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Poster display session

1496 - FOLFIRINOX as second-line chemotherapy for advanced pancreatic cancer: a subset analysis from the nation-wide multicenter observational study (JASPAC06)

Date

09 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Pancreatic Cancer

Presenters

noritoshi Kobayashi

Citation

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

Authors

N. Kobayashi1, K. Omae2, Y. Horita3, H. Ueno4, N. Mizuno5, K. Uesugi6, K. Sudo7, M. Ozaka8, H. Hayashi9, N. Okano10, K. Kamei11, A. Yamaguchi12, S. Kobayashi13, S. Suzuki14, S. Ishihara15, T. Uchiyama16, A. Todaka17, A. Fukutomi17

Author affiliations

  • 1 Clinical Oncology, Yokohama City University Hospital, 236-004 - Yokohama/JP
  • 2 Clinical Research Promotion Unit, Clinical Research Center, Shizuoka Cancer Center, 4118777 - Sunto-gun/JP
  • 3 Chemotherapy And Internal Medicine, Toyama Prefectural Central Hospital, 9308550 - Toyama/JP
  • 4 Department Of Hepatobiliary And Pancreatic Oncology, National Cancer Center Hospital, 1040045 - Tokyo/JP
  • 5 Department Of Gastroenterology, Aichi Cancer Center Hospital, 4648681 - Nagoya/JP
  • 6 Department Of Gastroenterology, National Hospital Organaization Shikoku Cancer Center, 7910280 - Matsuyama/JP
  • 7 Division Of Gastroenterology, Chiba Cancer Center, 2608717 - Chiba/JP
  • 8 Department Of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation For Cancer Research, 1358550 - Tokyo/JP
  • 9 Department Of Gastroenterology And Hepatology, Hokkaido University, 0608648 - Sapporo/JP
  • 10 Department Of Medical Oncology, Kyorin University Faculty of Medicine, 1818611 - Mitaka/JP
  • 11 Department Of Surgery, Kindai University Faculty of Medicine, 5898511 - Osakasayama/JP
  • 12 Department Of Gastroenterology, Kure Medical Center and Chugoku Cancer Center, 7370023 - Kure/JP
  • 13 Department Of Gastroenterology, Division Of Hepatobiliary And Pancreatic Medical Oncology, Kanagawa Cancer Center, 2410815 - Yokohama/JP
  • 14 Department Of Medical Oncology, Yamagata University Faculty of Medicine, 9909585 - Yamagata/JP
  • 15 Department Of Surgery, Fujita Health University, 4701192 - Toyoake/JP
  • 16 Department Of Surgery, Kikugawa General Hospital, 4390022 - Kikugawa/JP
  • 17 Division Of Gastrointestinal Oncology, Shizuoka Cancer Center, 4118777 - Sunto-gun/JP
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Resources

Abstract 1496

Background

The data of FOLFIRINOX as second-line chemotherapy in advanced pancreatic cancer are very limited. The JASPAC06 study, a nation-wide multicenter observational study of FOLFIRINOX for the patients with unresectable or recurrent pancreatic cancer as any line treatment, showed the favorable efficacy and safety in Japanese clinical practice.

Methods

The subjects were the patients with unresectable/recurrent pancreatic cancer who received FOLFIRINOX as second-line chemotherapy.

Results

Of the 399 evaluable patients in the JASPAC06 study, 44 patients were eligible. Patients characteristics were; median age, 62 years; male, 26(59%); ECOG-PS0/1, 30(68%)/14(32%); disease status recurrent/locally/metastatic, 4(9%)/8(18%)/32(73%); biliary drainage, 11(25%); UGT1A1 status *28 and *6 wild/single heterozygous/homozygous or double heterozygous/unknown, 25(57%)/16(36%)/2(5%)/1(2%). The initial dose was reduced in 28(64%) patients. The median time to treatment failure and the number of cycles were 4.5 (range, 6-573 days) months and 6 cycles (range, 1-13 or more). The major grade 3/4 adverse events were neutropenia in 29(66%) patients, leucopenia in 17(39%), anorexia in 7(16%), febrile neutropenia in 5(11%) and anemia in 5(11%). Fatal adverse event occurred in 1 patient, which was a sudden death. The median overall survival, progression free survival and 1-year survival rate were 10.1 (95%CI, 7.1-13.1), 4.1 (95%CI, 1.5-6.8) months and 41.0%, respectively. The overall response rate and disease control rate were 28% and 65%. The reasons for discontinuation of FOLFIRINOX, excluding 2 patients ongoing treatment, were tumor progression in 38(86%) and toxicity in 4(9%).

Conclusions

It was suggested that FOLFIRINOX as second-line chemotherapy in advanced pancreatic cancer was effective for the patients with good PS and toxicity was similar to that as the first-line treatment.

Clinical trial identification

UMIN000014658 26 July 2014

Legal entity responsible for the study

N/A

Funding

This trial was supported by Yakult Honsha Co., Ltd. and Daiichi Sankyo Co., Ltd.

Disclosure

H. Ueno: Honoraria: Yakult Honsha Co., Ltd Research Funding: Yakult Honsha Co., Ltd. N. Mizuno: Yakult Honsha Co., Ltd. S. Kobayashi: Honoraria: Yakuly Honsha Co., Ltd. A. Todaka: Honoraria: Yakult Honsha Co., Ltd, Daiichi Sankyo Co., Ltd. A. Fukutomi: Honoraria: Yakult Honsha Co. Ltd, Daiichi Sankyo Co., Ltd. All other authors have declared no conflicts of interest.

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