M. Yerolatsite , N. Torounidou , A. Batistatou , K. Katsanos , E. Lampri , A.-L. Amylidi , D. Mauri
{"title":"TAMs and PD-1 networking in esophageal cancer: literature review","authors":"M. Yerolatsite , N. Torounidou , A. Batistatou , K. Katsanos , E. Lampri , A.-L. Amylidi , 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}
B.C. Köhler , G.M. Haag , L. Le Cornet , P. Hoffmeister-Wittmann , M. Schmidt , A. Manjunath , N. Vaquero-Siguero , M. Jenzer , M. Gimmel , A. Stahler , A. Stein , M. Reichert , S. Kasper , M. Bitzer , D. Jäger , C. Springfeld , T.F. Weber , S. Fröhling , K. Steindorf , A. Trumpp , R. Jackstadt
{"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 , G.M. Haag , L. Le Cornet , P. Hoffmeister-Wittmann , M. Schmidt , A. Manjunath , N. Vaquero-Siguero , M. Jenzer , M. Gimmel , A. Stahler , A. Stein , M. Reichert , S. Kasper , M. Bitzer , D. Jäger , C. Springfeld , T.F. Weber , S. Fröhling , K. Steindorf , A. Trumpp , 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}
S.J. Klempner , R.A. Pazo-Cid , S. Lonardi , L. Swanson , M.J. Arango , P. Enzinger , A.H. Ko , G.M. Vaccaro , K. Yamaguchi , A. Saeed , K.-W. Lee , K. Shitara , D. Ilson , J.A. Ajani , R. Fuldeore , S. Braun , M.S. Broder , M.A. Shah
{"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 , R.A. Pazo-Cid , S. Lonardi , L. Swanson , M.J. Arango , P. Enzinger , A.H. Ko , G.M. Vaccaro , K. Yamaguchi , A. Saeed , K.-W. Lee , K. Shitara , D. Ilson , J.A. Ajani , R. Fuldeore , S. Braun , M.S. Broder , 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}
L. Weiss , D. Zhang , W.G. Kunz , S. Boeck , G. Curigliano , V. Subbiah , F. Lordick , T. Brummer , C.B. Westphalen , L. Boscolo Bielo
{"title":"Exploring the pathway: clinical utility and open challenges of targeting BRAF alterations in biliary tract cancers and gastrointestinal malignancies","authors":"L. Weiss , D. Zhang , W.G. Kunz , S. Boeck , G. Curigliano , V. Subbiah , F. Lordick , T. Brummer , C.B. Westphalen , L. Boscolo Bielo","doi":"10.1016/j.esmogo.2024.100129","DOIUrl":"10.1016/j.esmogo.2024.100129","url":null,"abstract":"<div><div>The <em>BRAF</em> proto-oncogene plays a key role in oncogenesis, promoting growth and survival through various genetic alterations. Most mutations involve the substitution of valine at amino acid position 600 (V600), resulting in a constitutively active protein, known as class I alterations. The most common class I mutation encodes for the BRAF<sup>V600E</sup> oncoprotein. Therapeutic targeting of BRAF<sup>V600E</sup> has led to the approval of dabrafenib plus trametinib for solid tumours [excluding colorectal cancer (CRC)] refractory to standard therapies. In gastrointestinal cancers, dabrafenib and trametinib have shown remarkable results in biliary tract cancers (BTC), establishing this combination as a viable second-line option for <em>BRAF</em><sup>V600E</sup>-mutant BTC. In CRC, intrinsic epidermal growth factor receptor (EGFR) activation circumvents <em>BRAF</em> inhibition, necessitating the concurrent use of EGFR inhibitors, whose treatment strategy led to the approval of encorafenib plus cetuximab for <em>BRAF</em><sup>V600E</sup> CRC.</div><div>Despite these advances, resistance to BRAF inhibitors is almost universal, often due to extracellular signal-regulated kinase (ERK)-mediated up-regulation of RAF dimers that is able to overcome the inhibition of BRAF monomers. This resistance mechanism has spurred the development of novel RAF inhibitors able to prevent or to inhibit RAF dimers. Additionally, several treatment strategies are currently being investigated, including multi-step vertical mitogen-activated protein kinase (MAPK) inhibition and targeting parallel signalling pathways capable of bypassing MAPK oncogenic inhibition. While noteworthy results have been achieved with <em>BRAF</em><sup>V600E</sup> inhibition, further research is needed to optimize BRAF-targeted therapies and address resistance mechanisms. Continued research and innovation are crucial to improving patient outcomes and addressing the complexities of <em>BRAF</em> mutations in human cancers.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"7 ","pages":"Article 100129"},"PeriodicalIF":0.0,"publicationDate":"2025-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143159537","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}
J. Sgouros , A. Eliades , K. Papadopoulou , N. Korfiatis , D. Papamichael , E. Fountzilas , E. Tsolaki , A. Achilleos , K. Tsangaras , C. Loizides , G. Oikonomopoulos , T. Makatsoris , E. Kypri , M. Ioannides , G. Koumbaris , G. Fountzilas , P.C. Patsalis , G. Pentheroudakis
