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.

Oral neglect as a marker of broader neglect: a cross-sectional investigation of orodental consultation letter of leukemic admitted patients in Iran.

BACKGROUND: Leukemia is the main malignant hematologic disease of children with different oral manifestations and clinical features. Attention to the oral manifestations is essential for better management. This study assessed the oral and dental consultations conducted in the admitted leukemic patients of an Iranian teaching hospital. METHODS: In this descriptive cross-sectional study, medical records of patients admitted in Yazd Shahid Sadoughi Hospital were evaluated. Records of 300 patients with leukemia were randomly selected. Data including demographic information on age, sex, type of oral problems, prescribed instructions and leukemia type were extracted from archived records and registered on the checklist. Finally, Data were analyzed by SPSS17 using Chi-square test. RESULTS: The results showed the average age ± SD of patients were 24.36 ± 23.91 with a range of 4 days to 86 years. Among 300 files, 167 belonged to males (55.7%) and 133 pertained to females (44.3%). The most prevalent type of underlying disease was ALL (Acute lymphocytic leukemia) with the frequency of 180 persons (60%). Only 12 (4%) of patients were referred to a specialist due to oral problems. Of all cases of consultation requests, 75% received consultation because of dental problems and 25% for mucosal problems. There was a statistically significant difference between age and consultation request (P = 0.002). CONCLUSIONS: According to the results of this study, orodental consultation request rate for admitted leukemic patients was low. Pediatric hematologist and oncologists to some extent had more interest to consult due to oral and dental problems rather than others.

Cox Regression and Parametric Models: Comparison of How They Determine Factors Influencing Survival of Patients with Non-Small Cell Lung Carcinoma

Background and objectives: The present study of survival rate of patients with non-small cell carcinoma (NSCLC) compared the efficiency of Cox semi-parametric vs. parametric models in determination of influencing factors. Methods: In this retrospective cohort study, data were gathered from 190 patients with a confirmed diagnosis of NSCLC referred to Shahid Sadoughi and Shohadaye Kargar Hospitals in Yazd, Iran during 2005 to 2014. To identify and compare factors influencing the survival rate, a Cox semi-parametric model was fitted to the data. Data analysis was performed using the R software version R3.3.1, and the significance level was set at 0.05. Results: The average age was 64.5 years. About 40% of patients had stage 4 disease. The median survival was 8 months. After comparing the models, the more efficient was the log-normal distribution (AIC=889.3829), with which disease stage, type of therapy, and age were significant factors. Among the different types of therapy, chemotherapy and radiotherapy yielded higher survival rates, and increased age was associated with lower survival. Conclusion: The most efficient model was a log-normal model. Implementation of optimal therapies at early stages can improve the survival of patients.

Prevalence of occult hepatitis b infection in iranian cancer patients before chemotherapy treatment / Prevalência de infecção oculta da hepatite B em pacientes iranianos com câncer antes do tratamento de quimioterapia

ABSTRACT Background Occult hepatitis B infection is characterized by negative hepatitis B surface antigen (HBsAg) and also detectable hepatitis B virus (HBV) -DNA, with or without hepatitis B core antibody (anti-HBc). HBV reactivation in individuals under immunosuppressive therapy is critical, occurring in occult HBV. Objective In this study, we aimed to determine the prevalence of occult HBV infection among hepatitis B surface antigen negative in cancer patients before receiving chemotherapy. Methods Sera from 204 cancer patients who were negative for HBsAg, were tested for anti-HBc antibodies. The samples that were negative for HBsAg but positive for anti-HBc also examined for HBV-DNA by polymerase chain reaction (PCR). Results Of the 204 HBsAg negative blood samples, 11 (5.4%) samples were positive for anti-HBc antibodies. HBV-DNA was detected in 9/11 (81%) of anti-HBc positive samples. Occult HBV infection in hematological cancers was more than solid cancers, 4.8% and 4.3% respectively. There was no significant difference in HBc antibody positivity based on vaccination, previous blood transfusions, history of familial hepatitis or biochemical parameters (ALT, AST, total and direct bilirubin levels) (P>0.05). Conclusion Screening of occult HBV infection by HBsAg, HBV DNA and anti HB core antibody should be suggested as a routine investigation in cancer patients before receiving chemotherapy.

