{"title":"Targeted therapy in TNBC: Exploring the role of antibody-drug conjugates with a focus on sacituzumab govitecan.","authors":"Nahida Siddiqui, Moduru Tejo Arun, Kummari Aparna, Madishetti Abhishek Murthy, Tadikonda Rama Rao","doi":"10.1177/10781552251316433","DOIUrl":"https://doi.org/10.1177/10781552251316433","url":null,"abstract":"<p><strong>Objectives: </strong>To underscore the prevalence and mortality of breast cancer and review advancements in metastatic TNBC management, with a particularly focus on the role of antibody-drug conjugates (ADCs), emphasizing the safety and therapeutic potential of Sacituzumab govitecan (SG) as a groundbreaking ADC.</p><p><strong>Data sources: </strong>This review gathers scientific data from the past decade, sourced from PUBMED, ClinicalTrials.gov, and Google Scholar to retrieve relevant studies focused on SG in metastatic TNBC treatment.</p><p><strong>Data summary: </strong>Breast cancer is the most common cancer in women, with TNBC being particularly aggressive and difficult to treat. Recent advancements, such as ADCs, have enhanced treatment options. The third-generation Trop-2-targeting ADC, SG, shows promise for metastatic TNBC. This review summarizes available scientific data on SG's safety, efficacy, and future potential. It also discusses ongoing clinical trials evaluating SG in various combinations, offering hope for improved therapeutic strategies in this high-risk group.</p><p><strong>Conclusions: </strong>ADCs hold great promise for transforming anti-tumor therapies over the next decade and SG has demonstrated substantial efficacy and a manageable safety profile in treating metastatic TNBC. Ongoing trials show that combining SG with immunotherapies enhances its potential, offering hope for better outcomes in patients with limited options. These findings highlight the need for further research to fully define SG's role in optimizing treatment strategies.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251316433"},"PeriodicalIF":1.0,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143052896","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Medication-related osteonecrosis of the jaw in patients with cancer using zoledronic acid and denosumab: Single-center retrospective study.","authors":"Motohiko Sano, Mai Amano, Miki Yamada, Yosuke Iijima, Shunsuke Hino, Hiroshi Sakagami, Norio Horie, Takahiro Kaneko","doi":"10.1177/10781552251316440","DOIUrl":"https://doi.org/10.1177/10781552251316440","url":null,"abstract":"<p><strong>Background: </strong>Medication-related osteonecrosis of the jaw (MRONJ) is a rare but potentially severe condition that significantly affects the quality of life of patients with cancer. This study evaluated MRONJ in patients with cancer treated with zoledronic acid (ZOA) and denosumab (Dmab).</p><p><strong>Methods: </strong>The survey investigated patients who were diagnosed with MRONJ at the Department of Oral and Maxillofacial Surgery after receiving either ZOA or Dmab at the Saitama Medical Center, Saitama Medical University, between April 1, 2022, and March 31, 2023.</p><p><strong>Results: </strong>Of 252 patients, 27 were ZOA users and 225 were Dmab users. MRONJ was not observed with ZOA. MRONJ was detected in 11 (4.9%) Dmab users, eight male and three female patients with a mean (± standard deviation) age of 74.6 (± 9.2) years (range 61-98 years). The total dose of Dmab was 2724 ± 1838 mg (range: 480-6360 mg). The time from Dmab administration to MRONJ onset was 28.0 ± 16.0 months (range 4.5-53.2 months). Of the 11 patients with MRONJ, four (36.4%) had visited a dentist within the last 12 months. One participant (9.1%) was informed about and understood MRONJ.</p><p><strong>Conclusions: </strong>MRONJ was only observed in Dmab users, with an incidence rate of 4.9%. The percentage of patients with MRONJ receiving regular dental check-ups was 36.4%, and only 9.1% of patients were aware of MRONJ, both of which are low rates. To reduce MRONJ in patients with cancer, face-to-face consultations with pharmacists could serve as a valuable opportunity to inform patients about MRONJ and encourage regular dental visits.