| 著者 |
Nishikawa, Kazuo
Otsuka, Taiga
Shimokawa, Mototsugu
| en |
Shimokawa, Mototsugu（Personal）
Clinical Research Institute, National Kyushu Cancer Center, 3-1-1 Notame, Minami-Ku, Fukuoka-Shi, Fukuoka, 811-1395, Japan.
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Search repository
Inagaki, Takashi
Komori, Azusa
Todaka, Akiko
Otsu, Satoshi
Shibuki, Taro
Nakazawa, Junichi
Arima, Shiho
Miwa, Keisuke
Koga, Futa
Ueda, Yujiro
Kubotsu, Yoshihito
Shimokawa, Hozumi
| en |
Shimokawa, Hozumi（Personal）
Japan Community Healthcare Organization Kyushu Hospital
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Search repository
Takeshita, Shigeyuki
| en |
Takeshita, Shigeyuki（Personal）
Japanese Red Cross Nagasaki Genbaku Hospital
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Search repository
細川, 歩
WEKO
33635
e-Rad_Researcher
90432111
| ja |
細川, 歩
宮崎大学
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| ja-Kana |
ホソカワ, アユム
|
| en |
Hosokawa, Ayumu
University of Miyazaki
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Search repository
Sakai, Tatsunori
Oda, Hisanobu
Kawahira, Machiko
Arita, Shuji
Honda, Takuya
Taguchi, Hiroki
Tsuneyoshi, Kengo
Fujita, Toshihiro
Sakae, Takahiro
Kawaguchi, Yasunori
| en |
Kawaguchi, Yasunori（Personal）
Asakura Medical Association Hospital
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Search repository
Shirakawa, Tsuyoshi
| en |
Shirakawa, Tsuyoshi（Personal）
Clinical Hematology Oncology Treatment Study Group
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Search repository
Mizuta, Toshihiko
Mitsugi, Kenji
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内容記述 |
Nanoliposomal irinotecan plus fluorouracil with leucovorin (NFF) is the standard treatment regimen after gemcitabine-based therapy in patients with unresectable pancreatic cancer. However, data on the efficacy and safety of NFF in terms of the presence or absence of biliary drainage (BD) or serum bilirubin levels prior to NFF are limited. Therefore, we analyzed whether these factors affect the efficacy and safety of NFF in the real world./The NAPOLEON-2 study consisted of a retrospective and a prospective phase. As the retrospective phase, we retrospectively evaluated 161 consecutive patients who received NFF as second- or later line treatment. The primary endpoint was overall survival (OS); other endpoints included progression-free survival, response rate, disease control rate, dose intensity, and adverse events (AEs). We compared the endpoints between the non-BD group and BD group first, and then between the serum total bilirubin ≥ 1.0 mg/dL group and < 1.0 mg/dL group./All patients received gemcitabine prior to NFF. No significant difference in OS was observed between the non-BD and BD groups (9.1 vs 7.6 months; hazard ratio (HR), 1.09; 95% confidence interval (CI), 0.72-1.66; P = 0.69). The rates of severe hematological AEs and biliary tract infections were higher in the BD group than in the non-BD group. A significant difference in OS was noted between the bilirubin ≥ 1.0 mg/dL and < 1.0 mg/dL group (5.4 vs 8.9 months; HR, 2.13; 95%CI, 1.18-3.84; P = 0.01). In addition, the rate of severe hematological AE was higher in the high bilirubin group (56% vs. 26%)./BD had minimal impact on the efficacy of NFF in daily practice. Patients with total bilirubin ≥ 1.0 mg/dL had shorter OS than those with total bilirubin < 1.0 mg/dL. |
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