ESMO Gastrointestinal Oncology最新文献

{"title":"This is not Lynch syndrome: lessons from misattributed diagnoses in constitutional mismatch repair deficiency","authors":"A.H. Mohammad ,&nbsp;E. Rohr ,&nbsp;A. Moise ,&nbsp;R.M. Abdulsalam ,&nbsp;W. Davalan ,&nbsp;A. Rizzolo ,&nbsp;A.S. Liberman ,&nbsp;C. Goudie ,&nbsp;L. Palma ,&nbsp;W.D. Foulkes","doi":"10.1016/j.esmogo.2024.100111","DOIUrl":"10.1016/j.esmogo.2024.100111","url":null,"abstract":"<div><h3>Background</h3><div>Underdiagnosis of constitutional mismatch repair deficiency (CMMRD) syndrome leads to suboptimal cancer surveillance and management of CMMRD patients. Assessing pitfalls that led to the misdiagnosis of CMMRD is important to improve care trajectories, and to highlight the importance of accurate molecular and pathology-based assessment of patients presenting with CMMRD-associated features.</div></div><div><h3>Materials and methods</h3><div>A retrospective chart review of two patients with molecularly confirmed CMMRD ascertained through the Medical Genetics service of the McGill University Health Centre (MUHC) was conducted to study the pathway and pitfalls to diagnosis. Records were reviewed and summarized as timelines to depict important events relating to diagnosis and management of CMMRD patients.</div></div><div><h3>Results</h3><div>Unfamiliarity with CMMRD contributed to a diagnosis delay and initiation of CMMRD-specific surveillance. Pitfalls along the diagnostic pathway included inaccurate clinical information relayed to pathologists, unfamiliarity with CMMRD-defining features on immunohistochemistry (IHC) analyses, IHC variability and unreliability, and lack of awareness of the pivotal role for medical genetics in the diagnosis of CMMRD.</div></div><div><h3>Conclusions</h3><div>Improved awareness of CMMRD in patients presenting with CMMRD-associated features can help guide IHC analysis and expedite referral to medical genetics for accurate molecular diagnosis. Consequently, timely CMMRD diagnosis improves surveillance and patient management and allows for appropriate genetic counseling for family members.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"6 ","pages":"Article 100111"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143147137","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":"PD-L1 as a response biomarker to chemotherapy plus immune checkpoint inhibitors in operable gastroesophageal adenocarcinoma: a meta-analysis of neoadjuvant clinical trials","authors":"A. Cammarota ,&nbsp;S.K. Kamarajah ,&nbsp;S. Markar ,&nbsp;E.C. Smyth","doi":"10.1016/j.esmogo.2024.100107","DOIUrl":"10.1016/j.esmogo.2024.100107","url":null,"abstract":"<div><h3>Background</h3><div>Perioperative chemoimmunotherapy [i.e. chemotherapy plus immune checkpoint inhibitor (ICI) (ChT–ICI)] is an investigational treatment for operable gastroesophageal adenocarcinoma (GEA) with unclear outcomes in an unselected population. We aimed to assess the cumulative treatment effect of ChT–ICI on pathological response rates, the surrogacy of pathological response rates on overall survival (OS), and the value of programmed death-ligand 1 (PD-L1) as a biomarker of response to ICIs in operable GEA.</div></div><div><h3>Methods</h3><div>We conducted a systematic review and meta-analysis of randomised clinical trials (RCTs) of ChT with or without ICIs with the primary outcome being pathological response rates [pathological complete response (pCR) and similar metrics]. A weighted linear regression model quantified the relationship between pathological response rates and OS using a determination coefficient (<em>R</em>²). A second meta-regression analysed the predictive effect of PD-L1 on pCR in trials of ICIs with ChT or chemoradiotherapy (CRT).</div></div><div><h3>Results</h3><div>A total of 18 records from 15 RCTs were included. Of 6624 patients, 5291 received ChT and 1333 ChT–ICI. ChT–ICI significantly improved pathological response rates [pooled odds ratio 3.18, 95% confidence interval (CI) 2.42-4.18, <em>P</em> &lt; 0.0001] compared with ChT (pooled odds ratio 1.66, 95% CI 1.33-2.07, <em>P</em> &lt; 0.0001). The correlation between pathological response and OS was low (<em>R</em>² = 0.12) but improved in recent trials (<em>R</em>² = 0.51) and those with ChT–biological agents, including ICIs (<em>R</em>² = 0.79). In the second analysis (11 studies, 633 patients), PD-L1 ≥5 was a significant predictor of response both individually (estimate: 0.73, 95% CI 0.28-1.18, <em>P</em> = 0.001) and after accounting for the backbone treatment (estimate: 0.80, 95% CI 0.28-1.33, <em>P</em> = 0.003).