ESMO Gastrointestinal Oncology最新文献

{"title":"Re-evaluating population-level screening recommendations to address increasing early-onset colorectal cancer rates in Australia: a modelling study☆","authors":"J.-B. Lew ,&nbsp;J. Worthington ,&nbsp;H. Ge ,&nbsp;Q. Luo ,&nbsp;E. Feletto ,&nbsp;K. Canfell ,&nbsp;T. Price ,&nbsp;Cancer Council Australia Colorectal Cancer Screening Working Party","doi":"10.1016/j.esmogo.2025.100136","DOIUrl":"10.1016/j.esmogo.2025.100136","url":null,"abstract":"<div><h3>Background</h3><div>The National Bowel Cancer Screening Program (NBCSP) sends free immunochemical faecal occult blood tests (iFOBTs) to eligible Australians aged 50-74 every 2 years. Rising early-onset colorectal cancer (CRC) rates in people under 50 have raised questions around optimising the NBCSP, contributing to the rationale for updating Australian CRC screening guidelines. To support this, alternative screening age ranges and approaches were evaluated.</div></div><div><h3>Methods</h3><div>A microsimulation model was used to estimate the impact of 2-yearly iFOBT screening starting at age 40, 45 or 50 and/or stopping at 74, 79, or 84 in cohorts with rising incidence rates. Yearly iFOBT screening and 5-yearly stool biomarker testing were also analysed.</div></div><div><h3>Results</h3><div>Lowering screening start ages to 45 or 40 could reduce CRC mortality rates by 5% and 10%, respectively, while extending stop ages to 79 or 85 could reduce CRC mortality rates by 3% and 5%, respectively. Lowering the start age would be more cost-effective and have a more favourable balance of benefits to harms versus raising the stop age.</div></div><div><h3>Conclusion</h3><div>As early-onset CRC rates increase, lowering the screening start age could reduce CRC burden while remaining cost-effective and limiting harms. Based on these findings and implementation considerations, the Cancer Council Australia Colorectal Cancer Screening Working Party determined that 2-yearly iFOBT screening from age 45 to 74 was the most favourable. These analyses supported the 2023 <em>Clinical practice guidelines for the prevention, early detection and management of colorectal cancer: Population Screening</em>, which led to the NBCSP including people aged 45-49 on an opt-in basis from July 2024.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"7 ","pages":"Article 100136"},"PeriodicalIF":0.0,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"CD147-expressed small extracellular vesicles enhance the detection of colorectal neoplasia with fecal immunochemical test","authors":"L.-C. Chang ,&nbsp;B.-R. Lin ,&nbsp;H.-M. Chiu ,&nbsp;M.-S. Wu ,&nbsp;T. Ochiya ,&nbsp;T.-L. Shen","doi":"10.1016/j.esmogo.2025.100140","DOIUrl":"10.1016/j.esmogo.2025.100140","url":null,"abstract":"<div><h3>Background</h3><div>Blood testing increases adherence to colorectal cancer (CRC) screening. The suboptimal detection of advanced adenoma (AA) and early-stage CRC by blood tests limits their application. The current study aims to investigate the diagnostic performance of CD147-expressed small extracellular vesicles (CD147) in the serum in combination with the fecal immunochemical test (FIT) for detecting AA and CRC.</div></div><div><h3>Patients and methods</h3><div>The case-control study enrolled 15 healthy controls and 50 CRC patients in the training cohort and 120 healthy controls, 50 non-AA patients, 50 AA patients, and 60 CRC patients in the validation cohort. CD147 was detected using the ExoScreen assay. The sensitivity and specificity of CD147 alone and combined with the FIT for detecting colorectal neoplasia were compared.</div></div><div><h3>Results</h3><div>CD147 could detect AA and CRC with a sensitivity of 58.0% and 71.7%, respectively. Combined with a 1-day FIT, the sensitivity for detecting AA and CRC would increase to 78.0% and 93.3%, respectively. Moreover, CD147 with 1-day FIT had a higher sensitivity than 1-day FIT alone for detecting proximal CRC (100% versus 89.5%). Besides, CD147 may detect 57.7% and 50.0% of the AA and CRC that FIT failed to detect, respectively. However, the specificity and false-positive rate of CD147 were inferior to those of FIT for detecting AA and CRC.