Farhad Shahi Associate Professor , Farahnaz Vafaeezadeh Post doctoral fellowship , Nafiseh Ansarinejad Associate Professor , Alireza Ahmadi Post doctoral fellowship , Ali Shahriari-Ahmadi Associate Professor , Alireza Ghazizadeh Associate Professor , Hassanali Vahedian Ardakani Associate Professor , Mohammad Reza Ravanbod Associate Professor , Sharareh Seifi Associate Professor , Mohammad Foratyazdi Associate Professor , Seyed Asadollah Mousavi Associate Professor , Mansour Rajabi Vahid Associate Professor , Hossein Rahimi Associate Professor , Mohammad Seghatoleslami Post doctoral fellowship , Seyed Mohsen Razavi Associate Professor , Amir Houshang Pourkhani Associate Professor , Davoud Babakhani Post doctoral fellowship , Nassim Anjidani Pharm. D.
A Post-Marketing Surveillance Study to Evaluate the Safety Profile of AlvotereⓇ (Docetaxel) in Iranian Patients Diagnosed with Different Types of Cancers Receiving Chemotherapy
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.
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