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.

Intraoperative radiation therapy for early stage breast cancer.

BACKGROUND AND OBJECTIVE: We report our experiences with Intraoperative radiation therapy (IORT) among breast cancer (BC) patients in our region. METHODS: All patients who received radical IORT from April 2014 on to March 2020 were included in the study. Patient selection criteria included: Age equal or older than 45 years old; All cases of invasive carcinomas (in cases of lobular carcinomas only with MRI and confirmation); Patients who were 45-50 years old with a tumor size of 0-2 cm, 50-55 years old with a tumor size of < 2.5 cm, and those who were ≥ 55 years old with a tumor size of < 3 cm; Invasive tumors only with a negative margin; Negative nodal status (exception in patients with micrometastasis); A positive estrogen receptor status. Primary endpoints included death and recurrence which were assessed using the Kaplan-Meier method. RESULTS: Overall, 252 patients entered the study. Mean (SD) age of patients was 56.43 ± 7.79 years. In total, 32.9% of patients had a family history of BC. Mean (SD) tumor size was 1.56 ± 0.55 cm. Mean (IQR) follow-up of patients was 36.3 ± 18.7 months. Overall, 8 patients (3.1%) experienced recurrence in follow-up visits (disease-free-survival of 96.1%), among which four (1.5%) were local recurrence, two (0.8%) were regional recurrence and two patients (0.8%) had metastasis. Median (IQR) time to recurrence was 46 (22, 53.7) months among the eight patient who had recurrence. Overall, one patient died due to metastasis in our series. Eleven patients (4.3%) with DCIS in our study received IORT. All these patients had free margins in histopathology examination and none experienced recurrence. CONCLUSION: Inhere we reported our experience with the use of IORT in a region where facilities for IORT are limited using our modified criteria for patient selection.

Intraoperative radiation therapy in non-breast cancer patients: A report of 26 cases from Shiraz, south of Iran.

Background: Intraoperative radiation therapy (IORT) is the delivery of radiation at the time of surgery. Whereas the dose delivered by external beam radiation therapy (EBRT) is limited by the tolerance of the surrounding normal tissues, IORT allows exclusion of a part or all of the dose-limiting sensitive structures by operative mobilization and/or direct shielding of these structures. The aim of the present study was to report the non-breast cancer patients' outcomes after receiving IORT in Shiraz, Iran. Methods: In this retrospective study, all cases who had received IORT and had non-breast malignancies were selected. Diagnosis was confirmed by biopsy. Additional imaging was done by sonography, magnetic resonance imaging (MRI) and computed tomography (CT). IORT was applied by self-shielded, LIAC 6-12 MeV Sordina mobile linear accelerator. Typically, a single dose of 10-21 Gy was given for maximally resected tumors. The statistical analyses were carried out using SPSS (version 21). Results: Twenty-six patients were treated with IORT alone or combined with EBRT. Different tumors were treated, including colorectal adenocarcinoma (10 cases, 38.4 %), Soft Tissue Sarcomas (STS, 11 cases, 42.3 %), head and neck cancers (3 cases, 11.5 %), one cervix malignancy case and one paravertebral fibromatosis case. Mean ± SD overall survival was 15±14.89 (0-38) and 34.3±15.72 (14-53) months for colorectal cancer and STS, respectively. Conclusion: IORT is mostly useful for pelvic and abdominal malignancies where normal bowel limits the dose that can be delivered with EBRT. However, the dose delivered in a single fraction with IORT is rarely sufficient for tumor control; therefore, IORT is usually preceded or followed by additional EBRT which should be further evaluated preferably in prospective randomized trials.