PMID- 25867537 OWN - NLM STAT- MEDLINE DCOM- 20151201 LR - 20181202 IS - 1473-4877 (Electronic) IS - 0300-7995 (Linking) VI - 31 IP - 6 DP - 2015 Jun TI - Prospective cohort study of clinical characteristics and management patterns for patients with non-small-cell lung cancer in the Russian Federation: EPICLIN-Lung. PG - 1117-27 LID - 10.1185/03007995.2015.1036015 [doi] AB - BACKGROUND: Lung cancer is a major cause of mortality in Russia. This study aimed to document the characteristics, clinical management, EGFR mutation status and outcomes of patients with non-small-cell lung cancer (NSCLC) throughout the Russian Federation to inform future management decisions. METHODS: This non-interventional, prospective cohort study (clinicaltrials.gov NCT01069835) was conducted at 33 sites across the Russian Federation. Patients with confirmed NSCLC were enrolled and followed for up to 12 months or until death. Investigators collected information on patient and disease characteristics, diagnosis and treatment patterns, clinical outcomes and adverse events (AEs). A logistic regression model was used to evaluate characteristics affecting tumor EGFR mutation status. RESULTS: Data were analyzed from 838 patients. Most (78.4%) were male and Caucasian (98%), mean age was 58.7 years and 26.5% were never-smokers. Squamous-cell carcinoma (54.3%) was the most prevalent histology, followed by adenocarcinoma (31%). Most patients presented with advanced disease (23.7% with stage IIIA, 14.1% with stage IIIB, 25.4% with stage IV) and 10.1% of patients had EGFR-mutation-positive tumors. EGFR mutation was significantly associated with female gender, never smoking, age and adenocarcinoma histology. First- or second-line chemotherapy had been performed in 370 and 96 patients, respectively, and median progression-free survival was 35 and 19.4 weeks, respectively. For 813 patients, 194 AEs were reported at visit 1. A median of two AEs was reported for patients who had at least one AE. Study limitations include potential site selection bias, short observation period, small sample size and inclusion of fewer than average stage III-IV patients. CONCLUSIONS: This study contributes to a better understanding of prognostic and predictive factors of NSCLC in the Russian Federation, which will enable optimal treatment selection in future clinical practice. Epidemiology of EGFR mutations in this NSCLC cohort was similar to other studies of NSCLC in Caucasian populations. FAU - Tjulandin, S AU - Tjulandin S AD - Russian Cancer Research Centre, Department of Clinical Pharmacology and Chemotherapy , Moscow , Russian Federation. FAU - Imyanitov, E AU - Imyanitov E FAU - Moiseyenko, V AU - Moiseyenko V FAU - Ponomarenko, D AU - Ponomarenko D FAU - Gurina, L AU - Gurina L FAU - Koroleva, I AU - Koroleva I FAU - Karaseva, V AU - Karaseva V LA - eng SI - ClinicalTrials.gov/NCT01069835 PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20150508 PL - England TA - Curr Med Res Opin JT - Current medical research and opinion JID - 0351014 RN - EC 2.7.10.1 (EGFR protein, human) RN - EC 2.7.10.1 (ErbB Receptors) SB - IM MH - Adenocarcinoma/drug therapy/genetics/pathology MH - Aged MH - Carcinoma, Non-Small-Cell Lung/*drug therapy/genetics/pathology MH - Carcinoma, Squamous Cell/drug therapy/genetics/pathology MH - Cohort Studies MH - Disease-Free Survival MH - ErbB Receptors/*genetics MH - Female MH - Humans MH - Lung Neoplasms/*drug therapy/genetics/pathology MH - Male MH - Middle Aged MH - Mutation MH - Prognosis MH - Prospective Studies MH - Russia OTO - NOTNLM OT - Disease management OT - EGFR mutation OT - NSCLC OT - Russian Federation OT - Therapeutic interventions OT - Treatment outcomes EDAT- 2015/04/14 06:00 MHDA- 2015/12/15 06:00 CRDT- 2015/04/14 06:00 PHST- 2015/04/14 06:00 [entrez] PHST- 2015/04/14 06:00 [pubmed] PHST- 2015/12/15 06:00 [medline] AID - 10.1185/03007995.2015.1036015 [doi] PST - ppublish SO - Curr Med Res Opin. 2015 Jun;31(6):1117-27. doi: 10.1185/03007995.2015.1036015. Epub 2015 May 8.