Relationship between neutropenia caused by nanoliposomal irinotecan/fluorouracil/leucovorin and treatment outcomes in the NAPOLEON-2 study (NN-2301)
Abstract
Abstract The relationship between nanoliposomal irinotecan/fluorouracil/leucovorin (NFF) treatment outcomes and neutropenia in patients with pancreatic cancer has not been thoroughly examined. Thus, we conducted a retrospective analysis of data from patients with pancreatic cancer who were treated with NFF to investigate this relationship. Neutropenia was assessed according to the Common Terminology Criteria for Adverse Events across three cutoffs: A (grade 0 versus grade 1–4), B (grades 0–1 versus 2–4), and C (grades 0–2 versus 3–4). The primary endpoint was overall survival (OS), and the secondary endpoints were overall response rate, progression-free survival (PFS), and relative dose intensity. Of the 161 patients, 93, 8, 22, 30, and 8 patients had neutropenia of grades 0, 1, 2, 3, and 4, respectively. The overall response rates differed significantly at cutoff C (p = 0.02), with the odds ratio for cutoff C being the highest, followed by cutoffs B and A. Significant differences in OS were observed at cutoffs A (hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.44–0.94; p = 0.02) and B (HR, 0.63; 95% CI, 0.43–0.92, p = 0.02). Similarly, PFS showed significant differences at cutoffs A and B (p < 0.01). NFF-induced neutropenia can be a useful prognostic factor for patients with pancreatic cancer.
Article Details
Authors (33)
Tomonori Araki
Yuki Sonoda
Mototsugu Shimokawa
Taiga Otsuka
Kohei Hayashi
Takuya Honda
Kazuhiko Nakao
Taro Shibuki
Junichi Nakazawa
Shiho Arima
Keisuke Miwa
Yoshinobu Okabe
Futa Koga
Yujiro Ueda
Yoshihito Kubotsu
Hozumi Shimokawa
Shigeyuki Takeshita
Azusa Komori
Kazuo Nishikawa
Satoshi Otsu
Ayumu Hosokawa
Hisanobu Oda
Tatsunori Sakai
Shuji Arita
Machiko Kawahira
Hiroki Taguchi
Kengo Tsuneyoshi
Yasunori Kawaguchi
Toshihiro Fujita
Takahiro Sakae
Tsuyoshi Shirakawa
Toshihiko Mizuta
Kenji Mitsugi