A Phase IV Efficacy Study of Formeta Plus Carboplatin as First-Line Treatment of Advanced Non-Squamous, Non-Small Cell Lung Cancer in Iran: An Affordable Price with Clinical Benefit

Abstract

Background: This study performed to assess the efficacy and safety of Formeta (generic form of Pemetrexed) plus<br />Carboplatin as first-line chemotherapy in advanced stage, non- squamous, non small cell lung cancer ( NSCLC) in Iran.<br />Methods: This was a post marketing single-arm phase IV efficacy study of Formeta (manufactured by Oncomed.,Czech<br />Republic ) and Carboplatin in chemo-naive advanced non-squamous NSCLC Iranian patients. Patients received up to six<br />cycles of Formeta (500 mg/m2) combined with Carboplatin (area under the curve: AUC 5) every 3 weeks. The primary<br />endpoint was the progression free survival (PFS) and secondary endpoints were safety and overall survival (OS).<br />Results: Fifty-two patients were enrolled between June 2014 to January 2016, and 44 patients were evaluable for both<br />safety and efficacy. Partial and complete responses were achieved in 19 (36.5 %) and 2 (3.8%) patients, respectively<br />as well as stable disease in 8 patients (15.3 %). Median of PFS and OS were 7.9 ± 1.1 months and 12.43±0.6 months,<br />respectively. Anemia was the most prevalent adverse events of this regimen. Grades 3 or 4 of adverse events were not<br />observed in any patients. Non-hematologic and other grades of hematologic toxicities were generally mild, and there<br />were no treatment-related deaths. Conclusion: The combination of Formeta and Carboplatin was effective in advanced<br />non-squamous NSCLC and can be a suitable candidate as first-line treatment in these patient's population.