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Objective To investigated the efficacy and toxic effects of combined chemotherapy of vinorelbine plus cisplatin or carboplatin in patients aged ≥ 70 years and with non-small cell lung cancer (NSCLC).Methods One hundred patients with lung cancer aged ≥70 years were enrolled in the study.Fifty patients in chemotherapy group were assigned to receive vinorelbine 25 mg/m2 at the first day and the fifth day plus cisplatin 60-70 mg/m2 or carboplatin 250 mg/m2 at the second day.All treatments were repeated every 3 or 4 weeks.Another fifty patients aged ≥ 70 years were taken as control group, not receiving treatment.The primary endpoint was survival.Results Forty-five patients were evaluable for response and the partial remission rate was 35.6% (16/45).One year survival rate was 37.8% and median survival time was 9.75 months in chemotherapy group.The median survival time was 4.0 months for patients in control group.All 50 patients in chemotherapy group were evaluable for toxic side effects.WHO grade Ⅲ incidences of leucopoenia, neutropenia and anemia were 38.0%, 52.0% and 2.2%, respectively.Grade IV incidence of neutropenia was 35.5%.WHO grade Ⅲ incidences of fatigue, constipation and vomit were 22.0%, 8.0% and 14.8%,respectively.Five patients failed to complete the treatment due to side effects.Conclusions Combined chemotherapy of vinorelbine plus platinum drugs is effective and tolerated in patients aged over 70 years with advanced NSCLC.Even patients with stable clinical effects shows benefit of survival time.
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<p><b>BACKGROUND</b>Matrix metalloproteinase-9 (MMP-9), endostatin (ES) and vascular endothelial growth factor (VEGF) are important angiogenic regulators for many neoplasms. The aim of this study is to judge clinical and prognostic values of detection of serum MMP-9, ES and VEGF in patients with non-small cell lung cancer (NSCLC).</p><p><b>METHODS</b>Serum levels of MMP-9, ES and VEGF were detected in 92 patients with NSCLC, 50 patients with pulmonary benign disease and 52 healthy controls by ELISA method.</p><p><b>RESULTS</b>The serum levels of MMP-9, ES and VEGF in NSCLC patients were significantly higher than those in patients with pulmonary benign disease and healthy controls (P=0.000, P=0.000, P=0.000). The sensitivity and specificity of serum MMP-9 was 92.51% and 79.10% with a cutoff value of 117.17 μg/L, 88.32% and 74.25% for ES with a cutoff value of 100.31 μg/L, and 83.40% and 75.63% for VEGF with a cutoff value of 380.32 ng/L. Serum MMP-9 and ES levels were significant prognostic factors for lung cancer patients (P=0.0145, P=0.008). The change of serum MMP-9 level after chemotherapy was a useful indicator of prognosis for NSCLC patients (P=0.0322).</p><p><b>CONCLUSIONS</b>The serum levels of MMP-9, ES and VEGF are significantly increased in patients with NSCLC. They might be used as prognostic parameters in patients with NSCLC.</p>
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<p><b>BACKGROUND</b>Gefitinib is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor which is used to treat advanced non-small cell lung cancer, especially adenocarcinoma. The aim of this study is to evaluate the efficacy, side effects and prognostic factors of gefitinib in adenocarcinoma of the lung.</p><p><b>METHODS</b>A total of 26 patients with advanced adenocarcinoma of the lung were enrolled in the study. Gefitinib was orally administered 250mg once daily until disease progression or the occurrence of intolerable toxicity. They were evaluated regularly and their survival was analyzed.</p><p><b>RESULTS</b>In 26 patients, there was 1 with complete regression (3.8%), 11 with partial response (42.3%), 9 with stable disease (34.6%) and 5 with progression of disease (19.2%). The objective response rate was 46.2% and the disease control rate was 80.8%. The median progression-free survival time was 8.2 months and the median overall survival time was 10.4 months. The 1-year survival rate was 31.6%. Age ( < 70 years old), skin rash and CEA decrease were significantly related to longer survival, however, times of prior chemotherapy and gefitinib treatment stage did not influence the survival. Mean PS (ECOG) was 3.0 before treatment, and 1.8 after treatment. Mean symptom relief time was 5.2 days.</p><p><b>CONCLUSIONS</b>Gefitinib is an effective target drug with slight side effect. It can significantly improve quality of life of patients with adenocarcinoma. It can be used as first-line therapy to patients who are not suitable for chemotherapy.</p>
