Effectiveness Of Gefitinib As The First-line Therapy In Patients With Advanced Lung Adenocarcinoma

Objective:In recent years,numerous studies showed that gefitinib (Iressa, ZD1839), a kind of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (EGFR-TKI) as the second and third-line treatment achieved significant efficacy in Asian patients with advanced NSCLC. Two phaseâ…¢randomized, open labelled control studies IPASS and First-SIGNAL that gefitinib compared with the standard chemotherapy as the first-line therapy in patients with advanced lung adenocarcinoma achieved a significant improvement of PFS. This study is to evaluate the clinical effectiveness and toxicity of first-line therapy of gefitinib in the patients with advanced lung adenocarcinoma.Methods:From June 2007 to August 2009,29 non-smoking or mild-smoking (stageâ…¢B,â…£) lung adenocarcinoma patients diagnosed by histologic or cytologic in the First Affiliated Hospital of Dalian Medical University were enrolled in this study. Gefitinib was given at a oral dose of 250mg daily until disease progression or serious toxicity. Among the 29 patients,14 cases were stageâ…¢B and 15 cases were stage IV, 18 females and 11 males, the median age was 65 years(from 46 years old to 78 years old), ECOG scores 0-1 was 18 cases and score 2 was 11 cases. Ahead of the treatment,patients underwent chest CT, abdominal CT and cranial MRI, tumor markers, whole blood test and liver/kidney function tests as baseline evaluation. Clinical symptoms and signs were observed daily after the treatment. Evaluated the physical and chemical examination after 6 weeks. Evaluated the effectiveness every 6 weeks using the criteria of RECIST which divided into complete response(CR), partial response(PR), stable disease(SD) and progressive disease(PD). Evaluated toxicity according to the criteria of NCI common toxicity grading(third edition).Results:The whole group patients can be evaluated, no patients achieve complete remission, partial response is 13 cases (44.9%), stable disease is 11 cases (37.9%) and progressive disease is 5 cases (17.2%). The objective response rate is 44.9% and the disease control rate is 82.8%. The median progression-free survival and median survival time is 5.5 months and 15.5 months.1-year survival rate is 72.4%. The group comparison shows that gender and age has no significant difference in objective response rate and disease control rate, while PS and staging is significant different in disease control rate.PS,age,staging and efficacy is significant different in progression-free survival(P<0.05, Log-rank univariate survival analysis). The main toxicity is rash and diarrhea (gradeâ… orâ…¡). No patient discontinued gefitinib treatment due to toxicity. The toxicity is rash 65.5%(19/29), diarrhea 37.9%(11/29), skin itching 24.1%(7/29), dry skin 17.2%(5/29), anorexia 10.3%(3/29)and hepatic dysfunction 10.3%(3/29). No interstitial lung disease or blood toxicity occurred.Conclusion:As the good effectiveness, accepted toxicity and oral convenience, gefitinib can be used as first-line therapy in selected patients with advanced lung adenocarcinoma.