ESMO Gastrointestinal Oncology最新文献

{"title":"Screening for second primary tumors in the aerodigestive tract in non-Asian populations with head and neck cancer – systematic review and meta-analysis","authors":"A.D.I. Maan ,&nbsp;S.E.M. van de Ven ,&nbsp;S. Keereweer ,&nbsp;R. Cornelissen ,&nbsp;P.D. Siersema ,&nbsp;A.D. Koch","doi":"10.1016/j.esmogo.2025.100167","DOIUrl":"10.1016/j.esmogo.2025.100167","url":null,"abstract":"<div><h3>Background</h3><div>Patients diagnosed with a primary tumor in the esophagus, lungs, or head and neck are at an increased risk for developing second primary tumors (SPTs) in these regions. Most studies on SPT prevalence focus on Asian populations, with limited data available for non-Asian groups, leaving the utility of screening unclear. This review aims to assess the yield of screening for SPTs in non-Asian populations following a primary tumor in these regions.</div></div><div><h3>Patients and methods</h3><div>A systematic literature search was conducted to identify studies on screening for esophageal, lung, or head and neck SPTs after a primary tumor diagnosis in any of these sites. The primary outcome was the prevalence by screening of all diagnosed SPTs in the esophagus, head and neck or lungs.</div></div><div><h3>Results</h3><div>Due to limited data on screening for SPTs after esophageal or lung tumors, this review focused solely on screening after primary head and neck tumors. A total of 26 studies with 8071 patients from non-Asian countries were included. The pooled prevalence for all SPTs was 5.4% [95% confidence interval (CI) 4.1% to 7.2%]. The pooled prevalence for esophageal SPTs individually was 5.3% (95% CI 3.7% to 7.7%), for head and neck SPTs 4.6% (95% CI 1.0% to 18.1%) and for lung SPTs 4.0% (95% CI 2.6% to 6.2%). Most SPTs were detected in combination with an index hypopharynx carcinoma (60.0%). The proportion of synchronous (45.3%) and metachronous (54.7%) SPTs was similar.</div></div><div><h3>Conclusion</h3><div>Endoscopic screening for esophageal SPTs in non-Asian countries should be considered, especially in patients with a primary hypopharynx carcinoma.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"8 ","pages":"Article 100167"},"PeriodicalIF":0.0,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143759572","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":"Feasibility and impact of Lynch syndrome genetic testing in newly diagnosed colorectal cancer patients: a multicenter observational study in Greece","authors":"S. Manolakou ,&nbsp;N. Tsoukalas ,&nbsp;E. Saloustros ,&nbsp;T. Makatsoris ,&nbsp;I. Boukovinas ,&nbsp;A. Christopoulou ,&nbsp;A. Karampeazis ,&nbsp;I. Bompolaki ,&nbsp;I.-I. Varthalitis ,&nbsp;E. Voulgaris ,&nbsp;K. Ballasis ,&nbsp;A. Boutis ,&nbsp;E. Galani ,&nbsp;C. Kalofonos ,&nbsp;A. Koumarianou ,&nbsp;C. Kourousis ,&nbsp;P. Papakotoulas ,&nbsp;C. Papandreou ,&nbsp;E.-I. Perdikouri ,&nbsp;A. Andreadou ,&nbsp;Z. Saridaki","doi":"10.1016/j.esmogo.2025.100153","DOIUrl":"10.1016/j.esmogo.2025.100153","url":null,"abstract":"<div><h3>Background</h3><div>Lynch syndrome (LS) is an autosomal dominant disorder associated with a heightened risk of specific cancers, caused by germline mutations in the mismatch repair (MMR) system, which leads to microsatellite instability (MSI). MSI-positive colorectal cancer (CRC) patients have an increased likelihood of LS. Despite this, LS germline genetic testing is not reimbursed by the National Health Authorities in Greece. To address this gap, the Hellenic Society of Medical Oncology (HeSMO) initiated a national program to screen and diagnose CRC patients with LS.</div></div><div><h3>Materials and methods</h3><div>From 2017 to 2019, 151 newly diagnosed CRC patients in Greece were enrolled. MSI molecular analysis was carried out, followed by next-generation sequencing (NGS) germline testing in MSI patients without sporadic alterations to identify LS.