{"title":"Phase II trial of radiotherapy plus Huachansu in elderly or chemotherapy-ineligible patients with locally advanced esophageal squamous cell carcinoma.","authors":"Qi Liu, Jingyi Shen, Yun Chen, Jialiang Zhou, Hui Luo, Jiaying Deng, Dashan Ai, Hongcheng Zhu, Shengnan Hao, Kuaile Zhao","doi":"10.1093/oncolo/oyaf325","DOIUrl":"https://doi.org/10.1093/oncolo/oyaf325","url":null,"abstract":"<p><strong>Background: </strong>Preclinical studies have demonstrated that Huachansu, a traditional Chinese medicine derived from toad venom, exhibits radiosensitizing properties. This study aimed to explore whether Huachansu plus radiotherapy can improve the tumor control in elderly and chemotherapy-ineligible patients with locally advanced esophageal squamous cell carcinoma (ESCC).</p><p><strong>Methods: </strong>Eligible patients were randomly assigned at a 1:1 ratio to receive either radiotherapy alone (RT) or combined Huachansu and radiotherapy (Huachansu+RT). The primary endpoint was locoregional control, and the secondary endpoints were overall survival (OS), progression-free survival (PFS), and treatment-related toxicities.</p><p><strong>Results: </strong>From September 2015 to January 2020, 126 patients who met the eligibility criteria were randomly assigned to the Huachansu+RT group (n = 65) or the RT alone group (n = 61) from three hospitals. At a median follow-up of 64.8 months (IQR 37.8-78.3), the median locoregional control time was 12.9 months (95% CI 0-27.0) in the Huachansu+RT group and 22.0 months (95% CI 0-52.0) in the RT alone group (HR = 1.35, 95% CI 0.82-2.22; P = 0.235). The median OS time was 15.0 months (95% CI 10.3-19.7) in the Huachansu+RT group and 17.2 months (95% CI 11.3-23.1) in the RT alone group (HR 1.03 95% CI 0.71-1.51 P = 0.868). There was no significant difference between the two groups in the incidence of acute grade 3 or higher adverse events.</p><p><strong>Conclusions: </strong>Compared with radiotherapy alone, concurrent radiotherapy with Huachansu injection did not improve the locoregional control rate or survival rate in elderly patients or chemotherapy-ineligible patients with locally advanced ESCC. The trial is registered with ClinicalTrials.org, NCT02647125.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145193974","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
OncologistPub Date : 2025-09-29DOI: 10.1093/oncolo/oyaf323
Tristan L Lim, Kamaneh Montazeri, Eric Wehrenberg-Klee, Antoine Desilets, Rino Seedor, Marlana Orloff, Takami Sato, Michael Caplan, Mariam El-Ashmawy, Benjamin Izar, Shaheer Khan, Inderjit Mehmi, Aleigha Lawless, Theodore S Hong, Omid Hamid, Richard D Carvajal, Alexander Shoushtari, Ryan J Sullivan
{"title":"Concurrent local therapy extends clinical benefit of tebentafusp in metastatic uveal melanoma patients.","authors":"Tristan L Lim, Kamaneh Montazeri, Eric Wehrenberg-Klee, Antoine Desilets, Rino Seedor, Marlana Orloff, Takami Sato, Michael Caplan, Mariam El-Ashmawy, Benjamin Izar, Shaheer Khan, Inderjit Mehmi, Aleigha Lawless, Theodore S Hong, Omid Hamid, Richard D Carvajal, Alexander Shoushtari, Ryan J Sullivan","doi":"10.1093/oncolo/oyaf323","DOIUrl":"https://doi.org/10.1093/oncolo/oyaf323","url":null,"abstract":"<p><strong>Background: </strong>Tebentafusp has significantly improved overall survival in HLA-A*02:01+ metastatic uveal melanoma (mUM) patients even in those with a best objective response of progressive disease. Thus, strategies to maintain tebentafusp therapy are critical. Here, we examine the efficacy and safety of adding concurrent local therapy (CLT) to tebentafusp upon radiological progression with tebentafusp alone.</p><p><strong>Patients and methods: </strong>This multicenter retrospective study included mUM patients treated with tebentafusp and CLT, consisting of extrahepatic soft tissue irradiation and liver-directed therapies (LDTs). Efficacy of target and nontarget sites were assessed per RECIST version 1.1. PFS with tebentafusp alone (PFS1) was compared to that after adding CLTs to tebentafusp upon progression (PFS1+PFS2). ctDNA responses were explored.</p><p><strong>Results: </strong>Of the 30 eligible patients, 21 (70%) received concurrent LDT, 7 (23%) had extrahepatic irradiation, and 2 (7%) had both. The objective response rate (ORR) was 12% (95% CI, 3-32) for tebentafusp alone and 28% (95% CI, 14-47) after adding CLTs. The disease-control rate with tebentafusp alone was 44% (95% CI, 25-65) versus 63% (95% CI, 44-78) after CLT. Median PFS1 was 5.8 months (95% CI, 2.8-13.4), while median PFS1+PFS2 was 14.8 months (95% CI, 9.2-NA). CLT thereby allowed treatment beyond progression with tebentafusp for approximately 9 months. Two patients (66%) had decreased ctDNA with tebentafusp alone, while four (100%) had decreased ctDNA after CLT. There were no treatment discontinuations due to toxicities from tebentafusp with CLT.