</div></div><div><h3>Conclusions</h3><div>Perioperative ChT–ICI improves pathological response rates in operable GEA and PD-L1 ≥5 is a significant biomarker of pCR, supporting stratification by PD-L1 and the design of biomarker-selected trials.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"6 ","pages":"Article 100107"},"PeriodicalIF":0.0,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142722394","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":"Practical management of oligometastatic gastric cancer","authors":"Y. Narita ,&nbsp;K. Muro ,&nbsp;D. Takahari","doi":"10.1016/j.esmogo.2024.100108","DOIUrl":"10.1016/j.esmogo.2024.100108","url":null,"abstract":"<div><div>Gastric cancer is one of the types of cancer with a high prevalence of morbidity. The frequency of esophagogastric junction cancer, 5-year survival rates, perioperative adjuvant therapy, and standard chemotherapeutic regimens for gastric cancer vary between Asian countries and the West. Although oligometastasis is considered an intermediate state between localized and systemic disease, no standardized definition regarding metastatic organ sites or international consensus in gastric cancer exists. Both local treatment, such as radical surgery and radiotherapy, and systemic chemotherapy can be employed for treating patients with gastric cancer with oligometastatic disease. Recently, evidence for oligometastatic gastric cancer has been accumulated, including findings from several clinical trials conducted in Asian and Western countries, focusing on both organ-specific and non-organ-specific oligometastatic gastric cancer. Here, we review the latest findings on oligometastasis in gastric cancer, including variations in treatment strategies between Western and Asian countries. Further investigation is needed to determine the most favorable practical management strategies for patients with metachronous oligometastasis in gastric cancer, including the use of molecular-targeted agents and immune checkpoint inhibitors. The results of ongoing trials may shed light on the optimal treatment approaches for oligometastatic disease.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"6 ","pages":"Article 100108"},"PeriodicalIF":0.0,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142704083","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":"Risk factor of severe diarrhea and enterocolitis induced by CAPOX: a retrospective multicenter study","authors":"A. Teixeira ,&nbsp;T. Felismino ,&nbsp;M.D. Donadio ,&nbsp;G. Catani ,&nbsp;A.L.M. da Silva ,&nbsp;R. Weschenfelder ,&nbsp;R.D. Peixoto ,&nbsp;J.M. O’Connor ,&nbsp;A.K. Coutinho ,&nbsp;R.P. Riechelmann","doi":"10.1016/j.esmogo.2024.100110","DOIUrl":"10.1016/j.esmogo.2024.100110","url":null,"abstract":"<div><h3>Background</h3><div>We have previously suggested that concurrent use of capecitabine plus oxaliplatin (CAPOX) and angiotensin receptor blockers (ARBs) significantly increased the risk of severe diarrhea and/or enterocolitis. We conducted a multicenter larger study to validate this finding, adjusting for other risk factors.</div></div><div><h3>Patients and methods</h3><div>This was a retrospective multicenter study of patients with colorectal cancer treated with at least one cycle of CAPOX. The primary endpoint was grade (G) ≥3 diarrhea and/or enterocolitis induced by CAPOX. Unadjusted and adjusted logistic regression models were used to evaluate risk factors for G ≥3 diarrhea and/or enterocolitis. <em>P</em> &lt; 0.05 was deemed significant.</div></div><div><h3>Results</h3><div>From April 2010 to December 2023, 362 patients were included. In univariate analyses, age ≥65 years, right-sided tumors, use of ARBs or angiotensin-converting enzyme inhibitors (ACEi), age-adjusted Charlson Comorbidity Index, and estimated glomerular filtration rate (eGFR) &lt;60 ml/min were associated with G ≥3 diarrhea and/or enterocolitis. In the multivariable analysis, age ≥65 years [odds ratio (OR) 2.71, 95% confidence interval (CI) 1.38-5.33, <em>P</em> = 0.004] and eGFR &lt;60 ml/min (OR 5.4, 95% CI 2.25-13.8, <em>P</em> &lt; 0.001), but not use of ARBs or ACEi, were significant.</div></div><div><h3>Conclusions</h3><div>Age ≥65 years and eGFR &lt;60 ml/min were independent risk factors for G ≥3 diarrhea/enterocolitis in patients treated with CAPOX. Concurrent use of ARBs or ACEi was not associated with G ≥3 diarrhea/enterocolitis.