***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: PURPOSE To evaluate the efficacy and tolerability of two doses of gefitinib ( Iressa [ ZD1839 ] ; AstraZeneca , Wilmington , DE ) , a novel epidermal growth factor receptor tyrosine kinase inhibitor , in patients with pretreated advanced non-small-cell lung cancer ( NSCLC ) . PATIENTS AND METHODS This was a r and omized , double-blind , parallel-group , multicenter phase II trial . Two hundred ten patients with advanced NSCLC who were previously treated with one or two chemotherapy regimens ( at least one containing platinum )  were r and omly assigned to receive either 250-mg or 500-mg oral doses of gefitinib once daily . RESULTS Efficacy was similar for the 250- and 500-mg/d groups . Objective tumor response rates were 18.4 % ( 95 % confidence interval [ CI ] , 11.5 to 27.3 ) and 19.0 % ( 95 % CI , 12.1 to 27.9 ) ; among evaluable patients , symptom improvement rates were 40.3 % ( 95 % CI , 28.5 to 53.0 ) and 37.0 % ( 95 % CI , 26.0 to 49.1 ) ; median progression-free survival times were 2.7 and 2.8 months ; and median overall survival times were 7.6 and 8.0 months , respectively . Symptom improvements were recorded for 69.2 % ( 250 mg/d ) and 85.7 % ( 500 mg/d ) of patients with a tumor response . Adverse events ( AEs ) at both dose levels were generally mild ( grade 1 or 2 ) and consisted mainly of skin reactions and diarrhea . Drug-related toxicities were more frequent in the higher-dose group . Withdrawal due to drug-related AEs was 1.9 % and 9.4 % for patients receiving gefitinib 250 and 500 mg/d , respectively . CONCLUSION Gefitinib showed clinical ly meaningful antitumor activity and provided symptom relief as second- and third-line treatment in these patients . At 250 mg/d , gefitinib had a favorable AE profile . Gefitinib 250 mg/d is an important , novel treatment option for patients with pretreated advanced NSCLC [ corrected CONTEXT More persons in the United States die from non-small cell lung cancer ( NSCLC ) than from breast , colorectal , and prostate cancer combined . In pre clinical testing , oral gefitinib inhibited the growth of NSCLC tumors that express the epidermal growth factor receptor ( EGFR ) , a mediator of cell signaling , and phase 1 trials have demonstrated that a fraction of patients with NSCLC progressing after chemotherapy experience both a decrease in lung cancer symptoms and radiographic tumor shrinkages with gefitinib . OBJECTIVE To assess differences in symptomatic and radiographic response among patients with NSCLC receiving 250-mg and 500-mg daily doses of gefitinib .  DESIGN , SETTING , AND PATIENTS Double-blind , r and omized phase 2 trial conducted from November 2000 to April 2001 in 30 US academic and community oncology centers . Patients ( N = 221 ) had either stage IIIB or IV NSCLC for which they had received at least 2 chemotherapy regimens . INTERVENTION Daily oral gefitinib , either 500 mg ( administered as two 250-mg gefitinib tablets ) or 250 mg ( administered as one 250-mg gefitinib tablet and 1 matching placebo ) . MAIN OUTCOME MEASURES Improvement of NSCLC symptoms ( 2-point or greater increase in score on the summed lung cancer subscale of the Functional Assessment of Cancer Therapy-Lung [ FACT-L ] instrument ) and tumor regression ( > 50 % decrease in lesion size on imaging studies ) . RESULTS Of 221 patients enrolled , 216 received gefitinib as r and omized . Symptoms of NSCLC improved in 43 % ( 95 % confidence interval [ CI ] , 33%-53 % ) of patients receiving 250 mg of gefitinib and in 35 % ( 95 % CI , 26%-45 % ) of patients receiving 500 mg . These benefits were observed within 3 weeks in 75 % of patients . Partial radiographic responses occurred in 12 % ( 95 % CI , 6%-20 % ) of individuals receiving 250 mg of gefitinib and in 9 % ( 95 % CI , 4%-16 % ) of those receiving 500 mg . Symptoms improved in 96 % of patients with partial radiographic responses . The overall survival at 1 year was 25 % . There were no significant differences between the 