ESMO Open最新文献

{"title":"Maintenance with 5-FU/LV-aflibercept after induction with FOLFIRI-aflibercept versus FOLFIRI-aflibercept until progression as second-line treatment in older adults with metastatic colorectal cancer: the AFEMA phase II randomized trial","authors":"P. García-Alfonso ,&nbsp;E. Elez ,&nbsp;J. Soto-Alsar ,&nbsp;D. Páez ,&nbsp;A. Fernández-Montes ,&nbsp;B. Graña ,&nbsp;A. Salud ,&nbsp;A. Yubero ,&nbsp;M.A. Gómez-España ,&nbsp;I. Macías ,&nbsp;G. Quintero ,&nbsp;C. López-López ,&nbsp;T. Fernández-Rodríguez ,&nbsp;C. Grávalos ,&nbsp;E. González-Flores ,&nbsp;M. Guix ,&nbsp;B. García Paredes ,&nbsp;J.J. Reina ,&nbsp;J.R. Rodríguez Mowbray ,&nbsp;J. Sastre ,&nbsp;E. Aranda","doi":"10.1016/j.esmoop.2024.103986","DOIUrl":"10.1016/j.esmoop.2024.103986","url":null,"abstract":"<div><h3>Background</h3><div>The combination chemotherapy i.v. 5-fluorouracil (5-FU), irinotecan, and aflibercept (FOLFIRI-A) is a standard second-line treatment of metastatic colorectal cancer (mCRC). The aim was to assess maintenance treatment in second-line setting in older patients (aged ≥70 years) with mCRC.</div></div><div><h3>Patients and methods</h3><div>We evaluated FOLFIRI-A given for six cycles followed by maintenance with 5-FU/leucovorin (LV)-A (arm A) or FOLFIRI-A (arm B) until progression in older adults with mCRC in the AFEMA randomized, open-label, non-inferiority phase II trial (EudraCT2016-004076-21/NCT03279289). Patients aged ≥70 years who previously failed oxaliplatin-fluoropyrimidine were randomly allocated (1 : 1) to either arm A (experimental) or arm B (control). After enrolling 35 patients, the FOLFIRI dose was reduced to level 1 in both arms due to toxicity. The primary endpoint was median progression-free survival (PFS); and secondary endpoints were median overall survival, objective response rate, and safety. Non-inferiority required the upper confidence interval (CI) limit to not exceed a hazard ratio (HR) of 1.5 (one-sided <em>α</em> = 0.075, 80% power).</div></div><div><h3>Results</h3><div>A total of 170 patients were randomly allocated to arm A or arm B (<em>n</em> = 85 each). The median follow-up was 12.2 versus 10.9 months in arm A versus arm B. Most patients died (83.5% versus 88.2% in arm A versus arm B), mainly from disease progression. PFS non-inferiority was met (HR = 0.78, 95% CI 0.566-1.076, <em>P</em> = 0.131) with a median PFS of 6.1 versus 5.5 months in arm A versus arm B. Median overall survival was similar in arms A and B (12.2 and 11.5 months, respectively) (HR = 0.89, 95% CI 0.640-1.227, <em>P</em> = 0.467). During the maintenance phase, severe asthenia (4.5% versus 21.6%, <em>P</em> = 0.038), serious adverse events (SAEs) (17.8% versus 37.8%, <em>P</em> = 0.049), and treatment-related SAEs (6.7% versus 10.8%, <em>P</em> = 0.695) were reduced in arm A versus arm B.</div></div><div><h3>Conclusion</h3><div>In older adults, induction with six cycles of FOLFIRI-A plus maintenance with 5-FU/LV-A was non-inferior to FOLFIRI-A until progression. Severe asthenia, SAEs, and treatment-related SAEs were reduced with 5-FU/LV-A maintenance.</div></div>","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"9 12","pages":"Article 103986"},"PeriodicalIF":7.1,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142721052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pazopanib in the real-world setting in soft tissue sarcomas: data from the Italian national registry","authors":"B. Vincenzi ,&nbsp;P.P. Olimpieri ,&nbsp;S. Celant ,&nbsp;A. Mazzocca ,&nbsp;A. Cortellini ,&nbsp;A. Comandone ,&nbsp;L. Tomassini ,&nbsp;S. Di Segni ,&nbsp;P. Russo ,&nbsp;P.G. Casali","doi":"10.1016/j.esmoop.2024.103995","DOIUrl":"10.1016/j.esmoop.2024.103995","url":null,"abstract":"<div><h3>Background</h3><div>Pazopanib is part of the therapeutic armamentarium for the treatment of patients with advanced non-adipocytic soft tissue sarcomas (STS) who have received prior chemotherapy, but its optimal use in STS histologies is still left to be further defined.