</div></div><div><h3>Results</h3><div>Of the patients, 76 (51.7%) exhibited MMR deficiency, with their tumors more likely to have mucinous histology (<em>P</em> &lt; 0.001) and stage II disease (<em>P</em> = 0.015). Fourteen patients with MSH2, MSH6, or PMS2 deficiency directly underwent germline analysis, and all were positive for LS. Sixteen MSI patients (20.5%) had sporadic BRAFV600E mutations, and another 16 had MLH1 promoter hypermethylation. Of the remaining 32 patients tested for germline mutations, 8 were positive for LS, accounting for 15% of CRC patients—a 2.9-fold greater proportion than expected, according to historic records. Testing asymptomatic relatives identified two first-degree relatives with MSH2 mutations.</div></div><div><h3>Conclusions</h3><div>These findings underscore the critical need for CRC-adapted preventive oncology and support the implementation of a national LS screening program in Greece, aligned with international guidelines.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"8 ","pages":"Article 100153"},"PeriodicalIF":0.0,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143696746","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":"T-cell invigoration to cell-free DNA ratio associated with anti-PD-1 response in gastric or gastro-esophageal junction adenocarcinoma: VOYAGER trial","authors":"A. Makiyama ,&nbsp;Q. Hu ,&nbsp;T. Nagasaka ,&nbsp;H. Katsuya ,&nbsp;A. Nishioka ,&nbsp;I. Yasufuku ,&nbsp;T. Kashiwada ,&nbsp;Y. Shinohara ,&nbsp;S. Otsu ,&nbsp;M. Shimokawa ,&nbsp;H. Saeki ,&nbsp;H. Baba ,&nbsp;E. Oki","doi":"10.1016/j.esmogo.2025.100148","DOIUrl":"10.1016/j.esmogo.2025.100148","url":null,"abstract":"<div><h3>Background</h3><div>Previous melanoma research suggests that host immune status and tumor burden impact anti-programmed cell death protein 1 (PD-1) therapy efficacy, favoring patients with low tumor burden and minimal T-cell exhaustion.</div></div><div><h3>Patients and methods</h3><div>We conducted a phase II, multicenter, single-arm (VOYAGER) trial to assess early induction of nivolumab monotherapy as third-line or later treatment in patients with gastric adenocarcinoma showing response or stable disease as per RECIST v1.1 during prior chemotherapy. Biomarker analyses evaluated associations between nivolumab efficacy, T-cell activation, and cell-free DNA (cfDNA) as a tumor burden surrogate. Activated T cells (Ki67+ PD-1+ CD8+ T cells) were measured by flow cytometry of peripheral blood mononuclear cells.</div></div><div><h3>Results</h3><div>The study met its primary endpoint with a progression-free survival (PFS) rate at 6 months of 35.7% [80% confidence interval (CI) 26.4% to 45.1%]; median PFS and overall survival (OS) were 4.0 (95% CI 2.3-5.7) months and 10.9 (95% CI 9.9-16.0) months, respectively. No new safety signals were observed. Biomarker analyses revealed that baseline T-cell invigoration rate was associated with both response rate (RR) and prognosis. Baseline cfDNA also exhibited an association with prognosis, but not with RR. Moreover, the ratio of baseline T-cell invigoration to baseline cfDNA was strongly associated with RR (<em>P</em> &lt; 0.05) and prognosis (<em>P</em> &lt; 0.05) in third-line treatment of nivolumab.</div></div><div><h3>Conclusions</h3><div>This study not only demonstrated that early induction of nivolumab as a later-line regimen is an alternative strategy but also identified clinically available predictors for PD-1 blockade therapy.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"8 ","pages":"Article 100148"},"PeriodicalIF":0.0,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143687003","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":"Expanding the potential of antibody–drug conjugates in gastrointestinal malignancies: beyond HER2 targets","authors":"P. Ntellas ,&nbsp;A. Athauda ,&nbsp;K. Sugiyama ,&nbsp;M.L. Le ,&nbsp;V. Crespi ,&nbsp;I. Chau","doi":"10.1016/j.esmogo.2025.100154","DOIUrl":"10.1016/j.esmogo.2025.100154","url":null,"abstract":"<div><div>Antibody–drug conjugates (ADCs) are an emerging class of targeted cancer therapeutics, combining the specificity of monoclonal antibodies with the potency of cytotoxic agents to deliver localized treatment while minimizing off-target effects. Recent