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Article

Treatment Effect and Safety of Nanoliposomal Irinotecan with Fluorouracil and Folinic Acid after Gemcitabine-Based Therapy in Patients with Advanced Pancreatic Cancer: A Multicenter, Prospective Observational Study

by
Masami Miki
1,
Nao Fujimori
2,*,
Keijiro Ueda
2,3,
Lingaku Lee
1,
Masatoshi Murakami
2,
Yu Takamatsu
2,
Yuzo Shimokawa
3,
Yusuke Niina
3,
Takamasa Oono
2,
Terumasa Hisano
1,
Masayuki Furukawa
1 and
Yoshihiro Ogawa
2
1
Department of Hepato-Biliary-Pancreatology, National Hospital Organization, Kyushu Cancer Center, Fukuoka 811-1347, Japan
2
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka 812-8582, Japan
3
Department of Gastroenterology, Kitakyushu Municipal Medical Center, Fukuoka 802-0077, Japan
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2022, 11(17), 5084; https://doi.org/10.3390/jcm11175084
Submission received: 2 July 2022 / Revised: 21 August 2022 / Accepted: 26 August 2022 / Published: 30 August 2022
(This article belongs to the Section Gastroenterology & Hepatopancreatobiliary Medicine)
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Abstract

Although the combination of nanoliposomal irinotecan plus fluorouracil/folinic acid (nal-IRI/FF) exhibited survival benefits in gemcitabine-refractory patients with advanced pancreatic cancer (APC) in the phase III NAPOLI-1 trial, there is limited data on the efficacy and safety of this regimen in real-world settings in Japan. This multicenter, prospective observational study enrolled patients with APC who received nal-IRI/FF after a gemcitabine-based regimen from July 2020 to June 2021. We collected and analyzed clinical data and conducted survival and multivariate analyses. Thirty-one (78%) of the 40 patients had metastases. Nal-IRI/FF was the second-line therapy in 36 patients (90%). The median duration was 3.2 months. The disease control rate was 57%. The median progression-free survival and overall survival (OS) were 4.5 months (95% confidence interval [CI]: 2.8–5.5) and 7.4 months (95% CI: 5.1–10.6), respectively. Common ≥grade 3 toxicities included neutropenia (28%) and fatigue (23%). Fatigue led to treatment discontinuation in 6 out of 10 patients. Multivariate analysis showed that a neutrophil-to-lymphocyte ratio > 4 was a significant risk factor for a short OS (hazard ratio (HR) = 3.08, 95% CI: 1.21–7.85, p = 0.02). In conclusion, nal-IRI/FF is an appropriate treatment option for APC following gemcitabine-containing regimens.
Keywords: nanoliposomal irinotecan; advanced pancreatic cancer; second-line therapy nanoliposomal irinotecan; advanced pancreatic cancer; second-line therapy

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MDPI and ACS Style

Miki, M.; Fujimori, N.; Ueda, K.; Lee, L.; Murakami, M.; Takamatsu, Y.; Shimokawa, Y.; Niina, Y.; Oono, T.; Hisano, T.; et al. Treatment Effect and Safety of Nanoliposomal Irinotecan with Fluorouracil and Folinic Acid after Gemcitabine-Based Therapy in Patients with Advanced Pancreatic Cancer: A Multicenter, Prospective Observational Study. J. Clin. Med. 2022, 11, 5084. https://doi.org/10.3390/jcm11175084

AMA Style

Miki M, Fujimori N, Ueda K, Lee L, Murakami M, Takamatsu Y, Shimokawa Y, Niina Y, Oono T, Hisano T, et al. Treatment Effect and Safety of Nanoliposomal Irinotecan with Fluorouracil and Folinic Acid after Gemcitabine-Based Therapy in Patients with Advanced Pancreatic Cancer: A Multicenter, Prospective Observational Study. Journal of Clinical Medicine. 2022; 11(17):5084. https://doi.org/10.3390/jcm11175084

Chicago/Turabian Style

Miki, Masami, Nao Fujimori, Keijiro Ueda, Lingaku Lee, Masatoshi Murakami, Yu Takamatsu, Yuzo Shimokawa, Yusuke Niina, Takamasa Oono, Terumasa Hisano, and et al. 2022. "Treatment Effect and Safety of Nanoliposomal Irinotecan with Fluorouracil and Folinic Acid after Gemcitabine-Based Therapy in Patients with Advanced Pancreatic Cancer: A Multicenter, Prospective Observational Study" Journal of Clinical Medicine 11, no. 17: 5084. https://doi.org/10.3390/jcm11175084

APA Style

Miki, M., Fujimori, N., Ueda, K., Lee, L., Murakami, M., Takamatsu, Y., Shimokawa, Y., Niina, Y., Oono, T., Hisano, T., Furukawa, M., & Ogawa, Y. (2022). Treatment Effect and Safety of Nanoliposomal Irinotecan with Fluorouracil and Folinic Acid after Gemcitabine-Based Therapy in Patients with Advanced Pancreatic Cancer: A Multicenter, Prospective Observational Study. Journal of Clinical Medicine, 11(17), 5084. https://doi.org/10.3390/jcm11175084

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