PMID- 23963141
OWN - NLM
STAT- MEDLINE
DCOM- 20140505
LR  - 20211021
IS  - 1532-1827 (Electronic)
IS  - 0007-0920 (Print)
IS  - 0007-0920 (Linking)
VI  - 109
IP  - 6
DP  - 2013 Sep 17
TI  - A phase-1b study of everolimus plus paclitaxel in patients with small-cell lung 
      cancer.
PG  - 1482-7
LID - 10.1038/bjc.2013.467 [doi]
AB  - BACKGROUND: The mammalian target of rapamycin (mTOR) pathway is dysregulated in 
      small-cell lung cancer (SCLC) and everolimus is an oral mTOR inhibitor. METHODS: 
      This phase-1b study assessed everolimus safety at the levels of 2.5, 5, or 10 mg 
      once daily in combination with paclitaxel (175 mg m(-2)) once every 3 weeks in 
      previously treated SCLC patients. The primary end point was to determine the 
      maximum tolerated dose of everolimus. RESULTS: Among 21 enrolled patients, common 
      drug-related adverse events were anaemia, neutropenia, thrombocytopenia, pain, 
      hyperglycemia, and stomatitis. Out of 11 evaluable patients treated with 
      everolimus at the level of 5 mg, 1 patient experienced dose-limiting toxicity 
      (DLT) of grade 4 febrile neutropenia and grade 3 thrombocytopenia. The other two 
      DLTs (grade 4 thrombocytopenia and grade 3 hyperglycemia) occurred in two out of 
      three patients receiving everolimus 10 mg. The overall objective response rate 
      was 28%. CONCLUSION: Everolimus showed an acceptable safety profile and 
      preliminary antitumour activity at the dose of 5 mg once daily when combined with 
      3-weekly paclitaxel 175 mg m(-2) in patients with SCLC.
FAU - Sun, J M
AU  - Sun JM
AD  - Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, 
      Sungkyunkwan University School of Medicine, 50 Irwon-dong, Gangnam-gu, Seoul 
      135-710, Korea.
FAU - Kim, J R
AU  - Kim JR
FAU - Do, I G
AU  - Do IG
FAU - Lee, S Y
AU  - Lee SY
FAU - Lee, J
AU  - Lee J
FAU - Choi, Y L
AU  - Choi YL
FAU - Ahn, J S
AU  - Ahn JS
FAU - Ahn, M J
AU  - Ahn MJ
FAU - Park, K
AU  - Park K
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
DEP - 20130820
PL  - England
TA  - Br J Cancer
JT  - British journal of cancer
JID - 0370635
RN  - 9HW64Q8G6G (Everolimus)
RN  - P88XT4IS4D (Paclitaxel)
RN  - W36ZG6FT64 (Sirolimus)
SB  - IM
MH  - Antineoplastic Combined Chemotherapy Protocols/*adverse effects/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Everolimus
MH  - Female
MH  - Humans
MH  - Lung Neoplasms/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Paclitaxel/administration & dosage/adverse effects
MH  - Sirolimus/administration & dosage/adverse effects/analogs & derivatives
MH  - Small Cell Lung Carcinoma/*drug therapy
PMC - PMC3776982
EDAT- 2013/08/22 06:00
MHDA- 2014/05/06 06:00
PMCR- 2014/09/17
CRDT- 2013/08/22 06:00
PHST- 2013/04/24 00:00 [received]
PHST- 2013/07/12 00:00 [revised]
PHST- 2013/07/21 00:00 [accepted]
PHST- 2013/08/22 06:00 [entrez]
PHST- 2013/08/22 06:00 [pubmed]
PHST- 2014/05/06 06:00 [medline]
PHST- 2014/09/17 00:00 [pmc-release]
AID - bjc2013467 [pii]
AID - 10.1038/bjc.2013.467 [doi]
PST - ppublish
SO  - Br J Cancer. 2013 Sep 17;109(6):1482-7. doi: 10.1038/bjc.2013.467. Epub 2013 Aug 
      20.