PMID- 30993397
OWN - NLM
STAT- MEDLINE
DCOM- 20200421
LR  - 20200421
IS  - 1432-0843 (Electronic)
IS  - 0344-5704 (Print)
IS  - 0344-5704 (Linking)
VI  - 84
IP  - 2
DP  - 2019 Aug
TI  - A single-arm phase II trial of weekly nanoparticle albumin-bound paclitaxel 
      (nab-paclitaxel) monotherapy after standard of chemotherapy for previously 
      treated advanced non-small cell lung cancer.
PG  - 351-358
LID - 10.1007/s00280-019-03843-0 [doi]
AB  - BACKGROUND: Few studies have investigated the clinical efficacy of third- and 
      later-line of chemotherapy after standard chemotherapy for previously treated 
      advanced non-small cell lung cancer (NSCLC). We prospectively evaluated the 
      efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) 
      following standard chemotherapies for previously treated advanced NSCLC. METHODS: 
      The eligible patients having adequate organ functions with performance status 0-2 
      were enrolled after completing standard chemotherapy. They received weekly 
      nab-paclitaxel 100 mg/m(2) intravenously on days 1, 8, and 15 every 3 weeks. The 
      primary end point was objective response rate (ORR). Median progression-free 
      survival (PFS), overall survival (OS), and adverse events (AEs) were evaluated as 
      secondary end points. RESULTS: This trial was discontinued because of late 
      accrual. Twenty two patients were enrolled from April 2013 and February 2019. The 
      total ORR was 22.7% [95% CI 7.8-45.4] and disease control rate (DCR) was 81.8% 
      [95% CI 59.7-94.8]. Median PFS was 3.4 months [95% CI 2.3-4.1] and median OS was 
      7.4 months [95% CI 4.2-10.7]. Median follow-up interval was 6.7 months 
      hematological AEs of Grade 3/4 included anemia (18%), leukopenia (18%), and 
      neutropenia (32%), while the most frequent nonhematological AEs were fatigue 
      (50%) and peripheral neuropathy (36.4%). Severe AEs related to treatment were 
      observed in only one patient. CONCLUSION: Nab-paclitaxel may be a safe and 
      effective later-line chemotherapeutic option for previously treated advanced 
      NSCLC after standard of chemotherapies based on other trials.
FAU - Kato, Yasuhiro
AU  - Kato Y
AUID- ORCID: 0000-0001-8585-1995
AD  - Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan 
      Cancer and Infectious Diseases Centre, Komagome Hospital, Honkomagome 3-18-22, 
      Bunkyo, Tokyo, 113-0021, Japan. y-kato@nms.ac.jp.
AD  - Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, 
      Nippon Medical School, Tokyo, Japan. y-kato@nms.ac.jp.
FAU - Okuma, Yusuke
AU  - Okuma Y
AD  - Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan 
      Cancer and Infectious Diseases Centre, Komagome Hospital, Honkomagome 3-18-22, 
      Bunkyo, Tokyo, 113-0021, Japan.
FAU - Watanabe, Kageaki
AU  - Watanabe K
AD  - Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan 
      Cancer and Infectious Diseases Centre, Komagome Hospital, Honkomagome 3-18-22, 
      Bunkyo, Tokyo, 113-0021, Japan.
FAU - Yomota, Makiko
AU  - Yomota M
AD  - Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan 
      Cancer and Infectious Diseases Centre, Komagome Hospital, Honkomagome 3-18-22, 
      Bunkyo, Tokyo, 113-0021, Japan.
FAU - Kawai, Shoko
AU  - Kawai S
AD  - Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan 
      Cancer and Infectious Diseases Centre, Komagome Hospital, Honkomagome 3-18-22, 
      Bunkyo, Tokyo, 113-0021, Japan.
FAU - Hosomi, Yukio
AU  - Hosomi Y
AD  - Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan 
      Cancer and Infectious Diseases Centre, Komagome Hospital, Honkomagome 3-18-22, 
      Bunkyo, Tokyo, 113-0021, Japan.
FAU - Okamura, Tatsuru
AU  - Okamura T
AD  - Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan 
      Cancer and Infectious Diseases Centre, Komagome Hospital, Honkomagome 3-18-22, 
      Bunkyo, Tokyo, 113-0021, Japan.
LA  - eng
SI  - JPRN/UMIN000010737
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20190416
PL  - Germany
TA  - Cancer Chemother Pharmacol
JT  - Cancer chemotherapy and pharmacology
JID - 7806519
RN  - 0 (130-nm albumin-bound paclitaxel)
RN  - 0 (Albumins)
RN  - P88XT4IS4D (Paclitaxel)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Albumins/pharmacology/*therapeutic use
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/pathology
MH  - Female
MH  - Humans
MH  - Lung Neoplasms/*drug therapy/pathology
MH  - Male
MH  - Middle Aged
MH  - Paclitaxel/pharmacology/*therapeutic use
PMC - PMC6647220
OTO - NOTNLM
OT  - Advanced non-small cell lung cancer
OT  - Chemotherapy
OT  - Later line setting
OT  - Nanoparticle albumin-bound paclitaxel
COIS- YH and YO have received honoraria from TAIHO PHARMACEUTICAL. The other authors 
      declare no conflicts of interest associated with this manuscript.
EDAT- 2019/04/18 06:00
MHDA- 2020/04/22 06:00
PMCR- 2019/04/16
CRDT- 2019/04/18 06:00
PHST- 2019/03/20 00:00 [received]
PHST- 2019/04/12 00:00 [accepted]
PHST- 2019/04/18 06:00 [pubmed]
PHST- 2020/04/22 06:00 [medline]
PHST- 2019/04/18 06:00 [entrez]
PHST- 2019/04/16 00:00 [pmc-release]
AID - 10.1007/s00280-019-03843-0 [pii]
AID - 3843 [pii]
AID - 10.1007/s00280-019-03843-0 [doi]
PST - ppublish
SO  - Cancer Chemother Pharmacol. 2019 Aug;84(2):351-358. doi: 
      10.1007/s00280-019-03843-0. Epub 2019 Apr 16.