Effect of Neoadjuvant Nab-Paclitaxel plus Gemcitabine Therapy on Overall Survival in Patients with Borderline Resectable Pancreatic Cancer: A Prospective Multicenter Phase II Trial (NAC-GA Trial)

Ken Ichi Okada, Toshio Shimokawa, Seiko Hirono, Manabu Kawai, Masayuki Sho, Sohei Satoi, Ippei Matsumoto, Hidetoshi Eguchi, Yoshiaki Murakami, Suguru Yamada, Mariko Doi, Hiroki Yamaue

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

We conducted a prospective multicenter phase II trial of patients with borderline resectable pancreatic carcinoma to investigate the efficacy of neoadjuvant nab-paclitaxel plus gemcitabine therapy on overall survival (OS). The clinical trial primarily evaluated OS time from the first day of protocol therapy as a primary endpoint. The secondary endpoints were recurrence-free survival from the first day of protocol therapy, safety of the protocol therapy (adverse effect), morbidity based on the Clavien Dindo classification of more than III, response rate, preoperative/postoperative tumor marker (CA 19-9, CEA), rate of normalization, reduction rate of the maximum standardized uptake value on positron emission tomography-computed tomography (limited to institutions where positron emission tomography-computed tomography was available), chemotherapeutic effect grade based on Evans' classification, resection rate, R0 resection rate, surgical data (operative time, blood loss, transfusion, postoperative hospital day), overall morbidity rates (reoperation, rate of readmission, mortality), patient rate in postoperative adjuvant therapy (entry rate, completion rate), dose intensity, quality of life regarding fatigue and malaise assessed by the questionnaire of FACIT-F (Japanese version), and peripheral sensory neuropathy assessed by the questionnaire of the FACT/GOG-NTX subscale (version 4; Japanese version). Sixty patients were included in the study, and 18 leading Japanese institutions and hospitals (all high-volume centers in pancreatic surgery) participated in this trial.

Original languageEnglish
Pages (from-to)343-346
Number of pages4
JournalOncology (Switzerland)
Volume93
Issue number5
DOIs
Publication statusPublished - Oct 1 2017
Externally publishedYes

Fingerprint

gemcitabine
Pancreatic Neoplasms
Survival
High-Volume Hospitals
Morbidity
Therapeutics
Patient Readmission
Peripheral Nervous System Diseases
Tumor Biomarkers
Operative Time
Reoperation
Blood Transfusion
Fatigue
Quality of Life
130-nm albumin-bound paclitaxel
Clinical Trials
Safety
Recurrence
Mortality

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Effect of Neoadjuvant Nab-Paclitaxel plus Gemcitabine Therapy on Overall Survival in Patients with Borderline Resectable Pancreatic Cancer : A Prospective Multicenter Phase II Trial (NAC-GA Trial). / Okada, Ken Ichi; Shimokawa, Toshio; Hirono, Seiko; Kawai, Manabu; Sho, Masayuki; Satoi, Sohei; Matsumoto, Ippei; Eguchi, Hidetoshi; Murakami, Yoshiaki; Yamada, Suguru; Doi, Mariko; Yamaue, Hiroki.

In: Oncology (Switzerland), Vol. 93, No. 5, 01.10.2017, p. 343-346.

Research output: Contribution to journalArticle

Okada, KI, Shimokawa, T, Hirono, S, Kawai, M, Sho, M, Satoi, S, Matsumoto, I, Eguchi, H, Murakami, Y, Yamada, S, Doi, M & Yamaue, H 2017, 'Effect of Neoadjuvant Nab-Paclitaxel plus Gemcitabine Therapy on Overall Survival in Patients with Borderline Resectable Pancreatic Cancer: A Prospective Multicenter Phase II Trial (NAC-GA Trial)', Oncology (Switzerland), vol. 93, no. 5, pp. 343-346. https://doi.org/10.1159/000478660
Okada, Ken Ichi ; Shimokawa, Toshio ; Hirono, Seiko ; Kawai, Manabu ; Sho, Masayuki ; Satoi, Sohei ; Matsumoto, Ippei ; Eguchi, Hidetoshi ; Murakami, Yoshiaki ; Yamada, Suguru ; Doi, Mariko ; Yamaue, Hiroki. / Effect of Neoadjuvant Nab-Paclitaxel plus Gemcitabine Therapy on Overall Survival in Patients with Borderline Resectable Pancreatic Cancer : A Prospective Multicenter Phase II Trial (NAC-GA Trial). In: Oncology (Switzerland). 2017 ; Vol. 93, No. 5. pp. 343-346.
@article{3ceec3279e114bc5a05aec3a4cdab9f5,
title = "Effect of Neoadjuvant Nab-Paclitaxel plus Gemcitabine Therapy on Overall Survival in Patients with Borderline Resectable Pancreatic Cancer: A Prospective Multicenter Phase II Trial (NAC-GA Trial)",
abstract = "We conducted a prospective multicenter phase II trial of patients with borderline resectable pancreatic carcinoma to investigate the efficacy of neoadjuvant nab-paclitaxel plus gemcitabine therapy on overall survival (OS). The clinical trial primarily evaluated OS time from the first day of protocol therapy as a primary endpoint. The secondary endpoints were recurrence-free survival from the first day of protocol therapy, safety of the protocol therapy (adverse effect), morbidity based on the Clavien Dindo classification of more than III, response rate, preoperative/postoperative tumor marker (CA 19-9, CEA), rate of normalization, reduction rate of the maximum standardized uptake value on positron emission tomography-computed tomography (limited to institutions where positron emission tomography-computed tomography was available), chemotherapeutic effect grade based on Evans' classification, resection rate, R0 resection rate, surgical data (operative time, blood loss, transfusion, postoperative hospital day), overall morbidity rates (reoperation, rate of readmission, mortality), patient rate in postoperative adjuvant therapy (entry rate, completion rate), dose intensity, quality of life regarding fatigue and malaise assessed by the questionnaire of FACIT-F (Japanese version), and peripheral sensory neuropathy assessed by the questionnaire of the FACT/GOG-NTX subscale (version 4; Japanese version). Sixty patients were included in the study, and 18 leading Japanese institutions and hospitals (all high-volume centers in pancreatic surgery) participated in this trial.",
author = "Okada, {Ken Ichi} and Toshio Shimokawa and Seiko Hirono and Manabu Kawai and Masayuki Sho and Sohei Satoi and Ippei Matsumoto and Hidetoshi Eguchi and Yoshiaki Murakami and Suguru Yamada and Mariko Doi and Hiroki Yamaue",
year = "2017",
month = "10",
day = "1",
doi = "10.1159/000478660",
language = "English",
volume = "93",
pages = "343--346",
journal = "Oncology",
issn = "0030-2414",
publisher = "S. Karger AG",
number = "5",

