***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: Background : Erlotinib ( Tarceva , OSI Pharmaceuticals , Melville , NY ) is an oral , epidermal growth factor receptor tyrosine kinase inhibitor that has antitumor activity and good tolerability in non-small cell lung cancer ( NSCLC ) . In particular , higher response rates have been reported in Asian patients than in Western patients . The aim of this study conducted by the Korean Cancer Study Group was to evaluate the efficacy and tolerability of erlotinib monotherapy as a palliative treatment for advanced NSCLC patients in Korea . Patients and Methods : Patients with histologically or cytologically confirmed stage IIIB or IV NSCLC including recurrent or metastatic disease , with performance status from 0 to 3 , were eligible either if they had received any anticancer treatment except epidermal growth factor receptor inhibitors or if they were unsuitable for chemotherapy because of poor performance status . Enrolled patients were treated with oral erlotinib at a dose of 150 mg daily until disease progression or development of intolerable toxicity . Results : A total of 120 patients were enrolled between January 2005 and May 2006 . Forty-four patients ( 36.7 % ) were female and 72 patients were current or former smoker . Fifty percent of patients had received one prior palliative chemotherapy regimens and 34.2 % had two or more prior palliative regimens . The overall tumor response rate was 24.2 % ( 95 % confidence interval [ CI ] , 16.8–32.8 % ) with 4 complete responses and 25 partial responses , and the disease control rate was 56.7 % . The favorable clinical variables for tumor response were female ( P = 0.001 ) , never smokers ( P = 0.041 ) , and adenocarcinoma ( P = 0.001 ) . The most common adverse event was skin rash ( 78 % of which grade 3 or 4 skin rash occurred in 13.3 % of the patients ) . With a median follow-up of 23.6 months , the median time to progression was 2.7 months ( 95 % CI , 2.2–3.2 ) , and the median overall survival was 12.9 months ( 95 % CI , 6.9–18.8 ) . By multivariate analysis , female and development of skin rash were significantly associated with longer time to progression and overall survival . Conclusion : Erlotinib monotherapy showed significant antitumor activity and an acceptable tolerability profile as a palliative treatment in advanced NSCLC patients in Korea , especially in females , never smokers , and patients with adenocarcinoma histology Purpose : The ISTANA ( IRESSA as Second-line Therapy in Advanced NSCLC — KoreA ) study compared gefitinib with docetaxel in patients with advanced or metastatic non – small cell lung carcinoma ( NSCLC ) pretreated with platinum-based chemotherapy . Experimental Design : We conducted a multicenter , r and omized , open-label phase III trial of gefitinib ( 250 mg/d ) versus docetaxel ( 75 mg/m2 day 1 every 3 weeks ) in patients with advanced or metastatic NSCLC treated with one previous platinum-based chemotherapy . The primary endpoint was progression-free survival . Results : A total of 161 patients ( male , 62 % ; never smoker , 41 % ; adenocarcinoma , 68 % ) were enrolled .  Progression-free survival was longer for gefitinib compared with docetaxel ( hazard ratio , 0.729 ; 90 % confidence interval , 0.533 - 0.998 ; one-sided P = 0.0441 ) . Gefitinib significantly improved objective response rate ( 28.1 % versus 7.6 % ; two-sided P = 0.0007 ) . In the final analysis of overall survival , the hazard ratio was 0.870 ( 95 % confidence interval , 0.613 - 1.236 ; two-sided P = 0.4370 ) . No significant differences were seen in the quality of life or symptom improvement rates between the two treatment groups . Gefitinib was well tolerated , was consistent with previous data and disease , and had fewer serious adverse events and fewer Common Terminology Criteria for Adverse Events grade 3 or 4 adverse events than docetaxel . The incidence of interstitial lung disease – type events was 3.7 % ( n = 3 ) with gefitinib and 3.9 % ( n = 3 ) with docetaxel . Conclusions : The primary endpoint of progression-free survival was longer with gefitinib than docetaxel , and the secondary endpoints showed superior objective response