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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.
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PURPOSE: This study aimed to evaluate the role of inflammatory blood markers in predicting the pathological response rate after neoadjuvant chemoradiation (neo-CRT) in patients with locally advanced rectal cancer (LARC). MATERIALS AND METHODS: In this prospective cohort study, we analyzed the data of patients with LARC who underwent neo-CRT and surgical removal of the rectal mass between 2020 and 2022 in a tertiary medical center. Patients were examined weekly during chemoradiation and neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), monocyte-to-lymphocyte ratio (MLR), and systemic immune inflammation index (SII) were calculated from weekly laboratory data. Wilcoxon signed-ranks and logistic regression analysis were utilized to determine whether any laboratory parameters during different time point assessments or their relative changes could predict the tumor response based on a permanent pathology review. RESULTS: Thirty-four patients were recruited for the study. Eighteen patients (53%) achieved good pathologic response. Statistical analysis by Wilcoxon signed-ranks method indicated significant rises in NLR, PLR, MLR, and SII on weekly assessments during chemoradiation. Having an NLR over 3.21 during chemoradiation was correlated with the response on a Pearson chi-squared test (p = 0.04). Also, a significant correlation was found between the PLR ratio over 1.8 and the response (p = 0.02). NLR ratio over 1.82 marginally missed a significant correlation with the response (p = 0.13). On multivariate analysis, a PLR ratio over 1.8 showed a trend for response (odds ratio = 10.4; 95% confidence interval, 0.9-123; p = 0.06). CONCLUSION: In this study, PLR ratio as an inflammatory marker showed a trend in the prediction of response in permanent pathology to neo-CRT.
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PURPOSE: The present study was conducted to compare dosimetric parameters for the heart and left lung between free breathing (FB) and deep inspiration breath hold (DIBH) and determine the most important potential factors associated with increasing the lung dose for left-sided breast radiotherapy using image analysis with 3D Slicer software. MATERIALS AND METHODS: Computed tomography-simulation scans in FB and DIBH were obtained from 17 patients with left-sided breast cancer. After contouring, three-dimensional conformal plans were generated for them. The prescribed dose was 50 Gy to the clinical target volume. In addition to the dosimetric parameters, the irradiated volumes and both displacement magnitudes and vectors for the heart and left lung were assessed using 3D Slicer software. RESULTS: The average of the heart mean dose (Dmean) decreased from 5.97 to 3.83 Gy and V25 from 7.60% to 3.29% using DIBH (p < 0.001). Furthermore, the average of Dmean for the left lung was changed from 8.67 to 8.95 Gy (p = 0.389) and V20 from 14.84% to 15.44% (p = 0.387). Both of the absolute and relative irradiated heart volumes decreased from 42.12 to 15.82 mL and 8.16% to 3.17%, respectively (p < 0.001); however, these parameters for the left lung increased from 124.32 to 223.27 mL (p < 0.001) and 13.33% to 13.99% (p = 0.350). In addition, the average of heart and left lung displacement magnitudes were calculated at 7.32 and 20.91 mm, respectively. CONCLUSION: The DIBH is an effective technique in the reduction of the heart dose for tangentially treated left sided-breast cancer patients, without a detrimental effect on the left lung.
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BACKGROUND & OBJECTIVE: Prediction of response to neoadjuvant treatment is an important part of treatment of patients with breast cancer. This study aimed to assess changes in serum levels of Cytokeratin 18 during neoadjuvant chemotherapy in patients with locally advanced breast cancer and its association with neoadjuvant treatments. METHODS: This research was performed on newly diagnosed breast cancer patients referred to Omid Radiotherapy Center and radiotherapy and oncology departments of Emam Reza and Ghaem hospitals, in Mashhad, Iran. Serum levels of M30 and M65 fragments of Cytokeratin 18 were measured before and 24 hours after the first course of neoadjuvant chemotherapy. Changes in serum levels of Cytokeratin 18 and its fragments and their correlation with pathologic response were analyzed. RESULTS: Pre- and post-chemotherapy levels of M30 were respectively 223.9±18.94 and 250.7±23.92 U/L (P=0.24). For M65, these levels were respectively 301.5±313.9 and 330.2±352.2 U/L (P=0.1). Changes in M30 level during chemotherapy in patients with and without pathologic complete response were -20±92.69 and 43.1±106.5, respectively (P=0.1). For M65, these changes were respectively -247±55 and 76±240 (P=0.1). Baseline levels of M30 and M65 had no relation with menopausal status, tumor grade, hormone receptor status, Ki67 expression, molecular subtype, and stage. CONCLUSION: Our findings showed statistically insignificant changes in the level of Caspase-cleaved- (M30) and uncleaved- (M65) cytokeratin 18 fragments (apoptotic and necrotic indicators, respectively) during neoadjuvant chemotherapy in patients with breast cancer. There was no notable relationship between tumor-related factors and either baseline levels or serum changes of CK18 fragments. Also, there was no correlation between M30/M65 level and pathologic response to neoadjuvant chemotherapy.