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Background and Objective: Due to the various inter-individual differences in the biological characteristics of tumor cells, as well as issues on the efficacy, adverse reactions, and defects of existing drugs, we compared the clinical efficacy and toxicity of pemetrexed and gemcitabine combined with cisplatin for the treatment of previously untreated advanced non-small cell lung cancer (NSCLC)., Methods: 251 patients were randomly divided into pemetrexed combined with cisplatin group (PP group) with 127 cases and gemcitabine combined with cisplatin group (GP group) with 124 cases. PP group received pemetrexed 500 mg/m² iv infusion d1 and cisplatin 75 mg/m² iv infusion d1, whereas GP group received gemcitabine 1,000 mg/m² iv infusion d1,8 and cisplatin 75 mg/m² iv infusion d1. The treatment cycle was once every three weeks. In addition, folic acid, vitamin B12, and dexamethasone were administered in both groups., Results: The total clinical effective rates in PP group and GP group were 25.20% and 17.74%, respectively. The total efficiencies of non-squamous cell carcinoma were 27.62% and 16.00%. The tumor progression duration in these two groups was 6.5 and 5.6 months, respectively. The median survival time in the two groups was 16.9 and 17.0 months, respectively, with 59.62% and 65.87% survival rates of 1 year and 27.28% and 27.93% survival rates of 2 years, respectively. The total efficacy of non-squamous cell carcinoma in the PP group was significantly higher than that in GP group. The results were statistically significant. However, there were no significant differences in total response rates, tumor progression duration, and median survival rates of 1 and 2 years. The rate of adverse reactions, including white blood cell reduction, lower platelet count, lower hemoglobin, and hair loss in the PP group was significantly lower than that in the GP group. The results were statistically significant., Conclusion: The clinical efficacy of pemetrexed and gemcitabine combined with cisplatin for the treatment of previously untreated advanced NSCLC was roughly the same, but the adverse reactions decreased significantly in the PP group compared with those in the GP group. Therefore, pemetrexed combined with cisplatin can be used as a safe and effective drug for clinical first-line treatment for previously untreated NSCLC.

Background and Objective: The Expand Access Program (EAP) of Iressa(gefitinib, ZD1839) in China was initiated in 2001 with the aim of providing gefitinib to non-small cell lung cancer (NSCLC) patients who failed to respond to standard treatment or who could not tolerate chemotherapy. The primary objective was to describe the quality of life (QoL), tumor control status, drug safety, and clinical/genomic features of active long-term survivors enrolled in the EAP. The secondary objective was to determine the clinical characteristics of long-term survivors in the EAP program., Methods: In this descriptive observational study, data were collected based on epidemiological research methods. The data of patients who were actively participating in the EAP and still undergoing gefitinib treatment were collected in a cross-sectional manner to reflect the current status of each patient. Meanwhile, the data of patients who had been on gefitinib treatment for more than three years and had already been terminated from the EAP or those who were fast progressors were collected retrospectively., Results: A total of 934 patients were screened in the EAP database. Among these patients, 25 were active long-term survivors still enrolled in the EAP and 34 were long-term survivors who had been terminated from the program. These 59 patients were enrolled in 15 different centers in China, and the remaining 875 patients were fast progressors. The median scores for the Functional Assessment of Cancer Therapy-Lung (FACT-L), Trial Outcome Index (TOI), and Lung Cancer Subscale (LCS) of the 25 long-term survivors were 64.5, 37 and 12.5, respectively. The performance status 0-1 accounted for 91.6% of the data observed during the cross-sectional survey. For active long-term survivors, the objective response rate was 37.5%, the disease control rate was 87.5%, and the median duration of response time was almost 68 months. In the long-term survivor group, no serious and new adverse events were reported. Patients who were aged under 65 years (68.5%), affected with adenocarcinoma (81.4%), female (55.9%), or had never smoked (71%) accounted for majority of the long-term survivors. The percentage of females was significantly higher in the long-term survivor group than in the fast progressor group (P=0.02). Three tissue samples were collected from each of the 24 active long-term survivors, and one patient was found to be positive of EGFR mutation. Twenty-two blood samples were also collected, and one patient tested positive for EGFR mutation. The Ki67 protein expression was also tested in three tissue samples, and two of these were found positive for Ki67 protein expression, with a response duration time of over 73 months., Conclusions: A 250 mg dose of gefitinib offers good QoL and is safe for advanced NSCLC long-term survivors even after more than three years of treatment. According to the evaluation of the current tumor control statuses of patients, gefitinib demonstrates good efficacy in these active long-term survivors.