250-mg and 500-mg doses in rates of symptom improvement ( P = .26 ) , radiographic tumor regression ( P = .51 ) , and projected 1-year survival ( P = .54 ) . The 500-mg dose was associated more frequently with transient acne-like rash ( P = .04 ) and diarrhea ( P = .006 ) . CONCLUSIONS Gefitinib , a well-tolerated oral EGFR-tyrosine kinase inhibitor , improved disease-related symptoms and induced radiographic tumor regressions in patients with NSCLC persisting after chemotherapy e19011 Background : The phase III BMS099 trial investigated cetuximab ( C ) added to taxane/carboplatin ( TC ) for 1st line treatment of advanced NSCLC  . Progression-free survival ( PFS ) was not significantly different with C ; response rate ( RR ) was significantly higher . Median overall survival ( OS ) was longer , with a difference not statistically significant , but similar in magnitude to the significant OS improvement from the FLEX trial ( cisplat/vinorelb±C ) . A secondary objective of the BMS099 study was to assess the effect of C on Lung Cancer Symptoms ( LCS ) . METHODS Chemonaïve patients ( pts ) with stage IIIB/IV NSCLC ( any histology or EGFR expression status ) were r and omized to TC±C.  LCS were measured using the functional assessment of cancer treatment-lung cancer subscale question naire ( FACT-LCS ) , given at baseline and before each therapy cycle until disease progression ( scoring 7 symptoms : breath loss , weight loss , clear thinking , coughing , appetite , chest tightness , breath ease , on a 0 - 4 scale ) . The main endpoints were rates of symptom response/progression ( ≥ 2 point improvement/decrease from baseline in 2 consecutive assessment s ) , compared between arms with a stratified Cochran-Mantel-Haenszel ( CMH ) test ; a stratified log-rank test was used to compare time to symptomatic progression . A Wei-Lachin test was used to compare between arms the changes from baseline in LCS score , and a longitudinal model was constructed to measure treatment effect on those score changes . RESULTS With 676 patients r and omized , the baseline compliance rates for the FACT-LCS question naire were 99.4 % and 99.1 % for CTC and TC respectively , decreasing by week 18 to 74.0 % and 66.4 % . Baseline FACT-LCS scores were similar across treatment arms ( median , 19.0 ) . Symptom response rates were similar with CTC vs TC ( 32.6 % vs 28.5 % , CMH P=0.26 ) , and time to symptomatic progression was not significantly different ( log-rank P=0.58 ) . Changes from baseline in FACT-LCS scores did not differ significantly between arms ( Wei Lachin P=0.912 ; longitudinal model P=0.81 ) . CONCLUSIONS The addition of C to TC for the 1st treatment of advanced NSCLC result ed in similar symptom response/progression rates and did not affect trends in LCS score changes throughout treatment . [ Table : see text ] PURPOSE Epidermal growth factor receptor ( EGFR ) gene copy number detected by fluorescent in situ hybridization ( FISH ) has proven to be useful for selection of non-small-cell lung cancer ( NSCLC ) patients for treatment with EGFR tyrosine kinase inhibitors .  Here , we evaluate EGFR FISH as a predictive marker in NSCLC patients receiving the EGFR monoclonal antibody inhibitor cetuximab plus chemotherapy .  PATIENTS AND METHODS Two hundred twenty-nine chemotherapy-naive patients with advanced-stage NSCLC were enrolled onto a phase II selection trial evaluating sequential or concurrent chemotherapy ( paclitaxel plus carboplatin ) with cetuximab . RESULTS EGFR FISH was assessable in 76 patients with available tumor tissue and classified as positive ( four or more gene copies per cell in > /= 40 % of the cells or gene amplification ) in 59.2 % . Response ( complete response/partial response ) was numerically higher in FISH-positive ( 45 % ) versus FISH-negative ( 26 % ) patients ( P = .14 ) , whereas disease control rate ( complete response/partial response plus stable disease ) was statistically superior ( 81 % v 55 % , respectively ; P = .02 ) . Patients with FISH-positive