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<p><b>BACKGROUND</b>Gensing Rg3 is an active component from ginseng. The aim of this study is to observe the clinical anticancer effect of Rg3 in combination with chemotherapy regimen NP (vinorelbine+cisplatin) in advanced non-small cell lung cancer (NSCLC).</p><p><b>METHODS</b>Stage III-IV NSCLC patients confirmed by pathology or cytology all received vinorelbine plus cisplatin for at least two cycles, and were randomized into two groups: patients in arm A also received placebo twice a day, while patients in arm B received two tablets of Rg3 twice a day for at least two months. The endpoints of the study were the efficacy, survival and tolerance of patients.</p><p><b>RESULTS</b>From July 2000 to May 2002, 115 patients were enrolled into the trial. The patients' characteristics were well balanced in the two groups. Sex of patients: male, 79; female 36. Types of pathology: adenocarcinoma, 71; squamous cell carcinoma, 29; adenosquamous carcinoma, 8; others, 7. TNM stage: stage III, 45; stage IV, 70. Prior chemotherapy: with, 17; without, 98. Prior radiotherapy: with, 15; without, 100. Prior surgical treatment: with, 23; without, 92. Nine patients discontinued from the trial due to severe adverse effects (5) and other reasons (4), so there were 106 patients evaluable for clinical efficacy. The response rate was 14.5% (8/55) in arm A, and 33.3% (17/51) in arm B (P=0.011). The survival time in arm A was 9.7 months (mean) and 8.0 months (median), and 15.3 months (mean) and 10.0 months (median) in arm B (P=0.0088).</p><p><b>CONCLUSIONS</b>Preliminary results show improvements in response rate and survival time (median and mean) in Rg3 arm compared with placebo arm. It is worthy to confirm the results in further clinical trials.</p>
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<p><b>BACKGROUND</b>Uroacitides is a group of cell differentiation inducers, which is purified from fresh human urine. Preclinical studies of Uroacitides have showed that cancer cells could be induced to differentiate, and the growth of cancer cells could be inhibited by Uroacitides. The aim of this study is to compare the efficacy and toxicity between Uroacitides combined with NP regimen and NP alone in treatment of advanced non-small cell lung cancer (NSCLC).</p><p><b>METHODS</b>Forty-two cases of advanced NSCLC were randomized into Uroacitides+NP and NP groups. NP group: NVB 25mg/m² on days 1 and 8, DDP 75mg/m² on day 1. Uroacitides combined with NP group: Uroacitides of 300mL was given through subclavian catheter daily for 7 days prior to the NP chemotherapy, then concurrently with NP regimen for 2 cycles, except the days of administration of chemotherapy.</p><p><b>RESULTS</b>In the Uroacitides+NP group, the overall response rate was 44.4%, and 20.0% in the NP group (P > 0.05). The median survival time was 9 months in the Uroacitides+NP group and 6 months in the NP group (P=0.0287). The main toxicities were myelosuppression, gastrointestinal reaction and alopecia, and there was no significant difference in incidences of toxicities between the two groups (P > 0.05).</p><p><b>CONCLUSIONS</b>Uroacitides combined with NP regimen shows a good curative effect and low toxicity, and may significantly prolong the median survival time for advanced NSCLC.</p>
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<p><b>BACKGROUND</b>Endostar™ (rh-endostatin, YH-16) is a new recombinant human endostatin developed by Medgenn Bioengineering Co. Ltd., Yantai, Shandong, P.R.China. Pre-clinical study indicated that YH-16 could inhibit tumor endothelial cell proliferation, angiogenesis and tumor growth. Phase I and phase II studies revealed that YH-16 was effective as single agent with good tolerance in clinical use.The current study was to compare the response rate , median ti me to progression (TTP) ,clinical benefit andsafety in patients with advanced non-small cell lung cancer ( NSCLC) , who were treated with YH-16 plus vi-norelbine and cisplatin (NP) or placebo plus NP.</p><p><b>METHODS</b>Four hundred and ninety-three histologically or cy-tologically confirmed stage IIIB and IV NSCLC patients , withlife expectancy > 3 months and ECOG perform-ance status 0-2 , were enrolledin a randomized ,double-blind ,placebo-controlled , multicenter trial ,either trialgroup : NP plus YH-16 (vinorelbine 25 mg/m² on day 1 and day 5 ,cisplatin 30mg/m² on days 2 to 4 , YH-167.5mg/m² on days 1 to 14) or control group : NP plus placebo (vinorelbine 25 mg/m² on day 1 and day 5 ,cis-platin 30 mg/m² on days 2 to 4 ,0.9% sodium-chloride 3 .75 ml on days 1 to 14) every 3 weeks for 2-6 cycles .The trial endpoints included response rate ,clinical benefit rate ,time to progression,quality of life and safety .