</div></div><div><h3>Design and methods</h3><div>Data on STS patients treated with pazopanib in Italy have been prospectively collected from July 2013 to December 2019 through a drug monitoring registry managed by the Italian Medicines Agency (AIFA). This nationwide observational cohort study included patients with advanced STS who received pazopanib. Clinicians were mandatorily requested to fill in the AIFA monitoring registry in order to prescribe pazopanib.</div><div>Patients were recorded on the basis of their clinical characteristics, histological subtype captured at the time of treatment start, and clinical outcome. Primary outcome was time to treatment discontinuation (TTD). Secondary outcomes recorded were frequency of dose reduction and time to first dose reduction.</div></div><div><h3>Results</h3><div>We analyzed data from 1964 sarcoma patients. The most represented histological subtypes were leiomyosarcoma (44.7%), undifferentiated sarcomas/not otherwise specified (11.5%), and synovial sarcoma (8.1%). Overall, the median TTD was 106 days. The variables significantly associated to shorter TTD were Eastern Cooperative Oncology Group performance status (1-2 versus 0), the number of previous lines of treatment (2-4 versus 0-1) and prescribed dose (200 mg or 400 mg versus 800 mg, all once daily). Among the most represented (&gt;20 patients) histological subtypes, we also observed longer TTD in patients with histological diagnosis of malignant solitary fibrous tumor if compared with undifferentiated sarcoma not otherwise specified.</div></div><div><h3>Conclusions</h3><div>In this nationwide observational real-world study, the outcomes are similar to those reported in the pivotal trial (PALETTE study). Our study includes a significant number of patients with rare/ultra-rare sarcoma subtypes and underlines possible differences in treatment duration among these histologies.</div></div>","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"9 12","pages":"Article 103995"},"PeriodicalIF":7.1,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142720973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lurbinectedin in extensive-stage small-cell lung cancer: a brief report of the IFCT-2105 LURBICLIN study☆","authors":"N. Girard ,&nbsp;F. Guisier ,&nbsp;A. Swalduz ,&nbsp;S. Van Hulst ,&nbsp;E. Pichon ,&nbsp;P. Lavaud ,&nbsp;L. Greillier ,&nbsp;A. Tiotiu ,&nbsp;A. Madroszyk ,&nbsp;O. Bylicki ,&nbsp;A. Canellas ,&nbsp;L. Belmont ,&nbsp;M. Zysman ,&nbsp;P.-A. Hauss ,&nbsp;B. Godbert ,&nbsp;C. Audigier-Valette ,&nbsp;C. Lebreton ,&nbsp;F. Morin ,&nbsp;V. Westeel","doi":"10.1016/j.esmoop.2024.103968","DOIUrl":"10.1016/j.esmoop.2024.103968","url":null,"abstract":"<div><h3>Background</h3><div>Small-cell lung cancer (SCLC) is a highly aggressive type of lung cancer. Lurbinectedin is recommended as second-/third-line treatment for advanced, previously treated SCLC.</div></div><div><h3>Materials and methods</h3><div>LURBICLIN is a nationwide, non-interventional, retrospective chart review study, based on the cohort of consecutive patients enrolled in the named patient use for lurbinectedin in France.</div></div><div><h3>Results</h3><div>A total of 312 patients were included. Lurbinectedin was delivered as second-line therapy in 138 (44%) patients. Grade 3-4 treatment-related adverse events were observed in 28 (9%) and 15 (5%) patients, respectively. Objective response rate (ORR) to lurbinectedin was 22% in the intention-to-treat population. After a median follow-up of 20.8 months, median progression-free survival (PFS) was 1.9 months [95% confidence interval (CI) 1.8-2.0 months]. At multivariate analysis, chemotherapy-free interval (CTFI) ≥ 90 days was an independent predictor of higher PFS [hazard ratio (HR) = 0.64, 95% CI 0.50-0.84, <em>P</em> &lt; 0.0001]. The median overall survival (OS) was 4.7 months (95% CI 4.0-5.4 months). At multivariate analysis, performance status &lt; 2 and CTFI ≥ 90 days were independent predictors of higher OS (HR = 0.71, 95% CI 0.53-0.95, <em>P</em> = 0.03; and HR = 0.58, 95% CI 0.44-0.76, <em>P</em> &lt; 0.0001, respectively). Overall, 147 (47%) patients had initiated subsequent systemic treatments.