advancements in ADC design focus on optimizing payloads, improving linker stability, and selecting effective target antigens. Additionally, innovative approaches such as small-molecule drug conjugates, immune-stimulating payloads, and bispecific or biparatopic antibodies are being explored to enhance specificity and efficacy. Despite challenges like neutralizing antibodies, toxicity, and variable efficacy, several ADCs have shown promise in patients with solid tumours. Particularly, in gastrointestinal cancers, ADCs targeting antigens such as claudin 18.2, c-MET, and CEACAM5 have demonstrated clinical activity offering potential alternatives to traditional human epidermal growth factor receptor 2 (HER2)-based therapies. Ongoing efforts to refine ADCs and explore novel formats offer significant potential to transform the treatment landscape of gastrointestinal cancers. This review examines the current state of ADC development for gastrointestinal malignancies, focusing on emerging targets and strategies beyond HER2.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"8 ","pages":"Article 100154"},"PeriodicalIF":0.0,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143643678","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":"GATA6 immunohistochemistry and prognosis after surgical resection of pancreatic adenocarcinoma: results from the ESPAC-4 trial","authors":"R.C. Grant ,&nbsp;K. Duan ,&nbsp;R. Jackson ,&nbsp;W. Greenhalf ,&nbsp;E. Costello-Goldring ,&nbsp;P. Ghaneh ,&nbsp;C. Halloran ,&nbsp;D. Palmer ,&nbsp;T. Hackert ,&nbsp;M. Büchler ,&nbsp;S. Hutchinson ,&nbsp;S. Ramotar ,&nbsp;A. Dodd ,&nbsp;J. Wilson ,&nbsp;F. Notta ,&nbsp;G. O’Kane ,&nbsp;J. Knox ,&nbsp;J. Neoptolemos ,&nbsp;S. Gallinger ,&nbsp;S.E. Fischer","doi":"10.1016/j.esmogo.2025.100138","DOIUrl":"10.1016/j.esmogo.2025.100138","url":null,"abstract":"<div><h3>Background</h3><div>No prognostic biomarker is currently used in clinical management of patients with surgically resected pancreatic cancer other than CA-19-9. In this study, we tested the prognostic value of GATA6 measured with immunohistochemistry and digital assistance.</div></div><div><h3>Patients and methods</h3><div>One hundred and ninety-three patients with resected pancreatic ductal adenocarcinoma from the ESPAC-4 trial of adjuvant gemcitabine and capecitabine were included. Two pathologists independently assessed GATA6 protein expression by immunohistochemistry in tissue microarray cores, manually and with digital assistance. Overall survival was compared across GATA6 levels using multivariate Cox proportional hazard regressions, with exploratory analyses evaluating recurrence-free survival and differential treatment effects.</div></div><div><h3>Results</h3><div>Interobserver concordance improved with digitally assisted scoring (kappa 0.72 versus 0.25, <em>P</em> &lt; 0.001). Median overall survival was 24.3 months [95% confidence interval (CI) 19.2-32.1 months] with low GATA6 expression versus 35.2 months (95% CI 29.9-53.0 months) with high GATA6 expression (adjusted hazard ratio 1.60, 95% CI 1.08-2.38, <em>P =</em> 0.02). Similar results were observed for recurrence-free survival (adjusted hazard ratio 1.45, 95% CI 0.99-2.14, <em>P =</em> 0.06). GATA6 expression was not associated with differential treatment effects.</div></div><div><h3>Conclusions</h3><div>GATA6 expression measured by immunohistochemistry with digital assistance was a prognostic biomarker among people with pancreatic adenocarcinoma treated with surgical resection and adjuvant chemotherapy.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"8 ","pages":"Article 100138"},"PeriodicalIF":0.0,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143535279","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":"Intrahepatic cholangiocarcinoma trends and treatment lines: real-world evidence from the French National Hospital Discharge database","authors":"M. Delaye ,&nbsp;B. Grenier ,&nbsp;A. Lièvre ,&nbsp;C. Neuzillet","doi":"10.1016/j.esmogo.2025.100152","DOIUrl":"10.1016/j.esmogo.2025.100152","url":null,"abstract":"<div><h3>Background</h3><div>Little is known about the therapeutic trajectory of patients treated in hospitals for intrahepatic cholangiocarcinoma (iCCA) and patterns of care in daily clinical practice.