BACKGROUND: To investigate the role of interferon-alpha (IFN-α) in completely resected stage I and II non-small cell lung cancer (NSCLC) patients. METHODS:Forty-four stageIandII NSCLC patients were randomized to two groups. Study group (surgery+IFN-α) received IFN-α injection, 3 million unit, every two days, with a period of treatment of 90 days. Control group (surgery only) received no adjuvant therapy until relapse or metastasis were detected. pTNM stage, histological types, relapse or metastasis, survival time were observed and evaluated. RESULTS: Median follow-up was 49.9 months. The 1-, 2-, 3-, 4-year survival rates were 90.5%, 80.9%, 52.4%, 52.4% in the study group and 95.2%, 80.9%, 66.0%, 50.8% in the control group respectively. No significant statistic difference was found between the two groups ( P = 0.663 9 ). Kaplan-Meier and Cox Model analysis showed pTNM stage ( P =0.010 2), N status ( P =0.015) and weight loss ( P =0.030) were prognostic factors in completely resected stage I and II NSCLC. CONCLUSIONS:Postoperative low-dose IFN-α short-term therapy cannot significantly improve 3- and 4-year survival rates of patients with stage I and II completely resected NSCLC.
RCT Entities:
BACKGROUND: To investigate the role of interferon-alpha (IFN-α) in completely resected stage I and II non-small cell lung cancer (NSCLC) patients. METHODS: Forty-four stageIand II NSCLCpatients were randomized to two groups. Study group (surgery+IFN-α) received IFN-α injection, 3 million unit, every two days, with a period of treatment of 90 days. Control group (surgery only) received no adjuvant therapy until relapse or metastasis were detected. pTNM stage, histological types, relapse or metastasis, survival time were observed and evaluated. RESULTS: Median follow-up was 49.9 months. The 1-, 2-, 3-, 4-year survival rates were 90.5%, 80.9%, 52.4%, 52.4% in the study group and 95.2%, 80.9%, 66.0%, 50.8% in the control group respectively. No significant statistic difference was found between the two groups ( P = 0.663 9 ). Kaplan-Meier and Cox Model analysis showed pTNM stage ( P =0.010 2), N status ( P =0.015) and weight loss ( P =0.030) were prognostic factors in completely resected stage I and II NSCLC. CONCLUSIONS: Postoperative low-dose IFN-α short-term therapy cannot significantly improve 3- and 4-year survival rates of patients with stage I and II completely resected NSCLC.