Relationship between initial dose, dose intensity, and survival in unresectable pancreatic cancer treated with nanoliposomal irinotecan, fluorouracil, and folinic acid
Abstract
Abstract While nanoliposomal irinotecan with fluorouracil and folinic acid (NFF) is a standard second-line regimen for unresectable pancreatic cancer (uPC) after gemcitabine-based therapy, the effects of initial dosing and relative dose intensity (RDI) in routine practice are unclear. We retrospectively analyzed 161 patients (median age 67 years; 55% male) with uPC treated with NFF at 20 Japanese institutions (June 2020–May 2021), comparing standard vs. reduced starting dose and RDI ≥80% vs. <80%. Overall survival (OS) was 8.1 vs. 8.8 months for standard vs. reduced dose ( p = 0.47; hazard ratio [HR], 1.15) and 7.5 vs. 9.2 months for RDI ≥80% vs. <80% ( p = 0.39; HR, 0.85). Progression-free survival (PFS) was 3.4 vs. 3.2 months ( p = 0.43) and 2.8 vs. 4.4 months ( p = 0.13), respectively, with similar response and disease control rates. Anemia, thrombocytopenia, and vomiting occurred more frequently in patients administered the standard starting dose, whereas severe non-hematologic adverse events were more frequently observed for RDI <80%. Reduced starting dose and RDI <80% were not associated with inferior survival, suggesting that individualized dose modification may be feasible. Future prospective studies are warranted to refine NFF dosing strategies.
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Authors: Yujiro Ueda, Hiroki Taguchi, Mototsugu Shimokawa, Taiga Otsuka, Hiroki Goto, Masafumi Oto, Shima Uneda, Minoru Yoshida, Taro Shibuki, Junichi Nakazawa, Shiho Arima, Keisuke Miwa, Futa Koga, Yoshihito Kubotsu, Hozumi Shimokawa, Shigeyuki Takeshita, Kazuo Nishikawa, Azusa Komori, Satoshi Otsu, Ayumu Hosokawa, Tatsunori Sakai, Hisanobu Oda, Machiko Kawahira, Shuji Arita, Takuya Honda, Kengo Tsuneyoshi, Toshihiro Fujita, Takahiro Sakae, Yasunori Kawaguchi, Tsuyoshi Shirakawa, Toshihiko Mizuta, Kenji Mitsugi
Institutions: Kumamoto University, Fukuoka University, Kagoshima University, Fukuoka Hospital, Saiseikai Kumamoto Hospital, Izumi City General Hospital, Yamaguchi University, Kurume University, National Cancer Center Hospital East, University of Miyazaki, Kumamoto University Hospital, Nagasaki University, Nagasaki University Hospital, Oita University, Japan Community Healthcare Organization, Japanese Red Cross Kumamoto Hospital, Kagoshima City Hospital, Ono Clinic, Kumamoto Medical Center, Kurume University Hospital, Saga-Ken Medical Centre Koseikan, Takamatsu Red Cross Hospital, Hamanomachi Hospital, Kyushu Hospital, Japanese Red Cross Society, Japan, Shikoku Cancer Center, University of Miyazaki Hospital, Kagoshima University Hospital, Miyazaki Prefectural Hospital, Sendai Shakai Hoken Hospital, Japan Hospital Association, Sasebo City General Hospital