Neoadjuvant Chemotherapy with Gemcitabine Plus Nab-Paclitaxel Regimen for Borderline Resectable Pancreatic Cancer with Arterial Involvement: A Prospective Multicenter Single-Arm Phase II Study Protocol.

Yoshihiro Miyasaka,Masafumi Inomata,Koji Okuda,Hideo Baba,Kazuyoshi Nishihara,Hiroyuki Shinchi,Hirokazu Noshiro,Hiroaki Nagano,Toshiharu Ueki,Takao Ohtsuka,Susumu Eguchi,Masafumi Nakamura

doi:10.29337/ijsp.142

Abstract

Introduction:Although neoadjuvant treatment is recommended for patients with borderline resectable pancreatic cancer (BRPC), no standard neoadjuvant regimen has been established for BRPC with arterial involvement (BRPC-A), which is associated with a higher risk of margin-positive resection and poorer prognosis than BRPC with only venous involvement. Gemcitabine plus nab-paclitaxel (GnP) has been reported to significantly reduce tumor size in metastatic pancreatic cancer, and some retrospective studies suggested that neoadjuvant GnP for BRPC improved resectability and survival.Methods and analysis:A prospective multicenter single-arm phase II study is conducted to evaluate the safety and efficacy of GnP as neoadjuvant chemotherapy for BRPC-A. The primary endpoint is the R0 resection rate. The secondary endpoints are the neoadjuvant chemotherapy response rate, resection rate, pathological response rate, incidence rate of adverse events, and quality of life.Ethics and dissemination:This study protocol was approved by the institutional review board of Kyushu University (no. 181). The results will be published in a peer-reviewed journal and will be presented at medical meetings.Highlights:Strategy for borderline resectable pancreatic cancer involving arteries (BRPC-A).There is no standard regimen for neoadjuvant chemotherapy for BRPC-A.Gemcitabine plus nab-paclitaxel (GnP) shows significant tumor shrinkage.Neoadjuvant GnP for BRPC-A increases resectability and margin-negative resection.

Highlights

Neoadjuvant treatment is recommended for patients with borderline resectable pancreatic cancer (BRPC), no standard neoadjuvant regimen has been established for BRPC with arterial involvement (BRPC-A), which is associated with a higher risk of margin-positive resection and poorer prognosis than BRPC with only venous involvement
Borderline resectable pancreatic cancer (BRPC) is a recently proposed category that carries a high risk of marginpositive resection when it is initially treated via surgical resection, and it is defined by the involvement of major vessels, such as the celiac artery, superior mesenteric artery, hepatic artery, or portal vein (PV) [1]
Pancreatic resection combined with resection and reconstruction of the PV/superior mesenteric vein (SMV) can be performed safely, and it is a common surgical procedure for patients with BRPC-PV [5, 6]

Summary

Methods and analysis

A prospective multicenter single-arm phase II study is conducted to evaluate the safety and efficacy of GnP as neoadjuvant chemotherapy for BRPC-A. The secondary endpoints are the neoadjuvant chemotherapy response rate, resection rate, pathological response rate, incidence rate of adverse events, and quality of life. Ethics and dissemination: This study protocol was approved by the institutional review board of Kyushu University TO CITE THIS ARTICLE: Miyasaka Y, Ohtsuka T, Eguchi S, Inomata M, Nishihara K, Shinchi H, Okuda K, Baba H, Nagano H, Ueki T, Noshiro H, Nakamura M, for the Kyushu study group of treatment for pancreatobiliary cancer. Neoadjuvant Chemotherapy with Gemcitabine Plus NabPaclitaxel Regimen for Borderline Resectable Pancreatic Cancer with Arterial Involvement: A Prospective Multicenter Single-Arm Phase II Study Protocol.

BACKGROUND

METHODS AND ANALYSIS

Findings

ETHICS AND DISSEMINATION