For Japanese pts, there are limited data of a small phase II trial of FFX (Okusaka, Cancer Sci 2014). In this multi-center retrospective study, we previously reported the preliminary results focusing on adverse events (AEs) of FFX (Ozaka, 2016 Gastrointestinal Cancers Symposium). In this presentation, we report updated results including efficacy.
The subjects were unresectable/recurrent PC pts who received FFX in practice during one year from 20 December 2013 and were followed until December 2015.
Totally, 400 pts were registered from 27 institutions in Japan. One pt was excluded from the analysis because of no administration of CPT-11. Pts characteristics were: median age 63 years; ECOG-PS 0/1/2 70/29/1%; disease status recurrent (rec)/locally advanced (LA)/metastatic (met) 20/20/60%; prior chemotherapy yes/no 37/63%; biliary stent before FFX 23%; UGT1A1 polymorphism *28 and *6 wild /single heterozygous/homozygous or double heterozygous 55/38/4%. 273 pts (68%) met the inclusion criteria of the Japanese phase II trial (ECOG-PS 6 M, adequate organ function). Median number of treatment cycles was 6. The relative dose intensities of L-OHP, CPT-11, bolus 5-FU and infusional 5-FU were 73%, 66%, 7%, 80%. The main grade 3/4 AEs were neutropenia (64%), leucopenia (31%), anorexia (14%), febrile neutropenia (13%). There were 5 treatment-related deaths. Multivariate analysis showed that female (Odds ratio (OR) 1.67; 95% CI, 1.07–2.61), ECOG-PS (OR 1.65; 1.06-2.57) and serum albumin level (OR 1.64; 1.08–2.49) were significant predictive factors of grade 3/4 AEs. Median overall (OS) and progression-free survivals (PFS) were 327 (95% CI, 294–360) and 140 (95% CI, 122–158) days. The overall response and disease control rates were 20% and 62%. Limited to the first-line chemotherapy, median OS and PFS by disease status (rec/LA/met) were 150/563/336 and 100/230/147 days.
Practical use of FFX for Japanese pts with unresectable/recurrent PC showed acceptable toxicities and compatible efficacy to the previous clinical trials.
Clinical trial identification
UMIN000014658 26 July 2014
Legal entity responsible for the study
Yakult Honsha Co.,Ltd., and Daiichi Sankyo Co.,Ltd.
N. Mizuno: Research funding: Taiho Pharmaceutical Co. Ltd., Merck Serono, AstraZeneca, Zeria Pharmaceutical, NanoCarrier, Eisai, MSD. Honoraria: Taiho Pharmaceutical Co. Ltd., Elli Lilly Japan K.K., Yakult Honsha Novartis, Pfizer, Kyowa-Hakko Kirin. N. Boku: Honorarium fron Yakult. H. Ueno: Honoraria: Taiho Pharmaceutical, Yakult Honsha, Chugai Pharmaceutical. Research Funding: Taiho Pharmaceutical, OncoTherapy Science, Eli Lilly Japan, Merck Serono Japan, Zeria Pharmaceutical, NanoCarrier. S. Kobayashi: Yakult Honsha: Honoraria: S. Nakamori: Eizai. Y. Yachi: Employee of Daiichi Sankyo CO., LTD. T. Henmi: Employee of Yakult Honsha Co.,Ltd. A. Fukutomi: Honoraria: Yakult Honsha Co.,Ltd, Daiichi Sankyo CO., LTD. All other authors have declared no conflicts of interest.