PMID- 31412347
OWN - NLM
STAT- MEDLINE
DCOM- 20191211
LR  - 20221207
IS  - 1423-0232 (Electronic)
IS  - 0030-2414 (Linking)
VI  - 97
IP  - 6
DP  - 2019
TI  - A Phase II Study of Cisplatin Plus Gemcitabine followed by Maintenance 
      Gemcitabine for Advanced Squamous Non-Small-Cell Lung Cancer: Kyoto Thoracic 
      Oncology Research Group 1302.
PG  - 327-333
LID - 10.1159/000501967 [doi]
AB  - BACKGROUND: There has been no study so far on gemcitabine continuous maintenance 
      therapy targeting only squamous non-small-cell lung cancer (NSCLC) patients. This 
      study aimed to assess the efficacy and safety of cisplatin plus gemcitabine 
      followed by maintenance gemcitabine for chemotherapy- naive Japanese patients 
      with advanced squamous NSCLC. METHODS: The patients received 4 cycles of 
      gemcitabine (1,000 mg/m2, days 1 and 8) and cisplatin (80 mg/m2, day 1) every 3 
      weeks, followed by gemcitabine alone as maintenance therapy every 3 weeks until 
      disease progression or unacceptable toxicity. The primary end point of the study 
      was progression-free survival (PFS) from the date of registration. RESULTS: From 
      May 2013 to October 2018, 26 patients were enrolled, and 25 patients received >/=1 
      cycle of planned treatment. Eighteen patients (69.2%) received 4 cycles of 
      cisplatin plus gemcitabine, and 16 patients (61.5%) received >/=1 cycle of 
      maintenance gemcitabine. The median PFS from the date of registration was 5.3 
      months (95% CI 2.9-7.3 months). In 16 patients who received >/=1 cycle of 
      maintenance gemcitabine, the median PFS from the date of maintenance gemcitabine 
      initiation was 3.8 months (95% CI 2.3-5.2 months). Their median overall survival 
      from the date of registration was 11.9 months (95% CI 7.5-26.5 months). During 
      the maintenance therapy, adverse events (AEs) were mostly Common Terminology 
      Criteria for AE grade 1. CONCLUSIONS: While this trial did not meet the primary 
      endpoint, the sufficient efficacy and feasibility of gemcitabine maintenance 
      therapy were suggested.
CI  - (c) 2019 S. Karger AG, Basel.
FAU - Ikeda, Satoshi
AU  - Ikeda S
AD  - Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan.
AD  - Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory 
      Center, Yokohama, Japan.
FAU - Yoshioka, Hiroshige
AU  - Yoshioka H
AD  - Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan, 
      hgyoshioka@gmail.com.
AD  - Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata, 
      Japan, hgyoshioka@gmail.com.
FAU - Kaneda, Toshihiko
AU  - Kaneda T
AD  - Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata, 
      Japan.
FAU - Yokoyama, Toshihide
AU  - Yokoyama T
AD  - Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan.
FAU - Niwa, Takashi
AU  - Niwa T
AD  - Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan.
FAU - Sone, Naoyuki
AU  - Sone N
AD  - Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan.
FAU - Ishida, Tadashi
AU  - Ishida T
AD  - Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan.
FAU - Morita, Mitsunori
AU  - Morita M
AD  - Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan.
FAU - Tomioka, Hiromi
AU  - Tomioka H
AD  - Department of Respiratory Medicine, Kobe City Medical Center West Hospital, Kobe, 
      Japan.
FAU - Komaki, Chihito
AU  - Komaki C
AD  - Department of Respiratory Medicine, Matsunami General Hospital, Gifu, Japan.
FAU - Hirabayashi, Masataka
AU  - Hirabayashi M
AD  - Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical 
      Center, Amagasaki, Japan.
FAU - Hasegawa, Yoshinori
AU  - Hasegawa Y
AD  - Department of Respiratory Medicine, Osaka Saiseikai Nakatsu Hospital, Osaka, 
      Japan.
FAU - Noguchi, Tetsuo
AU  - Noguchi T
AD  - Department of Respiratory Medicine, Nagahama City Hospital, Nagahama, Japan.
FAU - Nakano, Yasutaka
AU  - Nakano Y
AD  - Division of Respiratory Medicine, Department of Internal Medicine, Otsu, Japan.
FAU - Sakaguchi, Chikara
AU  - Sakaguchi C
AD  - Department of Pulmonary Medicine, Rakuwakai Otowa Hospital, Kyoto, Japan.
FAU - Yoshimura, Kenichi
AU  - Yoshimura K
AD  - Innovative Clinical Research Center, Kanazawa University Hospital, Kanazawa, 
      Japan.
FAU - Hirai, Toyohiro
AU  - Hirai T
AD  - Department of Respiratory Medicine, Graduate School of Medicine, Kyoto 
      University, Kyoto, Japan.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
DEP - 20190814
PL  - Switzerland
TA  - Oncology
JT  - Oncology
JID - 0135054
RN  - 0W860991D6 (Deoxycytidine)
RN  - Q20Q21Q62J (Cisplatin)
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality
MH  - Cisplatin/administration & dosage/adverse effects
MH  - Deoxycytidine/administration & dosage/adverse effects/analogs & derivatives
MH  - Humans
MH  - Lung Neoplasms/*drug therapy/mortality
MH  - Male
MH  - Middle Aged
MH  - Gemcitabine
OTO - NOTNLM
OT  - Cisplatin
OT  - Gemcitabine
OT  - Maintenance therapy
OT  - Squamous non-small-cell lung cancer
EDAT- 2019/08/15 06:00
MHDA- 2019/12/18 06:00
CRDT- 2019/08/15 06:00
PHST- 2019/06/12 00:00 [received]
PHST- 2019/07/07 00:00 [accepted]
PHST- 2019/08/15 06:00 [pubmed]
PHST- 2019/12/18 06:00 [medline]
PHST- 2019/08/15 06:00 [entrez]
AID - 000501967 [pii]
AID - 10.1159/000501967 [doi]
PST - ppublish
SO  - Oncology. 2019;97(6):327-333. doi: 10.1159/000501967. Epub 2019 Aug 14.