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Background  The objective of the study was to observe the efficacy and safety of pulsatile administration of high‐dose gefitinib or erlotinib in patients with advanced non‐small cell lung cancer ( NSCLC ) with secondary drug resistance to standard doses of tyrosine kinase inhibitor ( TKI)  treatment.    Materials and methods  We recruited 42  NSCLC  patients from our hospital, between  A ugust 2014 and  D ecember 2015, who had experienced drug resistance after one year of conventional treatment with gefitinib or erlotinib. The gefitinib group (29 patients) received one dose of 1000 mg gefitinib every four days. The erlotinib group (13 patients) received one dose of 450 mg erlotinib every three days. Treatments continued until disease progression according to  R esponse  E valuation  C riteria  I n  S olid  T umors 1.1 or development of intolerable toxicity.    Results  Median progression‐free survival ( PFS ) was 30 months (gefitinib vs. erlotinib: 31 vs. 24 months;  P  > 0.05). After high‐dose pulsatile administration, eight patients achieved a partial response ( PR ), 11 had stable disease ( SD ), and 23 had progressive disease ( PD ; relative risk 19.0%; disease control rate 45.2%; median  PFS  six months). Patients were categorized based on epidermal growth factor receptor gene mutation: exon 19 (no patients achieved complete response [ CR] , 4  PR , 6  SD , and 17  PD ) and exon 21 mutation groups (no patients achieved  CR , 4  PR , 5  SD , and 6  PD ).    Conclusion  High‐dose  TKI  pulsatile treatment is safe, efficient, and can improve prognoses for certain patients with advanced  NSCLC .

thoracic cancer

Study of efficacy and safety of pulsatile administration of high‐dose gefitinib or erlotinib for advanced non‐small cell lung cancer patients with secondary drug resistance:  A  single center, single arm, phase  II  clinical trial