{"title":"Anti-EGFR re-challenge with chemotherapy in RAS wild-type advanced colorectal cancer (A-REPEAT study): efficacy and correlations with tissue and plasma genotyping","authors":"J. Sgouros , A. Eliades , K. Papadopoulou , N. Korfiatis , D. Papamichael , E. Fountzilas , E. Tsolaki , A. Achilleos , K. Tsangaras , C. Loizides , G. Oikonomopoulos , T. Makatsoris , E. Kypri , M. Ioannides , G. Koumbaris , G. Fountzilas , P.C. Patsalis , G. Pentheroudakis","doi":"10.1016/j.esmogo.2024.100120","DOIUrl":"10.1016/j.esmogo.2024.100120","url":null,"abstract":"<div><h3>Background</h3><div>Approved treatments for colorectal cancer (CRC) patients pretreated with two lines of therapy are of limited efficacy. Anti-epidermal growth factor receptor (EGFR) re-challenge might represent an option in RAS wild-type tumours. This study aimed to evaluate the efficacy of anti-EGFR re-challenge strategies (panitumumab/chemotherapy).</div></div><div><h3>Materials and methods</h3><div>RAS wild-type metastatic CRC patients following first-line chemotherapy + anti-EGFR agent and second-line chemotherapy ± anti-vascular endothelial growth factor agent were eligible. Panitumumab with irinotecan or oxaliplatin-based chemotherapy was used. The primary objective was response rate (RR). Secondary objectives were safety, progression-free survival and overall survival. Next-generation sequencing-based genotyping in archived tissue and plasma was carried out to identify prognostic factors.</div></div><div><h3>Results</h3><div>The study closed prematurely, due to poor accrual, with 23 patients included. Most patients had primary tumours in the left colon/rectum, and the liver was the most common metastatic site. Treatment modifications were required in 74% of patients due to side-effects primarily, neutropenia and acneiform rash. One patient died from hepatic failure. The objective RR in the intention-to-treat population was 13%, and the disease control rate (DCR) was 52%. Forty-eight percent of patients tested via liquid biopsy had <em>RAS</em> mutations before re-challenge with panitumumab despite a median interval from previous anti-EGFR therapy of 12 months. Control of disease did not correlate with the results of liquid biopsy. RR and DCR in patients without <em>RAS</em> mutations in liquid biopsies were 18.2% and 54.5%, respectively.</div></div><div><h3>Conclusion</h3><div>Panitumumab/chemotherapy as an anti-EGFR re-challenge strategy had modest activity in our patient cohort.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"7 ","pages":"Article 100120"},"PeriodicalIF":0.0,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143159963","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}
M. Monticone , B. Rocca , A. Pretta , A. Scribante , M. Scartozzi , F. Del Farra
{"title":"What is the role of physical exercise after surgery for gastric cancer? A scoping review","authors":"M. Monticone , B. Rocca , A. Pretta , A. Scribante , M. Scartozzi , F. Del Farra","doi":"10.1016/j.esmogo.2024.100117","DOIUrl":"10.1016/j.esmogo.2024.100117","url":null,"abstract":"<div><div>The overall role of physical exercise (PE) in addressing the disabling effects of gastric cancer (GC) after surgery remains uncertain. This scoping review (ScR) aims to systematically collect, map, and present the current evidence on studies reporting data on PE in individuals with GC. This ScR followed the 2020 recommendations of the <em>Joanna Briggs Institute Methodological Guidance</em> and adhered to the <em>Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews</em>. A comprehensive search was conducted in PubMed, Scopus, and the Cochrane Central Register of Controlled Trials (CENTRAL) up to January 2024. Original studies were identified, and findings were presented both numerically and thematically. Out of 1115 articles initially identified, 9 studies met the inclusion criteria. The number of publications on this topic has increased over time, with most studies conducted in Western countries. Of the included studies, 6 (66.7%) were primary research articles, while 3 (33.3%) were systematic reviews. The overall sample size comprised 226 individuals, with a mean age of 61 ± 5.3 years. The studies consistently reported a positive impact of PE in both inpatient and outpatient settings. However, significant heterogeneity was observed in the types and characteristics of PE, outcome measures, and reference populations. Physiotherapists were the primary healthcare professionals involved in delivering care. This review highlights the need for further high-quality studies dedicated to investigating the role of PE after surgery for GC. In addition, multidisciplinary rehabilitation is recommended to address the complex needs of this patient population.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"7 ","pages":"Article 100117"},"PeriodicalIF":0.0,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143159538","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}
