ABSTRACT
<p><b>OBJECTIVE</b>To analyze the efficacy and quality of life and safety for paclitaxel and carboplatin (TC) and TC combined with endostar in the treatment of advanced non-small cell lung cancer (NSCLC).</p><p><b>METHODS</b>This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical study. A total of 126 cases of untreated advanced NSCLC were enrolled in this study. There were 63 patients in the TC control arm and TC combined endostar arm, respectively. All enrolled patients were continuously followed-up for disease progression and death.</p><p><b>RESULTS</b>The objective response rate (ORR) of TC combined with endostar arm was 39.3%, and that of TC control arm was 23.0%, P = 0.078. The progression-free survival rates for TC combined with endostar arm and TC control arm were 78.3% and 58.8%, respectively, in 24 weeks (P = 0.017). The hazard ratio for the risk of disease progression was 0.35 (95%CI 0.13 to 0.90, P = 0.030). The median time to progression (TTP) of the TC combined with endostar arm was 7.1 months and TC arm 6.3 months (P > 0.05). The follow-up results showed that the median survival time (mOS) of the TC + Endostar arm was 17.6 months; (95%CI 13.4 to 21.7 months), and the TC + placebo arm 15.8 months (95%CI 9.4 to 22.9 months) (P > 0.05). The quality of life scores (LCSS patient scale) after treatment of the TC combined with endostar arm was improved, and that of the TC group was improved after completion of two cycles and three cycles of treatment. The quality of life scores compared with baseline after the completion of one cycle treatment was significantly improved for both the TC combined with endostar arm (P = 0.028 and), and TC arm (P = 0.036). It Indicated that TC combined with endostar treatment improved the patient's quality of life in the early treatment. The difference of adverse and serious adverse event rates between the two groups was not significant (P > 0.05).</p><p><b>CONCLUSIONS</b>Compared with TC alone treatmrnt, TC combined with endostar treatment can reduce the risk of disease progression at early time (24 weeks), increase the ORR, and can be used as first-line treatment for advanced NSCLC. The TC combined with endostar treatment has good safety and tolerability, improves the quality of life, and not increases serious adverse effects and toxicity for patients with advanced NSCLC.</p>
Subject(s)
Humans , Antineoplastic Agents , Therapeutic Uses , Antineoplastic Combined Chemotherapy Protocols , Therapeutic Uses , Carboplatin , Carcinoma, Non-Small-Cell Lung , Drug Therapy , Pathology , Disease Progression , Disease-Free Survival , Double-Blind Method , Endostatins , Therapeutic Uses , Follow-Up Studies , Leukopenia , Lung Neoplasms , Drug Therapy , Pathology , Nausea , Neoplasm Staging , Paclitaxel , Prospective Studies , Quality of Life , Remission InductionABSTRACT
<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of gefitinib for the treatment of advanced non-small cell lung cancer (NSCLC).</p><p><b>METHODS</b>125 patients with advanced NSCLC who had failed or not tolerated or refused chemotherapy received 250 mg oral doses of gefitinib once daily until the disease progression or intolerable toxicity.</p><p><b>RESULTS</b>A total of 125 NSCLC patients were studied, the overall response rate (RR) and the disease control rate (DCR) after administration of gefitinib were 35.2% (44/125) and 77.6% (97/125), respectively. The median progression-free survival and the median survival time were 5.8 and 11.2 months, respectively. The one-year survival rate was 40.5%. The response rate was significantly higher in females, adenocarcinoma and nonsmokers than that in males, non-adenocarcinoma and smokers (P < 0.05). The response rate did not show significant differences regarding ECOG score or previous treatment. The median progression-free survival was significantly longer in ECOG PS 0-1 and gefitinib effective patients than that in ECOG PS >or= 2 and gefitinib ineffective patients (P < 0.01). The median survival time was significantly longer in adenocarcinoma, nonsmokers and gefitinib effective patients than that in non-adenocarcinoma, smokers and gefitinib ineffective patients (P < 0.05). The most common side effects were rash (51.2%) and diarrhea (34.4%), but usually were mild.</p><p><b>CONCLUSION</b>Gefitinib is effective and safe in the treatment of advanced NSCLC patients.</p>
Subject(s)
Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Adenocarcinoma , Drug Therapy , Pathology , Antineoplastic Agents , Therapeutic Uses , Carcinoma, Non-Small-Cell Lung , Drug Therapy , Pathology , Carcinoma, Squamous Cell , Drug Therapy , Pathology , Diarrhea , Disease-Free Survival , Exanthema , Follow-Up Studies , Lung Neoplasms , Drug Therapy , Pathology , Neoplasm Staging , Quinazolines , Therapeutic Uses , Survival RateABSTRACT
1.0～(?)1.5 cm(14.81%)(P=0.10).There was no lymph node metastasis in tumors less than 1.0 cm in diameter. The 5-year survival rates for cases with or without lymph node involvement were 92.31% and 60.0%,respectively,the difference was significant(P=0.000).The 5-year survival rates of 12 patients showing ground-glass opacity(GGO)on chest CT was 91.67% without any lymph node involvement.Conclusions:There is mediastinal and hilar lymph node involvement even with tumor diameter less than 2 cm.The results of the present study suggested that routine lymph node dissection is necessary even for cases with tumor diameter less than 2 cm.However,if the tumor is within 1.0 cm in diameter with obvious GGO showing on chest CT,these are good candidates for partial resection without mediastinal lymph node dissection.
