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. 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

Assessment of request, distribution and using of fresh frozen plasma in Hospital’s Emergency Department in Rasool Akram Hospital

Background: Uncontrolled prescribing of blood products can cause reduce blood bank reserves and inappropriate distribution of blood products. Objective: The goal of this study was to determine of fresh frozen plasma (FFP) transfusion indicators in emergency department. Methods: A cross-sectional study was done in patients admitted to the emergency department of Rasoul Akram, Tehran, Iran for one year (September 2016 to 2017). Findings: Seventy patients (47M/23F) were assessed with the mean age 57.96±18.22 years. Totally 294 units of fresh frozen plasma (FFP) were requested for patients and 93 units (31.64%) were used. The most indication for FFP unit request was acute and chronic anemia. Conclusion: Transfusion rate and index were within acceptable limits, while the crossmatch to transfusion ratio (C/T) was undesirable. Keywords: Products blood, Fresh frozen plasma, Transfusion ratio, Transfusion inde

Assessment of request, distribution and using of platelet concentrates in hospital’s emergency department of Rasool Akram in Tehran

Background: Indiscriminate or no indication prescribed blood products can increase health care costs, transmission of infection, infusion-related complications and improper disposal of blood products and inappropriate distribution of blood products can reduce blood bank reserves. Objective: This study was performed to determine the index of platelet concentrate transfusion in an emergency department. Methods: A cross-sectional study was done on 28 patients admitted in the emergency department, Rasool Akram hospital, Tehran for one year (October, 2014-2015). Infusion index include crossmatch / transfusion ratio (C/T Ratio), transfusion ratio (T%) and transfusion index (TI), separately were identified. Also, the non-infusion or incomplete injection units were recorded. For data analysis student T-Test and analysis of variance and chi-square were used. Findings: 17 (60.7%) cases were men and 11 (39.3%) were female with mean age 47.36±21.30 years. The most requests for platelet concentrate were pre-operation preparation (16 cases). In 15 cases, 10 units of platelet concentrate was request for the each patient. A total of 249 units of platelet concentrate were requested for 28 patients, which 141 units were used (56.62%). Transfusion ratio, C/T ratio and TI were 71.42%, 1.76 and 5.03, respectively. Conclusion: Based on the findings, the platelet concentrate transfusion indexes in the emergency department were acceptable and can be used as a suitable approach in the management of blood products in emergency departments of the hospital

Content of spiritual counselling for cancer patients undergoing chemotherapy in Iran:A qualitative content analysis

Background: Cancer is one of the leading causes of human death. Besides clinical treatment, cancer patients may need emotional and spiritual counselling to overcome their mental and morale problems. Such counselling sessions have been reported influential by many patients. We aimed to explore the structure of spiritual counselling sessions and their content as one of services provided to patients who experience chemotherapy in Iranian hospitals. Methods: Through a qualitative content analysis study, we recorded the discussions between a counsellor, who was a cleric as well, and cancer cases who were undergoing chemotherapy in a hospital in Tehran. The sessions were only recorded if the patient consented to attend at the study. All consideration were taken to avoid release of patients' identity. The recorded discussions were transcribed verbatim and analyzed thematically after each session, until no new theme was emerged. Result: Twenty two sessions were held. The patients aged 53 years old on average. The content of discussions were analyzed along which 165 codes emerged. Four general themes or phases were recognized through counseling as (i) history-Taking (including demographic, disease-related and spiritual history and characteristics), (ii) general advice, (iii) spiritual-religious advice, and (iv) dealing with patients' spiritual or religious ambiguities and paradoxes. Conclusion: Counselling of cancer patients needs special and in depth knowledge on spiritual and religious issues. The counsellor should be able to motivate patients, among whom many are disappointed, to follow the curative instructions well and stay hopeful about their treatment and life. Exploring and understanding what happens during a spiritual counselling session can counselling to the conformity and standardization of such interventions

Successful Treatment of A Catheter-Induced Superior Vena Cava Syndrome through Catheter-Directed Thrombolysis: A Case Report

Superior vena cava (SVC) syndrome is a medical condition resulting from the obstruction of the blood flow through the large central veins. Recently, central venous catheters have been reported as the increasingly common cause of this syndrome. We describe a 56-year-old woman with previous history of metastatic colon cancer, who had recently undergone central venous catheter insertion for her second chemotherapy course. Eight days following port insertion, she presented with signs and symptoms suggestive of acute SVC syndrome, which was successfully managed with catheter-directed thrombolysis. The pre-discharge transesophageal echocardiography and conventional angiography showed a patent SVC. The patient was discharged and remained asymptomatic over a 6-month follow-up. This case shows that catheter-directed thrombolysis may be used as a safe treatment for catheter-induced acute SVC syndrome in patients who have undergone catheter insertion in the central vein.