</div></div><div><h3>Patients and methods</h3><div>An observational retrospective study was conducted on the French National Hospital Discharge Database. All patients with a new diagnosis of iCCA who had a first hospital stay (S1) from January 2016 to December 2021 were included. They were followed up until December 2021, or in-hospital death, whichever occurred first. Crude annual hospitalization rates were computed. Treatment lines were identified with an artificial intelligence algorithm [Analysis of Treatment Lines using Alignment of Sequences (ATLAS)]. A multistate model was used to compute the transition rates between lines.</div></div><div><h3>Results</h3><div>Overall, 13 491 patients were included and the mean (standard deviation) follow-up duration was 13.1 months (17.9 months). The median age at S1 was 72.0 years and 55.9% were male. Nearly 20.7% were admitted via emergency services for S1, and 32.1% had metastases. Between 2016 and 2021, the crude annual rate of new iCCA cases increased from 3.08 [95% confidence interval (CI) 2.94-3.24] in 2016 (<em>n</em> = 1598) to 4.12 (95% CI 3.95-4.29) per 100 000 adult person-years in 2021 (<em>n</em> = 2188). Among 4855 patients receiving first-line systemic therapy (L1), 37.7% (95% CI 36.0% to 39.3%) received a second-line 2 (L2) during the follow-up. The median time between the start of L1 and the beginning of L2 was 7.0 months.</div></div><div><h3>Conclusions</h3><div>This study provides up-to-date national real-world data on iCCA, revealing an increasing burden year by year in France, a poor outcome of patients with iCCA on L1 systemic therapy, and the low proportion of patients receiving an L2.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"8 ","pages":"Article 100152"},"PeriodicalIF":0.0,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143549422","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":"The South Australian 177Lu-DOTATATE peptide receptor radionuclide therapy service: an 11-year review of toxicity, health-related quality of life, and survival","authors":"L.M. Altus ,&nbsp;J.C. Forster ,&nbsp;J. Mercurio ,&nbsp;M. Kitchener ,&nbsp;N. Corsini ,&nbsp;M. Nenke ,&nbsp;T. Price ,&nbsp;D. Patel ,&nbsp;R. Chew ,&nbsp;D. Moffat ,&nbsp;S. Unger ,&nbsp;G. Cehic","doi":"10.1016/j.esmogo.2025.100146","DOIUrl":"10.1016/j.esmogo.2025.100146","url":null,"abstract":"<div><h3>Background</h3><div>The aim of this study was to audit clinical and patient-reported outcomes of patients treated with [¹⁷⁷Lu]-DOTA-octreotate (¹⁷⁷Lu-DOTATATE) at a single Australian centre over an 11-year period.</div></div><div><h3>Methods</h3><div>A retrospective analysis of 189 patients with metastatic or locally advanced neuroendocrine neoplasms or tumours (NENs/NETs) or other somatostatin receptor-positive tumour treated with ¹⁷⁷Lu-DOTATATE at The Queen Elizabeth Hospital from 2011 to 2022 was carried out. Toxicity, radiological response, health-related quality of life (hr-QoL), and overall survival (OS) were summarised.</div></div><div><h3>Results</h3><div>Gastroenteropancreatic (NET) origin accounted for 75% of cases. The median age of diagnosis was 59 years and median age at first cycle of ¹⁷⁷Lu-DOTATATE at The Queen Elizabeth Hospital was 64.7 years (range 16.5-92.6 years). Of the 182 patients who commenced induction peptide receptor radionuclide therapy (iPRRT), 143 (79%) completed four or five induction cycles. There were 52 patients who received retreatment PRRT (rPRRT). When radiological response was assessed following completion of a full iPRRT course (≥four cycles, 131 patients), radiologically stable disease was seen in 76% of patients. A completed hr-QoL questionnaire was available for 760 cycles (92%). Significant improvements were found across multiple domains after iPRRT. Eight patients (4.2%) developed a haematological malignancy. Renal function declined at long-term but not short-term follow-up. Median duration of follow-up was 37.6 months (range 0.0-134.6 months) with a median OS from first cycle of PRRT 48.4 months (95% confidence interval 42.5-57.3 months).