Document Type: Research Articles
Tobacco Prevention and Control Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Background: This study performed to assess the efficacy and safety of Formeta (generic form of Pemetrexed) plus
Carboplatin as first-line chemotherapy in advanced stage, non- squamous, non small cell lung cancer ( NSCLC) in Iran.
Methods: This was a post marketing single-arm phase IV efficacy study of Formeta (manufactured by Oncomed.,Czech
Republic ) and Carboplatin in chemo-naive advanced non-squamous NSCLC Iranian patients. Patients received up to six
cycles of Formeta (500 mg/m2) combined with Carboplatin (area under the curve: AUC 5) every 3 weeks. The primary
endpoint was the progression free survival (PFS) and secondary endpoints were safety and overall survival (OS).
Results: Fifty-two patients were enrolled between June 2014 to January 2016, and 44 patients were evaluable for both
safety and efficacy. Partial and complete responses were achieved in 19 (36.5 %) and 2 (3.8%) patients, respectively
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,
respectively. Anemia was the most prevalent adverse events of this regimen. Grades 3 or 4 of adverse events were not
observed in any patients. Non-hematologic and other grades of hematologic toxicities were generally mild, and there
were no treatment-related deaths. Conclusion: The combination of Formeta and Carboplatin was effective in advanced
non-squamous NSCLC and can be a suitable candidate as first-line treatment in these patient’s population.