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"6 ","pages":"Article 100110"},"PeriodicalIF":0.0,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142704082","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":"Genetic and transcriptomic analyses of early-onset colon cancer (EOCC): a post hoc analysis of 2973 patients from two adjuvant randomized trials","authors":"A. Gandini ,&nbsp;C. Gallois ,&nbsp;H. Blons ,&nbsp;C. Mulot ,&nbsp;N. Agueeff ,&nbsp;C. Lepage ,&nbsp;R. Guimbaud ,&nbsp;L. Mineur ,&nbsp;J. Desramé ,&nbsp;B. Chibaudel ,&nbsp;A. de Reyniès ,&nbsp;T. André ,&nbsp;P. Laurent-Puig ,&nbsp;J. Taieb","doi":"10.1016/j.esmogo.2024.100106","DOIUrl":"10.1016/j.esmogo.2024.100106","url":null,"abstract":"<div><h3>Background</h3><div>Despite decreasing colon cancer (CC) incidence worldwide, an inverse trend is being registered since the late 1990s in people &lt;50 years old, possibly due to an increasing exposure to lifestyle-related risk factors/exposome. Early-onset CC (EOCC) typically manifests in more advanced stages and may harbor a distinct genetic profile. However, its prognosis remains controversial, and disease stratification through gene expression-based subtyping could potentially provide insight.</div></div><div><h3>Materials and methods</h3><div>We collected data from stage III CC patients enrolled in PETACC-8 and IDEA-France and we analyzed them according to a cut-off of 50 years of age, defining EOCC and late-onset CC (LOCC). Molecular analyses were carried out to evaluate mismatch repair deficiency (dMMR) and extended genetic profile. RNA-sequencing analyses were carried out to determine consensus molecular subtypes (CMS).</div></div><div><h3>Results</h3><div>A total of 2607 LOCC and 366 EOCC were included. When compared to LOCC, EOCC were in better general conditions and presented more advanced-stage diseases. EOCC were more often dMMR, CMS1, <em>RAS</em> wild-type, and mutated for <em>PTEN, CTNNB1, ERBB2,</em> and <em>DDR2</em>. Relapse-free survival (RFS) was similar in the two age groups (3-year rate 74% versus 76%), but differences were observed according to CMS. In CMS1, a better RFS was observed in mismatch repair-proficient (pMMR) EOCC versus LOCC (3-year rate 82% versus 63%, <em>P</em> = 0.041), while this was not observed in dMMR CMS1.</div></div><div><h3>Conclusions</h3><div>In conclusion, EOCCs are diagnosed in more advanced stages, are more often dMMR, harbor a specific genetic profile, and have similar RFS when compared to LOCC, even if the age effect on RFS appeared to vary among CMS groups.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"7 ","pages":"Article 100106"},"PeriodicalIF":0.0,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143159961","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":"Gastrin-releasing peptide receptor expression in gastrointestinal stromal tumours","authors":"M. Berndsen ,&nbsp;F. Puls ,&nbsp;A. Thornell ,&nbsp;Y. Arvidsson ,&nbsp;A. Muth ,&nbsp;S. Lindskog ,&nbsp;E. Elias","doi":"10.1016/j.esmogo.2024.100105","DOIUrl":"10.1016/j.esmogo.2024.100105","url":null,"abstract":"<div><h3>Background</h3><div>There are limited treatment options for patients with advanced or metastatic gastrointestinal stromal tumours (GISTs) that lack mutations targetable by tyrosine kinase inhibitors (TKIs) or that have developed resistance to TKIs. Gastrin-releasing peptide receptor (GRPR) theranostics may offer a viable option in GISTs. However, the expression of the GRPR in GIST has not been extensively studied.</div></div><div><h3>Materials and methods</h3><div>GRPR expression was evaluated using immunohistochemistry in two separate tissue microarrays from patients treated at Sahlgrenska University Hospital, one from the pre-TKI era (1983-2001) and the other from the post-TKI era (2014-2020). In total, 205 tumour samples were characterized as having low/none or moderate/high expression of the GRPR, and these were correlated with clinical characteristics and survival outcomes.</div></div><div><h3>Results</h3><div>In total, 80% of the tumour samples exhibited moderate or high expression of GRPR. GRPR expression was not associated with gender, age, tumour location, or risk group, as defined by the modified National Institutes of Health (NIH) consensus criteria. Neoadjuvant treatment with TKI was correlated with low/none GRPR expression (<em>P</em> = 0.04). In patients who underwent surgery with curative intent and did not receive neoadjuvant treatment, GRPR expression was not associated with survival outcomes.