Randomized Phase II Study of Pemetrexed Versus Gefitinib in Previously Treated Patients with Advanced Non-small Cell Lung Cancer / Journal of the Korean Cancer Association, 대한암학회지
Cancer Research and Treatment
; : 80-87, 2016.
Article
em En
| WPRIM
| ID: wpr-170078
Biblioteca responsável:
WPRO
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 ANDMETHODS:
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.Palavras-chave
Texto completo:
1
Base de dados:
WPRIM
Assunto principal:
Braço
/
Anorexia
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Carcinoma Pulmonar de Células não Pequenas
/
Intervalo Livre de Doença
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Tratamento Farmacológico
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Exantema
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Fadiga
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Receptores ErbB
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Anemia
Tipo de estudo:
Clinical_trials
Limite:
Humans
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Male
Idioma:
En
Revista:
Cancer Research and Treatment
Ano de publicação:
2016
Tipo de documento:
Article
País de publicação:
COREA DEL SUR
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COREIA DO SUL
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KR
/
SOUTH KOREA