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251316440"},"PeriodicalIF":1.0,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143052890","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Prevalence and predictive factors of chemotherapy-induced peripheral neuropathy in cancer patients: A cross-sectional single-center study in Pakistan.","authors":"Ismail Jadoon, Muhammad Arfat Yameen","doi":"10.1177/10781552251314348","DOIUrl":"https://doi.org/10.1177/10781552251314348","url":null,"abstract":"<p><p>Chemotherapy-induced peripheral neuropathy is a debilitating pain condition resulting from cancer treatment and is known to be associated with a decrease in health-related quality of life. This single-center cross-sectional study, conducted at Institute of Nuclear Medicine Oncology and Radiotherapy (INOR), Abbottabad, Pakistan, assessed the prevalence and severity of chemotherapy-induced peripheral neuropathy and its impact on quality of life in cancer patients undergoing chemotherapy. Patients completed the European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-CIPN20 questionnaires. Subscales are scored from 0 to 100, with higher scores indicating greater symptom severity. A total of 154 patients participated, with a mean age of 48.57 years (SD 14.22); 33.8% were male and 66.2% were female. The prevalence of sensory CIPN was 36.4%. The mean scores for the sensory, motor, and autonomic subscales of the QLQ-CIPN20 were 23.2 (SD 19.1), 16.6 (SD 15.8), and 14.8 (SD 17.2), respectively. CIPN symptom severity was negatively correlated with global health status/quality of life and physical, role, emotional, cognitive, and social functioning. There was no significant association with age, sex, body surface area, height, weight, or type of chemotherapeutic agent used. However, symptom severity increased with the number of treatment cycles completed (e.g., sensory, <i>p </i>= 0.003). CIPN was prevalent in this healthcare center and significantly impacted function and quality of life. These findings highlight the importance of developing strategies to mitigate CIPN and the need for routine screening of CIPN.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251314348"},"PeriodicalIF":1.0,"publicationDate":"2025-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143046973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mahi Patel, Christian M Gill, Robin Chamberland, Tyler Heflin, Rachel Mehringer
{"title":"Impact of adjunct bezlotoxumab for preventing <i>Clostridioides difficile</i> infection recurrence in patients post - hematopoietic stem cell transplantation.","authors":"Mahi Patel, Christian M Gill, Robin Chamberland, Tyler Heflin, Rachel Mehringer","doi":"10.1177/10781552241310099","DOIUrl":"https://doi.org/10.1177/10781552241310099","url":null,"abstract":"<p><strong>Background: </strong>Patients post hematopoietic stem cell transplant (HSCT) are highly susceptible to <i>Clostridioides difficile</i> infection (CDI). Exposure to antibiotic treatment, chemotherapeutic disruption to bacterial microbiome, immunosuppressive therapy, and prolonged hospitalizations synergistically contribute to the risk of CDI and its recurrence. The purpose of this study is to assess if the adjunctive administration of bezlotoxumab decreases the rate of recurrent CDI in patients post-HSCT.</p><p><strong>Study design: </strong>This retrospective cohort study included patients post allogeneic or autologous HSCT with CDI who were 18 years of age or older. The first cohort included patients who received standard-of-care (SOC) treatment for CDI. The second cohort included patients who received standard of care treatment for CDI in addition to bezlotoxumab. The primary objective was the proportion of patients with recurrence of CDI within 12 weeks of initial diagnosis after treatment with bezlotoxumab plus SOC compared with controls receiving SOC alone.</p><p><strong>Results: </strong>The primary outcome occurred in 2.7% of patients in the bezlotoxumab plus SOC group, and 7.1% of patients in the SOC alone group. Results of the primary outcome were not statistically significant between groups. No difference in CDI recurrence occurred between the two groups (5.4% vs 7.1%) at 6 months. Bezlotoxumab administration was well-tolerated with no documented adverse reactions.</p><p><strong>Conclusion: </strong>In conclusion, the use of bezlotoxumab did not lead to statistically significant decreases in CDI recurrence in patients post-HSCT. Future studies should be conducted with a larger number of HSCT patients receiving bezlotoxumab to provide supporting evidence of its role in reducing CDI recurrence.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552241310099"},"PeriodicalIF":1.0,"publicationDate":"2025-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143046970","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Eyelash trichomegaly complicating pembrolizumab for colorectal cancer.","authors":"N Alevizopoulos, D Alexandris","doi":"10.1177/10781552241313037","DOIUrl":"https://doi.org/10.1177/10781552241313037","url":null,"abstract":"<p><strong>Introduction: </strong>Pembrolizumab is an immune checkpoint inhibitor widely administered for the treatment of various malignancies. Despite its effectiveness, its distinctive mechanism of action may lead to immune-related adverse events, most frequently affecting cutaneous tissues. Hair-related adverse events, although uncommon, include conditions such as alopecia areata and alterations in hair texture or type.