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; Pâ¯=â¯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.
ABSTRACT
Background/aim: Gastrointestinal (GI) cancers are among the most common cancers in the world. Many risk factors may increase the chance of developing GI cancers. In recent years, a number of epidemiological studies have reported evidence of carcinogenic effects of opium in humans. This study aimed to investigate the relationship between opium use and GI cancer. Materials and methods: This case-control study was performed on 95 patients with GI cancer and 190 healthy individuals (matched for age, sex, place of residence, and smoking) in Rafsanjan, Iran, in 2018. Diet information, as well as history of smoking, the use of hookah, opium, and its derivatives was collected using a checklist in interview sessions. Conditional logistic regression was performed to investigate the proposed relationship and to estimate odds ratios (OR). Results: After adjusting the confounding variables, the use of opium was significantly associated with an increased risk of GI cancer development (OR = 5.95, 95% CI: 2.414.9). Also, a dose-response association was found between the cumulative use of opium and the risk of GI cancers. Consumption of fruit and vegetables reduced the risk of developing GI cancers in opium users (OR = 4.9 and 4.7, respectively). Conclusion: Opium, in the form used among drug users in this area, can lead to an increased risk of GI cancers. Fruit and vegetables have a protective and modifying effect on the risk of GI cancer development caused by opium consumption.