</div></div><div><h3>Conclusions</h3><div>CD147 is superior to FIT for detecting AA and proximal neoplasia. Moreover, CD147 can increase the sensitivity of FIT for detecting either AA or CRC by combinatory use. However, false positivity is the concern of CD147, which should be further resolved in the future.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"7 ","pages":"Article 100140"},"PeriodicalIF":0.0,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143394896","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Molecular analysis in pancreatic adenocarcinoma: a real-world study from high-volume French centres (CAPANCOBIO study)","authors":"C. Evrard ,&nbsp;M. Brugel ,&nbsp;G. Piessen ,&nbsp;G. Roth ,&nbsp;N. Williet ,&nbsp;V. Hautefeuille ,&nbsp;H. Trelohan ,&nbsp;M. Muller ,&nbsp;O. Bouché ,&nbsp;D. Tougeron","doi":"10.1016/j.esmogo.2025.100142","DOIUrl":"10.1016/j.esmogo.2025.100142","url":null,"abstract":"<div><h3>Background</h3><div>In pancreatic adenocarcinoma (PA) it is crucial to better understand the molecular biology and identify targetable molecular alterations to obtain therapeutic improvements.</div></div><div><h3>Methods</h3><div>The aim of the CAPANCOBIO study was to assess routine clinical practice regarding tumour somatic molecular analysis (SMA) in patients with unresectable PA. Tumour SMAs for patients with advanced PA were collected in nine high-volume French centres from September 2019 to October 2021 to identify factors influencing the prescription of SMA.</div></div><div><h3>Results</h3><div>Among the 397 patients included in the CAPANCOBIO study, 70 had an SMA (17.6%). The most frequent tests were next-generation sequencing analysis (70.0%). Among the 70 patients with SMA, 31 (44.3%) had at least one alteration detected, but only 6 patients had targetable alterations. Among these, only one patient (<em>n</em> = 1/6, 16.6%) was included in a clinical trial. Patients with SMA were younger (<em>P</em> &lt; 0.0001), more often female (<em>P</em> = 0.007), and more frequently had a family history of the <em>BRCA</em> cancer spectrum (<em>P</em> = 0.017).</div></div><div><h3>Conclusions</h3><div>Few patients with advanced PA had SMA of the tumour. Despite patients with targetable molecular alterations identified, very few patients were treated with targeted therapy and/or included in a clinical trial. It is essential to increase SMA for advanced PA in routine clinical practice to increase the use of targeted therapy and inclusions in clinical trials.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"7 ","pages":"Article 100142"},"PeriodicalIF":0.0,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143387239","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A stratified two-stage tumor molecular profiling algorithm to identify clinically actionable molecular alterations in pancreatic cancer☆","authors":"S. Hussung ,&nbsp;D. Akhoundova ,&nbsp;C. Pistoni ,&nbsp;D. Lenggenhager ,&nbsp;A. Töpfer ,&nbsp;C. Pauli ,&nbsp;B. Pestalozzi ,&nbsp;C. Britschgi ,&nbsp;M. Zoche ,&nbsp;M. Rechsteiner ,&nbsp;H. Moch ,&nbsp;A. Weber ,&nbsp;R. Fritsch","doi":"10.1016/j.esmogo.2025.100134","DOIUrl":"10.1016/j.esmogo.2025.100134","url":null,"abstract":"<div><h3>Background</h3><div>Tumor molecular profiling (TMP) for pancreatic cancer (PC) is recommended by current international guidelines, yet no testing standards exist. Moreover, the magnitude of benefit and the cost-effectiveness of comprehensive next-generation sequencing panels for PC are under debate.</div></div><div><h3>Materials and methods</h3><div>We implemented a stratified two-stage TMP algorithm for advanced PC. Stage 1 comprised immunohistochemistry for mismatch repair deficiency and targeted sequencing employing a 33-gene next-generation sequencing panel covering common PC drivers and DNA damage response genes. Based on pre-specified events (<em>KRAS</em> wild type, mismatch repair deficiency, molecular tumor board recommendation), subsequent comprehensive molecular testing was carried out (stage 2). We report molecular findings and patient outcomes.