现3级不良反应,即血小板减少症、白细胞减少症和贫血。结论安洛替尼联合伊立替康作为二线治疗6个月内复发的ES-SCLC患者疗效良好,且毒性可控。3 <患者;CTFI≤6个月患者的PFS和OS均长于CTFI≤3个月患者。先前的免疫治疗不影响随后的安洛替尼和伊立替康的疗效。它可能成为这一人群的一种新的治疗策略。本试验注册于www.clinicaltrials.gov (No. 5)。NCT04757779)。
Combination of anlotinib and irinotecan as second-line therapy in extensive-stage small-cell lung cancer relapsed within six months: a single-arm phase Ⅱ study
Purpose
There is still no satisfactory treatment strategy for patients with extensive-stage small-cell lung cancer (ES-SCLC) relapsed within 6 months after first-line treatment.
Patients and Methods
Subjects received 12 mg oral anlotinib on days 1–14 and irinotecan (65 mg/m2) on day 1 and 8 every 3 weeks (up to 4 cycles), followed by anlotinib maintainance therapy with anlotinib alone. The primary endpoint was objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), disease control rate (DCR), overall survival (OS) and safety.
Results
Thirty-seven patients were evaluable for efficacy and safety profile. ORR was 62.2 % (23/37) and DCR was 91.9 % (34/37). Median PFS and OS for all the patients were 4.5 and 7.2 months. PFS and OS of patients with a 3 < chemothrerapy-free survival (CTFI) ≤ 6 months were better than those of patients with a CTFI ≤ 3 months (PFS 6.5 vs 3.9 months, P = 0.0073; OS 18.5 vs 5.9 months, P < 0.001). Patients who previously received chemotherapy alone or chemotherapy combined with immunotherapy as first-line treatment had similar median PFS and OS (mPFS 4.4 vs 4.9 months, P = 0.38; mOS 7.2 vs 8.3 months, P = 0.79). Only three patients (8.5 %) suffered from Grade 3 adverse effects, which were thrombocytopenia, leukopenia, and anemia.
Conclusion
The combination of anlotinib and irinotecan as second-line treatment for ES-SCLC patients who relapsed within 6 months demonstrated promising efficacy and had manageable toxicities. Patients with 3 < CTFI ≤ 6 months had longer PFS and OS than those with CTFI ≤ 3 months. Previous immunotherapy did not affect the efficacy of subsequent anlotinib and irinotecan. It may become a novel therapeutic strategy for this population. The trial was registered with www.clinicaltrials.gov (No. NCT04757779).
期刊介绍:
Lung Cancer is an international publication covering the clinical, translational and basic science of malignancies of the lung and chest region.Original research articles, early reports, review articles, editorials and correspondence covering the prevention, epidemiology and etiology, basic biology, pathology, clinical assessment, surgery, chemotherapy, radiotherapy, combined treatment modalities, other treatment modalities and outcomes of lung cancer are welcome.