</p><p><strong>Conclusions: </strong>CLT with tebentafusp was well-tolerated, extending the duration of tebentafusp benefit in a highly selected mUM population. This merits further studies to assess clinical utility.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145193937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Intravenous haloperidol or chlorpromazine-which is more effective to improve agitation and communication in agitated delirium at the end of life?","authors":"Megumi Uchida, Tatsuya Morita, Tatsuo Akechi, Takuya Kawahara, Asao Ogawa, Kazuhiro Yoshiuchi, Naosuke Yokomichi, Akihiro Sakashita, Yoshihisa Matsumoto, Keiichi Uemura, Rika Nakahara, Satoru Iwase","doi":"10.1093/oncolo/oyaf324","DOIUrl":"https://doi.org/10.1093/oncolo/oyaf324","url":null,"abstract":"<p><strong>Background: </strong>Delirium frequently occurs in terminally ill patients with cancer. The purpose of this study was to determine whether intravenous haloperidol or chlorpromazine is more effective in improving agitation and communication in agitated delirium at the end of life.</p><p><strong>Patients and methods: </strong>All terminally ill patients with delirium treated in 39 specialized palliative care services were enrolled via the web. Delirium diagnosis and severity (Delirium Rating Scale-revised-98<DRS-R98>) were evaluated at the start of treatment (T0) and 72 h later (T1), and the psychotropic drugs used concomitantly at T1 were investigated. We evaluated whether there was an improvement in DRS-R98 agitation-related item scores and DRS-R98 communication-related item scores at T1 in patients with agitated cancer who received intravenous haloperidol or chlorpromazine from T0, and whether a significant difference existed between the two groups.</p><p><strong>Results: </strong>Of 818 enrolled participants, 424 experienced agitation at T0, comprising 183 in the haloperidol group and 68 in the chlorpromazine group. The concomitant benzodiazepine rates were 52% and 54% in the haloperidol and chlorpromazine groups, respectively. In both groups, improvement in DRS-R98 agitation item scores was observed at T1, but there was no significant difference in improvement between the two groups. Worsening in DRS-R98 communication item scores in both groups was observed at T1, but there was no significant difference in worsening scores between the two groups.</p><p><strong>Conclusion: </strong>Intravenous haloperidol and chlorpromazine are not statistically different for terminal agitation. These results should be validated in clinical trials.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145180403","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
OncologistPub Date : 2025-09-27DOI: 10.1093/oncolo/oyaf313
Maria J Fernandez Turizo, Maria A Velez, Beth Glenn, Amy L Cummings, Barbara Segarra-Vazquez, Sarah Gorbatov, Seung J Park, Collin Shen, Jackson P Lind-Lebuffe, Joseph M Unger, Edward B Garon
{"title":"Characteristics of clinical trials associated with appeal and return on investment to participants, A Review and Framework.","authors":"Maria J Fernandez Turizo, Maria A Velez, Beth Glenn, Amy L Cummings, Barbara Segarra-Vazquez, Sarah Gorbatov, Seung J Park, Collin Shen, Jackson P Lind-Lebuffe, Joseph M Unger, Edward B Garon","doi":"10.1093/oncolo/oyaf313","DOIUrl":"https://doi.org/10.1093/oncolo/oyaf313","url":null,"abstract":"<p><p>Despite decades of investment in clinical research infrastructure, patient participation in clinical trials remains strikingly low. In the United States, fewer than 1 in 10 adults report ever being invited to participate in a clinical trial, and among those, less than half ultimately enroll. In oncology, across all adult cancer patients, only about 8% enroll in a clinical trial, regardless of eligibility or trial availability. Active engagement of patients in cancer clinical trials substantially enhances scientific knowledge, and patient participation is required to obtain approval for novel therapeutics. Analyses focusing on evaluating if clinical trial participation improves survival for participants have yielded conflicting results. Yet, there is limited data or metrics to assess the specific attributes of oncology trials that