Malignant Pleural Mesothelioma, Non Small Cell Lung Cancer
Conditions
Keywords
NSCLC; Observational study; pemetrexed; PMS; Safety
Brief summary
The present study was a phase IV, post-marketing, observational study for safety evaluation of Alvopem® use in Iranian patients with non-small cell lung cancer and malignant pleural mesothelioma. No control groups were included in the study design. The primary objective of this study was safety assessment, including the incidence of adverse events (AEs).
Detailed description
The present study was a phase IV, post-marketing, observational study for safety evaluation of Alvopem® use in Iranian patients with non-small cell lung cancer and malignant pleural mesothelioma. Data was gathered in one booklet, which had 6 different periods. The patients' information assessed after each injection, every 3 weeks. These booklets were completed by designated physicians. The primary objective of this study was safety assessment, including the incidence and intensity of AEs and serious adverse events (SAEs). This study was single arm and the sample size of this study was 199 patients.
Interventions
DRUGPemetrexed
Alvopem® was administered every 3 weeks with a dose of 500 mg/m\^2
Sponsors
NanoAlvand
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients diagnosed with non-small cell lung cancer and malignant pleural mesothelioma under chemotherapy regimens with Alvopem® were enrolled in the study.
Exclusion criteria
There were no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment Including Treatment-related Adverse Events (Number of Participants Who Experienced at Least One Adverse Event (AE) or One Serious Adverse Event (SAE)) | This outcome was assessed throughout the study, up to 18 weeks (6 chemotherapy cycles). The duration of treatment was at the physicians' discretion based on the patient's condition | In this study, number of participants who experienced at least one adverse event (AE) or one serious adverse event (SAE) were assessed. The intensity of AEs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and terminology for AEs was chosen according to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term. Also, intensity, seriousness, onset of AEs, and interventions for management of the adverse events were documented in the booklet. For each AE, data was summarized using system organ class and preferred term of AEs and SAEs. Moreover, causality assessment was done based on the World health organization-Uppsala Monitoring Centre (WHO-UMC) system. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NanoAlvand Pemetrexed 500 mg/m\^2 pemetrexed, IV infusion
Pemetrexed: Alvopem® was administered every 3 weeks with a dose of 500 mg/m\^2 | 198 |
| Total | 198 |
Baseline characteristics
| Characteristic | NanoAlvand Pemetrexed |
|---|---|
| Age, Continuous | 61.11 years STANDARD_DEVIATION 11.36 |
| Alanine Aminotransferase (ALT) | 23.99 units/L STANDARD_DEVIATION 17.83 |
| Aspartate Aminotransferase (AST) | 23.78 units/L STANDARD_DEVIATION 21.72 |
| Bilirubin | 0.46 mg/dL STANDARD_DEVIATION 0.3 |
| Blood Urea Nitrogen (BUN) | 31.24 mg/dL STANDARD_DEVIATION 10.34 |
| Body Surface Area (BSA) | 1.75 m^2 STANDARD_DEVIATION 0.21 |
| Diagnosis MPM | 12 Participants |
| Diagnosis NSCLC | 186 Participants |
| Height | 166.44 cm STANDARD_DEVIATION 9.88 |
| Hemoglobin (Hb) | 12.68 g/dL STANDARD_DEVIATION 1.9 |
| Neutrophil | 7743 cells/μL STANDARD_DEVIATION 4541 |
| Platelet (PLT) | 324653 cells/μL STANDARD_DEVIATION 109183 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 198 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Serum Creatinine (SCr) | 1.02 mg/dL STANDARD_DEVIATION 0.22 |
| Sex: Female, Male Female | 68 Participants |
| Sex: Female, Male Male | 130 Participants |
| Smokers | 132 Participants |
| Weight | 66.93 Kg STANDARD_DEVIATION 14.74 |
| White Blood Cell (WBC) | 10519 cells/μL STANDARD_DEVIATION 4920 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 28 / 198 |
| other Total, other adverse events | 190 / 198 |
| serious Total, serious adverse events | 50 / 198 |
Outcome results
Primary
Safety Assessment Including Treatment-related Adverse Events (Number of Participants Who Experienced at Least One Adverse Event (AE) or One Serious Adverse Event (SAE))
In this study, number of participants who experienced at least one adverse event (AE) or one serious adverse event (SAE) were assessed. The intensity of AEs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and terminology for AEs was chosen according to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term. Also, intensity, seriousness, onset of AEs, and interventions for management of the adverse events were documented in the booklet. For each AE, data was summarized using system organ class and preferred term of AEs and SAEs. Moreover, causality assessment was done based on the World health organization-Uppsala Monitoring Centre (WHO-UMC) system.
Time frame: This outcome was assessed throughout the study, up to 18 weeks (6 chemotherapy cycles). The duration of treatment was at the physicians' discretion based on the patient's condition
Population: The safety population is defined as all patients who received at least one dose of the study drug. In this study, a total of 199 patients with non-squamous non-Small cell lung cancer (NSCLC) or malignant pleural mesothelioma (MPM) were enrolled. However, one patient was excluded from the safety analysis due to the absence of a recorded diagnosis, resulting in a safety population of 198 individuals.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NanoAlvand Pemetrexed | Safety Assessment Including Treatment-related Adverse Events (Number of Participants Who Experienced at Least One Adverse Event (AE) or One Serious Adverse Event (SAE)) | 190 Participants |