</div></div><div><h3>Conclusion</h3><div>Patients with advanced NEN/NET or other somatostatin receptor-positive malignancies treated with ¹⁷⁷Lu-DOTATATE at our centre had improved hr-QoL following iPRRT, with comparable toxicity and OS to other centres.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"8 ","pages":"Article 100146"},"PeriodicalIF":0.0,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143535236","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":"Continuous imaging to evaluate growth and drug responses of patient-derived colorectal tumouroids","authors":"B.C. Sakshaug ,&nbsp;E. Folkesson ,&nbsp;T.H. Haukaas ,&nbsp;M.S. Sigfúsdóttir ,&nbsp;H.H. Trøen ,&nbsp;S.B. Sperstad ,&nbsp;H.C.H. Bwanika ,&nbsp;C. Ringers ,&nbsp;I.A. Bergstrøm ,&nbsp;G. Klinkenberg ,&nbsp;T. Visnes ,&nbsp;Å. Flobak","doi":"10.1016/j.esmogo.2025.100137","DOIUrl":"10.1016/j.esmogo.2025.100137","url":null,"abstract":"<div><h3>Background</h3><div>The use of patient-derived tumouroids is expected to have major implications in preclinical drug testing and clinical decision support. Data acquisition from these samples in drug screens, however, is often limited by time-consuming procedures, scarce screening material, and destructive, single-parameter endpoint measurements.</div></div><div><h3>Design</h3><div>We seek to increase data collected from patient-derived tumouroids and here present a method for non-destructive, continuous image-based analysis of colorectal tumouroid growth and shape under chemotherapeutic perturbations, conducted within a clinically relevant timeframe.</div></div><div><h3>Results</h3><div>We assessed several readouts automatically derived from continuous imaging data and concluded that tumouroid growth, and the effect of growth inhibiting drugs, can be robustly monitored by measuring the total tumouroid-covered area in images. We also found that measures of average tumouroid size, diameter, and perimeter provide complementary insights.</div></div><div><h3>Conclusions</h3><div>Our tumouroid analysis method offers a strategy to maximise data extraction from non-destructive imaging techniques while preserving tumouroids for future research, all within a clinically relevant timeframe.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"7 ","pages":"Article 100137"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143534198","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":"Nanoliposomal irinotecan with fluorouracil and folinic acid in patients with unresectable or recurrent pancreatic cancer: a multicenter observational study (NAPOLEON-2)","authors":"T. Shirakawa ,&nbsp;M. Shimokawa ,&nbsp;T. Otsuka ,&nbsp;Y. Shinohara ,&nbsp;K. Toyodome ,&nbsp;W. Kusano ,&nbsp;J. Nakazawa ,&nbsp;T. Kodama ,&nbsp;M. Kawahira ,&nbsp;H. Shimokawa ,&nbsp;T. Koike ,&nbsp;F. Koga ,&nbsp;S. Yunotani ,&nbsp;S. Nakashita ,&nbsp;N. Oza ,&nbsp;S. Noge ,&nbsp;K. Murayama ,&nbsp;H. Oda ,&nbsp;N. Mitsui ,&nbsp;R. Kawasaki ,&nbsp;K. Mitsugi","doi":"10.1016/j.esmogo.2025.100150","DOIUrl":"10.1016/j.esmogo.2025.100150","url":null,"abstract":"<div><h3>Background</h3><div>Nanoliposomal irinotecan with fluorouracil and folinic acid (NFF) is a standard second- or later-line regimen after gemcitabine-based therapy for patients with unresectable or recurrent pancreatic cancer (urPC). However, limited prospective clinical data on the efficacy and safety of NFF in a real-world setting have been presented. Therefore, we conducted this observational, real-world study to investigate the efficacy and safety of NFF.</div></div><div><h3>Patients and methods</h3><div>We collected prospective data of urPC patients treated with NFF in 17 hospitals in Japan from 2021 to 2023. The primary endpoint was overall survival (OS). Secondary endpoints were overall response rate, disease control rate, progression-free survival, dose intensity, and adverse events (AEs).