K. Shimozaki , A. Ooki , Y. Yamahata , T. Aoyama , K. Yoshino , M. Tamba , S. Udagawa , S. Fukuoka , H. Osumi , T. Wakatsuki , E. Shinozaki , M. Ogura , K. Chin , K. Yamaguchi
{"title":"Managing zolbetuximab-induced nausea and vomiting: a proposal for a pragmatic approach in clinical practice","authors":"K. Shimozaki , A. Ooki , Y. Yamahata , T. Aoyama , K. Yoshino , M. Tamba , S. Udagawa , S. Fukuoka , H. Osumi , T. Wakatsuki , E. Shinozaki , M. Ogura , K. Chin , K. Yamaguchi","doi":"10.1016/j.esmogo.2024.100128","DOIUrl":"10.1016/j.esmogo.2024.100128","url":null,"abstract":"<div><h3>Background</h3><div>The global phase III SPOTLIGHT and GLOW trials confirmed the superiority of zolbetuximab plus chemotherapy over chemotherapy alone for claudin 18.2-positive advanced gastric cancer (AGC). However, severe nausea/vomiting during zolbetuximab infusion remains a significant safety concern. Our study aimed to evaluate the safety management strategy’s applicability in our institution.</div></div><div><h3>Patients and methods</h3><div>This registry-based observational study assessed the combination of fosnetupitant, dexamethasone, and 5-HT<sub>3</sub>-receptor antagonist in patients receiving zolbetuximab plus chemotherapy. The initial zolbetuximab infusion rate was set at 75 ml/h for the first 60 min, and then 250 ml/h thereafter. The primary endpoint was the feasibility of our management and vomiting prevention during cycle 1.</div></div><div><h3>Results</h3><div>Among 21 patients (median age 61 years; male 48%; diffuse-type histology 81%; prior gastrectomy 38%; peritoneal metastases 57%), the incidence of nausea/vomiting during zolbetuximab initiation in cycle 1 was 62%/9.5%, with a 62% infusion interruption rate. The median time to first nausea was 93 min (range 77-127 min); median interruption time was 40 min (16-68 min); and median total infusion time of zolbetuximab was 257 min (154-343 min). All patients successfully completed zolbetuximab administration in cycle 1, with an 81% vomiting prevention rate. At cycle 2 day 1, 3 of 14 patients (21%) experienced nausea, with no vomiting.</div></div><div><h3>Conclusion</h3><div>First-line zolbetuximab plus chemotherapy was safely introduced to real-world patients with claudin 18.2-positive AGC, with effective management of nausea and vomiting, applicable in clinical practice.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"7 ","pages":"Article 100128"},"PeriodicalIF":0.0,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143159959","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}
M.P. Ebert , W. Fischbach , S. Hollerbach , J. Höppner , D. Lorenz , M. Stahl , M. Stuschke , O. Pech , U. Vanhoefer , C. Bruns , C. Ell , M. Follmann , U. Goerling , L. Grenacher , J. Haardt , A.H. Hölscher , R. Hummel , W.T. Knoefel , J. Körber , R. Langer , R. Porschen
{"title":"German guidelines for the diagnosis and treatment of squamous-cell carcinoma and adenocarcinoma of the esophagus—version 4.0","authors":"M.P. Ebert , W. Fischbach , S. Hollerbach , J. Höppner , D. Lorenz , M. Stahl , M. Stuschke , O. Pech , U. Vanhoefer , C. Bruns , C. Ell , M. Follmann , U. Goerling , L. Grenacher , J. Haardt , A.H. Hölscher , R. Hummel , W.T. Knoefel , J. Körber , R. Langer , R. Porschen","doi":"10.1016/j.esmogo.2024.100112","DOIUrl":"10.1016/j.esmogo.2024.100112","url":null,"abstract":"<div><div>This guideline for the diagnosis and treatment of squamous-cell carcinoma and adenocarcinoma of the esophagus was developed and managed by the German Guideline Program in Oncology (GGPO) of the Association of the Scientific Medical Societies in Germany (AWMF), German Cancer Society (DKG), and German Cancer Aid (DKH). The guideline commission comprised multidisciplinary experts from various professional associations and organizations involved in the management of esophageal cancer, as well as a patient representative. Quality of the evidence is presented using Oxford evidence-based medicine system, and recommendations were graded in a formal consensus process using a recommendation grading scheme.