}

TY - JOUR

T1 - Effect of Neoadjuvant Nab-Paclitaxel plus Gemcitabine Therapy on Overall Survival in Patients with Borderline Resectable Pancreatic Cancer

T2 - A Prospective Multicenter Phase II Trial (NAC-GA Trial)

AU - Okada, Ken Ichi

AU - Shimokawa, Toshio

AU - Hirono, Seiko

AU - Kawai, Manabu

AU - Sho, Masayuki

AU - Satoi, Sohei

AU - Matsumoto, Ippei

AU - Eguchi, Hidetoshi

AU - Murakami, Yoshiaki

AU - Yamada, Suguru

AU - Doi, Mariko

AU - Yamaue, Hiroki

PY - 2017/10/1

Y1 - 2017/10/1

N2 - We conducted a prospective multicenter phase II trial of patients with borderline resectable pancreatic carcinoma to investigate the efficacy of neoadjuvant nab-paclitaxel plus gemcitabine therapy on overall survival (OS). The clinical trial primarily evaluated OS time from the first day of protocol therapy as a primary endpoint. The secondary endpoints were recurrence-free survival from the first day of protocol therapy, safety of the protocol therapy (adverse effect), morbidity based on the Clavien Dindo classification of more than III, response rate, preoperative/postoperative tumor marker (CA 19-9, CEA), rate of normalization, reduction rate of the maximum standardized uptake value on positron emission tomography-computed tomography (limited to institutions where positron emission tomography-computed tomography was available), chemotherapeutic effect grade based on Evans' classification, resection rate, R0 resection rate, surgical data (operative time, blood loss, transfusion, postoperative hospital day), overall morbidity rates (reoperation, rate of readmission, mortality), patient rate in postoperative adjuvant therapy (entry rate, completion rate), dose intensity, quality of life regarding fatigue and malaise assessed by the questionnaire of FACIT-F (Japanese version), and peripheral sensory neuropathy assessed by the questionnaire of the FACT/GOG-NTX subscale (version 4; Japanese version). Sixty patients were included in the study, and 18 leading Japanese institutions and hospitals (all high-volume centers in pancreatic surgery) participated in this trial.

AB - We conducted a prospective multicenter phase II trial of patients with borderline resectable pancreatic carcinoma to investigate the efficacy of neoadjuvant nab-paclitaxel plus gemcitabine therapy on overall survival (OS). The clinical trial primarily evaluated OS time from the first day of protocol therapy as a primary endpoint. The secondary endpoints were recurrence-free survival from the first day of protocol therapy, safety of the protocol therapy (adverse effect), morbidity based on the Clavien Dindo classification of more than III, response rate, preoperative/postoperative tumor marker (CA 19-9, CEA), rate of normalization, reduction rate of the maximum standardized uptake value on positron emission tomography-computed tomography (limited to institutions where positron emission tomography-computed tomography was available), chemotherapeutic effect grade based on Evans' classification, resection rate, R0 resection rate, surgical data (operative time, blood loss, transfusion, postoperative hospital day), overall morbidity rates (reoperation, rate of readmission, mortality), patient rate in postoperative adjuvant therapy (entry rate, completion rate), dose intensity, quality of life regarding fatigue and malaise assessed by the questionnaire of FACIT-F (Japanese version), and peripheral sensory neuropathy assessed by the questionnaire of the FACT/GOG-NTX subscale (version 4; Japanese version). Sixty patients were included in the study, and 18 leading Japanese institutions and hospitals (all high-volume centers in pancreatic surgery) participated in this trial.

UR - http://www.scopus.com/inward/record.url?scp=85025481251&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85025481251&partnerID=8YFLogxK

U2 - 10.1159/000478660

DO - 10.1159/000478660

M3 - Article

C2 - 28719890

AN - SCOPUS:85025481251

VL - 93

SP - 343

EP - 346

JO - Oncology

JF - Oncology

SN - 0030-2414

IS - 5

ER -