hold greater appeal or return on investment to participants, limiting researchers' ability to determine if these factors vary across different populations. Our group demonstrated that patients with limited English proficiency were unlikely to participate in studies not sponsored by industry as compared to industry-sponsored studies. If trial participation for specific populations can differ by sponsor type, it could also differ by the trial's appeal or return on investment. While the underrepresentation of racial and ethnic minority groups in trials is attributed to multiple factors, it is possible that patients from these groups are less likely to be offered participation in studies with higher appeal or return on investment, due to systemic biases, disparities in recruitment practices and/or lack of access. In this manuscript, we propose a systematic framework for evaluating attributes of interventional oncology clinical trials, with an emphasis on the study's purpose, experimental design and investigational agent. This framework aims to pinpoint characteristics that may enhance trials' appeal or return on investment to participants and could lay a foundation for future research. This will allow investigators to assess the return on investment of appeal of studies offered across different patient populations.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145180234","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
OncologistPub Date : 2025-09-27DOI: 10.1093/oncolo/oyaf318
Guangpeng Chen, Jianbo Zhu, Chunli Jian, Xu Chen, Kai Niu, Qiao Yang, Shu Tang, Si Qin, Yongdong Feng, Lijiao Xie, Wenlei Zhuo, Jianguo Sun
{"title":"Efficacy and safety of Rh-endostatin in the treatment of radiation pneumonitis in non-small cell lung cancer.","authors":"Guangpeng Chen, Jianbo Zhu, Chunli Jian, Xu Chen, Kai Niu, Qiao Yang, Shu Tang, Si Qin, Yongdong Feng, Lijiao Xie, Wenlei Zhuo, Jianguo Sun","doi":"10.1093/oncolo/oyaf318","DOIUrl":"https://doi.org/10.1093/oncolo/oyaf318","url":null,"abstract":"<p><strong>Background: </strong>Radiation pneumonitis (RP) is the common adverse event related to thoracic radiotherapy in patients with non-small cell lung cancer (NSCLC). The treatment of RP needs to be improved.</p><p><strong>Methods: </strong>NSCLC patients with grade 2 or higher RP were enrolled and randomly assigned into two groups: Rh-endostatin group (Rh-endostatin + glucocorticoid) and control group (glucocorticoid only). The primary endpoint was RP relapse rate.</p><p><strong>Results: </strong>A total of 40 patients were included. The relapse rate of RP was significantly lower in Rh-endostatin group (15.0% vs. 45%, P = 0.038). Though the remission rate of RP was similar in the two groups, the combined therapy significantly reduced the interval from RP treatment to RP remission (0.92 vs. 1.47 months, P = 0.048). The RP mortality rate was 5.0% and 35.0% in the Rh-endostatin group and control group, respectivly (P = 0.044). The incidence of pulmonary fibrosis was numerically lower in Rh-endostatin group (25.0% vs.45.0%, P = 0.185). The circulating lymphocyte levels in Rh-endostatin group significantly increased after treatment, when compared to the control group. The median progression-free survival was 7.8 months and 6.0 months respectively (hazard ratio [HR] 0.95, 95% confidence interval [CI] 0.40-2.23, P = 0.910). The median overall survival was 16.0 months and 7.7 months in two groups respectively (HR 0.56, 95%CI 0.27-1.16, P = 0.119). There was no significant difference between the two groups in adverse events.</p><p><strong>Conclusion: </strong>This prospective randomized study provides evidence that the combination of Rh-endostatin and glucocorticoids can reduce RP relapse rates and promote remission without increasing adverse events in advanced NSCLC patients.</p><p><strong>Discussion: </strong>This Discussion can take one of two forms: 350 words and two salient graphics, such as a table, schema, waterfall plot, image or graph; or 450 words with a single salient graphic. This discussion is part of the Abstract and as such needs to be distinct from the extended Discussion at the end of the paper. Citation of references should be done in the extended Discussion at the end of the CTR; references (up to 5) should be cited in the Author Summary only if absolutely necessary.