Efficacy of liposomal irinotecan + 5-FU/LV vs. S-1 in gemcitabine-refractory metastatic pancreatic cancer: a real-world study using inverse probability of treatment weighting.

IF 6.9 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Hiroshi Imaoka, Masafumi Ikeda, Satoshi Kobayashi, Akihiro Ohba, Masayuki Ueno, Yuko Suzuki, Hidetaka Tsumura, Nana Kimura, Shinya Kawaguchi, Yasuyuki Kawamoto, Kohei Nakachi, Kunihiro Tsuji, Noritoshi Kobayashi, Reiko Ashida, Naohiro Okano, Kumiko Umemoto, Gou Murohisa, Ayumu Hosokawa, Akinori Asagi, Hiroko Nebiki, Rei Suzuki, Takeshi Terashima, Ryusuke Shibata, Kazuhito Kawata, Toshifumi Doi, Hiroshi Ohyama, Yohei Kitano, Kazuhiko Shioji, Hiroyuki Okuyama, Atsushi Naganuma, Yuji Negoro, Yasunari Sakamoto, Satoshi Shimizu, Chigusa Morizane, Makoto Ueno, Junji Furuse, Hiroaki Nagano
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引用次数: 0

Abstract

Background: S-1 monotherapy had previously been widely used as a second-line treatment for pancreatic cancer (PC) after gemcitabine-based chemotherapy mainly in Japan. Based on the results of the NAPOLI-1 trial, the recommended second-line therapy is now liposomal irinotecan plus fluorouracil/folinic acid (nal-IRI + 5-FU/LV). However, there have been no studies comparing nal-IRI + 5-FU/LV therapy with S-1 monotherapy.

Methods: The main objective of this study was to compare overall survival (OS) in patients treated with nal-IRI + 5-FU/LV and those treated with S-1 monotherapy as second-line treatments, using the inverse probability of treatment weighting (IPTW) method. This study was conducted in 31 institutions participating in Japan Oncology Network in Hepatobiliary and Pancreas. To minimize potential biases due to the retrospective design, IPTW analysis was performed with multiple imputation, and imputed IPTW-adjusted hazard ratios and corresponding 95% confidence intervals (CIs) were estimated using a Cox proportional hazards model and combined into pooled estimates.

Results: A total of 463 metastatic PC patients were enrolled in this study (257 in the S-1 monotherapy group and 206 in the nal-IRI + 5-FU/LV group). The median OS was 7.50 months (95% CI 4.18-12.69 months) in the nal-IRI + 5-FU/LV group and 5.72 months (95% CI 2.76-10.79 months) in the S-1 monotherapy group. In the IPTW-adjusted Cox proportional hazards model, nal-IRI + 5-FU/LV was associated with a significant OS benefit (pooled IPTW-adjusted hazard ratio, 0.779; 95% CI 0.399-0.941; p = 0.025).

Conclusion: These findings support the use of nal-IRI + 5-FU/LV as standard second-line treatment for PC patients after gemcitabine-based chemotherapy.

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来源期刊
Journal of Gastroenterology
Journal of Gastroenterology 医学-胃肠肝病学
CiteScore
12.20
自引率
1.60%
发文量
99
审稿时长
4-8 weeks
期刊介绍: The Journal of Gastroenterology, which is the official publication of the Japanese Society of Gastroenterology, publishes Original Articles (Alimentary Tract/Liver, Pancreas, and Biliary Tract), Review Articles, Letters to the Editors and other articles on all aspects of the field of gastroenterology. Significant contributions relating to basic research, theory, and practice are welcomed. These publications are designed to disseminate knowledge in this field to a worldwide audience, and accordingly, its editorial board has an international membership.
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