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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

発表形態:
原著論文
主要業績:
主要業績
単著・共著:
共著
発表年月:
2021年04月
DOI:
10.29337/ijsp.142
会議属性:
指定なし
査読:
有り
リンク情報:

日本語フィールド

著者:
*Yoshihiro Miyasaka, Takao Ohtsuka, Susumu Eguchi, Masafumi Inomata, Kazuyoshi Nishihara, Hiroyuki Shinchi, Koji Okuda, Hideo Baba, Hiroaki Nagano, Toshiharu Ueki, Hirokazu Noshiro, Masafumi Nakamura, Kyushu study group of treatment for pancreatobiliary cancer
題名:
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
発表情報:
Int J Surg Protoc 巻: 25 号: 1 ページ: 55-60
キーワード:
borderline resectable pancreatic cancer; gemcitabine; nab-paclitaxel; neoadjuvant
概要:
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.
抄録:

英語フィールド

Author:
*Yoshihiro Miyasaka, Takao Ohtsuka, Susumu Eguchi, Masafumi Inomata, Kazuyoshi Nishihara, Hiroyuki Shinchi, Koji Okuda, Hideo Baba, Hiroaki Nagano, Toshiharu Ueki, Hirokazu Noshiro, Masafumi Nakamura, Kyushu study group of treatment for pancreatobiliary cancer
Title:
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
Announcement information:
Int J Surg Protoc Vol: 25 Issue: 1 Page: 55-60
Keyword:
borderline resectable pancreatic cancer; gemcitabine; nab-paclitaxel; neoadjuvant
An 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.


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