</div></div><div><h3>Results</h3><div>NFF was administered to 150 patients with a mean age of 72 years. The median follow-up period was 7.2 months. All patients had previously received gemcitabine-based therapy. The median OS was 7.8 months; median progression-free survival was 3.7 months; median overall response rate was 11%; and median disease control rate was 56%. Median relative dose intensity was 72.7% with nanoliposomal irinotecan and 79.4% with fluorouracil. Grade 3/4 hematological and nonhematological AEs occurred in 52 and 70 patients, respectively. Neutropenia (28%) and anorexia (19%) were common grade 3/4 AEs. Subanalysis of patients with second-line and third- or later-line therapy demonstrated no significant difference in OS (7.4 versus 7.8 months, respectively; <em>P</em> = 0.88). Integrated analysis of the prospective and retrospective phases of the study showed that median OS was 8.0 months.</div></div><div><h3>Conclusions</h3><div>NFF has an appropriate efficacy and safety profile and is a candidate for second- or later-line therapy for urPC.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"8 ","pages":"Article 100150"},"PeriodicalIF":0.0,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143510431","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":"Is survival influenced by metastatic site in synchronous metastatic pancreatic adenocarcinoma (PDAC)? A prospective real-world BACAP study","authors":"E. Alouani ,&nbsp;C. Canivet ,&nbsp;B. Bournet ,&nbsp;L. Buscail ,&nbsp;J. Selves ,&nbsp;B. Napoleon ,&nbsp;L. Palazzo ,&nbsp;N. Flori ,&nbsp;P. Guibert ,&nbsp;A.-C. Brunac ,&nbsp;C. Maulat ,&nbsp;F. Muscari ,&nbsp;F.-Z. Mokrane ,&nbsp;S. Gourgou ,&nbsp;L. Roca ,&nbsp;R. Guimbaud ,&nbsp;N. Fares","doi":"10.1016/j.esmogo.2025.100144","DOIUrl":"10.1016/j.esmogo.2025.100144","url":null,"abstract":"<div><h3>Background</h3><div>Advanced pancreatic ductal adenocarcinoma (PDAC) carries a dismal prognosis with a 5-year survival rate of 3%. While treated as an even population, previous retrospective studies suggested significantly different survival rates for patients with lung-only metastases when compared with other patients. This study aims to explore prospectively the difference in survival outcome based on initial site of metastases in synchronous metastatic PDAC.</div></div><div><h3>Patients and methods</h3><div>This is a prospective observational study including all adult patients with synchronous metastatic PDAC in BACAP (national Anatomo-Clinical Database on Pancreatic Adenocarcinoma). Data regarding patients’ demographics, tumor characteristics and survival outcomes were analyzed.</div></div><div><h3>Results</h3><div>Overall, 559 patients were included (52.8% male, mean age 69 years) of which 26 (4.7%), 65 (11.6%), 299 (53.5%) and 169 (30.2%) patients had lung-only, peritoneal-only, liver-only and multi-site metastases at diagnosis, respectively. The median overall survival (OS) was significantly different according to metastatic site (<em>P</em> &lt; 0.001) with a median OS for lung-only, peritoneum-only, liver-only and multi-site of 12.6 months [95% confidence interval (CI) 9.7-16.9 months], 8.6 months (95% CI 5.4-11.5 months), 7.9 months (95% CI 6.5-8.9 months) and 4.5 months (95% CI 3.9-5.8 months), respectively. The median progression-free survival (PFS) was also significantly different according to metastatic site (<em>P</em> &lt; 0.01) with a median PFS of 6.3 months (95% CI 2.7-9.1 months), 5.1 months (95% CI 3.7-6.2 months), 4.7 months (95% CI 3.3-5.7 months) and 3.2 months (95% CI 2.6-4.1 months), respectively.</div></div><div><h3>Conclusions</h3><div>Patients with lung-only metastases represented 4.7% of synchronous metastatic PDAC patients and exhibited improved survival. These results suggest that a subset of patients with synchronous metastatic PDAC could benefit from more aggressive locoregional treatments.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"8 ","pages":"Article 100144"},"PeriodicalIF":0.0,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143510430","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}