</p><p><strong>Case report: </strong>A 63-year-old male patient presented with eyelash trichomegaly following two cycles of pembrolizumab infusion.</p><p><strong>Treatment and outcome: </strong>The patient experienced discomfort due to the eyelash trichomegaly, prompting him to consider discontinuing the treatment. However, the patient's neoplastic disease demonstrated a complete radiologic response, which encouraged him to continue the therapy.</p><p><strong>Discussion: </strong>This case illustrates a unique documentation of pembrolizumab-induced eyelash trichomegaly. While immune checkpoint inhibitors like pembrolizumab are known to cause hair-related adverse events, reports of eyelash trichomegaly remain rare. This case emphasizes the necessity for clinicians to remain vigilant about such uncommon side effects to ensure comprehensive patient management.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552241313037"},"PeriodicalIF":1.0,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143028827","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Prajakta Harish Patil, Mrunal Pradeep Desai, Gayathri Baburaj, Mahadev Rao, Vijayanarayana Kunhikatta, Karthik Udupa, Ananth Pai, P C Jagadish
{"title":"A single-centre retrospective evaluation of potential drug-drug interactions in breast cancer patients undergoing CDK 4/6 inhibitors chemotherapy.","authors":"Prajakta Harish Patil, Mrunal Pradeep Desai, Gayathri Baburaj, Mahadev Rao, Vijayanarayana Kunhikatta, Karthik Udupa, Ananth Pai, P C Jagadish","doi":"10.1177/10781552251314811","DOIUrl":"https://doi.org/10.1177/10781552251314811","url":null,"abstract":"<p><strong>Introduction: </strong>The utilization of CDK4/6 inhibitors has led to compromised survival rates for breast cancer patients. Consequently, certain treatment aspects, involving adherence and drug-to-drug interactions, are gaining prominence. To develop chemotherapy regimens that are both effective and efficient, our main objective was to thoroughly characterize the drug-drug interactions that occur between cyclin-dependent kinase inhibitors and concurrently prescribed medications in hospitalized breast cancer patients.</p><p><strong>Methods: </strong>In the current retrospective analysis, (January 2017 to January 2023), the baseline characteristics of patients under CDK4/6 chemotherapy were collected by reviewing the patient's medical records. Utilizing drug interactions checker softwares including Micromedex<sup>®</sup> online database system, Drugs.com<sup>®</sup> interaction checker, and UpToDate Lexicomp<sup>®</sup>, the potential for drug-drug interactions was further assessed.</p><p><strong>Results: </strong>In this retrospective analysis, total of 75 co-medications were prescribed along with palbociclib and ribociclib. Upon analysing all co-prescribed classes of drugs, the potential drug interactions of palbociclib and ribociclib with analgesics, acid-reducing agents, and statins occurred frequently in cancer patients. In the 21-patient cohort, 17 patients (80.95%), were found to be having prevalence of potential drug-drug interactions out of which 41.26% had major pharmacokinetic interactions, 42.85% were moderate ones, while 15.87% were pharmacodynamic interactions.</p><p><strong>Conclusion: </strong>The retrospective analysis identified the potential risks associated with drug-drug interactions of cyclin-dependent kinase 4/6 inhibitors. Potentially, the application of drug interaction detectors could facilitate additional implementation of research specially designed for interventions aimed at enhancing patient care.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251314811"},"PeriodicalIF":1.0,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143023795","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kofi Boamah Mensah, Martin Asitanga Asambo, Joseph Attakorah, Ebenezer Wiafe, Adwoa Oforiwaa Kwakye, Neelaveni Padayachee, Varsha Bangalee
{"title":"Clinicians knowledge of cancer: A study in Ghana's Bono region.","authors":"Kofi Boamah Mensah, Martin Asitanga Asambo, Joseph Attakorah, Ebenezer Wiafe, Adwoa Oforiwaa Kwakye, Neelaveni Padayachee, Varsha Bangalee","doi":"10.1177/10781552241312392","DOIUrl":"https://doi.org/10.1177/10781552241312392","url":null,"abstract":"<p><strong>Background: </strong>Cancer is a growing public health concern in Ghana, with rising prevalence, incidence, and mortality rates. Clinicians play a crucial role in cancer prevention and control by providing accurate information and early detection services. This study assessed the level of cancer knowledge among a cross-section of clinicians in the Bono region of Ghana, focusing on their knowledge of cancer, signs, symptoms, and risk factors.