</div></div><div><h3>Conclusions</h3><div>LURBICLIN confirms the activity of lurbinectedin in patients with SCLC with a manageable safety profile. Lurbinectedin monotherapy provides an alternative option for SCLC patients.</div></div>","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"9 12","pages":"Article 103968"},"PeriodicalIF":7.1,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142720975","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A machine learning-based analysis of nationwide cancer comprehensive genomic profiling data across cancer types to identify features associated with recommendation of genome-matched therapy","authors":"H. Ikushima ,&nbsp;K. Watanabe ,&nbsp;A. Shinozaki-Ushiku ,&nbsp;K. Oda ,&nbsp;H. Kage","doi":"10.1016/j.esmoop.2024.103998","DOIUrl":"10.1016/j.esmoop.2024.103998","url":null,"abstract":"<div><h3>Background</h3><div>The low probability of identifying druggable mutations through comprehensive genomic profiling (CGP) and its financial and time costs hinder its widespread adoption. To enhance the effectiveness and efficiency of cancer precision medicine, it is critical to identify patient characteristics that are most likely to benefit from CGP.</div></div><div><h3>Patients and methods</h3><div>This nationwide retrospective study employed machine learning models to predict the identification of genome-matched therapies by CGP, utilizing a national database covering 99.7% of the patients who underwent CGP in Japan from June 2019 to November 2023. Prediction models were constructed for the overall cancer population, specific cancer types, and adolescent and young adult (AYA) group. The SHapley Additive exPlanations (SHAP) algorithm was applied to elucidate clinical features contributing to model predictions.</div></div><div><h3>Results</h3><div>This study included 60 655 patients [mean age (standard deviation), 60.8 years (14.5 years); 50.1% males]. CGP identified at least one genome-matched therapy in 11 227 cases (18.5%). The best prediction model was eXtreme Gradient Boosting (XGBoost) with an area under the receiver operating characteristic curve of 0.819. Cancer type was the most important predictor (negative for pancreas and positive for breast and lung), followed by the age, presence of liver metastasis, and number of metastatic sites. Analysis of cancer type-specific models identified several organ-specific features, including the sex, interval between the cancer diagnosis and CGP, sampling site, and CGP panel. Among 3455 AYA patients, genome-matched therapies were identified in 459 patients (13.3%). The AYA-specific model achieved an area under the receiver operating characteristic curve of 0.768, with bone tumor identified as a negative predictor in addition to those identified in the overall cancer population model.</div></div><div><h3>Conclusion</h3><div>Several factors predicting the identification of genome-matched therapies through CGP were identified for the overall cancer population and cancer type-specific subpopulations. Expedited CGP is recommended for patients who match the identified profile to facilitate early targeted therapy.</div></div>","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"9 12","pages":"Article 103998"},"PeriodicalIF":7.1,"publicationDate":"2024-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142698781","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Collagen signature adds prognostically significant information to staging for breast cancer","authors":"Z. Li ,&nbsp;D. Kang ,&nbsp;S. Xu ,&nbsp;G. Xi ,&nbsp;L. Li ,&nbsp;L. Zheng ,&nbsp;W. Guo ,&nbsp;F. Fu ,&nbsp;C. Wang ,&nbsp;J. Ma ,&nbsp;X. Han ,&nbsp;S. Xu ,&nbsp;J. Chen ,&nbsp;J. Chen","doi":"10.1016/j.esmoop.2024.103990","DOIUrl":"10.1016/j.esmoop.2024.103990","url":null,"abstract":"<div><h3>Background</h3><div>Tumor-associated collagen signature (TACS) is an independent prognostic factor for breast cancer. However, it is unclear whether the complete collagen signature, including TACS, the TACS-based collagen microscopic features (TCMF1), and the TACS-based nuclear features (TCMF2), can provide additional prognostic information for the current tumor–node–metastasis (TNM) staging system.