评价多剂量聚乙二醇伊立替康（JK1201I）作为二线单药治疗小细胞肺癌（SCLC）患者的安全性、耐受性和初步疗效。根据“3  3”剂量递增原则，患者每 3 周接受静脉注射 JK1201I 180 或 220mg/m2，共四个周期。评估无进展生存期（PFS）、总生存期（OS）、中位无进展生存期（mPFS）和中位总生存期（mOS）。 Kaplan-Meier 方法用于分析 PFS 和总体 OS。 mPFS 和 mOS 采用 Brookmeyer 和 Crowley 方法。本研究纳入 29 例 III-IV 期 SCLC 患者（IIIa 期，n = 1；IIIb 期，n = 1；IV 期，n = 27）。其中，180mg/m2剂量组有26名患者入组，220mg/m2剂量组有3名患者入组。在治疗的前 28 天期间没有发现剂量限制性毒性 (DLT)。 180mg/m2 组记录了 3 级或以上不良事件，包括腹泻（11.5%，3/26）、中性粒细胞减少症（7.7%，2/26）和白细胞减少症（7.7%，2/26）。在220mg/m2组中，1名患者（33.3%，1/3）出现中性粒细胞减少症或白细胞减少症。在180mg/m2组中，38.5%（10/26）的患者达到客观缓解率（ORR），疾病控制率（DCR）为73.1%（19/26）。 mPFS 和 mOS 分别为 3.4 个月和 12.1 个月。在220mg/m2组中，一名患者病情稳定，一名患者病情进展（PD）。 ORR、DCR、mPFS 和 mOS 分别为 0% (0/3) 和 33.3% (1/3)、2.7 个月和 2.7 个月。 JK1201I 作为 SCLC 的二线单药疗法表现出良好的疗效和相对较低的毒性，需要进一步的大规模临床研究来更详细地评估其功效。© 2024 作者。约翰·威利出版的癌症医学

To evaluate the safety, tolerability, and preliminary efficacy of multiple doses of pegylated irinotecan (JK1201I) as a second-line monotherapy for treating small-cell lung cancer (SCLC) patients.According to the "3 + 3" dose-escalation principle, patients received intravenous JK1201I at 180 or 220 mg/m2 once every 3 weeks for four cycles. Progression-free survival (PFS), overall survival (OS), median progression-free survival (mPFS), and median overall survival (mOS) were evaluated. The Kaplan-Meier method was used to analyze PFS and overall OS. Brookmeyer and Crowley's method was used for mPFS and mOS.This study included 29 patients with stage III-IV SCLC (stage IIIa, n = 1; stage IIIb, n = 1; and stage IV, n = 27). Of these, 26 patients were enrolled in the 180 mg/m2 dose group, and 3 patients were enrolled in the 220 mg/m2 dose group. No dose-limiting toxicity (DLT) was noted during the first 28 days of treatment. Grade 3 or higher adverse events were recorded in the 180 mg/m2 group, including diarrhea (11.5%, 3/26), neutropenia (7.7%, 2/26), and leukopenia (7.7%, 2/26). In the 220 mg/m2 group, one patient (33.3%, 1/3) experienced neutropenia or leukopenia. In the 180 mg/m2 group, 38.5% (10/26) of patients achieved an objective response rate (ORR), with a disease control rate (DCR) of 73.1% (19/26). The mPFS and mOS were 3.4 and 12.1 months, respectively. In the 220 mg/m2 group, one patient had stable disease, and one had progressive disease (PD). The ORR, DCR, mPFS, and mOS were 0% (0/3) and 33.3% (1/3), 2.7 months and 2.7 months, respectively.JK1201I exhibits promising efficacy and relatively low toxicities as a second-line monotherapy for SCLC, warranting further large-scale clinical studies to evaluate its efficacy in greater detail.© 2024 The Author(s). Cancer Medicine published by John Wiley & Sons Ltd.