Jian’an Huang¹, Yong Gao²,Jianying Zhou³, Zhiyong Ma⁴, Xinhua XU⁵, KunTian⁶ Yanbin Zhou⁷, Lu Li⁸,Rui Ma⁹, Ping Yv¹⁰, Luandi Yao¹¹, Chao Zhu¹¹

¹Suzhou the First Affiliated Hospital ofSoochow University Department of Respiratory. ²Shanghai Shanghai East Hospital Departmentof Oncology. ³Lung Disease Center First Affiliated Hospital of Zhejiang University, Department of Respiratory. ⁴Ward 2 Henan Cancer HospitalDepartment ofRespiratory. ⁵Department of Oncolo Central Hospital ofYichang Citythe First Clinical Medical College of Three Gorges University. ⁶Chengdu General Hospital of Chengdu MilitaryRegion of PLA Department of Respiratory Internal Medicine. ⁷Guangzhou the First Affiliated Hospital ofSun Yat-sen University Department of Respiratory. ⁸Department of Thorac West China Hospital Sichuan University.⁹Shenyang Liaoning Cancer Hospital &Institute Department of Medical Oncology.¹⁰chengdu Cancer Hospital of Sichuan Province Departmentof Pulmonary Oncology. ¹¹Shanghai Lilly China Drug Development andMedical Affairs Center Department of medicine.

Objective：Superiorefficacyof pemetrexed with favorable tolerability has been demonstrated in both of the2nd-line and the maintenance setting for patients with non-squamousnon-smallcell lung cancer (NSCLC) in global studies. This prospective observationalstudy aimed to evaluate safety and effective ness of pemetrexed as 2nd-line ormaintenance monotherapy for Chinese patients with advancednon-squamous NSCLC inroutine clinical practice, with a primary objective toestimate the proportionof treatment-emergent adverse events (TEAEs) experienced at least once and the frequencyof seriousadverse events (SAEs). Method：Chinesepatients with unresectable locally advanced or metastatic non-squamous NSCLC treatedwith pemetrexed as 2nd-line or maintenance monotherapy in routineclinicalpractice were enrolled separately in two cohorts. Pemetrexed was administered onday 1 of a 21-day cycle via 500mg/m² intravenous infusion with premedicationof folic acid, vitamin B12, and dexamethasone until diseaseprogression, intolerabletoxicity, death or discontinuation due to otherreasons. Safety profile wasanalyzed in all patients who received at least 1 dose of pemetrexed includingsummarized counts of adverse events (AEs) by Common Terminology Criteria forAdverse Events (CTCAE) version 4.0 and the relationship to study drug. Results：Atotal of 70 patients enrolled from July 2012 to July 2013 were included insafety population (30 in the 2nd-line therapy cohort and 40 in the maintenancetherapy cohort). For the safety results, TEAEs (all grades) possibly drug-relatedwith the incidence rate≥5.0% in the 2nd-line therapy cohort included fatigue (30.0%),alanine eaminotransferase elevation (16.7%), and aspartate aminotransferaseelevation(16.7%). While those in the maintenance therapy cohort includedfatigue (5.0%) and decreased appetite (5.0%). Only one case of dyspnea reportedin the maintenance therapy cohort was Grade 3, other possibly drug-relatedTEAEs were either Grade 1 or 2. Among 3 cases of SAEs reported, 1 (2.5%) caseof grade 3 dyspnea and 1 (2.5%) case of grade 2 hypotension which occurredsimultaneously in a patient receiving maintenance monotherapy were consideredto be possibly drug-related. Only 1 (3.3%) case of possibly drug-relateddiscontinuation was reported, which was due to Grade 1 fatigue in the 2nd-linetherapy cohort. No drug-related death was reported. In the tumor-responsequalified (TRQ) population, the overall response rate (ORR) was 9.5% and 4.0%in the 2nd-line and maintenance therapy cohort respectively, while the diseasecontrol rate (DCR) was 52.4% and 60.0% in the two cohorts respectively. Thepreliminary median progression-free survival (PFS) in the second-line therapycohort was 4.30 months, while in the maintenance therapy cohort was 3.25 months.Conclusion：Thisinterim analysis demonstrated that in real-world pemetrexed monotherapy forChinese patients with advancednon-squamous NSCLC was well tolerated, and theeffectiveness profile accorded with previous studies. This observational studyis still on going, and more datawill be disclosed in future.

Keywords：non-squamous non-smallcell lung cancer (NSCLC)