Randomized Phase II Study of Pemetrexed Versus Gefitinib in Previously Treated Patients with Advanced Non-small Cell Lung Cancer.
- Author:
Young Saing KIM
1
;
Eun Kyung CHO
;
Hyun Sun WOO
;
Junshik HONG
;
Hee Kyung AHN
;
Inkeun PARK
;
Sun Jin SYM
;
Sun Young KYUNG
;
Shin Myung KANG
;
Jeong Woong PARK
;
Sung Hwan JEONG
;
Jinny PARK
;
Jae Hoon LEE
;
Dong Bok SHIN
Author Information
- Publication Type:Original Article
- Keywords: Pemetrexed; Gefitinib; Non-small cell lung cancer; Epidermal growth factor receptor; Second-line
- MeSH: Anemia; Anorexia; Arm; Carcinoma, Non-Small-Cell Lung*; Disease-Free Survival; Drug Therapy; Exanthema; Fatigue; Humans; Male; Receptor, Epidermal Growth Factor
- From:Cancer Research and Treatment 2016;48(1):80-87
- CountryRepublic of Korea
- Language:English
- Abstract: PURPOSE: This study aimed to evaluate the efficacy and safety of pemetrexed versus gefitinib in patients with advanced non-small cell lung cancer (NSCLC) previously treated with chemotherapy. MATERIALS AND METHODS: Patients with advanced (stage IIIB or IV) or recurrent NSCLC were randomly assigned to receive either 500 mg/m(2) of pemetrexed intravenously every 3 weeks or gefitinib 250 mg/day orally. The primary end point was progression-free survival (PFS) at 6 months. RESULTS: A total of 95 patients were enrolled (47 for pemetrexed and 48 for gefitinib). Most patients were male (72%) and current/ex-smokers (69%), and 80% had non-squamous cell carcinoma. The epidermal growth factor receptor (EGFR) mutation status was determined in 38 patients (40%); one patient per each arm was positive for EGFR mutation. The 6-month PFS rates were 22% and 15% for pemetrexed and gefitinib, respectively (p=0.35). Both arms showed an identical median PFS of 2.0 months and a median overall survival (OS) of 8.5 months. In EGFR wild-type patients, higher response rate (RR) and longer PFS as well as OS were achieved via pemetrexed compared with gefitinib, although there were no significant differences (RR: 39% vs. 9%, p=0.07; median PFS: 6.6 months vs. 3.1 months, p=0.45; median OS: 29.6 months vs. 12.9 months, p=0.62). Toxicities were mild in both treatment arms. Frequently reported toxicities were anemia and fatigue for pemetrexed, and skin rash and anorexia for gefitinib. CONCLUSION: Both pemetrexed and gefitinib had similar efficacy with good tolerability as second-line treatment in unselected patients with advanced NSCLC. However, pemetrexed is considered more effective than gefitinib for EGFR wild-type patients.