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145180450","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A Prospective Study of Serum Folate Levels in Patients with Solid Tumors Treated with Olaparib.","authors":"Jamile Shammo, Laura Owczarzak, Nicole K Yun, Lois Winkelman, Sanjib Basu, Ruta Rao, Amina Ahmed, Summer Dewdney, Melody Cobleigh, Lydia Usha","doi":"10.1093/oncolo/oyaf321","DOIUrl":"https://doi.org/10.1093/oncolo/oyaf321","url":null,"abstract":"<p><strong>Background: </strong>Olaparib is a polyadenosine 5'-disphosphoribose polymerase inhibitor approved to treat advanced ovarian cancers with germline mutations. The link between olaparib-induced anemia and folate deficiency was described in a retrospective case series in which 87.5% of patients developed concomitant folate deficiency and anemia. We sought to prospectively evaluate this association.</p><p><strong>Patients and methods: </strong>This is an open-label prospective trial of patients with solid tumors treated with olaparib to determine the frequency and timing of folate deficiency anemia. Patients who developed grade 1 anemia (Hgb < 12.0 g/dL) concomitantly with folate deficiency (serum folate < 7.0 ng/mL) were randomized to receive placebo or folic acid. Secondary endpoints included the impact of folic acid supplementation on serum folate and hemoglobin, transfusion needs, and need for olaparib treatment interruption, dose reduction, or drug discontinuation.</p><p><strong>Results: </strong>Nine subjects were enrolled, with ovarian or breast cancer. Two patients were randomized to forgo folate supplementation, two were randomized to receive folate, and the rest were not randomized per protocol. Three withdrew due to disease progression. All patients demonstrated decreased folate levels after initiation of olaparib, 8 occurring within 3 months. 7 patients developed a concomitant grade 1 anemia. Folate deficiency did not correlate with clinically significant anemia.</p><p><strong>Conclusions: </strong>This trial demonstrated folate deficiency in nearly all patients starting olaparib within weeks but, deficiencies did not result in a clinically significant anemia. Folate levels normalized with supplementation and improved with olaparib discontinuation. This data warrant checking serum folate in patients receiving olaparib who develop anemia and replacing folate if deficiency is found.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145180170","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
OncologistPub Date : 2025-09-27DOI: 10.1093/oncolo/oyaf314
Elysse Bautista-González, Yanin Chavarri-Guerra, Anne Peasey, Hynek Pikhart, Cecilia Vindrola-Padros
{"title":"The Role of Patient Navigation Programs in Early Cancer Care in Mexico: A Multi-Case Qualitative Study.","authors":"Elysse Bautista-González, Yanin Chavarri-Guerra, Anne Peasey, Hynek Pikhart, Cecilia Vindrola-Padros","doi":"10.1093/oncolo/oyaf314","DOIUrl":"https://doi.org/10.1093/oncolo/oyaf314","url":null,"abstract":"<p><strong>Background: </strong>In Mexico, academic publications on patient navigation are notably scarce. Thus, limited evidence in Mexico suggests that patient navigation programs (PNP) may play a promising role in early cancer care. The study's aim is to identify and describe PNP in Mexico, particularly their role in early diagnosis and opportune treatment.</p><p><strong>Methods: </strong>through an exploratory qualitative cross-sectional case study design. Five different programs were identified using snowball sampling. Thematic guides were developed. Data were collected through funnel-shaped semi-structured interviews with patient navigation providers. After familiarizing with the identified themes, codes were generated inductively.</p><p><strong>Results: </strong>PNP in Mexico navigate one or multiple types of cancer patients, using heterogeneous sources of funding, navigate one or multiple levels of healthcare and from within or outside of the healthcare system; they aim to improve access to healthcare, address barriers, and reduce wait times. However, PNP often engage in activities that are not aligned with their objectives. In assessing their impact, disparities are not measured, and none collect data on time intervals.</p><p><strong>Conclusion: </strong>Using theoretical frameworks and logic models can support the implementation of new PNP, guide early diagnosis and treatment outcome measurement, and assess impact-ultimately helping ensure financial sustainability.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145180390","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
OncologistPub Date : 2025-09-27DOI: 10.1093/oncolo/oyaf309
Jing Huang, Qiang He, Jufang Wang, Chunbao Zhai
