Department of Gastroenterology, Kanagawa Cancer Center, Yokohama City, Japan.
Department of Data Science, National Cancer Center Hospital East, Kashiwa City, Japan.
Oncologist. 2022 Oct 1;27(10):e774-e782. doi: 10.1093/oncolo/oyac157.
Gemcitabine plus nab-paclitaxel (GnP) has been a standard treatment for unresectable pancreatic cancer (uPC); however, the current treatment status and usefulness in older adults with uPC remain unclear. Therefore, we aimed to investigate the patient background and compare the efficacy and safety of GnP versus other treatments in older adults with uPC.
In this prospective observational study, we enrolled 233 eligible patients aged ≥76 years with pathologically proven, clinically uPC, and no history of chemotherapy from 55 Japanese centers during September 2018-September 2019. The main endpoints were overall survival (OS), progression-free survival (PFS), and safety. Geriatric assessments were performed upon registration and after 3 months. To adjust for confounders, we conducted propensity score-matched analyses.
GnP, gemcitabine alone (Gem), best supportive care, and other therapies were administered to 116, 72, 16, and 29 patients, respectively. In the propensity score-matched analysis, 42 patients each were selected from the GnP and Gem groups. The median OS was longer in the GnP group than in the Gem group (12.2 vs. 9.4 months; hazard ratio [HR], 0.65; 95% CI, 0.37-1.13). The median PFS was significantly longer in the GnP group than in the Gem group (9.2 vs. 3.7 months; HR, 0.38; 95% CI, 0.23-0.64). The incidence of severe adverse events was higher with GnP than with Gem; however, the difference was not significant.
GnP is more efficacious than Gem in patients aged ≥76 years with uPC despite demonstrating a higher incidence of severe adverse events.
吉西他滨联合白蛋白紫杉醇（GnP）是不可切除胰腺癌（uPC）的标准治疗方法；然而，目前对于年龄较大的 uPC 患者的治疗现状和疗效尚不清楚。因此，我们旨在调查患者背景，并比较 GnP 与其他治疗方法在年龄较大的 uPC 患者中的疗效和安全性。
在这项前瞻性观察性研究中，我们从 2018 年 9 月至 2019 年 9 月期间，从日本的 55 个中心共纳入了 233 名年龄≥76 岁、经病理证实、临床诊断为 uPC 且无化疗史的合格患者。主要终点为总生存期（OS）、无进展生存期（PFS）和安全性。在登记时和 3 个月后进行老年评估。为了调整混杂因素，我们进行了倾向评分匹配分析。
116 名患者接受 GnP、72 名患者接受吉西他滨单药治疗（Gem）、16 名患者接受最佳支持治疗、29 名患者接受其他治疗。在倾向评分匹配分析中，从 GnP 组和 Gem 组中各选择了 42 名患者。GnP 组的中位 OS 长于 Gem 组（12.2 个月 vs. 9.4 个月；风险比 [HR]，0.65；95%置信区间，0.37-1.13）。GnP 组的中位 PFS 明显长于 Gem 组（9.2 个月 vs. 3.7 个月；HR，0.38；95%置信区间，0.23-0.64）。GnP 组严重不良事件的发生率高于 Gem 组；然而，差异无统计学意义。
尽管 GnP 组严重不良事件发生率较高，但与 Gem 相比，在年龄较大的 uPC 患者中，GnP 更有效。
