Randomized Phase II Study of Pemetrexed Versus Gefitinib in Previously Treated Patients with Advanced Non-small Cell Lung Cancer
Cancer Research and Treatment 2016³â 48±Ç 1È£ p.80 ~ p.87
±è¿µ»ý(Kim Young-Saing) - Gachon University Gil Medical Center Department of Internal Medicine Division of Hematology and Oncology
Á¶Àº°æ(Cho Eun-Kyung) - Gachon University Gil Medical Center Department of Internal Medicine Division of Hematology and Oncology
¿ìÇö¼±(Woo Hyun-Sun) - Gachon University Gil Medical Center Department of Internal Medicine Division of Hematology and Oncology
È«ÁؽÄ(Hong Jun-Shik) - Gachon University Gil Medical Center Department of Internal Medicine Division of Hematology and Oncology
¾ÈÈñ°æ(Ahn Hee-Kyung) - Gachon University Gil Medical Center Department of Internal Medicine Division of Hematology and Oncology
¹ÚÀαÙ(Park In-Keun) - Gachon University Gil Medical Center Department of Internal Medicine
½É¼±Áø(Sym Sun-Jin) - Gachon University Gil Medical Center Department of Internal Medicine Division of Hematology and Oncology
°æ¼±¿µ(Kyung Sun-Young) - Gachon University Gil Medical Center Department of Internal Medicine Division of Pulmonary and Critical Care Medicine
°½Å¸í(Kang Shin-Myung) - Gachon University Gil Medical Center Department of Internal Medicine Division of Pulmonary and Critical Care Medicine
¹ÚÁ¤¿õ(Park Jeong-Woong) - Gachon University Gil Medical Center Department of Internal Medicine Division of Pulmonary and Critical Care Medicine
Á¤¼ºÈ¯(Jeong Sung-Hwan) - Gachon University Gil Medical Center Department of Internal Medicine Division of Pulmonary and Critical Care Medicine
¹ÚÁøÈñ(Park Jin-Ny) - Gachon University Gil Medical Center Department of Internal Medicine Division of Hematology and Oncology
ÀÌÀçÈÆ(Lee Jae-Hoon) - Gachon University Gil Medical Center Department of Internal Medicine Division of Hematology and Oncology
½Åµ¿º¹(Shin Dong-Bok) - Gachon University Gil Medical Center Department of Internal Medicine Division of Hematology and Oncology
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©÷ 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.
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Pemetrexed, Gefitinib, Non-small cell lung cancer, Epidermal growth factor receptor, Second-line
KMID :
0939920160480010080
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pemetrexed and gefitinib had similar efficacy, but pemetrexed is considered more effective than gefitinib for epidermal growth factor receptor (EGFR) wild-type patients