Ken-Ichi Okada1, Manabu Kawai1, Seiko Hirono1, Sohei Satoi2, Hiroaki Yanagimoto2, Tatsuya Ioka3, Motoki Miyazawa1, Atsushi Shimizu1, Yuji Kitahata1, Hiroki Yamaue4. 1. Second Department of Surgery, Wakayama Medical University, Wakayama, 641-8510, Japan. 2. Department of Surgery, Kansai Medical University, Hirakata, Japan. 3. Department of Hepatobiliary and Pancreatic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan. 4. Second Department of Surgery, Wakayama Medical University, Wakayama, 641-8510, Japan. yamaue-h@wakayama-med.ac.jp.
Abstract
PURPOSE: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
PURPOSE: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: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: Quisette P Janssen; Stefan Buettner; Mustafa Suker; Berend R Beumer; Pietro Addeo; Philippe Bachellier; Nathan Bahary; Tanios Bekaii-Saab; Maria A Bali; Marc G Besselink; Brian A Boone; Ian Chau; Stephen Clarke; Mary Dillhoff; Bassel F El-Rayes; Jessica M Frakes; Derek Grose; Peter J Hosein; Nigel B Jamieson; Ammar A Javed; Khurum Khan; Kyu-Pyo Kim; Song Cheol Kim; Sunhee S Kim; Andrew H Ko; Jill Lacy; Georgios A Margonis; Martin D McCarter; Colin J McKay; Eric A Mellon; Sing Yu Moorcraft; Ken-Ichi Okada; Alessandro Paniccia; Parag J Parikh; Niek A Peters; Hans Rabl; Jaswinder Samra; Christoph Tinchon; Geertjan van Tienhoven; Eran van Veldhuisen; Andrea Wang-Gillam; Matthew J Weiss; Johanna W Wilmink; Hiroki Yamaue; Marjolein Y V Homs; Casper H J van Eijck; Matthew H G Katz; Bas Groot Koerkamp Journal: J Natl Cancer Inst Date: 2019-08-01 Impact factor: 13.506
Authors: Quisette P Janssen; Jacob L van Dam; Isabelle G Kivits; Marc G Besselink; Casper H J van Eijck; Marjolein Y V Homs; Joost J M E Nuyttens; Hongchao Qi; Hjalmar J van Santvoort; Alice C Wei; Roeland F de Wilde; Johanna W Wilmink; Geertjan van Tienhoven; Bas Groot Koerkamp Journal: Ann Surg Oncol Date: 2021-06-17 Impact factor: 5.344