tumors had a median progression-free survival time of 6 months compared with 3 months for FISH-negative patients ( P = .0008 ) . Median survival time was 15 months for the FISH-positive group compared with 7 months for patients who were FISH negative . ( P = .04 ) . Furthermore , survival favored FISH-positive patients receiving concurrent therapy . CONCLUSION These results are the first to suggest that EGFR FISH is a predictive factor for selection of NSCLC patients for cetuximab plus chemotherapy . Prospect i ve validation of these findings is warranted PURPOSE Epidermal growth factor receptor ( EGFR ) tyrosine kinase inhibitors have demonstrated antitumor activity in patients with non-small-cell lung cancer ( NSCLC ) . This study examined the safety profile of the monoclonal antibody EGFR inhibitor , cetuximab , when added to paclitaxel and carboplatin in untreated patients with stage IV NSCLC . Secondary objectives included efficacy and paclitaxel and carboplatin pharmacokinetics during cetuximab treatment . PATIENTS AND METHODS Patients with tumor evidence of EGFR by immunohistochemistry , performance status of 0 to 2 , and measurable disease received paclitaxel 225 mg/m2 with carboplatin area under the curve = 6 on day 1 every 3 weeks . Cetuximab was administered at 400 mg/m2 , 1 week before paclitaxel and carboplatin , then weekly at 250 mg/m2 . The regimen continued until disease progression or intolerable toxicity . RESULTS Thirty-one of 32 enrolled patients were treated . The most common cetuximab toxicity was rash in 84 % of patients ( grade 3 in 13 % ) . Pharmacokinetic sampling did not reveal an interaction between carboplatin , paclitaxel , and cetuximab . An objective response was observed in eight patients ( 26 % ) . With a median follow-up of 19 months , the median time to progression was 5 months , median survival was 11 months , and the 1- and 2-year survival rates were 40 % and 16 % , respectively . CONCLUSION The combination of cetuximab , paclitaxel , and carboplatin was safe and well tolerated in this population of stage IV patients .  The response rate , time to progression , and median survival were slightly superior to historical controls treated with paclitaxel and carboplatin alone . A r and omized phase II trial has completed accrual BACKGROUND Use of cetuximab , a monoclonal antibody targeting the epidermal growth factor receptor ( EGFR ) , has the potential to increase survival in patients with advanced non-small-cell lung cancer . We therefore compared chemotherapy plus cetuximab with chemotherapy alone in patients with advanced EGFR-positive non-small-cell lung cancer . METHODS In a multinational , multicentre , open-label , phase III trial , chemotherapy-naive patients ( > or=18 years ) with advanced EGFR-expressing histologically or cytologically proven stage wet IIIB or stage IV non-small-cell lung cancer were r and omly assigned in a 1:1 ratio to chemotherapy plus cetuximab or just chemotherapy . Chemotherapy was cisplatin 80 mg/m(2 ) intravenous infusion on day 1 , and vinorelbine 25 mg/m(2 ) intravenous infusion on days 1 and 8 of every 3-week cycle ) for up to six cycles . Cetuximab-at a starting dose of 400 mg/m(2 ) intravenous infusion over 2 h on day 1 , and from day 8 onwards at 250 mg/m(2 ) over 1 h per week-was continued after the end of chemotherapy until disease progression or unacceptable toxicity had occurred . The primary endpoint was overall survival . Analysis was by intention to treat . This study is registered with Clinical Trials.gov , number NCT00148798 . FINDINGS Between October , 2004 , and January , 2006 , 1125 patients were r and omly assigned to chemotherapy plus cet 
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Our data showed that the addition of cetuximab to chemotherapy would improve overall survival and overall response rate .
It may provide new option for clinical treatment for untreated advanced non-small-cell lung cancer .
The side effects of E-chemo are predictable and manageable