Safety evaluation of the trastuzumab biosimilar in Iranian women with HER2-positive breast cancer undergoing adjuvant chemotherapy: a post-marketing surveillance.

BACKGROUND: Trastuzumab is a humanized monoclonal antibody against the human epidermal growth factor receptor 2 (HER2). This post-marketing surveillance evaluates the safety of a trastuzumab biosimilar (AryoTrust), produced by AryoGen Co. Iran in Iranian women with HER2-positive non-metastatic breast cancer (BC). RESEARCH DESIGN AND METHODS: The patients who had undergone adjuvant chemotherapy regimens received trastuzumab every 3 weeks for nine cycles. The study started in February 2017 and finished in August 2022. Data regarding safety were collected using booklets and then analyzed. RESULTS: A total of 597 women with a mean ±SD age of 48.13 ± 10.18 years underwent 5,313 injection cycles. They received pre-study chemotherapies consisting of anthracyclines, taxanes, both, or other medications in 6.70, 7.20, 82.41, and 2.01% of the cases, respectively. One hundred and thirty-nine patients experienced at least one adverse event (AE). The most common AEs were decreased ejection fraction (EF, 5.7%), peripheral neuropathy (5.36%), and nausea (5.19%). Meningioma was the only life-threatening serious AE. Furthermore, bone pain and infusion-related reactions were the two most common grade three AEs. Nevertheless, the mean EF of patients did not change notably during the study. CONCLUSIONS: The results demonstrate that this trastuzumab biosimilar is a generally well tolerated and safe treatment for HER2-positive BC. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov identifier is NCT06021379.

Management of radiation-induced proctitis.

The occurrence of chronic proctitis as a side effect among radiotherapy patients is about 5%. Radiation proctitis and consequent development of chronic proctitis are not associated to each other. However, a lot of samples of proctitis that are limited easily could be treated by typical remedial techniques. Improvements in radiotherapy techniques that make possible the delivery of superior doses of radiation could easily reduce both chronic and acute proctitis. The step-by-step remedial procedure for treatment of this disorder starts with conservative remedial management and includes iron substitution as a second-line therapy. For patients who did not receive initial therapies, sucralfate injection, topical corticosteroids, and antidiarrhea therapy were provided as a means of aggressive care. In cases of continuous rectal bleeding, remedial laser techniques and formaldehyde administration should be attempted before surgical therapy. When surgical therapy is required, a descending or transverse colostomy must be carried out. Advanced methods such as intraperitoneal injections of formalin or novel methods of cold therapy and radiofrequency ablation (RFA) provide a wider remedial field. Exceptionally, unanticipated conclusion of neosquamous wound healing via RFA may have additional preponderances in stopping symptoms and may require better assessment through accurate randomized examination. Since aggressive treatments like coloanal anastomosis and colorectal surgery are correlated with remarkable mortality and morbidity, they must be considered as the final course of remedial treatment.

Exsanguinating Hemorrhage during Open Biopsy in a Primary Breast Angiosarcoma: A Case Report.

Angiosarcomas are endothelial cell neoplasms in the lining of the blood vessel wall and account for about 0.04% of all breast malignancies with a high rate of error in primary diagnosis. The breast angiosarcoma is a rare and uncommon pathology and has been described mostly as case reports. Indeed, only a limited number of cases have been published. Accordingly, the natural history of this tumor and its clinical course remain unclear, and as a consequence, no uniform treatment strategy exists. We present the clinical course and challenges in the diagnosis of a primary angiosarcoma of the breast in a young woman, presenting with a mass in her left breast. Fine-needle aspiration and core needle biopsy failed to confer a correct diagnosis. She suffered severe bleeding at the time of open biopsy and underwent total mastectomy, followed by adjuvant chemotherapy. Young women with solid breast tumors, especially those that are highly vascular, should be considered malignant until proven otherwise. Accurate diagnosis may be difficult. Open biopsy can be diagnostic, although exsanguinating bleeding may occur. Thus, performing open biopsy in locations other than equipped operating rooms may be hazardous and should be avoided.