</div></div><div><h3>Results</h3><div>A total of 94 PC patients were included in the study. Some 63/94 (67.0%) patients underwent TMP according to the algorithm, of which 5/63 (7.9%) fulfilled criteria for subsequent stage 2 comprehensive testing. A total of 31/94 (33%) patients underwent upfront comprehensive molecular testing outside the algorithm based on referring physician’s request. Compared with algorithm testing, upfront comprehensive testing detected a higher number of pathogenic molecular alterations/patient (median: five versus three, <em>P</em> = 0.0005), however no additional actionable alterations. Actionable alterations were identified in 25/94 (26.6%) cases, including DNA damage response gene alterations, KRAS G12C and targetable drivers in <em>KRAS</em> wild type tumors. Patients receiving targeted therapy based on molecular profile showed superior survival (progression-free survival, overall survival) compared with patients without targeted treatment.</div></div><div><h3>Conclusions</h3><div>Stratified two-stage TMP reliably identifies actionable alterations in PC patients, with potential therapeutic benefit. The proposed TMP algorithm might be as effective, yet more feasible and economic compared with comprehensive upfront testing.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"7 ","pages":"Article 100134"},"PeriodicalIF":0.0,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143377394","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Virtual reality support during systemic cancer therapy to improve anxiety/depressive symptoms and reduce toxicity in patients with gastrointestinal cancers—OncoVR","authors":"S. Kasper ,&nbsp;S. Liszio ,&nbsp;K. Schorrmann ,&nbsp;M. Gerigk ,&nbsp;S. Jovic ,&nbsp;O. Basu ,&nbsp;K. Kostbade ,&nbsp;B. Goraus ,&nbsp;A. Elsakka ,&nbsp;B. Puladi ,&nbsp;J. Kleesiek ,&nbsp;M. Schuler ,&nbsp;G. Luijten ,&nbsp;J. Egger","doi":"10.1016/j.esmogo.2025.100135","DOIUrl":"10.1016/j.esmogo.2025.100135","url":null,"abstract":"<div><h3>Background</h3><div>Systemic cancer therapy may trigger anxiety/depressive symptoms and toxicity. Relaxation techniques can help alleviate toxicities but their implementation in clinical practice is challenging. We hypothesize that virtual reality (VR) systems which project a relaxing nature environment may help to reduce psychological stress and toxicities of cancer therapies. This trial aims to evaluate the feasibility of a supportive VR intervention in patients receiving cancer therapies in an outpatient setting.</div></div><div><h3>Patients and methods</h3><div>OncoVR is a randomized, open-label, cross-over trial to investigate the feasibility and impact of VR support during cancer therapy to improve anxiety, depressive symptoms, and toxicity in patients with gastrointestinal cancers. In total, 54 participants will be assigned to receive systemic therapy with VR support, followed by a subsequent course without VR support (arm A). Patients in arm B will first receive therapy without VR support, followed by a subsequent course with VR support. Primary endpoints are the feasibility of VR support (80% of the patients can tolerate its use for a minimum duration of 20 min), and changes in anxiety/depressive symptoms using the Hospital Anxiety and Depression Scale (HADS-D) and Positive and Negative Affect Schedule (PANAS) questionnaires. Secondary endpoints include the incidence and severity of therapy-associated toxicities per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) and Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE) grading, and patient experience using the Player Experience Inventory (PXI) questionnaire.