</p><p><strong>Method: </strong>This was a cross-sectional study conducted using a validated questionnaire. The recruitment included doctors, pharmacists, nurses, laboratory technologists, radiographers, pharmacy technologists and other healthcare staff from four hospitals. Correlation between continuous variables and knowledge, signs and symptoms, and risk factors of cancer were assessed using bivariate correlation analysis.</p><p><strong>Results: </strong>Our findings showed that the majority of participants (96.6%, n = 237) had adequate knowledge of cancer, with most (91.7%, n = 225 and 62.8%, n = 154) demonstrating adequate knowledge of cancer signs and risk factors, respectively. However, significant knowledge gaps were identified regarding specific warning signs and symptoms, such as indigestion, changes in bowel or bladder habits, and persistent cough or hoarseness. Moreover, a substantial portion of participants lacked knowledge of risk factors like excessive meat intake, insufficient physical activity, and a lack of fruits and vegetables.</p><p><strong>Conclusion: </strong>This study underscores the need to implement strategies for enhancing cancer awareness and knowledge among healthcare professionals in Ghana, with a particular focus on addressing the identified knowledge gaps. Clinicians should be empowered to effectively educate the public on cancer signs, symptoms, risk factors, and the importance of early detection.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552241312392"},"PeriodicalIF":1.0,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143023884","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jacob Noble, Clay Irvine, Amy Tevaarwerk, Kristin Cole, Vishal Shah, Kathleen Gander, Scott A Soefje
{"title":"Evaluation and comparison of infusion reactions related to prophylactic medication timing for taxane administration.","authors":"Jacob Noble, Clay Irvine, Amy Tevaarwerk, Kristin Cole, Vishal Shah, Kathleen Gander, Scott A Soefje","doi":"10.1177/10781552241313058","DOIUrl":"https://doi.org/10.1177/10781552241313058","url":null,"abstract":"<p><strong>Introduction: </strong>Taxane medications, paclitaxel, and docetaxel, are chemotherapy agents that have a higher incidence of reported hypersensitivity and infusion reactions. To help classify these reactions, the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) is utilized. Prophylactic medications have been used to decrease the incidence and severity of these events. At our institution, medications that patients can receive prior to the initiation of a taxane infusion are a histamine 1 receptor antagonist (H1RA), histamine 2 receptor antagonist (H2RA), a steroid or a combination of these medications. The purpose of this retrospective review was to compare the rates and severity of infusion reactions based on the timing of prophylactic medication administration in the first and second doses of taxane infusions.</p><p><strong>Methods: </strong>Patients who received paclitaxel or docetaxel from January 30<sup>th</sup>, 2022, through January 30<sup>th</sup>, 2023, were included in the analysis. To assist in the identification of a reaction, taxane administrations were flagged for review if a rescue medication was administered after the start of a paclitaxel or docetaxel infusion. The rates and severity of infusion reactions were analyzed based on the timing of prophylactic medication administration. A sub-group analysis comparing infusion reaction characteristics between taxanes given, was performed.</p><p><strong>Results: </strong>Of the 1486 taxane infusions that were completed within the year, 249 infusion reactions were confirmed and graded utilizing the NCI CTCAE. When examining the first and second doses of a taxane (N = 536), we identified 222 infusions reactions. The odds of a patient having an infusion reaction, during the first and second doses, was found to be less likely for patients given a prophylactic medication 30 min prior to receiving a taxane compared to those who did not receive a pre-medication (p = 0.037).</p><p><strong>Conclusion: </strong>This multisite retrospective study showed that administration of prophylactic medications 30 to 80 min prior to the first and second infusion of a taxane was the optimal timing to decrease the likelihood of patients having an infusion reaction. No difference in the severity of the reaction was seen. Most patients were able to complete the entire infusion, regardless of what rescue medications were used following the infusion reaction.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552241313058"},"PeriodicalIF":1.0,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143007059","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sai Santhosha Mrudula Alla, Yogesh Tekuru, Moraboina Sai Lokesh, Deekshitha Alla, Patel Tvisha, Soujanya Tirupati, Aradhya Singh, Yeshala Tejaswini, Mariya Mahmood, Nanki Pratap Siingh, Bodipudi Vineetha
