PMID- 25590835
OWN - NLM
STAT- MEDLINE
DCOM- 20150410
LR  - 20210109
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 94
IP  - 2
DP  - 2015 Jan
TI  - Erlotinib plus capecitabine as first-line treatment for older Chinese patients 
      with advanced adenocarcinoma of the lung (C-TONG0807): an open-label, single arm, 
      multicenter phase II study.
PG  - e249
LID - 10.1097/MD.0000000000000249 [doi]
LID - e249
AB  - Preclinical studies have shown synergism between epidermal growth factor receptor 
      (EGFR) tyrosine kinase inhibitors and antifolates in solid tumors. This study is 
      to investigate the efficacy and tolerability of erlotinib plus capecitabine as 
      first-line treatment in older Chinese patients (>/= 65 years) with lung 
      adenocarcinoma. This is an open-label, single arm, multicenter phase II clinical 
      trial. Sixty- two patients with previously untreated stage IIIB/IV adenocarcinoma 
      and age 65 years or above were enrolled at four tertiary teaching hospitals and 2 
      provincial hospitals in China; 58 patients fulfilled the study requirements. 
      Erlotinib (150 mg/day) and capecitabine (1000 mg/m2 twice daily on days 1-14) 
      were administered during every 21-day cycle. The primary endpoint was the 
      non-progression rate at 12 weeks. EGFR and K-ras mutation rates were determined 
      using PCR. Tumor expression of different biomarkers was assessed using 
      immunohistochemistry. In a cohort of 58 patients, 34 patients had no disease 
      progression at 12 weeks following treatment. The objective response rate was 
      29.3%, and the disease control rate was 75.9%. The objective response rate was 
      significantly higher in patients with EGFR mutations than in those with wild-type 
      EGFR. Patients with thymidine phosphorylase-negative tumors had significantly 
      longer overall survival after one year than patients with thymidine 
      phosphorylase-positive tumors. Forty-four patients had at least one primary 
      adverse events (AEs), including skin rash (n = 30), grade 3 AEs (n = 17), and 
      grade 4 AEs (n = 7). This is the first phase II clinical trial to assess 
      erlotinib plus capecitabine combination therapy as first-line treatment in older 
      patients with lung adenocarcinoma. Erlotinib/capecitabine chemotherapy was 
      significantly better in patients with EGFR mutations and in those with thymidine 
      phosphorylase-negative tumors. The use of fluorouracil derivatives for the 
      treatment of lung adenocarcinoma warrants further study.
FAU - Zhao, Hong-Yun
AU  - Zhao HY
AD  - From the Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology 
      in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 
      Guangdong, China (H-YZ, YH, LZ); Department of Internal Medicine, Cancer Hospital 
      of Ha'erbin Medical University, Haerbin, Heilongjiang, China (G-YC, X-LL); 
      Department of Oncology, Jiangsu Cancer Hospital, Nanjing, Jiangsu, China (J-FF, 
      M-QS); Department of Oncology, Jilin Cancer Hospital, Changchun, Jilin, China 
      (YC, L-XM); Chemotherapy Center, Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 
      China (Y-PZ, C-PG); and Department Chemotherapy, Cancer Hospital of Guangxi 
      Medical University, Nanning, Guangxi, China (X-QS, DZ).
FAU - Chen, Gong-Yan
AU  - Chen GY
FAU - Huang, Yan
AU  - Huang Y
FAU - Li, Xiao-Li
AU  - Li XL
FAU - Feng, Ji-Feng
AU  - Feng JF
FAU - Shi, Mei-Qi
AU  - Shi MQ
FAU - Cheng, Ying
AU  - Cheng Y
FAU - Ma, Li-Xia
AU  - Ma LX
FAU - Zhang, Yi-Ping
AU  - Zhang YP
FAU - Gu, Cui-Ping
AU  - Gu CP
FAU - Song, Xiang-Qun
AU  - Song XQ
FAU - Zhou, Da
AU  - Zhou D
FAU - Zhang, Li
AU  - Zhang L
LA  - eng
SI  - ClinicalTrials.gov/NCT00816868
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Biomarkers)
RN  - 0 (Quinazolines)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 6804DJ8Z9U (Capecitabine)
RN  - DA87705X9K (Erlotinib Hydrochloride)
RN  - EC 2.4.2.4 (Thymidine Phosphorylase)
RN  - U3P01618RT (Fluorouracil)
SB  - IM
MH  - Adenocarcinoma/*drug therapy/genetics/metabolism/pathology
MH  - Adenocarcinoma of Lung
MH  - Aged
MH  - Antineoplastic Agents/administration & dosage/adverse effects
MH  - Biomarkers
MH  - Capecitabine
MH  - China
MH  - Deoxycytidine/administration & dosage/adverse effects/*analogs & derivatives
MH  - Disease-Free Survival
MH  - Drug Synergism
MH  - Drug Therapy, Combination
MH  - Erlotinib Hydrochloride
MH  - Female
MH  - Fluorouracil/administration & dosage/adverse effects/*analogs & derivatives
MH  - Genes, erbB-1/*genetics
MH  - Genes, ras/genetics
MH  - Humans
MH  - Lung Neoplasms/*drug therapy/genetics/metabolism/pathology
MH  - Male
MH  - Mutation
MH  - Neoplasm Staging
MH  - *Quinazolines/administration & dosage/adverse effects
MH  - Thymidine Phosphorylase/metabolism
MH  - Treatment Outcome
PMC - PMC4602552
COIS- The authors declare that there is no conflict of interest.
EDAT- 2015/01/16 06:00
MHDA- 2015/04/11 06:00
PMCR- 2015/01/16
CRDT- 2015/01/16 06:00
PHST- 2015/01/16 06:00 [entrez]
PHST- 2015/01/16 06:00 [pubmed]
PHST- 2015/04/11 06:00 [medline]
PHST- 2015/01/16 00:00 [pmc-release]
AID - 00005792-201501020-00005 [pii]
AID - 10.1097/MD.0000000000000249 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2015 Jan;94(2):e249. doi: 10.1097/MD.0000000000000249.