Efficacy and safety of icotinib as first-line therapy in patients with advanced non-small-cell lung cancer

Abstract

Background and objectiveSeveral clinical trials have proven that icotinib hydrochloride, a novel epidermal growth factor receptor (EGFR)–tyrosine kinase inhibitor, exhibits encouraging efficacy and tolerability in patients with advanced non-small-cell lung cancer (NSCLC) who failed previous chemotherapy. This study was performed to assess the efficacy and toxicity of icotinib as first-line therapy for patients with advanced pulmonary adenocarcinoma with EGFR-sensitive mutation.Patients and methodsThirty-five patients with advanced NSCLC with EGFR-sensitive mutation who were sequentially admitted to the First Affiliated Hospital of Xi’an Jiaotong University from March 2012 to March 2014 were enrolled into our retrospective research. All patients were administered icotinib as first-line treatment. The tumor responses were evaluated using Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1).ResultsAmong the 35 patients, the tumor objective response rate (ORR) and disease control rate were 62.9% (22/35) and 88.6% (31/35), respectively. The median progression-free survival was 11.0 months (95% confidence interval [CI]: 10.2–11.8 months), and median overall survival was 21.0 months (95% CI: 20.1–21.9 months). The most common drug-related toxicities were rashes (eleven patients) and diarrhea (nine patients), but these were generally manageable and reversible.ConclusionIcotinib monotherapy is effective and tolerable as first-line treatment for patients with advanced lung adenocarcinoma with EGFR-sensitive mutation.

WITHDRAWN: EGFR exon 19 deletion is associated with favorable overall survival after first-line icotinib therapy in advanced non-small cell lung cancer patients: a retrospective, multiple-center, real-world study

“…In the IPASS [4], OPTIMAL [11], WJTOG34O5 [6], NEJ002 [12], and EURAC [13] clinical studies, gefitinib or erlotinib yielded a prolonged median PFS compared with chemotherapy (9.2-13.1 months versus 4.6-6.3 months) and an increased response rate (64%-82% versus 30.7-47.3%) compared with chemotherapy for patients with sensitive EGFR mutations. Meanwhile, the efficacy of icotinib in this study is similar to previous retrospective studies, which showed an ORR of 48.6%-66.7%, a DCR of 94.4-95.6%, a median PFS of 11.0-14.9 months, and a median OS of 21.0-37.0 months [14,15].…”

Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors for Central Nervous System Metastases from Non-Small Cell Lung Cancer

“…Icotinib is a novel EGFR‐TKI approved for the second‐ or third‐line treatment of advanced NSCLC by the State Food and Drug Administration of the People's Republic of China . Preclinical data on the ability of icotinib to cross the BBB are lacking; however, CSF penetration in patients with brain metastases from NSCLC has been reported as 1.2%–9.7% across three different dose levels (125–500 mg), with a significant correlation between icotinib concentration in the CSF and plasma .…”

Survival difference between EGFR Del19 and L858R mutant advanced non-small cell lung cancer patients receiving gefitinib: a propensity score matching analysis

“…Many retrospective and prospective studies, as well as meta-analyses, that have studied NSCLC patients with various lines of EGFR-TKI treatment have demonstrated longer progression-free survival (PFS) and occasionally more favorable overall survival (OS) in those with Del19 than in those with the L858R or other mutations (6)(7)(8). In contrast, other clinical studies, including phase III trials, have demonstrated no difference in the efficacy of EGFR-TKI treatment according to the EGFR mutation type (9)(10)(11)(12). Therefore, whether there are differences in survival between patients with these common EGFR mutations remains controversial.…”