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Poster display session

4970 - Risk factors for febrile neutropenia(FN) in unresectable/recurrent pancreatic cancer(PC) patients(pts) receiving FOLFIRINOX(FFX) from JASPAC06 study

Date

09 Sep 2017

Session

Poster display session

Presenters

Mitsuhito Sasaki

Citation

Annals of Oncology (2017) 28 (suppl_5): v209-v268. 10.1093/annonc/mdx369

Authors

M. Sasaki1, H. Ueno1, K. Omae2, T. Goto3, G. Murohisa4, N. Mizuno5, M. Ozaka6, S. Kobayashi7, K. Uesugi8, N. Kobayashi9, H. Hayashi10, K. Sudo11, N. Okano12, Y. Horita13, K. Kamei14, T. Hosokawa15, T. Henmi16, M. Kobayashi17, A. Todaka18, A. Fukutomi18

Author affiliations

  • 1 Department Of Hepatobiliary And Pancreatic Oncology, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 2 Clinical Research Promotion Unit, Shizuoka Cancer Center , Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 3 Department Of Gastroenterology And Hematology/oncology, Asahikawa Medical University, Asahikawa/JP
  • 4 Department Of Gastroenterology, Seirei Hamamatsu General Hospital, hamamatsu/JP
  • 5 Department Of Gastroenterology, Aichi Cancer Center Hospital, Nagoya/JP
  • 6 Department Of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation For Cancer Research, 1358550 - Tokyo/JP
  • 7 Department Of Gastroenterology, Hepatobiliary And Pancreatic Medical Oncology Division, Kanagawa cancer center, 2418515 - Yokohama/JP
  • 8 Department Of Gastroenterology, National Hospital Organaization Shikoku Cancer Center, 7910280 - Matsuyama/JP
  • 9 Department Of Medical Oncology, Yokohama City University Hospital, 236-004 - Yokohama/JP
  • 10 Department Of Gastroenterology And Hepatology, Hokkaido University, 0608648 - Sapporo/JP
  • 11 Department Of Gastroenterology, Chiba Cancer Center, 2608717 - Chiba/JP
  • 12 Department Of Medical Oncology, Kyorin University Faculty of Medicine, 1818611 - Tokyo/JP
  • 13 Chemotherapy And Internal Medicine, Toyama Prefectural Central Hospital, 9308550 - Toyama/JP
  • 14 Department Of Surgery, Kindai University Faculty of Medicine, 5898511 - Osaka-sayama/JP
  • 15 Medical Science Department, Daiichi Sankyo Co.,Ltd, 1038426 - Tokyo/JP
  • 16 Post-marketing Surveillance Pharmacovigilance Department, Yakult Honsha Co.,Ltd, 1040061 - Tokyo/JP
  • 17 Clinical Trial Promotion Section, Shizuoka industrial Foundation Pharma Valley Center, 4110934 - Tokyo/JP
  • 18 Divison Of Gastrointestinal Oncology, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
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Resources

Abstract 4970

Background

FFX is considered one of the standard chemotherapy regimens for chemo-naïve unresectable/recurrent PC pts with good performance status (PS), but can be associated with significant toxicity. A high incidence of FN (22%) was reported from a Japanese phase II trial of FFX. The aim of this study was to clarify the risk factors for FN in these pts.

Methods

We used data obtained from the JASPAC06 study. The subjects were pts with unresectable/recurrent PC who received FFX during one year from Dec. 20, 2013. All the subjects were registered and their clinical data were sent to the data center. The logistic regression model was used to estimate odds ratios (ORs) of the potential risk factors for the development of FN.

Results

A total of 399 pts were included in this analysis. Pts characteristics were: median age 63 years; ECOG-PS 0/1/2, 70/29/1%; disease status locally advanced/metastatic/recurrent, 20/60/20%; 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%; Dose reduction at initial treatment yes/no, 68/32%. The median number of treatment cycles was 6. FN occurred in 13% of the pts. A multivariate logistic regression analysis showed that the pretreatment white blood cell count(WBC) < 4000/μL(OR: 4.29, 95%CI: 1.08 to 15.1, p = 0.028), platelet count(Plt) < 15*104/μL (OR: 2.41, 95% CI: 1 to 5.7, p = 0.046), serum total bilirubin(T-Bil) > 1.0mg/dL (OR: 5.83, 95% CI: 2.28 to 14.9, p = 0.0002), tumor location in pancreatic head (OR: 2.53, 95%CI: 1.17 to 5.76, p = 0.022) and no initial dose reduction (OR: 6.13, 95% CI: 2.81 to 14.4, p 

Conclusions

Pretreatment WBC < 4000/μL, Plt < 15*104/μL, T-Bil > 1.0mg/dL, tumor location and no initial dose reduction might be risk factors for the development of FN in unresectable/recurrent PC pts receiving FFX. The predictive factors proposed in our study could be utilized to select the pts at a high risk for the development of FN who may benefit from dose reduction or G-CSF prophylaxis.

Clinical trial identification

UMIN00014658

Legal entity responsible for the study

JASPAC

Funding

Yakult Honshu Co., Ltd., and Daiichi Sankyo Co., Ltd.

Disclosure

H. Ueno: Honoraria: Yakult Honsha Co., Ltd Research Funding: Yakult Honsha Co., Ltd. N. Mizuno: Research funding: Zeria Pharmaceutical, Taiho Pharmaceutical Co. Ltd., Merck Serono, AstraZeneca, NanoCarrier, Eisai, and MSD, Honoraria: Yakult Honsha Co., Ltd, Taiho Pharmaceutical Co. Ltd., Novartis, Pfizer and Kyowa-Hakko Kirin. S. Kobayashi: Honoraria: Yakult Honsha. N. Okano: Research FundingYakult Honsha Co., Ltd, Daiichi Sankyo Co.,Ltd. T. Hosokawa: 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. Advisory Role: Yakult Honsha Co.,Ltd. All other authors have declared no conflicts of interest.

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