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"7 ","pages":"Article 100135"},"PeriodicalIF":0.0,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143159540","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and characterization of orthotopic patient-derived xenograft models of peritoneal metastatic mucinous appendiceal adenocarcinoma","authors":"I. Ito ,&nbsp;V.K. Pattalachinti ,&nbsp;A.M.G. Yousef ,&nbsp;S. Chowdhury ,&nbsp;M.M. Fanaeian ,&nbsp;E. Haque ,&nbsp;B.B. Gunes ,&nbsp;M. Yousef ,&nbsp;E.R. Salle ,&nbsp;M.A. Zeineddine ,&nbsp;S. Ji ,&nbsp;R. Li ,&nbsp;W. Wang ,&nbsp;B.A. Helmink ,&nbsp;M.W. Taggart ,&nbsp;M.G. White ,&nbsp;K.F. Fournier ,&nbsp;N.W. Fowlkes ,&nbsp;J.P. Shen","doi":"10.1016/j.esmogo.2025.100133","DOIUrl":"10.1016/j.esmogo.2025.100133","url":null,"abstract":"<div><h3>Background</h3><div>Appendiceal adenocarcinomas (AAs) are a rare and heterogeneous group of tumors for which few preclinical models exist. The lack of preclinical models of AA has hindered drug development and is a major factor in why AA remains without a single Food and Drug Administration-approved systemic treatment.</div></div><div><h3>Materials and methods</h3><div>Tumors from 16 patients with appendiceal neoplasms (15 AAs and 1 high-grade appendiceal neoplasm) were implanted into the flank and the peritoneal cavity of immunodeficient mice leading to the successful establishment of three AAPDX models. Histological, immunohistochemical, genetic, and transcriptomic comparisons of patient and patient-derived xenograft (PDX) tumors were carried out.</div></div><div><h3>Results</h3><div>Higher tumor grade, peritoneal implantation, and RAS/RAF mutation were associated with successful tumor engraftment. Comparison of histological, immunohistochemical, and molecular analyses including both RNA and DNA sequencing revealed that the PDX models recreate many of the features of metastatic AAs, but also displayed several differences between paired PDX and human tumors, highlighting the intratumoral heterogeneity of AAs within each patient. Notably tumors from two patients with primarily low-grade mucinous adenocarcinoma converted to high-grade histology in PDX. Transcriptomic comparison of patient and PDX tumors identified increased Myc and E2F signaling, suggesting that activation of Myc may be a driver of the dedifferentiation of AAs. The established PDX models were able to undergo serial passaging and expansion and exhibited stable histological features during this process, allowing for drug testing.</div></div><div><h3>Conclusions</h3><div>These molecularly profiled, orthotopic PDX models of metastatic AAs represent a unique resource for future exploration to identify novel therapies for this orphan disease.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"7 ","pages":"Article 100133"},"PeriodicalIF":0.0,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143159957","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Breath- and blood-based molecular assessment for gastroesophageal cancer","authors":"S. Vanstraelen ,&nbsp;F. Van Herpe ,&nbsp;J. Dekervel ,&nbsp;P. Nafteux","doi":"10.1016/j.esmogo.2025.100132","DOIUrl":"10.1016/j.esmogo.2025.100132","url":null,"abstract":"<div><div>Gastroesophageal cancer remains a significant health care problem characterized by diagnosis at advanced stages, rendering a significant proportion of patients ineligible for curative treatment. Conversely, early diagnosis and treatment of gastroesophageal cancer demonstrates markedly improved outcomes, with 5-year overall survival rates ranging from 83% to 96%. To date, gastroesophageal cancer surveillance primarily focuses on patients with Barrett’s esophagus, relying on invasive upper endoscopy. However, despite its high specificity, upper endoscopy demonstrates a suboptimal cancer yield and moderate missed rates, compromising its cost-effectiveness for screening in the general population. Moreover, screening strategies for gastroesophageal cancer are still lacking, in part owing to the invasiveness of current diagnostic methods.</div><div>To overcome these challenges, innovative minimally invasive technologies have emerged, including metabolomics of exhaled breath, and detection of circulating tumor DNA or proteomics in blood. Promising results from phase I diagnostic trials emphasize the potential of these approaches to advance early detection and monitoring of gastroesophageal cancer. As these methods further refine and consistently demonstrate adequate sensitivity and specificity, they are poised to challenge existing diagnostic modalities. This progress may prompt reconsideration of current one-size-fits-all paradigms, facilitating the evolution toward a patient-tailored management of gastroesophageal cancer.