Department of Clinical Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-Ku, Nagoya, Aichi, 464-8681, Japan.
Department of Medical Oncology, Faculty of Medicine, Kindai University, Osaka-Sayama, Japan.
Int J Clin Oncol. 2023 Jun;28(6):756-763. doi: 10.1007/s10147-023-02330-0. Epub 2023 Mar 21.
The present study aimed to compare the efficacy and safety of nivolumab (NIVO) and irinotecan (IRI) and to identify clinical factors that facilitate treatment selection.
Patients with advanced gastric cancer (AGC) who underwent NIVO or IRI treatment between November 2016 and June 2018 at three institutions were retrospectively reviewed. The inclusion criteria were histologically confirmed gastric/gastroesophageal adenocarcinoma pretreated with fluoropyrimidines and taxanes, no previous NIVO or IRI treatment, and adequate organ function. Main outcome measures were objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and adverse events. Interaction between treatment groups and clinical factors regarding OS were tested using a multivariate Cox proportional hazards model adjusted for relevant variables.
Both NIVO (n = 71) and IRI (n = 61) groups had similar baseline characteristics, except for sex distribution. NIVO and IRI groups had ORR of 20% and 6%, median PFS of 1.6 and 1.8 months, and median OS of 6.4 and 6.4 months, respectively. Interaction analysis did not reveal any significant interaction between NIVO and IRI related to OS for various factors. NIVO group tended to have fewer ≥ grade 3 adverse events than IRI group, especially neutropenia (3% vs. 28%) and febrile neutropenia (1% vs. 8%). In the NIVO group, one patient developed pneumonitis, and four patients developed skin reactions.
Although no remarkable differences in efficacy were found between IRI and NIVO for AGC, NIVO had a better safety profile compared to IRI. We found no clinical markers that can assist treatment decisions.
本研究旨在比较纳武利尤单抗（NIVO）和伊立替康（IRI）的疗效和安全性，并确定有助于治疗选择的临床因素。
回顾性分析了 2016 年 11 月至 2018 年 6 月在三家机构接受 NIVO 或 IRI 治疗的晚期胃癌（AGC）患者。纳入标准为经组织学证实的胃/胃食管腺癌，氟嘧啶和紫杉烷预处理，无既往 NIVO 或 IRI 治疗，且器官功能良好。主要观察指标为客观缓解率（ORR）、无进展生存期（PFS）、总生存期（OS）和不良事件。采用多变量 Cox 比例风险模型，对 OS 相关的治疗组和临床因素进行交互作用检验，并调整了相关变量。
NIVO（n=71）和 IRI（n=61）组的基线特征相似，除了性别分布。NIVO 和 IRI 组的 ORR 分别为 20%和 6%，中位 PFS 分别为 1.6 和 1.8 个月，中位 OS 分别为 6.4 和 6.4 个月。交互分析显示，在各种因素中，NIVO 和 IRI 与 OS 之间均无显著的交互作用。与 IRI 组相比，NIVO 组的不良事件≥3 级发生率较低，尤其是中性粒细胞减少症（3%比 28%）和发热性中性粒细胞减少症（1%比 8%）。在 NIVO 组中，有 1 例患者发生肺炎，4 例患者发生皮肤反应。
尽管 IRI 和 NIVO 对 AGC 的疗效无明显差异，但与 IRI 相比，NIVO 的安全性更好。我们未发现有助于治疗决策的临床标志物。
