A double-blind, randomized comparison study between Zytux� vs MabThera® in treatment of CLL with FCR regimen: Non-inferiority clinical trial

Background: Chronic lymphocytic leukemia (CLL) is characterized by accumulation of B cells in blood, lymphoid tissues and bone marrow. Addition of rituximab to CLL chemotherapy regimens has been associated with improved survival. The aim of this study was to establish efficacy and safety of Zytux� in comparison to MabThera® in treatment of CLL. Materials and Methods: Seventy CLL patients who met the criteria for entering the study were randomized into two groups (35 patients in each group). Both groups received Fludarabine and Cyclophosphamide plus Rituximab as part of the FCR regimen. Group A was treated with Zytux�, and group B was treated with MabThera®. A non-inferiority margin of 20 for the primary outcome was defined to examine the similarity between Zytux� and MabThera®. Results: Baseline demographic characteristics showed no statistically significant difference between the two groups. The two treatment groups were comparable in terms of laboratory and clinical findings, cellular index changes and CD (5, 19, 20 and 23) counts during therapy cycles and at the end of the treatment period. Regarding safety results, Zytux� demonstrated a similar profile of adverse reactions in comparison to MabThera®. Moreover, the overall response rate was 88 and 89 for Zytux� and MabThera®, respectively (CI -0.17, 0.18). Conclusion: Results showed non-inferiority of Zytux� in terms of efficacy and adverse events as a biosimilar version of MabThera®. © 2018, Tehran University of Medical Sciences (TUMS). All rights reserved

A double-blind, randomized comparison study between Zytux� vs MabThera® in treatment of CLL with FCR regimen: Non-inferiority clinical trial

Background: Chronic lymphocytic leukemia (CLL) is characterized by accumulation of B cells in blood, lymphoid tissues and bone marrow. Addition of rituximab to CLL chemotherapy regimens has been associated with improved survival. The aim of this study was to establish efficacy and safety of Zytux� in comparison to MabThera® in treatment of CLL. Materials and Methods: Seventy CLL patients who met the criteria for entering the study were randomized into two groups (35 patients in each group). Both groups received Fludarabine and Cyclophosphamide plus Rituximab as part of the FCR regimen. Group A was treated with Zytux�, and group B was treated with MabThera®. A non-inferiority margin of 20 for the primary outcome was defined to examine the similarity between Zytux� and MabThera®. Results: Baseline demographic characteristics showed no statistically significant difference between the two groups. The two treatment groups were comparable in terms of laboratory and clinical findings, cellular index changes and CD (5, 19, 20 and 23) counts during therapy cycles and at the end of the treatment period. Regarding safety results, Zytux� demonstrated a similar profile of adverse reactions in comparison to MabThera®. Moreover, the overall response rate was 88 and 89 for Zytux� and MabThera®, respectively (CI -0.17, 0.18). Conclusion: Results showed non-inferiority of Zytux� in terms of efficacy and adverse events as a biosimilar version of MabThera®. © 2018, Tehran University of Medical Sciences (TUMS). All rights reserved

Prevalence, risk factors and molecular evaluation of hepatitis E virus infection among pregnant women resident in the northern shores of Persian Gulf, Iran

Background Although Iran is reported to be an endemic country for hepatitis E virus (HEV), data on the prevalence of HEV infection among pregnant women are scarce and the epidemiology of HEV is unknown in most parts of the country. Therefore, this study was conducted to elucidate the prevalence, risk factors and genotypic pattern of HEV infection among pregnant women resident in the northern shores of Persian Gulf. This is the first report on the epidemiology of HEV infection among pregnant women in this territory. Methods From October 2016 to May 2017, 1331 pregnant women participated in this study. The mean age ± SD of participants was 27.93±5.7 years with a range of 14–45 years. Serum samples of pregnant women were screened for the presence of anti-HEV total antibodies, anti-HEV IgG and anti-HEV IgM using commercially available ELISA kits (DIA.PRO, Milan, Italy). All anti-HEV IgG and anti-HEV IgM positive samples were tested for HEV RNA using two independent reverse transcriptase polymerase chain reaction (RT-PCR) assays, targeting ORF2 and ORF3 of HEV genome. In addition, 92 anti-HEV seronegative samples as well as 50 pooled seronegative samples were evaluated by two independent RT-PCR assays for validation of results. Results Of the 1331 pregnant women, 84 women (6.3%, 95% CI: 5.1%-7.7%) were positive for anti-HEV antibodies, of which 83 women had anti-HEV IgG, and 11 women (0.83%, 95% CI: 0.47%-1.47%) had anti-HEV IgM. The highest rate of HEV seroprevalence was observed among Afghan immigrants (68.0%), uneducated pregnant women (46.51%) and those residents in Bushehr city (8.75%). All anti-HEV IgG and/or IgM positive samples were found to be negative for HEV RNA. In addition, all of the evaluated anti-HEV seronegative samples were negative for HEV RNA. HEV seropositivity among pregnant women was statistically associated with age, ethnicity, place of residence, number of pregnancies, and level of education. So that, low education levels, Afghan, residence in Bushehr city, age group >34 years, and more parities were risk factors for exposure to HEV. In contrast, HEV seropositivity was not associated with stage of gestation, history of abortion, and time of sampling. Conclusion The northern shores of Persian Gulf in Iran, with HEV seroprevalence of 6.3%, can be classified as an endemic geographical region for hepatitis E, and residents of Bushehr city, Afghan immigrants and uneducated women are the main at-risk populations in this territory. © 2018 Farshadpour et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited

Feasibility and Therapeutic Potential of Peptide Receptor Radionuclide Therapy for High-Grade Gliomas

PURPOSE: This pilot study tested the principle that 177Lu-DOTATATE may be applied to patients with high-grade gliomas (HGGs) that are either inoperable or refractory to the standard conventional treatments and also assessed whether this approach could be a viable therapeutic plan in this dilemma. METHODS: In this prospective study, 16 subjects experiencing HGGs that were either inoperable or refractory to the standard conventional treatments were included. All the patients checked for somatostatin receptor expression on the tumors. The patients were treated with 1 to 4 cycles of IV 177Lu-DOTATATE. The primary end point was radiological response after peptide receptor radionuclide therapy, and the secondary end point was improved quality of life using Karnofsky Performance Score and Eastern Cooperative Oncology Group score. RESULTS: In total, 16 subjects (10 males and 6 females) with a mean age of 55.68 ± 13.17 years (26-73 years) participated in the study. Of them, 8 patients were new HGG cases, and 8 patients had recurrent tumors. The participants' responses to treatments were complete remission in 12.5% of (n = 2), partial remission in 31.25% (n = 5), disease stability in 18.7% (n = 3), and disease progression in 37.5% (n = 6). In total, pretreatment and posttreatment Karnofsky Performance Score and Eastern Cooperative Oncology Group scores did not improved (P > 0.05). The patients were followed up from 1 month to 26 months (median, 3 months). CONCLUSIONS: This preliminary result suggests that peptide receptor radionuclide therapy using 177Lu-DOTATATE may be associated with positive effects in patients with HGGs (grade III-IV). However, this approach should be evaluated in a more homogeneous group of patients with more favorable performance status

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. © 202