</div></div><div><h3>Patients and methods</h3><div>We included 941 patients with breast cancer from three cohorts: the training (<em>n</em> = 355), internal (<em>n</em> = 334), and external validation cohorts (<em>n</em> = 252). TACS and TCMF1 were obtained by multiphoton microscopy (MPM). TCMF2 was extracted on the hematoxylin and eosin images colocated with MPM images. They were linearly combined to establish a complete collagen signature score for reclassifying current TNM staging into stage Ⅰ (II and Ⅲ)/low risk and stage Ⅰ (II and Ⅲ)/high risk.</div></div><div><h3>Results</h3><div>The low-risk collagen signatures ‘downstaged’ patients in stage II or Ⅲ, while the high-risk collagen signatures ‘upstaged’ patients with stage Ⅰ tumors. After incorporating the complete collagen signature into the current TNM staging system, the modified staging system had a higher ability to stratify patients [referent, Ⅰ-new; Ⅱ-new, hazard ratio (HR) 8.655, 6.136, and 4.699 in the training, internal validation, and external validation cohorts, respectively; Ⅲ-new, HR 14.855, 11.201, and 13.245 in the corresponding three cohorts, respectively] than the current TNM staging system (referent, Ⅰ; Ⅱ, HR 1.642, 1.853, and 1.371 in the corresponding three cohorts, respectively; Ⅲ, HR 4.131, 4.283, and 3.711 in the corresponding three cohorts, respectively). Furthermore, the modified staging system showed a higher area under the curve than the current TNM staging system (training cohort: 0.843 versus 0.683; internal validation cohort: 0.792 versus 0.661; and external validation cohort: 0.793 versus 0.646).</div></div><div><h3>Conclusions</h3><div>The complete collagen signature is an independent predictor of survival outcomes in breast cancer. It adds significant information about the biological behavior of the disease to staging for breast cancer.</div></div>","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"9 12","pages":"Article 103990"},"PeriodicalIF":7.1,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142692354","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Challenges in using tumor mutational burden as a post-treatment biomarker","authors":"H. Taban ,&nbsp;Y. Ergun","doi":"10.1016/j.esmoop.2024.103999","DOIUrl":"10.1016/j.esmoop.2024.103999","url":null,"abstract":"","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"9 12","pages":"Article 103999"},"PeriodicalIF":7.1,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142675376","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A simple prognostic score to predict recurrence after pancreaticoduodenectomy for ampullary carcinoma: results from the French prospective FFCD-AC cohort","authors":"G. Roth ,&nbsp;A. Pellat ,&nbsp;G. Piessen ,&nbsp;K. le Malicot ,&nbsp;L. Schwarz ,&nbsp;C. Gallois ,&nbsp;D. Tougeron ,&nbsp;V. Hautefeuille ,&nbsp;M. Jary ,&nbsp;S. Benoist ,&nbsp;M. Amil ,&nbsp;R. Desgrippes ,&nbsp;M. Muller ,&nbsp;T. Lecomte ,&nbsp;M. Guillet ,&nbsp;C. Locher ,&nbsp;C. Genet ,&nbsp;S. Manfredi ,&nbsp;O. Bouché ,&nbsp;J. Taieb","doi":"10.1016/j.esmoop.2024.103988","DOIUrl":"10.1016/j.esmoop.2024.103988","url":null,"abstract":"<div><h3>Background</h3><div>Ampullary carcinoma (AC) is a rare and severe gastrointestinal cancer with a disease recurrence rate of around 40% after curative-intent surgery and for which the main prognostic factors and adjuvant treatment decision remain a matter of debate.