</p><p><b>RESULTS</b>Of 486 assessable patients , overall response rate was 35.4% in trial group and 19.5% in controlgroup (P=0 .0003) . The median TTP was 6 .3 months and 3 .6 months for trial group and control group respectively (P < 0 .001) . The clinical benefit rate was 73 .3 %in trial group and 64.0% in control group (P=0 .035) .In untreated patients of trial group and control group ,the response rate was 40 .0% and 23.9%(P=0 .003) ,the clinical benefit rate was 76 .5 % and 65 .0 % (P=0 .023) ,the median TTP was 6 .6 and 3 .7months (P=0 .0000) ,respectively .In pretreated patients of trial group and control group ,the response ratewas 23.9% and 8.5%(P=0 .034) ,the clinical benefit rate was 65.2% and 61.7%(P=0 .68) ,the median TTP was 5 .7 and 3 .2 months (P=0 .0002) ,respectively . The relief rate of clinical symptoms in trial groupwas higher than that of those in control group ,but no significance existed (P > 0 .05) . The score of quality oflife in trial group was significantly higher than that in control group (P=0 .0155) after treatment . There were no significant differences in incidence of hematologic and non-hematologic toxicity , moderate and severe sideeffects betweentrial group and control group .</p><p><b>CONCLUSIONS</b>The addition of YH-16 to NP regimen results in significantly and clinically meaningful improvement in response rate , median time to tumor progression,and clinical benefit rate compared with NP alone in advanced NSCLC patients . YH-16 in combination with chemotherapy shows a synergic activity and a favorable toxic profile in advanced cancer patients .</p>
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<p><b>BACKGROUND</b>To evaluate the efficacy, side-effects, median survival duration and survival rate of vinorelbine (NVB) combined with cisplatin (DDP) in the treatment of non-small cell lung cancer (NSCLC).</p><p><b>METHODS</b>A total of 220 patients with inoperable NSCLC received NVB and DDP combined chemotherapy: NVB 25-30 mg/(m²*d) on days 1 and 5 (or 8), DDP 60-80 mg/(m²*d) on day 2. The schedule was repeated every 28 days. The efficacy and side-effects were analysed and followed-up after at least two cycles of chemotherapy.</p><p><b>RESULTS</b>The overall response rate (CR+PR) was 30.9% (68/220). The response rate was 31.3% (51/163) in initial treatment group, and 29.8% (17/57) in retreatment group. The median survival duration was 8.3 months. The 1-, 2- and 3-year survival rates were 39.23%, 19.31% and 6.32%, respectively. The main side-effects were myelosuppression and digestive tract reactions.</p><p><b>CONCLUSIONS</b>Vinorelbine plus cisplatin is an effective and well-tolerated regimen for non small cell lung cancer and myelosuppression is its dose-limiting toxicity.</p>
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<p><b>BACKGROUND</b>To evaluate the activity and toxicity of paclitaxel as second-line treatment for advanced non-small cell lung cancer (NSCLC).</p><p><b>METHODS</b>Forty patients with recurrent advanced NSCLC were enrolled. Thirty-six patients were managed with regular regimen. Paclitaxel 135 mg/m², 3 h, on day 1; DDP 75 mg/m² or carboplatin 300-350 mg/m² on day 2. Four patients were managed with weekly regimen. Paclitaxel 60 mg/m²,3 h, on days 1,8,15; DDP 75 mg/m² on day 2. It was repeated every three or four weeks, up to two to four cycles.</p><p><b>RESULTS</b>Thirty-six cases were evaluated for response and 27 for survival. The objective response rate was 13.9% (5/36). At least one tumor-related symptom relief was observed in 21 patients (58.3%). The median survival duration was 26.4 weeks and 1-year survival rate was 8% (4/36). The main toxicities included myelosuppression, fatigue and myalgia-arthralgia neuropathy.</p><p><b>CONCLUSIONS</b>Paclitaxel has advantage to be well-tolerated and improve tumor-related symptom. Further studies with standardization of dose and regimen will be needed to clarify its role in the second-line treatment.</p>
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<p><b>OBJECTIVE</b>To evaluate the efficacy and toxicity of Serratia marcescens (S311) vaccine in the treatment of malignant pleural effusion.</p><p><b>METHODS</b>Thirty-four patients with malignant pleural effusion were given S311 as intrapleural injection with a dose of 10(9) U (0.32 mg) on D 1, 8 and 15, and observed for four weeks.</p><p><b>RESULTS</b>The overall response rate (CR + PR) was 97.1% (CR in 12 patients and PR in 21 patients). The systemic toxicity was mild, including fever (82.4%), pleuritic pain (50.7%), nansea (26.5%), dyspnea (17.5%) and chills (5.9%).</p><p><b>CONCLUSION</b>Serratia marcescens vaccine is effective for malignant pleural effusion, with tolerable toxic effects. Further study is warranted.</p>