Background: It is uncertain that the effect of multimodality treatment with operation on survival for locally advanced non-small cell lung cancer (NSCLC). The aim of this study is to evaluate the effect of multimodality treatment with or without operation on survival for locally advanced NSCLC., Methods: From May 1992 to May 1999, 114 patients with locally advanced NSCLC were divided into two arms. Arm A (n=56): 39 cases were at stage IIIA, and 17 at stage IIIB; Median KPS was 80 (range from 70 to 90 ); Multimodality treatment program included operation, chemotherapy, radiotherapy and traditional Chinese herb medicine. Of them, lobectomy plus mediastinal systematic lymph node dissection or lymph node sampling accounted for 49 cases, sleeve lobectomy plus mediastinal lymph node dissection for 5 cases, and pneumonectomy for 2 cases. Preoperative or adjuvant chemotherapy regimens included MVP (mitomycin C, vindesine, cisplatin), NP (vinorelbine, cisplatin), TC (paclitaxel, carboplatin), GP (gemcitabine, cisplatin), which were repeated every 4 weeks for 4-6 cycles. Total dose of radiotherapy for lesions in the lung or mediastinal field was 5000-6000cGy. Arm B (n=58): 23 cases were at stage IIIA, and 35 at stage IIIB; Median KPS was 70 (range from 60 to 90); Treatment program was the same approximately as arm A except for no operation., Results: Arm A: (1) Metastatic locations in follow-up, in turn, showed as: lymph node, pleural-lung, bone, brain, liver, pericardium, skin and adrenal; (2) Median survival was 27 months, and 1-, 2- and 5-year survival rate was 82.1%, 60.7% and 25.0% respectively. Arm B: (1) Metastatic locations in follow-up, in turn, showed as: lymph node, pleural-lung, bone, brain, liver, pericardium, skin, adrenal, pancreatic and esophageal metastasis; (2) Median survival was 13 months, and 1-, 2- and 5-year survival rate was 53.4%, 31.0% and 1.7% respectively. Median survival duration of Arm A was significantly superior to Arm B (P=0.0001). There were significant differences in 1-, 2- and 5-year survival rate between the two groups (Chi-Square=9.4, P < 0.01; Chi-Square=8.9, P < 0.01;Chi-Square=11.5, P < 0.01)., Conclusions: Compared with non-operative multimodality treatment, operative multimodality treatment including lobectomy or pneumonectomy with mediastinal lymph node dissection can remarkably improve the survival in patients with locally advanced NSCLC.

Background: To evaluate the diagnostic values of multiple tumor marker protein biochip detective system for lung cancer., Methods: The serum levels of 12 tumor markers, including CA199, NSE, CEA, CA242, CA125, CA153, AFP, ferritin, free-PSA, PSA, β-HCG and HGH, were measured in 108 lung cancer patients, 48 patients with benign pulmonary lesion and 145 healthy by the detective system., Results: The positive rates were 83.33% (90/108), 52.08% (25/48) and 28.97% (42/145) in lung cancer, benign pulmonary lesion and healthy groups, respectively. The lung cancer group had significantly higher positive rate than that of the controls (Chi-Square=16.75 and 73.32, both P < 0.001); There was significant difference of positive rate in various clinical stages of lung cancer (Chi-Square=7.89, P=0.048), but not in different pathologic classification. Serum CA199, CEA and CA242 levels were closely correlated with clinical staging (F=2.84, P=0.041; F= 3.49, P=0.018; F =5.22, P=0.002). The positive rate of CEA in adenocarcinoma was higher, but no significant difference was observed (Chi-Square=0.71, P=0.07). NSE in small cell lung cancer had the highest positive rate (Chi-Square=19.03, P < 0.001). Combined measurement of the twelve markers had higher sensitivity (Chi-Square= 368.58, P < 0.001), but less specificity (Chi-Square= 369.87, P < 0.001)., Conclusions: Combined measurement of various serum tumor markers using protein biochip can significantly increase the diagnostic sensitivity for lung cancer. Meanwhile, it is also significant for defining clinical stage, identificating pathologic classification, as well as monitoring therapeutic efficacy. As its specificity and positive predictive value are lower, it is more suitable to be used as a surveying tool for symptomless people, especially for high risk people for lung cancer.