</div></div><div><h3>Patients and methods</h3><div>The FFCD-AC cohort is a French nationwide prospective cohort, which included patients with non-metastatic resected AC. The primary objective of this study was to describe prognostic factors associated with disease-free survival (DFS) and overall survival (OS) after pancreaticoduodenectomy (PD) so as to propose a user-friendly score to better estimate the risk of recurrence. The secondary objective was to study the benefit of adjuvant therapy in terms of DFS and OS.</div></div><div><h3>Results</h3><div>Three hundred and seventy patients with resected AC were included. Median follow-up was 40.6 months. Median age was 68.5 years (32.0-87.0 years), 53.8% of patients were male and 56.1%/37.4%/6.5% had an Eastern Cooperative Oncology Group performance status 0/1/2, respectively. Pathological subtype was intestinal/pancreatobiliary/mixed-undetermined in 29.5%/40.5%/30.0% of patients, respectively. Adjuvant chemotherapy was carried out in 61% of patients. In multivariable analysis, stage III tumor [hazard ratio (HR) 2.86, (95% confidence interval {95% CI}: 1.89-4.17), <em>P</em> &lt; 0.0001], high tumor grade [HR 2.51, (95% CI: 1.42-4.43), <em>P</em> = 0.002] and non-intestinal subtype [HR 1.58, (95% CI: 1.00-2.49), <em>P</em> = 0.052] were associated with shorter DFS. A score based on these three parameters divided patients into low (<em>n</em> = 83), intermediate (<em>n</em> = 133) and high risk (<em>n</em> = 96) with median DFS not reached (NR)/73.1/15.2 months and a median OS NR/86.1/38.2 months, respectively. After propensity score matching, adjuvant chemotherapy was associated with longer DFS [HR 0.57, (95% CI: 0.45-0.72), <em>P</em> &lt; 0.0001] in the cohort.</div></div><div><h3>Conclusion</h3><div>Our integrated score based on three easy-to-collect items—lymph node invasion, tumor grade and non-intestinal subtypes—seems highly prognostic in resected AC and needs to be confirmed in an external validation dataset to help adjuvant treatment decision making.</div></div>","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"9 12","pages":"Article 103988"},"PeriodicalIF":7.1,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142675375","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"HER2DX genomic test in early-stage HER2-positive breast cancer","authors":"S.M. Tolaney ,&nbsp;N. Tung ,&nbsp;A.C. Wolff ,&nbsp;A. DeMichele ,&nbsp;J.M. Cejalvo ,&nbsp;O. Martínez-Sáez ,&nbsp;T. Pascual ,&nbsp;A.G. Waks ,&nbsp;M. Martín ,&nbsp;E. Ciruelos ,&nbsp;N. Harbeck ,&nbsp;L.A. Carey ,&nbsp;J. Cortés ,&nbsp;G. Curigliano ,&nbsp;A. Prat","doi":"10.1016/j.esmoop.2024.103987","DOIUrl":"10.1016/j.esmoop.2024.103987","url":null,"abstract":"<div><div>Therapies targeting human epidermal growth factor receptor 2 (HER2)-positive breast cancer significantly impact patient outcomes, quality of life, and health care systems. While chemotherapy and trastuzumab improve survival in early-stage HER2-positive breast cancer, variability in clinical and biological characteristics leads to different response to therapies and outcomes. Clinical guidelines provide general recommendations, but significant uncertainty persists in identifying an optimal treatment plan for individual patients. The HER2DX genomic test informs treatment decisions for stage 1-3 HER2-positive breast cancer by integrating biological factors and clinical factors (tumor size and nodal status). It provides three scores relevant to patient management: long-term prognosis (risk score), likelihood of achieving pathological complete response (pCR score), and <em>ERBB2</em> mRNA expression (ERBB2 score). This article offers an expert overview of HER2DX, covering score interpretation, clinical applications, ongoing studies, and future directions. By analyzing the genomic profiles of HER2-positive tumors, HER2DX provides independent information regarding therapeutic responses and disease prognosis, thereby enabling physicians to navigate the increasing complexity of managing patients with HER2-positive early breast cancer. Key findings show that HER2DX predicts relapse-free survival and probability of pCR to a variety of neoadjuvant therapy regimens, which aids in personalizing treatment plans that could reduce over-treatment and under-treatment. The article underscores expert recommendations to help integrate HER2DX into clinical practice, aiming to enhance decision making and clinical outcomes.