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对纳米脂质体伊立替康联合5-氟尿嘧啶和亚叶酸作为转移性胰腺腺癌患者三线或更后线治疗的真实世界分析。

A real-world analysis of nanoliposomal-irinotecan with 5-fluorouracil and folinic acid as third- or later-line therapy in patients with metastatic pancreatic adenocarcinoma.

作者信息

Chun Jung Won, Woo Sang Myung, Lee Sang Hyub, Choi Jin Ho, Park Namyoung, Kim Joo Seong, Cho In Rae, Paik Woo Hyun, Lee Woo Jin, Ryu Ji Kon, Kim Yong-Tae

机构信息

Center for Liver and Pancreatobiliary Cancer, National Cancer Center, Goyang-si, Korea.

Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul 110-744, Korea.

出版信息

Ther Adv Med Oncol. 2022 Aug 29;14:17588359221119539. doi: 10.1177/17588359221119539. eCollection 2022.

Abstract

BACKGROUND

Nanoliposomal encapsulation of irinotecan (nal-IRI) with 5-fluorouracil and leucovorin (5-FU/LV) has shown a survival benefit for gemcitabine-pretreated patients with metastatic pancreatic adenocarcinoma (mPAC). The aim of this study was to evaluate the effectiveness and safety of nal-IRI with 5-FU/LV for use beyond second-line treatment after standard frontline therapy for mPAC.

METHOD

This multicenter, retrospective, non-comparative observational study included mPAC patients who received nal-IRI plus 5-FU/LV as third- or later-line therapy after disease progression on first-line FOLFIRINOX (FFX) or gemcitabine plus nab-paclitaxel.

RESULTS

In all, 128 patients who received nal-IRI plus 5-FU/LV beyond second-line treatment between October 2017 and July 2021 were analyzed. Most patients (82%) received nal-IRI plus 5-FU/LV as a third-line treatment. The median overall survival (OS) was 4.9 months and the median progression-free survival (PFS) was 2.4 months. Patients with better Eastern Cooperative Oncology Group (ECOG) performance status experienced significantly longer OS (ECOG 0, 8.7 months; ECOG 1, 4.8 months; ECOG 2, 2.9 months; < 0.001) and PFS (3.9 months; 2.1 months; 1.5 months; = 0.019). Patients who had not been previously treated with FFX or had a time to progression of 7 months or more on FFX experienced longer OS and PFS than those who did not (6.1 months and 5.6 4.1 months, = 0.053; 3.6 months and 2.4 2.1 months, = 0.002). The most common adverse events were neutropenia (56%) and anemia (51%).

CONCLUSION

Our real-world data indicated that nal-IRI plus 5-FU/LV can be effective not only as second-line therapy, but also as third-line or later-line treatment in selected patients. Nal-IRI plus 5-FU/LV may be particularly beneficial for the survival of patients that maintain good general condition or those with favorable prior experience to irinotecan.

摘要

背景

伊立替康纳米脂质体(nal-IRI)联合5-氟尿嘧啶和亚叶酸钙(5-FU/LV)已显示对吉西他滨预处理的转移性胰腺腺癌(mPAC)患者有生存获益。本研究的目的是评估nal-IRI联合5-FU/LV在mPAC标准一线治疗后用于二线以上治疗的有效性和安全性。

方法

这项多中心、回顾性、非对照观察性研究纳入了在一线FOLFIRINOX(FFX)或吉西他滨联合白蛋白结合型紫杉醇治疗疾病进展后接受nal-IRI联合5-FU/LV作为三线或更后线治疗的mPAC患者。

结果

共分析了2017年10月至2021年7月期间接受nal-IRI联合5-FU/LV二线以上治疗的128例患者。大多数患者(82%)接受nal-IRI联合5-FU/LV作为三线治疗。中位总生存期(OS)为4.9个月,中位无进展生存期(PFS)为2.4个月。东部肿瘤协作组(ECOG)体能状态较好的患者OS(ECOG 0,8.7个月;ECOG 1,4.8个月;ECOG 2,2.9个月;P<0.001)和PFS(3.9个月;2.1个月;1.5个月;P = 0.019)显著更长。未接受过FFX治疗或在FFX上疾病进展时间达7个月或更长时间的患者,其OS和PFS比未达到上述情况的患者更长(6.1个月对4.1个月,P = 0.053;3.6个月对2.1个月,P = 0.002)。最常见的不良事件是中性粒细胞减少(56%)和贫血(51%)。

结论

我们的真实世界数据表明,nal-IRI联合5-FU/LV不仅作为二线治疗有效,而且在选定患者中作为三线或更后线治疗也有效。nal-IRI联合5-FU/LV可能对一般状况良好或对伊立替康有良好既往治疗经历的患者的生存特别有益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/92cc/9434681/47b43a53b400/10.1177_17588359221119539-fig1.jpg

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