</div></div><div><h3>Conclusions</h3><div>This study is the first to investigate GRPR expression in a large cohort of GIST tumours. Our results demonstrate that most GIST tumours exhibit a moderate to high expression of the receptor, suggesting that GRPR theranostics could be a viable option for TKI-resistant GIST. Interestingly, tumours that were pretreated with TKI showed lower expression levels of GRPR, indicating a need for further studies to explore this finding.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"6 ","pages":"Article 100105"},"PeriodicalIF":0.0,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142578047","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":"Single-cell RNA sequencing of appendiceal adenocarcinoma reveals a low proportion of epithelial cells and a fibroblast enriched tumor microenvironment","authors":"B.B. Gunes ,&nbsp;N.J. Hornstein ,&nbsp;M. Wang ,&nbsp;M. Yousef ,&nbsp;M.M. Fanaeian ,&nbsp;A. Yousef ,&nbsp;S. Chowdhury ,&nbsp;M.A. Zeineddine ,&nbsp;C. Haymaker ,&nbsp;B. Helmink ,&nbsp;K. Fournier ,&nbsp;J.P. Shen","doi":"10.1016/j.esmogo.2024.100094","DOIUrl":"10.1016/j.esmogo.2024.100094","url":null,"abstract":"<div><h3>Background</h3><div>Appendiceal adenocarcinoma (AA) is an understudied gastrointestinal malignancy. Treatment is guided by its proximal counterpart, colorectal cancer (CRC), despite recent studies demonstrating AA’s unique mutational landscape and poor response to CRC chemotherapy. In this study, we describe AA on a single-cell level and uncover features highlighting the contrast between AA and CRC; we believe these findings will support AA as a unique disease entity and encourage further disease-specific focus.</div></div><div><h3>Materials and methods</h3><div>Three patients with peritoneal metastases from AA and one from CRC profiled with 5′ single-cell RNA sequencing.</div></div><div><h3>Results</h3><div>Traditional k-means clustering analysis of &gt;30 000 cells revealed three canonical compartments and 11 major cell types. AA samples were mostly comprised of stromal cells (56%), while healthy appendix samples had significantly more immune and epithelial cells. Strikingly, fibroblasts were the most abundant cell type in AA with cancer-associated fibroblasts from the mucinous AA tumors showing a distinct profile from goblet cell AA or CRC. Pseudobulk analysis comparing tumor cells from AA with normal appendiceal epithelial cells demonstrated up-regulation of a diverse range of oncogenic pathways including inflammatory, epithelial–mesenchymal transition, and angiogenesis.</div></div><div><h3>Conclusions</h3><div>As the first application of single-cell technology to AA these data provide insight into the intratumor heterogeneity of AA and highlight the important contribution of the tumor microenvironment in this orphan disease. These results also reinforce multiple observations that AA is a unique disease entity from CRC and targeting the tumor microenvironment should be considered as a therapeutic strategy.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"6 ","pages":"Article 100094"},"PeriodicalIF":0.0,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142527264","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":"DNA methylation markers for sensitive detection of circulating tumor DNA in patients with gastroesophageal cancers","authors":"N. Øgaard ,&nbsp;C.R. Iden ,&nbsp;S.Ø. Jensen ,&nbsp;S.M. Mustafa ,&nbsp;E. Aagaard ,&nbsp;J.B. Bramsen ,&nbsp;L.B. Ahlborn ,&nbsp;J.P. Hasselby ,&nbsp;K.S. Rohrberg ,&nbsp;M.P. Achiam ,&nbsp;C.L. Andersen ,&nbsp;M. Mau-Sørensen","doi":"10.1016/j.esmogo.2024.100104","DOIUrl":"10.1016/j.esmogo.2024.100104","url":null,"abstract":"<div><h3>Background</h3><div>Patients with gastric and gastroesophageal junction adenocarcinomas (G-GEJ ACs) face poor outcomes. Thus sensitive biomarkers for improved clinical management are highly warranted. Detection of circulating tumor DNA (ctDNA) using DNA methylation biomarkers is a highly sensitive approach for cancer detection and management. Here, we explored the potential of a tumor-agnostic test targeting DNA methylation to detect ctDNA in patients with resectable and advanced G-GEJ ACs.</div></div><div><h3>Material and methods</h3><div>A tumor-agnostic digital PCR test—TriMeth—targeting the gastrointestinal cancer-specific methylated genes <em>C9orf50</em>, <em>KCNQ5</em>, and <em>CLIP4</em> was carried out on a total of 131 study patients. DNA from surgical tumor specimens of 29 patients with G-GEJ ACs and plasma cell-free DNA from 52 patients with advanced and resectable G-GEJ ACs, and from 50 healthy controls, were analyzed.