rate , good tolerability , and similar quality of life improvement rates for gefitinib than docetaxel . Therefore , gefitinib is an important valid treatment option for second-line therapy for Korean NSCLC patients . Clin Cancer Res ; 16(4 ) ; PURPOSE To confirm the promising phase II results of docetaxel monotherapy , this phase III trial was conducted of chemotherapy for patients with advanced non-small-cell lung cancer ( NSCLC ) who had previously failed platinum-containing chemotherapy . PATIENTS AND METHODS A total of 373 patients were r and omized to receive either docetaxel 100 mg/m(2 ) ( D100 ) or 75 mg/m(2 ) ( D75 ) versus a control regimen of vinorelbine or ifosfamide ( V/I ) . The three treatment groups were well-balanced for key patient characteristics . RESULTS Overall response rates were 10.8 % with D100 and 6.7 % with D75 , each significantly higher than the 0.8 % response with V/I ( P = .001 and P = .036 , respectively ) . Patients who received docetaxel had a longer time to progression ( P = .046 , by log-rank test ) and a greater progression-free survival at 26 weeks ( P = .005 , by chi(2 ) test ) . Although overall survival was not significantly different between the three groups , the 1-year survival was significantly greater with D75 than with the control treatment ( 32 % v 19 % ; P = .025 , by chi(2 ) test ) . Prior exposure to paclitaxel did not decrease the likelihood of response to docetaxel , nor did it impact survival . There was a trend toward greater efficacy in patients whose disease was platinum-resistant rather than platinum-refractory and in patients with performance status of 0 or 1 versus 2 . Toxicity was greatest with D100 , but the D75 arm was well-tolerated . CONCLUSION This first r and omized trial in this setting demonstrates that D75 every 3 weeks can offer clinical ly meaningful benefit to patients with advanced NSCLC whose disease has relapsed or progressed after platinum-based chemotherapy PURPOSE To evaluate whether treatment with single-agent docetaxel would result in longer survival than would best supportive care in patients with non-small-cell lung cancer who had previously been treated with platinum-based chemotherapy .  Secondary end points included assessment of response ( docetaxel arm only ) , toxicity , and quality of life . PATIENTS AND METHODS Patients with performance statuses of 0 to 2 and stage IIIB/IV non-small-cell lung cancer with either measurable or evaluable lesions were eligible for entry onto the study if they had undergone one or more platinum-based chemotherapy regimens and if they had adequate hematology and biochemistry parameters . They were excluded if they had symptomatic brain metastases or if they had previously been treated with paclitaxel .  Patients were stratified by performance status and best response to cisplatin chemotherapy and were then r and omized to treatment with docetaxel 100 mg/m(2 ) ( 49 patients ) or 75 mg/m(2 ) ( 55 patients ) or best supportive care . Patients in both arms were assessed every 3 weeks . RESULTS One hundred four patients ( 103 of whom were eligible for entry onto the study ) were well balanced for prognostic factors . Of 84 patients with measurable lesions , six ( 7 . 1 % ) achieved partial responses ( three patients at each dose level ) . Time to progression was longer for docetaxel patients than for best supportive care patients ( 10.6 v 6.7 weeks , respectively ; P < .001 ) , as was median survival ( 7.0 v 4.6 months ; log-rank test , P = .047 ) . The difference was more significant for docetaxel 75 mg/m(2 ) patients , compared with corresponding best supportive care patients ( 7.5 v 4.6 months ; log-rank test , P = .010 ; 1-year survival , 37 % v 11 % ; chi(2 ) test , P = .003 ) . Febrile neutropenia occurred in 11 patients treated with docetaxel 100 mg/m(2 ) , three of whom died , and in one patient treated with docetaxel 75 mg/m(2 ) . Grade 3 or 4 nonhematologic toxicity , with the exception of diarrhea , occurred at a similar rate in both the docetaxel and best supportive care groups . CONCLUSION Treatment with docetaxel is associated with significant prolongation of survival , and at a dose of 75 mg/m(2 ) , the benefits