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"7 ","pages":"Article 100112"},"PeriodicalIF":0.0,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143159964","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":"Eligibility and workload implications of adjuvant immunotherapy in patients with resected esophageal and gastroesophageal junction (ESO/GEJ) cancer","authors":"T.H. Lee , S. Gill","doi":"10.1016/j.esmogo.2024.100115","DOIUrl":"10.1016/j.esmogo.2024.100115","url":null,"abstract":"<div><h3>Background</h3><div>The CheckMate (CM) 577 trial demonstrated the efficacy of 12 months of adjuvant nivolumab for esophageal (ESO)/gastroesophageal junction (GEJ) cancer patients with residual pathological disease after neoadjuvant chemoradiation. Nivolumab is now an approved and funded regimen in British Columbia (BC). This retrospective study examines its real-world eligibility and resource implications.</div></div><div><h3>Materials and methods</h3><div>We conducted an ethics board-approved chart review of patients who underwent <em>CROSS</em> chemoradiation at BC Cancer from January 2016 to December 2020. Patient eligibility was determined per CM577 and <em>GIAJNIV</em> criteria. We assessed the resource impact of nivolumab by projecting the number of MD and chemotherapy visits, and anticipated G3/4 toxicity events per the CM577 trial.</div></div><div><h3>Results</h3><div>We identified 677 patients (63% ESO and 37% GEJ; 74% adenocarcinomas and 25% squamous cell carcinomas). Among the 460 who had resection, 79% had residual pathological disease. 68% (<em>n</em> = 249) and 88% (<em>n</em> = 321) were eligible for adjuvant nivolumab per CM577 and <em>GIAJNIV</em> criteria, respectively. In BC, this equates to ∼60 patients/year, resulting in 768 additional chemotherapy and potentially an equal number of MD visits, totaling 256 MD workhours annually. With a 34% G3/4 toxicity rate, an estimated 20 patients/year may require medical intervention.</div></div><div><h3>Conclusions</h3><div>Adjuvant nivolumab is an important treatment option for resected ESO/GEJ cancer patients. Our findings suggest that a substantial portion (88%) of those with residual pathological disease would be eligible for 12 months of therapy. In addition to treatments costs, the implementation of new therapy indications should consider the additional workload impact on oncologists.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"7 ","pages":"Article 100115"},"PeriodicalIF":0.0,"publicationDate":"2025-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143160897","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}
A. Lamarca , J. Adeva , I. Ales Díaz , R. Alvarez Gallego , A.J. Muñoz Martín , T. Macarulla Mercade
{"title":"Maintenance chemotherapy in biliary tract tumours in the era of immuno-chemotherapy","authors":"A. Lamarca , J. Adeva , I. Ales Díaz , R. Alvarez Gallego , A.J. Muñoz Martín , T. Macarulla Mercade","doi":"10.1016/j.esmogo.2024.100116","DOIUrl":"10.1016/j.esmogo.2024.100116","url":null,"abstract":"<div><div>Biliary tract tumours (BTCs) are malignancies with a poor prognosis. Regarding first-line therapy options, cisplatin and gemcitabine (CisGem) alone has been the standard therapy option for more than a decade. This has changed recently, due to the incorporation of immunotherapy into this combo, with latest studies showing how the addition of immunotherapy with either durvalumab or pembrolizumab can improve patients’ outcomes. However, the adequate duration of CisGem in advanced BTCs has remained an open debate. We provide a detailed summary and discussion on current evidence in terms of adequate duration of chemotherapy in the immuno-chemotherapy era, with the aim of informing best practice. Based on the data available and summarised here, the differences are small and individual decisions should be pursued for the sake of not compromising the bone marrow reserve for delivering second-line therapies. In the era of immuno-chemotherapy, maintenance chemotherapy seems to be of very limited benefit and maintenance with the checkpoint inhibitors being utilised seems sufficient. For patients being treated with chemotherapy alone, maintenance chemotherapy should also be carefully considered and decisions individualised.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"7 ","pages":"Article 100116"},"PeriodicalIF":0.0,"publicationDate":"2025-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143160880","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}