Open AccessStudy 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
Author(s) -
Zhu Yanzhe,
Du Yingying,
Liu Hu,
Ma Tai,
Shen Yuanyuan,
Pan Yueyin
Publication year - 2016
Publication title -
thoracic cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.823
H-Index - 28
eISSN - 1759-7714
pISSN - 1759-7706
DOI - 10.1111/1759-7714.12384
Subject(s) - medicine , erlotinib , gefitinib , single center , oncology , lung cancer , pulsatile flow , pharmacology , drug , cancer , epidermal growth factor receptor
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 .