Post-Marketing Surveillance of a generic Oxaliplatin (AlvoxalⓇ) in Iranian Patients with Cancer.

BACKGROUND: CRC is the second and third most common cancer in women and men, respectively. The national comprehensive cancer network guidelines recommend oxaliplatin-based chemotherapy as a preferred regimen for patients with advanced or metastatic colon cancer. Oxaliplatin is also used in the off-label treatment of gastric cancer. FDA uses post-marketing study commitments to gather additional information about a product's safety, efficacy, or optimal use. It is necessary to perform safety monitoring after marketing authorization is received; such monitoring can be done by means of characterizing the safety of drugs in patients being treated in real-world clinical practice settings. OBJECTIVES: This Phase IV study aimed to evaluate the safety profile of a brand-name formulation of the generic drug oxaliplatin (AlvoxalⓇ, NanoAlvand, Tehran, Iran) in Iranian patients diagnosed with either colorectal or other, different types of cancer. METHODS: Patients with colorectal cancer, gastric cancer, or other malignancies receiving oxaliplatin as a part of their treatment were included in this open-label, multicenter, observational Phase IV study. This study aimed to assess the safety profile of oxaliplatin in patients diagnosed with different cancers. FINDINGS: A total of 483 patients from 16 cities in Iran were enrolled. The most common malignancy was colorectal cancer (55.49%), followed by gastric cancer (28.16%). Based on the results, 405 patients experienced at least 1 adverse event. Most of these adverse events were grade 1 or 2, and the most commonly reported adverse event was anemia (60.66%). During the study, 26 serious adverse events occurred in 15 (3.11%) patients, which were perhaps related to oxaliplatin. There were no remarkable differences in the incidences of adverse events in the system organ classes of blood and lymphatic system disorders, gastrointestinal disorders, or nervous system disorders among patients with different malignancies (ie, colorectal cancer, gastric cancer, and other malignancies) or between genders. The results of this open-label, multicenter, observational, postmarketing surveillance study demonstrated no unexpected safety findings from the use of this oxaliplatin product (AlvoxalⓇ) in Iranian patients diagnosed with different types of cancer. CONCLUSIONS: This Phase IV study provides data on the safety profile of a number of chemotherapy regimens containing an oxaliplatin product given to Iranian patients diagnosed with different types of cancer.

ST-Segment-Elevation Myocardial Infarction Unmasking Underlying Systemic Lupus Erythematosus or Representing Thrombotic Thrombocytopenic Purpura? Report of a Challenging Case.

Thrombotic thrombocytopenic purpura (TTP) is a multisystem disorder that frequently manifests itself with renal and neurological involvements. Cardiac involvement, however, has been rarely reported. In this report, we present a rare case of acquired TTP with acute myocardial infarction (AMI) as the initial manifestation. Although AMI was successfully managed by percutaneous coronary intervention, the patient developed hemolytic anemia, fever, marked thrombocytopenia, oliguria, and renal dysfunction, requiring treatment with plasma exchange and corticosteroids. TTP, albeit extremely rare, should be considered in cases with unexpected thrombocytopenia during acute-phase treatment for AMI as it can be highly lethal if not treated immediately.

Association between Ki-67 expression and clinicopathological features in prognosis of breast cancer: A retrospective cohort study.

BACKGROUND: Breast cancer is the most common diagnosed female cancer. Breast cancer is also the leading cause of cancer death in females accounting for 13.7% of female cancer-related mortality globally. Variable known prognostic factors such as histological tumor type, tumor size, nodal status, grade, age, and estrogen receptor (ER) status and the proliferation marker - Ki-67 influence the type of treatment decision. The purpose of this present study is to investigate the association between Ki-67 expression with several clinicopathological variables and patients' outcome. MATERIALS AND METHODS: This is a retrospective cohort study from September 2008 to March 2017; 165 newly diagnosed breast cancer patients were enrolled in the study. Ki67 levels were measured using immunohistochemistry and compared with clinicopathological variables. The relation of Ki67 expression with disease-free survival (DFS) and overall survival (OS) was also analyzed. RESULTS: The result of this study revealed that age, tumor size, menopausal status, and human epidermal growth factor receptor 2 (HER2) status had no effect on the patients' outcome. Patients with ER-positive, progesterone receptor (PR)-positive, and HER2-negative tumors expressed a higher rate of Ki-67 (>10%) than patients with ER-negative, PR-negative, and HER2-positive tumors, respectively. However, we found that Ki-67 levels were not significantly increased statistically with ER, PR, and HER2 statuses. There was a statistically significant correlation between Ki-67 expression and with higher stages of the disease. Multivariate analysis showed that Ki-67 expression could not to be an independent prognostic factor for 5-year OS and DFS. Furthermore, p53 status was only prognostic factor for 5-year OS whereas higher stages of disease and p53 status were prognostic factors for 5-year DFS. CONCLUSION: Ki67 could not be an independent variable for prediction of breast cancer outcome.

Factors Affecting the Incidence and Severity of Oral Mucositis Following Hematopoietic Stem Cell Transplantation.

Background: Patients who receive hematopoietic stem cell transplantation (HSCT) experience several complications that oral mucositis (OM) is a frequent symptom. This study was designed to evaluate the incidence, risk factors, prophylaxis and treatment strategies for established OM. Materials and Methods: We included 173 adult patients who received autologous or allogeneic hematopoietic stem cell transplantation in this study. The World Health Organization oral toxicity scale was used to assess the severity of OM. Patients received two prophylactic regimens: regimen 1 contained nystatin, chlorhexidine, povidone iodine and amphotericin B. Regimen 2 contained nystatin and povidone iodine. 70 patients (40.5%) received the first prophylaxis regimen, 89 patients (51.4%) received the second prophylaxis regimen and the remaining 14 patients (8.1%) were not adherence to the use of the mouthwashes and were excluded from the analysis. Results: OM was detected in 60.7% of patients with mean (SD) age of 38.1±14.6 years. Multivariate analysis showed that only the female gender and the prophylactic regimen were the significant predictors of OM. Conclusion: We found that addition of amphotericin B and chlorhexidine, to the nystatin and povidone iodine resulted in a significant beneficial effect in prevention OM.

Clavicular Chondrosarcoma: A Case Report and Brief Review of the Literature.

Clavicular bone tumors occur in less than 0.5 percent of bone tumors. Primary chondrosarcoma is very rare even among clavicle tumors. The main symptom is a touchable mass in 69 % of patients. Dedicated centers using FNA and cytology can reach a correct diagnosis in 94% of cases. Treatment planning is done using simple X-ray, CT-scan, shoulder MRI, chest CT-scan and whole body technetium scan. Treatment of choice for primary chondrosarcoma of clavicle is surgical resection.