752P - FOLFIRINOX as second-line chemotherapy for advanced pancreatic cancer: A subset analysis from the nation-wide multicenter observational study (JASPAC06)

Abstract

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.