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

Khosravi, Adnan; Salimi, Babak; Esfahani-Monfared, Zahra; Seifi, Sharareh; Mirtavoos-Mahyari, Hanifeh

doi:10.22034/APJCP.2018.19.10.2973

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

Document Type : Research Articles

Authors

¹ Tobacco Prevention and Control Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.

² Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.

10.22034/APJCP.2018.19.10.2973

Abstract

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.

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