Alvopem® (pemetrexed) safety assessment in patients with non-small cell lung cancer or malignant pleural mesothelioma: a post-marketing surveillance

Sharareh Seifi; Babak Salimi; Zahra Esfahani Monfared; Cyrus Sabahi; Hamidreza Kafi; Adnan Khosravi

doi:10.1186/s40545-023-00524-5

Alvopem^® (pemetrexed) safety assessment in patients with non-small cell lung cancer or malignant pleural mesothelioma: a post-marketing surveillance

J Pharm Policy Pract. 2023 Jan 25;16(1):16. doi: 10.1186/s40545-023-00524-5.

Authors

Sharareh Seifi¹, Babak Salimi^{1

2}, Zahra Esfahani Monfared¹, Cyrus Sabahi³, Hamidreza Kafi⁴, Adnan Khosravi^{5

6}

Affiliations

¹ Chronic Respiratory Disease Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
² Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar Roundabout, Tehran, 1956944413, Iran.
³ Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
⁴ Medical Department, Orchid Pharmed Company, No 12, 70th Alley, Seyed Jamaledin Asad Abadi St., Yousef Abad, Tehran, Iran.
⁵ Chronic Respiratory Disease Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran. khosravi.adnan1400@gmail.com.
⁶ Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar Roundabout, Tehran, 1956944413, Iran. khosravi.adnan1400@gmail.com.

Abstract

Background: Lung cancer is the leading cause of cancer deaths worldwide in both men and women, and non-small cell lung cancer (NSCLC) accounts for the majority (~ 85%) of lung cancers. This post-marketing surveillance (PMS) study aimed to evaluate the safety of Pemetrexed (Alvopem^®, NanoAlvand, Iran) in Iranian patients with lung cancer or mesothelioma.

Methods: The present study is an observational, single-center, open-label, and post-authorization study. All eligible non-squamous NSCLC and malignant pleural mesothelioma (MPM) patients who received pemetrexed based on the physicians' decision, were enrolled.

Results: A total of 199 patients with non-squamous NSCLC [186 patients (93.47%) or MPM (12 patients (6.03%)] were enrolled from March 2016 to February 2020. The most common reported adverse event (AE) was anemia (89.39%), followed by neutropenia (28.79%) and leukopenia (24.75%). The most important grade 3 AEs were anemia and neutropenia, with the incidence rate of 3.54% and 7.58%, respectively. No grade 4 AEs were reported. Moreover, the results of our study showed negative statistically significant correlations between patients' age and mean neutrophil count (r = - 0.17; P = 0.0156) and hemoglobin (r = - 0.16; P = 0.0201) in all six visits.

Conclusions: The results of this open-label, observational PMS showed that Pemetrexed (Alvopem^®) is safe in patients with non-squamous NSCLC patients receiving pemetrexed-containing regimens.

Trial registration: The trial was registered at ClinicalTrials.gov (NCT04843007) in April 13th, 2021.

Keywords: Non-small cell lung cancer; Observational study; Pemetrexed; Post-marketing surveillance; Safety.

Associated data

ClinicalTrials.gov/NCT04843007