吉西他滨联合 S-1 方案与吉西他滨联合白蛋白紫杉醇方案治疗初治晚期胰腺导管腺癌的疗效和安全性。

Efficacy and safety of gemcitabine plus S-1 gemcitabine plus nab-paclitaxel in treatment-naïve advanced pancreatic ductal adenocarcinoma.

机构信息

Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China.

4+4 Medical Doctor Program, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China.

出版信息

Cancer Biol Med. 2023 Aug 29;20(10):765-78. doi: 10.20892/j.issn.2095-3941.2023.0189.

OBJECTIVE

Gemcitabine plus nab-paclitaxel (GnP) is the standard first-line therapy for advanced pancreatic ductal adenocarcinoma (PDAC). S-1, an oral fluoropyrimidine derivative, as compared with gemcitabine, is non-inferior in terms of overall survival (OS) and is associated with lower hematologic toxicity. Accordingly, S-1 is a convenient oral alternative treatment for advanced PDAC. This study was aimed at comparing the efficacy and safety of gemcitabine plus S-1 (GS) GnP as first-line chemotherapy for advanced PDAC.

METHODS

Patients with advanced PDAC who received first-line GS or GnP at the Peking Union Medical College Hospital between March 2011 and November 2022 were evaluated.

RESULTS

A total of 300 patients were assessed, of whom 84 received GS and 216 received GnP. The chemotherapy completion rate was higher with GS than GnP (50.0% 30.3%, = 0.0028). The objective response rate (ORR) was slightly higher (14.3% 9.7%, = 0.35), and the median OS was significantly longer (17.9 months 13.3 months, = 0.0078), in the GS group than the GnP group. However, the median progression-free survival (PFS) did not significantly differ between groups. Leukopenia risk was significantly lower in the GS group than the GnP group (14.9% 28.1%, = 0.049).

CONCLUSIONS

As first-line chemotherapy for advanced PDAC, the GS regimen led to a significantly longer OS than the GnP regimen. The PFS, ORR, and incidence of severe adverse events were comparable between the GS and GnP groups.

目的

吉西他滨联合 nab-紫杉醇（GnP）是晚期胰腺导管腺癌（PDAC）的标准一线治疗方案。替吉奥（S-1）是一种口服氟嘧啶衍生物，其总生存期（OS）与吉西他滨相当，但血液学毒性较低。因此，S-1 是晚期 PDAC 一种方便的口服替代治疗方法。本研究旨在比较吉西他滨联合 S-1（GS）和 GnP 作为晚期 PDAC 一线化疗的疗效和安全性。

方法

评估 2011 年 3 月至 2022 年 11 月期间在北京协和医院接受一线 GS 或 GnP 治疗的晚期 PDAC 患者。

结果

共评估了 300 例患者，其中 84 例接受 GS 治疗，216 例接受 GnP 治疗。GS 组的化疗完成率高于 GnP 组（50.0% vs. 30.3%， = 0.0028）。GS 组的客观缓解率（ORR）略高（14.3% vs. 9.7%， = 0.35），中位 OS 明显更长（17.9 个月 vs. 13.3 个月， = 0.0078）。然而，两组的中位无进展生存期（PFS）无显著差异。GS 组的白细胞减少风险明显低于 GnP 组（14.9% vs. 28.1%， = 0.049）。