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安柔比星联合培非格司亭作为小细胞肺癌二线化疗的一线预防的安全性和有效性。

Safety and efficacy of amrubicin with primary prophylactic pegfilgrastim as second-line chemotherapy in patients with small cell lung cancer.

机构信息

Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.

Department of Respiratory Medicine and Allergology, Sapporo Medical University School of Medicine, Sapporo, Japan.

出版信息

Thorac Cancer. 2023 Dec;14(35):3475-3482. doi: 10.1111/1759-7714.15140. Epub 2023 Oct 24.

Abstract

BACKGROUND

Amrubicin (AMR) regimens have shown efficacy as second-line treatment in patients with small cell lung cancer (SCLC); however, adverse events such as febrile neutropenia (FN) sometimes preclude their use. Further, the safety and efficacy of AMR with primary prophylactic pegfilgrastim (P-PEG) have not been sufficiently evaluated. In this study, we evaluated the safety and efficacy of AMR with or without P-PEG as second-line chemotherapy for SCLC.

METHODS

We retrospectively reviewed patients with SCLC who received AMR as second-line chemotherapy at Shizuoka Cancer Center, between December 2014 and November 2021. Based on presence/absence of P-PEG in their regimen, patients (n = 60) were divided into P-PEG (n = 21) and non-P-PEG groups, and their clinical outcomes were evaluated.

RESULTS

Median of AMR treatment cycles was five (range: 1-39 cycles) in P-PEG group and four (range: 1-15 cycles) in non-P-PEG group. The incidence of FN (4.8% vs. 30.8%; p = 0.02) and AMR dose reduction because of adverse events (4.8% vs. 25.6%; p = 0.08) were lower in the P-PEG group than in the non-P-PEG group. The objective response rates were 52.4% and 30.8%, and median progression-free and overall survival were 4.7 and 3.0 months, and 9.6 and 6.8 months, in the P-PEG and non-P-PEG groups, respectively.

CONCLUSIONS

AMR with P-PEG as second-line chemotherapy for SCLC reduced the incidence of FN at a maintained AMR dose intensity and was associated with favorable tumor responses and survival outcomes. P-PEG should be considered for patients treated with AMR for SCLC including refractory relapsed SCLC.

摘要

背景

氨柔比星(AMR)方案在小细胞肺癌(SCLC)患者二线治疗中显示出疗效;然而,发热性中性粒细胞减少症(FN)等不良反应有时会妨碍其使用。此外,AMR 联合培非格司亭(P-PEG)作为 SCLC 一线预防性治疗的安全性和疗效尚未得到充分评估。在这项研究中,我们评估了 AMR 联合或不联合 P-PEG 作为 SCLC 二线化疗的安全性和疗效。

方法

我们回顾性分析了 2014 年 12 月至 2021 年 11 月在静冈癌症中心接受 AMR 二线化疗的 SCLC 患者。根据其方案中是否存在 P-PEG,患者(n=60)分为 P-PEG(n=21)和非 P-PEG 组,并评估了他们的临床结局。

结果

P-PEG 组的 AMR 治疗周期中位数为 5 个(范围:1-39 个周期),而非 P-PEG 组为 4 个(范围:1-15 个周期)。FN 的发生率(4.8% vs. 30.8%;p=0.02)和因不良反应而减少 AMR 剂量的发生率(4.8% vs. 25.6%;p=0.08)在 P-PEG 组均低于非 P-PEG 组。P-PEG 和非 P-PEG 组的客观缓解率分别为 52.4%和 30.8%,中位无进展生存期和总生存期分别为 4.7 个月和 3.0 个月、9.6 个月和 6.8 个月。

结论

在维持 AMR 剂量强度的情况下,将 P-PEG 联合 AMR 作为 SCLC 的二线化疗可降低 FN 的发生率,并与良好的肿瘤反应和生存结局相关。对于接受 AMR 治疗的 SCLC 患者,包括难治性复发性 SCLC 患者,应考虑使用 P-PEG。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/948b/10719656/a6c0a13a03c8/TCA-14-3475-g003.jpg

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