{"title":"Talimogene laherparepvec (T-VEC) as a treatment for melanoma: A systematic review.","authors":"Sai Santhosha Mrudula Alla, Yogesh Tekuru, Moraboina Sai Lokesh, Deekshitha Alla, Patel Tvisha, Soujanya Tirupati, Aradhya Singh, Yeshala Tejaswini, Mariya Mahmood, Nanki Pratap Siingh, Bodipudi Vineetha","doi":"10.1177/10781552241312920","DOIUrl":"https://doi.org/10.1177/10781552241312920","url":null,"abstract":"<p><strong>Background and aims: </strong>Melanoma now presents an average risk of 1 in 50 in the Western world. Talimogene laherparepvec (T-VEC), an FDAapproved oncolytic virus derived from Herpes Simplex Virus type 1 (HSV-1), has proven effective in reducing morbidity and mortality from melanoma but causes adverse effects like chills, fever, exhaustion, and injection site discomfort. Research focuses on combining T-VEC with immune checkpoint inhibitors, such as pembrolizumab, to enhance its efficacy and broaden its application.</p><p><strong>Methods: </strong>A systematic search was conducted using PubMed, Scopus, Web of Science, Google Scholar, and ProMED, adhering to PRISMA guidelines. Results were tabulated and analyzed.</p><p><strong>Results: </strong>This review included 15 studies comprising nine cohorts, four case reports, a case series, and a randomized control trial, involving 779 melanoma patients in stages IIIB to IV, 58% of whom were male with a mean age of 65 years. Treatment duration with T-VEC averaged 35.07 weeks, with dosages ranging from 10^6 to 10^8 PFU/ml. The intervention yielded a mean DRR of 41.87% and an ORR of 62.2%. The most common side effect was chills, affecting 21.69% of participants. Pyrexia was reported by 20.41% of participants, followed by influenzalike illness (14.89%).</p><p><strong>Conclusion: </strong>T-VEC effectively improves ORR and DRR in melanoma patients. However, further research is needed on combination therapy prospects and its adverse effects.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552241312920"},"PeriodicalIF":1.0,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143007063","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Grace Mosallam, Eric S Winer, Julia H Keating, Yael Flamand, Loriel J Solodokin
{"title":"Utility of ursodiol prophylaxis against sinusoidal obstruction syndrome (SOS)/ veno-occlusive disease (VOD) in acute leukemia patients receiving gemtuzumab-ozogamicin (GO) or inotuzumab-ozogamicin (InO).","authors":"Grace Mosallam, Eric S Winer, Julia H Keating, Yael Flamand, Loriel J Solodokin","doi":"10.1177/10781552241313473","DOIUrl":"https://doi.org/10.1177/10781552241313473","url":null,"abstract":"<p><strong>Purpose: </strong>Sinusoidal obstructive syndrome (SOS)/veno-occlusive disease (VOD) is a serious complication in hematopoietic stem-cell transplant (HSCT) patients. Gemtuzumab-ozogamicin (GO) and InO are known to cause SOS/VOD in leukemic and transplant populations. Due to limited data on ursodiol prophylaxis in non-HSCT patients, we aimed to assess hepatotoxicity, SOS/VOD incidences, time to hepatotoxicity, and confirmed SOS/VOD in adults receiving GO or InO ± ursodiol.</p><p><strong>Methods: </strong>A multicenter, retrospective chart review of adult acute leukemia patients who received ≥1 dose of GO or InO at DFCI/some of the Harvard Cancer Centers during 4-year period (9/1/2017-9/1/2021). Acute promyelocytic leukemia patients and post-GO or InO HSCT-recipients (100-day follow-up period) were excluded. Descriptive summaries are provided, direct comparisons were made using Student T-test (continuous variables) and Fisher's exact test (categorical variables).</p><p><strong>Results: </strong>In our population (N = 82), 87.8% received ursodiol and 12.2% did not. There were no significant differences in baseline to peak hepatic labs. The No-Ursodiol Group had higher incidence of Grade 3 aspartate aminotransferase (AST) transaminitis vs. the Ursodiol Group (60% vs. 20.8%; p = 0.015), and a trend towards shorter mean time to Grade 3 AST transaminitis (18.5 vs. 23.8 days; p = 0.30). Moreover, 4.2% of Ursodiol Group developed SOS/VOD vs. 0% in the No-Ursodiol Group (NS). Three patients developed SOS/VOD: 2 received GO, 1 received InO, and 2 were alive by the end of the follow-up period.</p><p><strong>Conclusion: </strong>In our cohort, ursodiol prophylaxis in adults receiving GO/InO is not associated with lower incidences of hepatotoxicity, SOS/VOD, or time to Grade 3 AST transaminitis, but is associated with decreased incidence of AST elevations.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552241313473"},"PeriodicalIF":1.0,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143007065","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}