[A randomized, controlled, multicenter clinical trial comparing pemetrexed/cisplatin and gemcitabine/cisplatin as first-line treatment for advanced nonsquamous non-small cell lung cancer].
OBJECTIVE
Platinum-based doublet chemotherapy is still the standard first-line treatment for non-small cell lung cancer (NSCLC). Previous studies have demonstrated that pemetrexed combined with platinum had promising efficacy and safety profile in NSCLC, especially in patients with nonsquamous NSCLC. This trial was conducted to evaluate the efficacy and safety of pemetrexed made in China as first-line treatment.


METHODS
The present study was a randomized, controlled, multicenter clinical trial. Patients were randomly assigned (1:1) to receive cisplatin plus pemetrexed chemotherapy (PC group) or gemcitabine plus cisplatin (GC group) every 3 weeks. The primary end point was progression free survival (PFS) and the secondary end points included 1 year survival rate, objective response rate (ORR), survival without grade 3/4 toxicity (SWT3/4) and safety profile.


RESULTS
A total of 288 patients from 20 institutions across China were enrolled into the study. Based on the Full Analyses Set (FAS), the PFS was 168 days (5.6 months) vs 140 days (4.7 months) (P=0.16), one year survival rate was 50.0% vs 54.9% (P=0.47), ORR was 24.4% vs 14.2% (P=0.06) in the PC group and the GC group, respectively; Survival without grade 3/4 toxicity was 11.3 months in GC group vs 8.1 months in PC group (P=0.23). In terms of the safety, side effects were less observed on the PC group (81.95% vs 93.75%, P=0.003). The main side effects included leukopenia, neutropenia, emesis, anemia, thrombopenia.


CONCLUSIONS
The both regimens have similar efficacy as the treatment for advanced nonsquamous NSCLC, but pemetrexed plus cisplatin regimen has better safety profile and seems to have longer PFS, which makes it a new option as the first line setting.
Department of Medical Oncology, Sun Yat-sen University Cancer Center, 510060 Guangzhou, China.
Yan
Y
Huang
Yunpeng
Y
Liu
Jianying
J
Zhou
Nong
N
Xu
Baolan
B
Li
Gang
G
Wu
Jian
J
Fang
Kai
K
Li
Xiaoqing
X
Liu
Wei
W
Liu
You
Y
Lu
Mengzhao
M
Wang
Wenchao
W
Liu
Houjie
H
Liang
Yiping
Y
Zhang
Cheng
C
Huang
Shunjin
S
Wang
Yajie
Y
Wang
Shiying
S
Yu
Jianhua
J
Chang
Zhehai
Z
Wang
Zhihuang
Z
Hu
Li
L
Zhang
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D005971:Glutamates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006147:Guanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D008875:Middle Aged; D009367:Neoplasm Staging; D000068437:Pemetrexed; D016896:Treatment Outcome; D000093542:Gemcitabine
D000970:Antineoplastic Agents; D005971:Glutamates; D000068437:Pemetrexed; D003841:Deoxycytidine; D006147:Guanine; D002945:Cisplatin; D000093542:Gemcitabine