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

Our plain-English summary of Alvopem® (pemetrexed) safety assessment in patients with non-small cell lung cancer or malignant pleural mesothelioma: a post-marketing surveillance, by S. Seifi, B. Salimi, Z.E. Monfared, et al (Journal of Pharmaceutical Policy and Practice, 2023).

The study

• Authors: S. Seifi, B. Salimi, Z.E. Monfared, C. Sabahi, H. Kafi, A. Khosravi
• Journal: Journal of Pharmaceutical Policy and Practice
• Published: 2023;16(1):16
• Cited by: 2 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

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.

© 2023. The Author(s).

In plain English

This study checked the safety of Alvopem, a generic Iranian version of the cancer drug pemetrexed, after marketing. It did not study asbestos exposure. At one Tehran lung disease centre, 199 patients were enrolled from March 2016 to February 2020. Of 198 analyzed, 186 had non-squamous non-small cell lung cancer and 12 malignant pleural mesothelioma. Patients received an average of 4.6 cycles of pemetrexed with carboplatin. The most commonly reported adverse event (recorded during treatment, not necessarily drug-caused) was anemia, in 178 of 198 patients (printed as 89.99%), followed by neutropenia (29.29%) and leukopenia (24.75%). Grade 3 or 4 anemia occurred in 7.58% and grade 3 or 4 neutropenia in 3.54%. No grade 4 adverse events were reported. Seventy patients (35.35%) had at least one serious adverse event. Older age had a weak but statistically significant link with lower neutrophil counts and hemoglobin. The authors concluded that the drug is safe in patients with non-squamous non-small cell lung cancer receiving pemetrexed-containing regimens. They noted that too few mesothelioma patients were included to generalize to that group, and that there was no control group.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Observational, single-center, open-label post-marketing surveillance study of drug safety, with no control group
• Who was studied: 199 patients with non-squamous non-small cell lung cancer or malignant pleural mesothelioma were enrolled from March 2016 to February 2020 at the National Research Institute of Tuberculosis and Lung Disease, Iran. One patient was excluded because the diagnosis was not recorded. Of the 198 analyzed, 186 had non-small cell lung cancer and 12 had malignant pleural mesothelioma.
• Exposure: Treatment with generic pemetrexed (Alvopem) at 500 mg per square metre of body surface, combined with carboplatin (dose AUC5), for a mean of 4.6 cycles. Asbestos exposure was not studied; asbestos appears only in the background description of mesothelioma.
• Main results:
  • Among the 198 patients analyzed, the most commonly reported adverse events were anemia (178 patients, printed as 89.99%), neutropenia (58, 29.29%) and leukopenia (49, 24.75%). These were adverse events recorded during treatment, not necessarily caused by the drug.
  • The authors assessed whether each of 957 adverse events was related to the drug. 786 (82.13%) were judged possibly related, 141 (14.73%) unlikely related, and 30 (3.13%) could not be assessed.
  • Grade 3 neutropenia occurred in 3.54% of patients and grade 3 anemia in 7.58%. No grade 4 adverse events or interstitial lung disease were reported.
  • 190 of 198 patients (95.96%) had at least one adverse event, and 22 (11.11%) had at least one grade 3 or 4 adverse event.
  • 184 patients (92.93%) had at least one adverse event judged at least possibly related to the drug.
  • 70 of 198 patients (35.35%), reported as 23 men and 47 women, had at least one serious adverse event. 45 serious adverse events (22.73%) were judged at least possibly related to the drug.
  • Across all treatment cycles, older age had a weak but statistically significant negative correlation with mean neutrophil count (r minus 0.17; P = 0.016) and with hemoglobin (r minus 0.16; P = 0.020).
  • The incidence of anemia differed between patients older and younger than 56 (92.48% vs. 83.08%; P = 0.044). The authors interpreted this as a higher incidence in those older than 56.
• The authors' conclusion: The authors concluded that the generic pemetrexed (Alvopem) is safe in patients with non-squamous non-small cell lung cancer receiving pemetrexed-containing regimens. Their conclusion does not extend to the mesothelioma patients.
• Limitations the authors state:
  • Only a small number of malignant pleural mesothelioma patients were included, which makes it difficult to apply the safety results to that group.
  • There was no control group.

Topics

Medical terms in this study, explained in our Lexicon: Pemetrexed (Alimta), Non-Small Cell Lung Cancer, Pleural Mesothelioma, Lung Cancer, Mesothelioma, Neutropenia, Incidence.

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