</div></div>","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"9 12","pages":"Article 103987"},"PeriodicalIF":7.1,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142652310","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prognostic value of tumor-infiltrating lymphocytes in distal extrahepatic bile duct carcinoma","authors":"S.-Y. Jun ,&nbsp;S. An ,&nbsp;S.-M. Hong ,&nbsp;J.-Y. Kim ,&nbsp;K.-P. Kim","doi":"10.1016/j.esmoop.2024.103969","DOIUrl":"10.1016/j.esmoop.2024.103969","url":null,"abstract":"<div><h3>Background</h3><div>The assessment of tumor-infiltrating lymphocytes (TILs) has led to the development of various immunotherapies beyond their predictive potential in gastrointestinal malignancies. However, the clinicopathologic and prognostic values of TILs have yet to be well elucidated in distal extrahepatic bile duct carcinoma (DBDC).</div></div><div><h3>Patients and methods</h3><div>We evaluated stromal TILs (sTILs) and intraepithelial TILs (iTILs) in 405 surgically resected DBDCs to analyze their correlations with overall survival (OS) and recurrence-free survival (RFS) and with clinicopathologic parameters according to the eighth edition of the American Joint Committee on Cancer scheme.</div></div><div><h3>Results</h3><div>High levels of sTIL density (sTIL^High; &gt;5%) and iTIL count (iTIL^High; &gt;3) were found in 245 (61%) and 74 cases (18%), respectively. sTIL^High was more commonly found in larger tumors (<em>P</em> = 0.048) diffusely involving both intra- and extrapancreatic bile ducts (<em>P</em> = 0.013), in tumors with lower T category (<em>P</em> = 0.002), and in tumors without pancreatic (<em>P</em> = 0.003) or duodenal invasion (<em>P</em> &lt; 0.001). iTIL^High was associated with tumors with papillary or nodular growth pattern (<em>P</em> &lt; 0.001) without perineural invasion (<em>P</em> = 0.006). Both sTIL^High and iTIL^High significantly predicted better OS (<em>P</em> = 0.009 and 0.036, respectively) and RFS (<em>P</em> = 0.003 and 0.026, respectively). sTIL consistently provided prognostic predictability in OS, even when tested with different quantitative cut-offs and prognostically stratified OS (<em>P</em> = 0.006) and RFS (<em>P</em> = 0.005) on multivariate analysis. The survival benefit of sTIL^High persisted regardless of the stage in both OS (<em>P =</em> 0.010 for lower stages I and II and <em>P</em> = 0.001 for higher stages III and IV) and RFS (<em>P =</em> 0.004 and 0.025 for lower- and higher-stage tumors, respectively).</div></div><div><h3>Conclusions</h3><div>sTILs were superior to iTILs in predicting survival, and it was shown to be a strong prognosticator for DBDC patients regardless of the stage. The utility of sTILs may extend beyond prognostication to aid in predicting therapeutic responses in DBDC patients.</div></div>","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"9 11","pages":"Article 103969"},"PeriodicalIF":7.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142593152","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corrigendum to “Under-reporting of subjective symptoms and its prognostic value: a pooled analysis of 12 cancer clinical trials”","authors":"L. Arenare ,&nbsp;R. Di Liello ,&nbsp;P. De Placido ,&nbsp;C. Gridelli ,&nbsp;A. Morabito ,&nbsp;S. Pignata ,&nbsp;F. Nuzzo ,&nbsp;A. Avallone ,&nbsp;E. Maiello ,&nbsp;P. Gargiulo ,&nbsp;C. Schettino ,&nbsp;A. Gravina ,&nbsp;C. Gallo ,&nbsp;P. Chiodini ,&nbsp;M. Di Maio ,&nbsp;F. Perrone ,&nbsp;M.C. Piccirillo","doi":"10.1016/j.esmoop.2024.103693","DOIUrl":"10.1016/j.esmoop.2024.103693","url":null,"abstract":"","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"9 11","pages":"Article 103693"},"PeriodicalIF":7.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142748561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}