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A Post-Marketing Surveillance Study to Evaluate the Safety Profile of Alvotereⓡ (Docetaxel) in Iranian Patients Diagnosed With Different Types of Cancers Receiving Chemotherapy Publisher



Shahi F1 ; Vafaeezadeh F1 ; Ansarinejad N2 ; Ahmadi A3 ; Shahriariahmadi A2 ; Ghazizadeh A4 ; Vahedian Ardakani H5 ; Ravanbod MR6 ; Seifi S7 ; Foratyazdi M5 ; Mousavi SA1 ; Rajabi Vahid M8 ; Rahimi H9 ; Seghatoleslami M10 Show All Authors
Authors
  1. Shahi F1
  2. Vafaeezadeh F1
  3. Ansarinejad N2
  4. Ahmadi A3
  5. Shahriariahmadi A2
  6. Ghazizadeh A4
  7. Vahedian Ardakani H5
  8. Ravanbod MR6
  9. Seifi S7
  10. Foratyazdi M5
  11. Mousavi SA1
  12. Rajabi Vahid M8
  13. Rahimi H9
  14. Seghatoleslami M10
  15. Razavi SM2
  16. Pourkhani AH11
  17. Babakhani D1
  18. Anjidani N12
Show Affiliations
Authors Affiliations
  1. 1. Department of Medical Oncology, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Department of Hematology and Oncology, Iran University of Medical Sciences, Tehran, Iran
  3. 3. Department of Oncology, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran
  4. 4. Medicine Department of Hematology-Medical Oncology, Rafsanjan University of Medical Sciences, Rafsanjan, Iran
  5. 5. Department of Oncology, Medicine Shahid Sadoughi University of Medical Sciences, Yazd, Iran
  6. 6. Department of Hematology and Oncology, Bushehr University of Medical Sciences, Bushehr, Iran
  7. 7. Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  8. 8. Department of Hematology and Oncology, Zanjan University of Medical Sciences, Zanjan, Iran
  9. 9. Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
  10. 10. Health research institute, Research Center of Thalassemia & Hemoglobinopathy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
  11. 11. Oncology and Hematology, Clinical Research Development Center, Sayad Shirazi Hospital, Golestan University Of Medical Sciences, Gorgan, Iran
  12. 12. Head of Medical Department, Orchid Pharmed Company, Tehran, Iran

Source: Current Therapeutic Research - Clinical and Experimental Published:2022


Abstract

Background: Docetaxel is a clinically well established antimitotic chemotherapy medication. Labeled docetaxel indications are breast cancer, gastric cancer, head and neck cancer, non–small cell lung cancer, and prostate cancer. Objective: This is a Phase IV study to evaluate the safety profile of docetaxel (Alvotere; NanoAlvand, Iran) in Iranian patients diagnosed with different types of cancers receiving chemotherapy regimens with docetaxel. Methods: Patients who received Alvotere as a part of their chemotherapy regimen were enrolled in this Phase IV, observational, multicenter, open-label study. Alvotere was administrated as a single agent or in combination with other chemotherapy agents. Safety parameters in each cycle were assessed, and the related data were recorded in booklets. Findings: A total of 411 patients with different types of cancers were enrolled from 25 centers in Iran. The most common malignancies among participants were breast cancer (49.88%), followed by gastric cancer (22.63%). Participants’ mean age was 53.33 years, and the mean total dose used in each cycle was 132 mg. According to the results, 341 patients experienced at least 1 adverse event, that the most common was alopecia (41.12%). In total, 92 (22.38%) patients had at least 1 adverse event of grade 3 or 4, and 25 (6.08%) patients showed 54 serious adverse events, which the causality assessment for all was possibly related to Alvotere. There was a significant difference between men and women in the incidence of skin and subcutaneous tissue disorders (55.63% in women vs 41.73% in men; P = 0.009). Also, the incidence of gastrointestinal disorders, nervous system disorders, skin and subcutaneous tissue disorders, hepatic enzymes increase, and fluid retention was significantly higher (P < 0.05) in patients receiving anthracyclines in their chemotherapy regimens. Conclusions: The findings of this open-label, observational, multicenter, postmarketing surveillance showed that Alvotere appears to have an acceptable safety profile in Iranian cancer patients receiving chemotherapeutic regimens. (Curr Ther Res Clin Exp. 2022; 82:XXX–XXX) © 2022 Elsevier HS Journals, Inc. © 2021