{"title":"Prognostic value of miR-21 in CRC, PDAC, and ESCC: Updated systematic review and Meta-Analysis.","authors":"Jing Huang, Qiang He, Jufang Wang, Chunbao Zhai","doi":"10.1093/oncolo/oyaf309","DOIUrl":"https://doi.org/10.1093/oncolo/oyaf309","url":null,"abstract":"<p><strong>Objective: </strong>This study aims to conduct a systematic review of the prognostic value of miR-21 expression levels in patients with colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), and esophageal squamous cell carcinoma (ESCC).</p><p><strong>Methods and results: </strong>We searched the PubMed, Embase, and CENTRAL databases for relevant studies published up to August 25, 2023. Sixteen studies, totaling 3096 patients, were included. High miR-21 expression was associated with higher HR values and decreased overall survival (OS) in CRC and PDAC, but this effect was not statistically significant in ESCC. The pooled HRs for CRC, PDAC, and ESCC were 1.54 (95% CI: 1.14 to 2.07; P = 0.004; I2 = 71%), 2.11 (95% CI: 1.81 to 2.46; P < 0.001; I2 = 0%), and 1.79 (95% CI: 0.82 to 3.92; P = 0.15; I2 = 75%), respectively. Patients with high miR-21 expression had higher HR values and decreased disease-free survival (DFS) compared to those with low miR-21 expression in all three cancer types. The pooled HRs for CRC, PDAC, and ESCC were 1.88 (95% CI: 1.36 to 2.60; P < 0.001; I2 = 59%), 2.04 (95% CI: 1.34 to 3.11; P < 0.001; I2 = 17%), and 1.77 (95% CI: 1.04 to 3.03; P = 0.04; I2 = 36%), respectively.</p><p><strong>Conclusion: </strong>Elevated miR-21 expression levels are associated with poorer OS and DFS in patients with colorectal cancer, pancreatic cancer, and esophageal cancer. However, due to heterogeneity in the results, further large-sample, high-quality studies are needed to validate these findings.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145180370","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
OncologistPub Date : 2025-09-27DOI: 10.1093/oncolo/oyaf319
Pankaj Kumar Garg
{"title":"The Indiscriminate Nature of Cancer: A Great Equalizer.","authors":"Pankaj Kumar Garg","doi":"10.1093/oncolo/oyaf319","DOIUrl":"https://doi.org/10.1093/oncolo/oyaf319","url":null,"abstract":"","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145180434","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
OncologistPub Date : 2025-09-26DOI: 10.1093/oncolo/oyaf311
Sara M Tolaney, Guru P Sonpavde, Paolo Tarantino, Maryam B Lustberg, Hope S Rugo
{"title":"Clinical Perspective on Management of Key Adverse Events With Sacituzumab Govitecan.","authors":"Sara M Tolaney, Guru P Sonpavde, Paolo Tarantino, Maryam B Lustberg, Hope S Rugo","doi":"10.1093/oncolo/oyaf311","DOIUrl":"https://doi.org/10.1093/oncolo/oyaf311","url":null,"abstract":"<p><p>Sacituzumab govitecan (SG) is a first-in-class trophoblast cell surface antigen-2-directed antibody-drug conjugate that selectively delivers a well-characterized and potent payload of SN-38 to cancer cells and the surrounding environment. In the United States, SG is indicated for unresectable, locally-advanced or metastatic triple-negative breast cancer (TNBC) and hormone receptor-positive/human epidermal growth factor receptor 2-negative (immunohistochemistry 0, 1+, or 2+/in situ hybridization-negative) breast cancer (HR+/HER2- BC). Real-world management of SG-related adverse events can vary widely from clinical studies. Therefore, it is vital to provide clinicians with first-hand experience to aid in the management and support of patients before treatment initiation. In clinical studies (IMMU-132-01, ASCENT, TROPiCS-02, and TROPHY-U-01), the pooled incidence of key adverse events was 61% for neutropenia, 64% for diarrhea, 51% for fatigue, and 45% for alopecia. Here, we discuss the incidence of neutropenia, diarrhea, fatigue, and alopecia associated with SG treatment and provide recommendations on their management based on established guidelines and personal clinical experience. We also discuss important risk factors such as UGT1A1 polymorphism and advanced age (eg, ≥65 years). From our practical experience, we present a case of a patient with TNBC experiencing neutropenia and diarrhea and another with HR+/HER2- BC experiencing diarrhea. Our review provides practicing oncologists considering SG therapy important information regarding its safe and appropriate use in real-world settings to maximize clinical benefit for patients with locally-advanced or metastatic TNBC and HR+/HER2- BC.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145180330","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}