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

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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

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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    Okada, K. I., 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), 93(5), 343-346. https://doi.org/10.1159/000478660