</div></div><div><h3>Results</h3><div>Methylated tumor DNA was detected by TriMeth in all of the surgical tumor specimens (29/29, 100%). Furthermore, TriMeth detected ctDNA in plasma from 31/52 (60%) patients with G-GEJ AC, including in 13/17 (76%) advanced cases, and 18/35 (51%) resectable cases. ctDNA was not detected in healthy controls (0/50, 0%).</div></div><div><h3>Conclusions</h3><div>This study demonstrates that TriMeth may hold potential as a biomarker for identifying ctDNA in patients with G-GEJ ACs. The study sets the scene for ongoing larger clinical studies investigating the performance of TriMeth in different clinical settings.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"6 ","pages":"Article 100104"},"PeriodicalIF":0.0,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142441720","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":"Prognostic markers in oesophageal and gastric cancer review. Are they ready for clinical practice?","authors":"V. Kunene ,&nbsp;M. Ding ,&nbsp;M. Yap ,&nbsp;E.A. Griffiths ,&nbsp;P. Taniere ,&nbsp;D. Fackrell ,&nbsp;S. Butler ,&nbsp;G. Contino","doi":"10.1016/j.esmogo.2024.100091","DOIUrl":"10.1016/j.esmogo.2024.100091","url":null,"abstract":"<div><div>Oesophageal and gastric cancer outcomes remain poor despite the introduction of new treatments in the past decade. Most patients subjected to chemotherapy or surgery do not, in the long term, benefit from treatment but suffer side-effects. Although next-generation sequencing has accelerated the identification of various genomic aberrations, most have yet to be applied to routine clinical practice. Here, we review published data from systemic reviews and meta-analyses from the past 8 years reporting prognostic markers and why these have not gained traction in clinical practice and how we can improve on this.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"6 ","pages":"Article 100091"},"PeriodicalIF":0.0,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142419896","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":"Health-related quality of life with bemarituzumab plus mFOLFOX6 in patients with FGFR2b-overexpressing, advanced gastric or gastroesophageal junction cancer","authors":"Z.A. Wainberg ,&nbsp;P.C. Enzinger ,&nbsp;S. Qin ,&nbsp;K. Yamaguchi ,&nbsp;J. Wang ,&nbsp;X. Zhou ,&nbsp;A. Gnanasakthy ,&nbsp;K. Taylor ,&nbsp;A. Yusuf ,&nbsp;I. Majer ,&nbsp;A. Jamotte ,&nbsp;Y.-K. Kang","doi":"10.1016/j.esmogo.2024.100095","DOIUrl":"10.1016/j.esmogo.2024.100095","url":null,"abstract":"<div><h3>Background</h3><div>In the phase II, randomized, double-blind FIGHT trial (NCT03694522), treatment with bemarituzumab plus mFOLFOX6 resulted in improvements in progression-free survival and overall survival relative to mFOLFOX6 alone in previously untreated locally advanced or metastatic gastric or gastroesophageal junction cancer with fibroblast growth factor receptor 2b overexpression. Using data from the final analysis, we analyzed patient-reported outcomes (PROs) to evaluate the impact of adding bemarituzumab to mFOLFOX6 on health-related quality of life (HRQoL).</div></div><div><h3>Materials and methods</h3><div>Patients were randomized 1 : 1 to bemarituzumab plus mFOLFOX6 (<em>n</em> = 77) or placebo plus mFOLFOX (<em>n</em> = 78). European Organisation for Research and Treatment of Cancer Core 30-item Quality of Life (EORTC QLQ-C30) and the EuroQol EQ-5D-5L questionnaires were administered at baseline, week 6, every 8 weeks thereafter, and at end-of-treatment visit. Least-squares mean changes from baseline in PRO scale scores were estimated using mixed models for repeated measures; time to deterioration and improvement were assessed using Cox proportional hazards models. Analyses were exploratory <em>post hoc</em>.</div></div><div><h3>Results</h3><div>PRO scale scores at baseline and compliance rates across PRO assessments over time were similar between the bemarituzumab and placebo arms. Least-squares mean changes from baseline on key EORTC QLQ-C30 scales (global health status/QoL, physical functioning, fatigue, nausea and vomiting, and appetite loss) and the EQ-5D-5L visual analog scale were similar over time between treatment arms. Analyses of time to deterioration, sustained deterioration, and improvement suggested similar HRQoL between treatment arms.</div></div><div><h3>Conclusions</h3><div>Treatment with bemarituzumab plus mFOLFOX6 was associated with sustained HRQoL relative to mFOLFOX6 alone.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"6 ","pages":"Article 100095"},"PeriodicalIF":0.0,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142419895","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}