of docetaxel therapy outweigh the risks Our objective was to evaluate gefitinib ( IRESSA ) , an epidermal growth factor receptor tyrosine kinase inhibitor , versus docetaxel as second-line monotherapy for advanced non-small-cell lung cancer ( NSCLC ) . SIGN ( Second-line Indication of Gefitinib in NSCLC ; code 1839IL/0503 ) was a multicenter , r and omized , parallel-group , open-label , phase II trial that investigated oral gefitinib ( 250 mg/day ) or i.v . docetaxel ( 75 mg/m2 every 3 weeks ) in patients with advanced NSCLC who had previously received one chemotherapy regimen . The primary objective was assessment of symptom improvement ( using the FACT-L Lung Cancer Subscale ) . Secondary objectives included quality of life ( FACT-L total score ) , response rate ( using RECIST ) , overall survival and safety . This trial recruited 141 patients ( 68 to gefitinib and 73 to docetaxel ) who received treatment for a median duration of 3.0 ( gefitinib ) and 2.8 ( docetaxel ) months . Similar efficacy was observed with gefitinib and docetaxel , 36.8 and 26.0 % symptom improvement rates , 33.8 and 26.0 % quality -of-life improvement rates , 13.2 and 13.7 % objective response rates , and 7.5 and 7.1 months median overall survival , respectively . Fewer drug-related adverse events were observed with gefitinib compared with docetaxel ( all grade s : 51.5 versus 78.9 % ; Common Toxicity Criteria grade 3/4 : 8.8 versus 25.4 % ) . There were no withdrawals or deaths due to drug-related adverse events with gefitinib , while three patients withdrew and three died due to adverse events in the docetaxel group that were possibly drug related . We conclude efficacy with gefitinib was similar to docetaxel , but with a more favorable tolerability profile , in the second-line treatment of advanced NSCLC . These results support further investigation of gefitinib in this disease setting BACKGROUND Erlotinib , docetaxel , and pemetrexed are approved for the second-line treatment of non-small-cell lung cancer ( NSCLC ) , but no head-to-head data from large clinical trials are available . We undertook the Tarceva In Treatment of Advanced NSCLC ( TITAN ) study to assess the efficacy and tolerability of second-line erlotinib versus chemotherapy in patients with refractory NSCLC . METHODS TITAN was an international , r and omised multicentre , open-label , phase 3 study that was done at 77 sites in 24 countries . Chemotherapy-naive patients with locally advanced , recurrent , or metastatic NSCLC received up to four cycles of first-line platinum doublet chemotherapy , after which patients with disease progression during or immediately after chemotherapy were offered enrolment into TITAN . Enrolled patients were r and omly assigned ( 1:1 ) by a minimisation method to ensure balanced stratification , to receive erlotinib 150 mg/day or chemotherapy ( st and ard docetaxel or pemetrexed regimens , at the treating investigators ' discretion ) , until unacceptable toxicity , disease progression , or death . Patients were stratified by disease stage , Eastern Cooperative Oncology Group performance status , smoking history , and region of residence . The primary endpoint was overall survival in the intention-to-treat population . TITAN was halted prematurely because of slow recruitment . This study is registered with Clinical Trials.gov , number NCT00556322 . FINDINGS Between April 10 , 2006 , and Feb 24 , 2010 , 2590 chemotherapy-naive patients were treated with first-line platinum doublet chemotherapy , of whom 424 had disease progression and were enrolled into TITAN . 203 patients were r and omly assigned to receive erlotinib and 221 were assigned to receive chemotherapy .  Median follow-up was 27·9 months ( IQR 11·0 - 36·0 ) in the erlotinib group and 24·8 months ( 12·1 - 41·6 ) in the 
    Output:
    
Both interventions had comparable efficacy as second-line treatments for patients with advanced NSCLC , and EGFR-TKI monotherapy was associated with less toxicity and better tolerability .
Moreover , our data also demonstrated that EGFR- TKI monotherapy tended to be more effective in East Asian patients in terms of PFS and ORR compared with st and ard second-line chemotherapy .