</div><div>In this article, we review the current minimally invasive breath- and blood-based diagnostic approaches for gastroesophageal cancer, elucidating the underlying biologic basis of identifiable biomarkers. As these approaches will become an integral part of future diagnostic paradigms, understanding the operational mechanisms, strengths, and limitations of these approaches is crucial for optimizing their implementation and interpretability in clinical practice.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"7 ","pages":"Article 100132"},"PeriodicalIF":0.0,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143159962","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"TAMs and PD-1 networking in esophageal cancer: literature review","authors":"M. Yerolatsite ,&nbsp;N. Torounidou ,&nbsp;A. Batistatou ,&nbsp;K. Katsanos ,&nbsp;E. Lampri ,&nbsp;A.-L. Amylidi ,&nbsp;D. Mauri","doi":"10.1016/j.esmogo.2024.100130","DOIUrl":"10.1016/j.esmogo.2024.100130","url":null,"abstract":"<div><h3>Background</h3><div>The tumor microenvironment (TME) exerts a profound influence on the progression of cancer cells. Tumor-associated macrophages (TAMs), the most abundant cell population within the TME, exhibit a complex, dual role. On the one hand, TAMs promote inflammation and help eliminate cancer cells; on the other hand, they often adopt an anti-inflammatory role that contributes to the evolution of cancer cells. Furthermore, the programmed cell death protein 1/programmed death-ligand 1 (PD-1/PD-L1) signaling pathway plays a critical role in both the adaptive and innate immune responses. This study aims to understand the roles of TAMs and the PD-1/PD-L1 signaling network in esophageal cancer.</div></div><div><h3>Methods</h3><div>We conducted a systematic review of published data using the Medline (PubMed), Scopus, and Cochrane databases. We included articles that investigated the coexistence of TAMs and the PD-1/PD-L1 pathway in esophageal cancer. Studies that evaluated the clinical prognosis of patients with elevated levels of PD-1-positive TAMs were also incorporated.</div></div><div><h3>Results</h3><div>Six articles comprising a total of 822 patients were included in the review. The data indicate a positive correlation between PD-L1 expression and TAMs infiltration. Additionally, patients with high levels of PD-1-positive TAMs tend to have a worse prognosis compared with those with lower levels.</div></div><div><h3>Conclusions</h3><div>TAMs play a crucial role in regulating the PD-1/PD-L1 network and the progression of esophageal cancer. Further studies are necessary, however, to clarify the roles of TAMs and the PD-1/PD-L1 network in esophageal cancers.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"7 ","pages":"Article 100130"},"PeriodicalIF":0.0,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143159536","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"TROPHIT1—a randomized, open-label, multicenter, phase II/III trial of sacituzumab govitecan compared to standard of care in metastatic colorectal cancer patients","authors":"B.C. Köhler ,&nbsp;G.M. Haag ,&nbsp;L. Le Cornet ,&nbsp;P. Hoffmeister-Wittmann ,&nbsp;M. Schmidt ,&nbsp;A. Manjunath ,&nbsp;N. Vaquero-Siguero ,&nbsp;M. Jenzer ,&nbsp;M. Gimmel ,&nbsp;A. Stahler ,&nbsp;A. Stein ,&nbsp;M. Reichert ,&nbsp;S. Kasper ,&nbsp;M. Bitzer ,&nbsp;D. Jäger ,&nbsp;C. Springfeld ,&nbsp;T.F. Weber ,&nbsp;S. Fröhling ,&nbsp;K. Steindorf ,&nbsp;A. Trumpp ,&nbsp;R. Jackstadt","doi":"10.1016/j.esmogo.2024.100118","DOIUrl":"10.1016/j.esmogo.2024.100118","url":null,"abstract":"<div><h3>Background</h3><div>Colorectal cancer (CRC) ranks among the most common malignancies worldwide. Response rates to standard-of-care (SOC) treatment drop sharply beyond the second treatment line. Trophoblast cell surface antigen-2 (TROP2) acts in a plethora of cellular processes and ectopic expression is detected in a significant percentage of CRCs. Sacituzumab govitecan (SG) is composed of a TROP2-directed antibody armed with the topoisomerase inhibitor SN38. Thus, SG delivers SN38 to TROP2-expressing cancer cells. SG is approved for the treatment of metastatic breast cancer. Phase I/II data revealed a favorable safety profile and early signs of clinical activity in unselected metastatic CRC (mCRC).