title: Impact of treatment duration of neoadjuvant FIRINOX in patients with borderline resectable pancreatic cancer: a pilot trial.
abstract: The aim of this pilot study is to confirm the safety and efficacy of neoadjuvant therapy and also treatment duration efficacy using modified FOLFIRINOX for patients with borderline resectable pancreatic cancer (BRPC).
  
  
  
  The study is a prospective multicenter pilot trial conducted on patients with BRPC. Intervention for clinical trials: Modified FOLFIRINOX (without bolus 5-FU and LV, also decreased the dose of irinotecan; FIRINOX) was given to the first five patients in the 4-cycle group of the regimen and next five patients in the 8-cycle group. The primary end point was the toxicity of the therapy and one of the secondary end points were the optimal duration.
  
  
  
  The overall rate of grade 3 and 4 events was 80 %: 3 patients (60 %) in the four-cycle group and five patients (100 %) in the eight-cycle group had grade 3 or 4 adverse events. There was no incidence of serious adverse effect such as febrile neutropenia, sepsis, liver abscess or uncontrollable diarrhea. There was no clinically relevant morbidity presented in patients who underwent surgery. R0 rates by intention to treat were 60.0 % in the four-cycle group and 40 % in the eight-cycle group (P = 0.999). The histopathologic treatment effect based on the Evans grade revealed grade I (n = 1), IIa (n = 3) in the four-cycle group and grade I (n = 2), IIa (n = 1) in the eight-cycle group.
  
  
  
  FIRINOX therapy was feasible and safe for strictly selected patients with BRPC. Four cycles of FIRINOX would be sufficient for patients with BRPC as neoadjuvant therapy.
authors: Second Department of Surgery, Wakayama Medical University, Wakayama, 641-8510, Japan.
authors: Ken-Ichi
authors: K
authors: Okada
authors: Second Department of Surgery, Wakayama Medical University, Wakayama, 641-8510, Japan.
authors: Manabu
authors: M
authors: Kawai
authors: Second Department of Surgery, Wakayama Medical University, Wakayama, 641-8510, Japan.
authors: Seiko
authors: S
authors: Hirono
authors: Department of Surgery, Kansai Medical University, Hirakata, Japan.
authors: Sohei
authors: S
authors: Satoi
authors: Department of Surgery, Kansai Medical University, Hirakata, Japan.
authors: Hiroaki
authors: H
authors: Yanagimoto
authors: Department of Hepatobiliary and Pancreatic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors: Tatsuya
authors: T
authors: Ioka
authors: Second Department of Surgery, Wakayama Medical University, Wakayama, 641-8510, Japan.
authors: Motoki
authors: M
authors: Miyazawa
authors: Second Department of Surgery, Wakayama Medical University, Wakayama, 641-8510, Japan.
authors: Atsushi
authors: A
authors: Shimizu
authors: Second Department of Surgery, Wakayama Medical University, Wakayama, 641-8510, Japan.
authors: Yuji
authors: Y
authors: Kitahata
authors: Second Department of Surgery, Wakayama Medical University, Wakayama, 641-8510, Japan. yamaue-h@wakayama-med.ac.jp.
authors: Hiroki
authors: H
authors: Yamaue
mesh_terms: D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage; D023381:Endpoint Determination; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D010190:Pancreatic Neoplasms / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D010865:Pilot Projects; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D005472:Fluorouracil
keywords: Borderline resectable; Neoadjuvant chemotherapy; Pancreatic carcinoma; Treatment duration