678P - Observational study of FOLFIRINOX (FFX) for unresectable/recurrent pancreatic cancer (PC) in Japanese patients (pts)(JASPAC 06): final results

Date 08 October 2016
Event ESMO 2016 Congress
Session Poster Display
Topics Pancreatic Cancer
Presenter Nobumasa Mizuno
Citation Annals of Oncology (2016) 27 (6): 207-242. 10.1093/annonc/mdw371
Authors N. Mizuno1, A. Todaka2, K. Mori3, N. Boku4, M. Ozaka5, H. Ueno6, S. Kobayashi7, K. Uesugi8, N. Kobayashi9, H. Hayashi10, K. Sudo11, N. Okano12, Y. Horita13, K. Kamei14, S. Yukisawa15, S. Nakamori16, Y. Yachi17, T. Henmi18, M. Kobayashi19, A. Fukutomi2
  • 1Department Of Gastroenterology, Aichi Cancer Center Hospital, 464-8681 - Nagoya/JP
  • 2Division Of Gastrointestinal Oncology, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 3Clinical Research Promotion Unit, Clinical Research Center, Shizuoka Cancer Center, Shizuoka/JP
  • 4Division Of Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo/JP
  • 5Department of gastroenterology, Cancer Institute Hospital of JFCR, Tokyo/JP
  • 6Hepatobiliary And Pancreatic Oncology Division, National Cancer Center Hospital, Tokyo/JP
  • 7Division Of Hepatobiliary And Pancreatic Medical Oncology, Kanagawa Cancer Center, Yokohama/JP
  • 8Departments Of Gastroenterology, Shikoku Cancer Center, Matsuyama/JP
  • 9Depertment Of Oncology, Yokohama City University Hospital, Yokohama/JP
  • 10Department Of Gastroenterology And Hepatology, Hokkaido University Hospital, Sapporo/JP
  • 11Division Of Gastroenterology, Chiba Cancer Center, Chiba/JP
  • 12Department Of Medical Oncology, Kyorin University School of Medicine, 181-8611 - Mitaka/JP
  • 13Department Of Medical Oncology, Toyama Prefectural Central Hospital, Toyama/JP
  • 14Department Of Surgery, Kindai University Faculty of Medicine, Osaka-sayama/JP
  • 15Departement Of Medical Oncology, Tochigi Cancer Center, Utsunomiya/JP
  • 16Department Of Hepato-biliary-pancreatic Surgery, National Hospital Organization Osaka National Hospital, 540-0006 - Osaka/JP
  • 17Pharmacovigilance Department, Daiichi Sankyo Co.,Ltd., Tokyo/JP
  • 18Post-marketing Surveilannce Pharmacovigilance Department, Yakult Honsha Co.,Ltd., Tokyo/JP
  • 19Clinical Trial Promotion Section, Public Interest Incorporated Foundation- Shizuoka Industrial Foundation- Pharma Valley Center, Shizuoka/JP



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.