</div></div><div><h3>Patients and methods</h3><div>TROPHIT1 is an open-label, randomized, multicenter, phase II/III trial to investigate the efficacy of SG in mCRC. Patients being refractory to ≥2 lines of prior therapy and an irinotecan-free interval of at least 6 months are enrolled. In the first part of the study, 20 patients are enrolled in the single-agent SG arm. Upon clinical efficacy in the first part, additional 60 patients are randomized (1 : 1) in the second part to single-agent SG compared with SOC. The primary endpoint is progression-free survival. TROPHIT1 contains a translational research program to unravel the determinants of resistance.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"7 ","pages":"Article 100118"},"PeriodicalIF":0.0,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143159541","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Consensus guidance for prevention and management of nausea and vomiting in patients treated with zolbetuximab + chemotherapy: a RAND/UCLA modified Delphi panel study","authors":"S.J. Klempner ,&nbsp;R.A. Pazo-Cid ,&nbsp;S. Lonardi ,&nbsp;L. Swanson ,&nbsp;M.J. Arango ,&nbsp;P. Enzinger ,&nbsp;A.H. Ko ,&nbsp;G.M. Vaccaro ,&nbsp;K. Yamaguchi ,&nbsp;A. Saeed ,&nbsp;K.-W. Lee ,&nbsp;K. Shitara ,&nbsp;D. Ilson ,&nbsp;J.A. Ajani ,&nbsp;R. Fuldeore ,&nbsp;S. Braun ,&nbsp;M.S. Broder ,&nbsp;M.A. Shah","doi":"10.1016/j.esmogo.2024.100131","DOIUrl":"10.1016/j.esmogo.2024.100131","url":null,"abstract":"<div><h3>Background</h3><div>This study aims to develop consensus-based guidelines to prevent and manage nausea and vomiting in patients treated with zolbetuximab plus chemotherapy.</div></div><div><h3>Materials and methods</h3><div>An international Delphi panel included 15 experts who were involved in phase II or III clinical studies of zolbetuximab. A rating survey was developed, informed by literature and clinical experience, consisting of hypothetical scenarios of patients and interventions to prevent and manage nausea and vomiting during treatment with zolbetuximab plus chemotherapy. In April 2024, panelists rated the appropriateness of interventions on a scale of 1-9, discussed areas of disagreement in a virtual meeting, and repeated ratings following the meeting. The consensus was summarized based on responses to the second-round survey.</div></div><div><h3>Results</h3><div>Areas of agreement were broader in the second-round survey than in the first-round survey, with panelists agreeing on 84.8% of ratings (second round) compared with 55.9% (first round). Agreement was reached on at least one management strategy for before and during the first zolbetuximab infusion and subsequent infusions. The Delphi panel endorses using the National Comprehensive Cancer Network® (NCCN®)-recommended regimens for high emetic risk prophylactically. During infusions, the Delphi panel suggested modifying the zolbetuximab infusion rate, interrupting zolbetuximab infusions temporarily for 30-60 min, administering antiemetic medications not used for prophylaxis, and/or providing intravenous hydration.</div></div><div><h3>Conclusions</h3><div>These consensus-based guidelines can be utilized by clinicians to guide the prevention and management of nausea and vomiting in patients treated with zolbetuximab plus chemotherapy so that patients can continue receiving treatment and achieve benefits.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"7 ","pages":"Article 100131"},"PeriodicalIF":0.0,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143159958","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}