RESUMO Contexto A infecção oculta da hepatite B caracteriza-se por antígeno de superfície da hepatite B (AgHBs) negativo com vírus detectável da hepatite B (HBV) -DNA, com ou sem anticorpo de núcleo da hepatite B (anti-HBc). A reativação do HBV em indivíduos sob terapia imunossupressora é crítica, originando a infecção oculta pelo VHB. Objetivo Este estudo teve como objetivo determinar a prevalência de infecção oculta pelo VHB entre em pacientes com câncer e com antígeno de superfície da hepatite B negativo antes de receber quimioterapia. Métodos Soro de 204 pacientes com câncer que foram negativos para AgHBs, foram testados para anticorpos anti-HBc. As amostras que foram negativos para AgHBs, mas positivo para anti-HBc foram também examinadas para HBV-DNA, por reação em cadeia da polimerase. Resultados Entre 204 amostras de sangue AgHBs negativas, 11 (5,4%) foram positivos para anticorpos anti-HBc. HBV-DNA foi detectado em 9/11 (81%) das amostras positivas de anti-HBc. Infecção oculta de VHB em câncer hematológico foi maior que em cânceres sólidos, 4,8% e 4,3% respectivamente. Não houve diferença significativa na positividade anti-HBc, com base na vacinação, transfusões de sangue anteriores, história de hepatite familiar ou parâmetros bioquímicos (ALT, AST, total e níveis de bilirrubina total) (P & gt; 0,05). Conclusão A triagem de infecção oculta por AgHBs, HBV-DNA e anti-anticorpo de núcleo HB deve ser sugerida como uma investigação de rotina em pacientes com câncer antes de receber a quimioterapia.

PREVALENCE OF OCCULT HEPATITIS B INFECTION IN IRANIAN CANCER PATIENTS BEFORE CHEMOTHERAPY TREATMENT.

BACKGROUND: Occult hepatitis B infection is characterized by negative hepatitis B surface antigen (HBsAg) and also detectable hepatitis B virus (HBV) -DNA, with or without hepatitis B core antibody (anti-HBc). HBV reactivation in individuals under immunosuppressive therapy is critical, occurring in occult HBV. OBJECTIVE: In this study, we aimed to determine the prevalence of occult HBV infection among hepatitis B surface antigen negative in cancer patients before receiving chemotherapy. METHODS: Sera from 204 cancer patients who were negative for HBsAg, were tested for anti-HBc antibodies. The samples that were negative for HBsAg but positive for anti-HBc also examined for HBV-DNA by polymerase chain reaction (PCR). RESULTS: Of the 204 HBsAg negative blood samples, 11 (5.4%) samples were positive for anti-HBc antibodies. HBV-DNA was detected in 9/11 (81%) of anti-HBc positive samples. Occult HBV infection in hematological cancers was more than solid cancers, 4.8% and 4.3% respectively. There was no significant difference in HBc antibody positivity based on vaccination, previous blood transfusions, history of familial hepatitis or biochemical parameters (ALT, AST, total and direct bilirubin levels) (P>0.05). CONCLUSION: Screening of occult HBV infection by HBsAg, HBV DNA and anti HB core antibody should be suggested as a routine investigation in cancer patients before receiving chemotherapy.

Association of body mass index with hemoglobin concentration and iron parameters in Iranian population.

Background. Studies have reported that obesity has an adverse effect on iron metabolism. Obesity is characterized by chronic, low-grade, systemic inflammation and anemia of chronic disease with elevated serum ferritin and decreased level of serum iron, transferrin saturation, and hemoglobin. Therefore, we examined the association of body mass index with hemoglobin concentration and iron parameters in this study. Methods. This cross-sectional study was conducted in Yazd to assess the relation of body mass index with hemoglobin and iron parameters among 406 adult patients 18-65 years old. Diabetes and conditions that could influence body iron stores were excluded. Results. There is no difference in hemoglobin concentrations, MCV, serum iron, TIBC, transferrin saturation index, and ferritin between normal weight, overweight, and obese persons. Conclusion. Nutritional status of persons and intake of high iron foods by obese persons should be considered. Also, other inflammatory markers should be evaluated in the future studies.

Differentiation of bone marrow mesenchymal stem cells into chondrocytes after short term culture in alkaline medium.

BACKGROUND: Bone marrow mesenchymal stem cells (MSCs) are one of the undifferentiated multipotential cell sources of human body. MSCs have the capacity to form a variety of cell types, especially chondrocytes and osteocytes. Learning about responses of MSCs to external milieu and chemical factors such as pH could recommend new approaches for preparation of suitable scaffolds for bone and cartilage tissue engineering. In present study, the effect of alkaline medium on chondrogenic and osteogenic differentiation of rat MSCs was evaluated. METHODS: MSCs were harvested from bone marrow of animals and then the response of passage1 and 2 of MSCs (P1 MSCs & P2 MSCs) to the culture in alkaline medium (pH: 8) was evaluated. Cytochemical and immunocytochemical staining were performed to distinguish chondrocytes and osteocytes. Real-time PCR was performed to evaluate the type II collagen and osteopontin mRNA levels. RESULTS: Staining for type II collagen, a chondrocytic specific marker, revealed that after one-week culture in alkaline medium, a considerable amount of P1 MSCs had shown chondrocytic morphology. By prolonging the culture period up to 4 weeks, osteogenic cells with expanded matrix and mineralized areas around them were appeared. Results of real-time PCR showed that P1 MSCs after one week culture in alkaline medium expressed highest rate of type II collagen and osteopontin mRNA among all groups. CONCLUSION: This study demonstrated that alkaline medium is a potent chondrogenic differentiation inducer for MSCs in their first passage.