en Clinical Medicine Clinical Medicine مقاله پژوهشی Original Research Article <p style="text-align: justify;"><span style="font-size:16px;"><span style="font-family:Times New Roman;"><strong new="" roman="" style="font-family: " times=""><span style="color:#ffffff;"><span style="background-color:#16a085;">Background and Objective:</span></span>&nbsp;</strong><span style="line-height:200%"><span style="line-height:200%">Breast cancer (BC) is the leading cause of cancer mortality among women in different countries around the world, including India. Monoclonal antibodies (MoAbs) have emerged as a promising targeted treatment for BC, improving the survival rate of these patients with minimum adverse effects. This study aimed to investigate the severity of the adverse effects of MoAbs in an Indian population.</span></span><br> <strong new="" roman="" style="font-family: " times=""><span style="color:#ffffff;"><span style="background-color:#16a085;">Materials and Methods:</span></span>&nbsp;</strong><span style="background:#f8f9fa"><span style="line-height:200%"><span style="line-height:200%">This <span style="background:white">longitudinal </span>descriptive study was conducted on 120 BC patients over six months in a tertiary care hospital in Bangalore, India, in 2020. A data collection form was used to gather relevant data. The collected data were analyzed by SPSS Version 21, using Chi-square and Fisher&rsquo;s exact tests. A P-value less than 0.05 was considered statistically significant.</span></span></span><br> <strong new="" roman="" style="font-family: " times=""><span style="color:#ffffff;"><span style="background-color:#16a085;">Results:</span></span></strong>&nbsp;<span style="background:#f8f9fa"><span style="line-height:200%"><span style="line-height:200%">Among 97 patients evaluated in this study (including 29 patients in the non-exposed group), the adverse effects of BC were observed in all age groups. Most adverse effects were attributed to trastuzumab (37.50%; CI: 31.6-44) and bevacizumab (26.78%; CI: 20.9-31.8). The MoAbs were well tolerated by the patients, causing minimum adverse effects that were manageable by supportive therapy. Anemia was the most prevalent adverse effect. Evaluation of the null hypothesis indicated that the adverse effects of MoAbs depended on their amount and composition. The results of analysis using the Naranjo scale revealed that most of the adverse effects were probable (67%) and possible (32%), respectively. Also, according to the WHO scale, most of the adverse effects were under the categories of probable (61.20%) and possible (38.14%), respectively. </span></span></span><br> <strong new="" roman="" style="font-family: " times=""><span style="color:#ffffff;"><span style="background-color:#16a085;">Conclusion:</span></span>&nbsp;</strong><span style="line-height:200%"><span style="line-height:200%">Based on the present results, the adverse effects of MoAbs were manageable by supportive care. Anemia was found to be the most prevalent adverse effect. Meanwhile, no potential adverse cardiovascular event was observed in patients on trastuzumab, except one case of dilated cardiomyopathy.</span></span></span></span></p> Naranjo scale, Monoclonal antibodies, Breast cancer 255 260 http://journal.zums.ac.ir/browse.php?a_code=A-10-6348-1&slc_lang=en&sid=1 Fares Najari najari.hospital@sbmu.ac.ir 5200319475328460076734 5200319475328460076734 Yes Dept. of Legal Medicine, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran Amirhossein Setayesh amirhosseinsetayesh789@gmail.com 5200319475328460076735 5200319475328460076735 No Dept. of Pharmacy Practice, T. John College of Pharmacy, Rajiv Gandhi University of Health Sciences, Bengaluru, Karnataka, India E. Gopinath 5200319475328460076736 5200319475328460076736 No Dept. of Pharmacy Practice, T. John College of Pharmacy, Rajiv Gandhi University of Health Sciences, Bengaluru, Karnataka, India Sahar Mirzaei 5200319475328460076737 5200319475328460076737 No Dept. of Legal Medicine, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran