PMID- 34011119
OWN - NLM
STAT- MEDLINE
DCOM- 20210601
LR  - 20230103
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 100
IP  - 20
DP  - 2021 May 21
TI  - A phase II study of gemcitabine plus nab-paclitaxel as first-line therapy for 
      locally advanced pancreatic cancer.
PG  - e26052
LID - 10.1097/MD.0000000000026052 [doi]
LID - e26052
AB  - Gemcitabine plus nab-paclitaxel (GnP) is widely used in clinical practice, 
      despite a lack of prospective data to validate its efficacy in locally advanced 
      pancreatic cancer (LAPC). We conducted a phase II study of GnP for LAPC to assess 
      its efficacy and safety.We performed a single-arm, single-institution study with 
      GnP in 24 patients with LAPC. The treatment protocol included successive 
      administration of gemcitabine (1000 mg/m2) and nab-paclitaxel (125 mg/m2). The 
      primary endpoint was the tumor overall response rate (ORR), and secondary 
      endpoints were overall survival (OS), progression-free survival (PFS), and 
      adverse events (AEs).The median PFS was 11.0 months, median OS was 21.2 months, 
      ORR was 62.5%, and 37.5% of the patients had stable disease. Four (16.7%) of the 
      patients were converted to surgical resection; 3 of these achieved R0 resection. 
      Grade 3 to 4 AEs included hematological (neutropenia, 64%; thrombocytopenia, 
      12%), nonhematological (cholangitis, 16%), and sensory neuropathy (4%). These AEs 
      were manageable and tolerable.The GnP treatment in patients with LAPC showed 
      favorable tumor shrinkage, good toxicity profile, and enabled conversion to 
      surgical resection in a subset of patients; therefore, GnP is an option for 
      first-line chemotherapy in patients with LAPC.
CI  - Copyright (c) 2021 the Author(s). Published by Wolters Kluwer Health, Inc.
FAU - Fukahori, Masaru
AU  - Fukahori M
AUID- ORCID: 0000-0002-4916-6381
AD  - Division of Gastroenterology, Department of Internal Medicine, Kurume University 
      School of Medicine.
AD  - Multidisciplinary Treatment Cancer Center, Kurume University Hospital.
FAU - Miwa, Keisuke
AU  - Miwa K
AD  - Multidisciplinary Treatment Cancer Center, Kurume University Hospital.
FAU - Murotani, Kenta
AU  - Murotani K
AD  - Biostatistics Center, Kurume University.
FAU - Naito, Yoshiki
AU  - Naito Y
AD  - Department of Diagnostic Pathology, Kurume University Hospital, Kurume-shi.
FAU - Ushijima, Tomoyuki
AU  - Ushijima T
AD  - Division of Gastroenterology, Department of Internal Medicine, Kurume University 
      School of Medicine.
AD  - Multidisciplinary Treatment Cancer Center, Kurume University Hospital.
FAU - Sakaue, Takahiko
AU  - Sakaue T
AD  - Division of Gastroenterology, Department of Internal Medicine, Kurume University 
      School of Medicine.
FAU - Tanaka, Toshimitsu
AU  - Tanaka T
AD  - Division of Gastroenterology, Department of Internal Medicine, Kurume University 
      School of Medicine.
AD  - Multidisciplinary Treatment Cancer Center, Kurume University Hospital.
FAU - Nagasu, Sachiko
AU  - Nagasu S
AD  - Multidisciplinary Treatment Cancer Center, Kurume University Hospital.
FAU - Suga, Hideya
AU  - Suga H
AD  - Division of Gastroenterology, Yanagawa Hospital, Chikushi-machi, Yanagawa-shi, 
      Fukuoka, Japan.
FAU - Kakuma, Tatsuyuki
AU  - Kakuma T
AD  - Biostatistics Center, Kurume University.
FAU - Okabe, Yoshinobu
AU  - Okabe Y
AD  - Division of Gastroenterology, Department of Internal Medicine, Kurume University 
      School of Medicine.
FAU - Torimura, Takuji
AU  - Torimura T
AD  - Division of Gastroenterology, Department of Internal Medicine, Kurume University 
      School of Medicine.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (130-nm albumin-bound paclitaxel)
RN  - 0 (Albumins)
RN  - 0 (Antimetabolites, Antineoplastic)
RN  - 0W860991D6 (Deoxycytidine)
RN  - P88XT4IS4D (Paclitaxel)
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Albumins/*therapeutic use
MH  - Antimetabolites, Antineoplastic/*therapeutic use
MH  - Carcinoma, Pancreatic Ductal/*drug therapy/mortality/pathology
MH  - Deoxycytidine/*analogs & derivatives/therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Paclitaxel/*therapeutic use
MH  - Pancreatic Neoplasms/*drug therapy/mortality/pathology
MH  - Progression-Free Survival
MH  - Prospective Studies
MH  - Survival Rate
MH  - Treatment Outcome
MH  - Gemcitabine
PMC - PMC8137062
COIS- The authors have no funding and conflicts of interests to disclose.
EDAT- 2021/05/21 06:00
MHDA- 2021/06/02 06:00
PMCR- 2021/05/21
CRDT- 2021/05/20 01:01
PHST- 2020/09/03 00:00 [received]
PHST- 2021/05/03 00:00 [accepted]
PHST- 2021/05/20 01:01 [entrez]
PHST- 2021/05/21 06:00 [pubmed]
PHST- 2021/06/02 06:00 [medline]
PHST- 2021/05/21 00:00 [pmc-release]
AID - 00005792-202105210-00100 [pii]
AID - MD-D-20-08495 [pii]
AID - 10.1097/MD.0000000000026052 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2021 May 21;100(20):e26052. doi: 
      10.1097/MD.0000000000026052.