吉西他滨难治性不可切除胰腺癌二线治疗在真实世界中的疗效

Efficacy of second-line treatment for gemcitabine-refractory unresectable pancreatic cancer in a real-world setting.

作者信息

Wang Qianqian, Lv Nan, Xu Dong, Wu Yang, Wu Junli, Gao Wentao, Wei Jishu, Xiao Bin, Tu Min, Jiang Kuirong

机构信息

Pancreas Center, The First Affiliated Hospital of Nanjing Medical University, 300 Guangzhou Road, Nanjing, Jiangsu, 210029, China.

Pancreas Institute of Nanjing Medical University, Nanjing, China.

出版信息

BMC Cancer. 2025 Jul 24;25(1):1209. doi: 10.1186/s12885-025-14601-2.

DOI:10.1186/s12885-025-14601-2

PMID:40707920

Abstract

BACKGROUND

This study aimed to compare the benefits and identify the best second-line treatment regimen for gemcitabine-refractory unresectable pancreatic cancers.

PATIENTS AND METHODS

This retrospective analysis included 144 patients with unresectable pancreatic cancer who underwent a gemcitabine-based regimen as the first-line treatment. 57, 37, and 50 patients received oxaliplatin-, irinotecan-based, and modified FOLFIRINOX (mFFX) regimens, respectively. The primary endpoint of this study was progression-free survival (PFS) and the secondary endpoints were overall survival (OS), response rate, and treatment-related toxicity.

RESULTS

There were no significant differences in median PFS (mPFS) (4.6 months vs. 2.9 months, P = 0.627, HR = 1.128, 95%CI 0.693-1.836) and median OS (mOS) (6.5 months vs. 10.2 months, P = 0.108, HR = 0.664, 95%CI 0.392-1.125) between irinotecan- and oxaliplatin-based groups. The mOS was significantly longer in the mFFX group than in the Iri/Oxa group (pooled the irinotecan- and oxaliplatin-based groups) (10.7 months vs. 8.8 months, P = 0.035, HR = 1.560, 95%CI 1.037-2.347), whereas no statistical difference was observed in mPFS between the two groups (4.4 months vs. 4.2 months, P = 0.222, HR = 1.247, 95%CI 0.866-1.797). However, after propensity score matching adjustment, no significant differences were found in mPFS (3.5 months vs. 4.2 months, P = 0.290, HR = 0.763, 95%CI 0.448-1.297) and mOS (8.5 months vs. 12.4 months, P = 0.464, HR = 1.262, 95%CI 0.673-2.367) between mFFX and Iri/Oxa groups. Survival analysis by performance status showed that patients with good performance status lived longer than those with poor performance status (10.8 months vs. 7.7 months, P = 0.000, HR = 2.194, 95%CI 1.408-3.420), suggesting that patient performance status, rather than the treatment regimen, was the primary factor affecting overall survival during second-line treatment.

CONCLUSIONS

In the second-line treatment of pancreatic cancer, the efficacy of common treatment regimens is not significantly different, while a good performance status is the key factor influencing survival. Thus, it is recommended that supportive care be enhanced concurrently with systemic therapy in patients with pancreatic cancer.

摘要

背景

本研究旨在比较吉西他滨难治性不可切除胰腺癌的获益情况，并确定最佳二线治疗方案。

患者与方法

本回顾性分析纳入了144例接受以吉西他滨为基础方案作为一线治疗的不可切除胰腺癌患者。57例、37例和50例患者分别接受了基于奥沙利铂、伊立替康的方案以及改良FOLFIRINOX（mFFX）方案。本研究的主要终点为无进展生存期（PFS），次要终点为总生存期（OS）、缓解率及治疗相关毒性。

结果

基于伊立替康组与基于奥沙利铂组之间的中位PFS（mPFS）（4.6个月对2.9个月，P = 0.627，HR = 1.128，95%CI 0.693 - 1.836）和中位OS（mOS）（6.5个月对10.2个月，P = 0.108，HR = 0.664，95%CI 0.392 - 1.125）无显著差异。mFFX组的mOS显著长于伊立替康/奥沙利铂组（合并基于伊立替康和基于奥沙利铂的组）（10.7个月对8.8个月，P = 0.035，HR = 1.560，95%CI 1.037 - 2.347），而两组之间的mPFS未观察到统计学差异（4.4个月对4.2个月，P = 0.222，HR = 1.247，95%CI 0.866 - 1.797）。然而，在倾向评分匹配调整后，mFFX组与伊立替康/奥沙利铂组之间的mPFS（3.5个月对4.2个月，P = 0.290，HR = 0.763，95%CI 0.448 - 1.297）和mOS（8.5个月对12.4个月，P = 0.464，HR = 1.262，95%CI 0.673 - 2.367）无显著差异。根据体能状态进行的生存分析显示，体能状态良好的患者比体能状态差的患者生存时间更长（10.8个月对7.7个月，P = 0.000，HR = 2.194，95%CI 1.408 - 3.420），这表明患者的体能状态而非治疗方案是影响二线治疗期间总生存的主要因素。