title: Study of Gefitinib and Pemetrexed as First-Line Treatment in Patients with Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation.
abstract: To evaluate the efficacy and safety of a combination regimen of gefitinib and pemetrexed as first-line chemotherapy in advanced EGFR-mutated non-small cell lung cancer (NSCLC) patients. Patients and methods Patients with advanced non-squamous NSCLC harboring asensitive EGFR mutation were included in this study and randomly divided into gefitinib + placebo group and gefitinib + pemetrexed group. Pemetrexed or placebo was administered on day 1 at a dose of 500 mg/m(2), and gefitinib was sequentially administered on days 2 ~ 16. This treatment regimen was repeated every 3 weeks until disease progression. All investigators and participants were masked to treatment allocation. The overall response rate (ORR) and disease control rate (DCR) of gefitinib + pemetrexed group were higher than that of gefitinib + placebo group but only the difference of DCR between two groups was statistically significant (P < 0.05). The median progression-free survival (PFS) of gefitinib + placebo group and gefitinib + pemetrexed group were 14.0 months vs. 18 months respectively and the difference was statistically significant (P < 0.05). The 2-year PFS rates of gefitinib + pemetrexed group (20.00 %) was higher than that of gefitinib + placebo group (8.89 %) and the difference was statistically significant (P < 0.05). The median overall survival (OS) of gefitinib + placebo group and gefitinib + pemetrexed group were 32.0 months vs. 34 months respectively and the difference was not statistically significant (P > 0.05). The 3-year OS rates of gefitinib + pemetrexed group (44.44 %) was higher than that of gefitinib + placebo group (35.56 %) but the difference was not statistically significant (P > 0.05). Major grade 3 or 4 hematological toxicities included neutropenia, leukopenia and anemia. The main grade 3 or 4 non-hematological toxicities were infection, increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels, fatigue, diarrhea and pneumonitis. The difference of toxicities between two groups was not statistically significant (P > 0.05). The combination regimen of gefitinib + pemetrexed used in this study showed a higher ORR and DCR, longer median PFS and acceptable toxicity.
authors.affiliation: Department of Cardiothoracic Surgery, The Third People's Hospital of Nantong, Jiangsu, China.
authors.forename: Chaolun
authors.initials: C
authors.lastname: An
authors.affiliation: Department of Cardiothoracic Surgery, Changhai Hospital of Shanghai, Shanghai, China.
authors.forename: Jiajun
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Department of Cardiothoracic Surgery, The Third People's Hospital of Nantong, Jiangsu, China.
authors.forename: Hongjun
authors.initials: H
authors.lastname: Chu
authors.affiliation: Department of Pathology, The Third People's Hospital of Nantong, Jiangsu, China.
authors.forename: Chunyan
authors.initials: C
authors.lastname: Gu
authors.affiliation: Department of Pathology, The Third People's Hospital of Nantong, Jiangsu, China.
authors.forename: Feng
authors.initials: F
authors.lastname: Xiao
authors.affiliation: Department of Cardiothoracic Surgery, The Third People's Hospital of Nantong, Jiangsu, China.
authors.forename: Fengwei
authors.initials: F
authors.lastname: Zhu
authors.affiliation: Department of Cardiothoracic Surgery, The Third People's Hospital of Nantong, Jiangsu, China.
authors.forename: Rujian
authors.initials: R
authors.lastname: Lu
authors.affiliation: Department of Cardiothoracic Surgery, The Third People's Hospital of Nantong, Jiangsu, China.
authors.forename: Hai
authors.initials: H
authors.lastname: Shi
authors.affiliation: Department of Cardiothoracic Surgery, The Third People's Hospital of Nantong, Jiangsu, China.
authors.forename: Hongfei
authors.initials: H
authors.lastname: Zhang
authors.affiliation: Department of Human Anatomy, Medical College, Nantong University, 19 Qixiu Road, Nantong, Jiangsu Province, 226001, China. ntuyixin@foxmail.com.
authors.forename: Xin
authors.initials: X
authors.lastname: Yi
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics; D018450:Disease Progression; D018572:Disease-Free Survival; D066246:ErbB Receptors / Q000235:genetics*; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics; D008297:Male; D009154:Mutation / Q000235:genetics*; D000068437:Pemetrexed / Q000008:administration & dosage; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage; D011799:Quinazolines / Q000008:administration & dosage; D015996:Survival Rate
chemical_list: D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D000068437:Pemetrexed; C512478:EGFR protein, human; D066246:ErbB Receptors; D000077156:Gefitinib
keywords: Advanced non-small cell lung cancer; EGFR mutation; Gefitinib; Pemetrexed