There are concerns about more severe toxicities of FOLFIRINOX use in case with recurrent disease after pancreatic resection, because a certain number of these patients suffer from malnutrition, weight loss, and diabetes mellitus induced by pancreatic exocrine or endocrine insufficiency. Today, FOFIRINOX is widely adopted also in recurrent disease after resection beside metastatic disease studied in the ACCORD trial, yet can be associated with significant severe toxicity. We aimed to clarify toxicity and tolerance of FOLFIRNOX use in patients with recurrent disease after resection.
This study was carried out as an incidental research of JASPAC 06 study which examined multi-institutional experience with FOLFIRINOX use in pancreatic cancer by registration study. We focused on toxicity and tolerance of FOLFIRINOX use in case with recurrent disease after resection, and correlated them with those of locally advanced or metastatic disease group.
From Nov. 2014 to May. 2015, 399 patients were registered in JASPAC 06, 80 patients (20%) had recurrent disease, 78 (20%) had locally advanced disease, and 241 (60%) had metastatic disease. There were no difference in background such as age, sex, ECOG PS, pathology and CA19-9 level between recurrent disease group and locally advanced or metastatic disease group. FOLFIRINOX was initiated as modified manner in 69% of recurrent group and 67% of locally advanced or metastatic group. The major grade 3-4 toxicities observed in recurrent group and locally advanced or metastatic disease group were neutropenia (68% vs 63%), febrile neutropenia (4% vs 15%, p = 0.007), thrombocytopenia (4% vs 3%), anemia (8% vs 10%), fatigue (4% vs 3%), anorexia (14% vs 14%). The median treatment duration and median treatment cycle in recurrence group and locally advanced or metastatic group was 2.9 months vs 4.1 months, and 4cycle vs 6cycle. There was no difference in relative dose intensity between two groups.
Toxicity and tolerance of FOLFIRINOX use in recurrent disease after pancreatic resection were similar to those of use in locally advanced or metastatic disease.
Clinical trial identification
Legal entity responsible for the study
Japan Adjuvant Study Group of Pancreatic Cancer.
Yakult Honsha Co., Ltd., Daiichi Sankyo Co., Ltd. and Pharma Valley Center.
S. Nakamori: Eisai Co. Ltd. A. Todaka: Honoraria: Yakult Honsha Co., Ltd, Daiichi Sankyo 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.