Pub Date : 2026-01-16DOI: 10.1016/j.ejca.2026.116244
Michael Sandherr , Enrico Schalk , Werner J. Heinz , Philipp Köhler , Stefan W. Krause , Blasius Liss , Lea Kausche , Hartmut Link , Sibylle C. Mellinghoff , Martin Schmidt-Hieber , Nikolai Schuelper , Karsten Spiekermann , Rosanne Sprute , Ruth Seggewiss-Bernhardt
Introduction
Febrile neutropenia, a common complication of systemic antineoplastic therapy, varies in risk depending on malignant disease, treatment, and patient factors. The risk increases with the depth and duration of neutropenia and can be reduced with prophylactic use of G-CSF. International guidelines are conflicting in several aspects and do not reflect all patient groups. We therefore updated the 2014 Infectious Diseases Working Party (AGIHO) guideline of the German Society of Hematology and Medical Oncology (DGHO) on evidence-based recommendations for the use of G-CSF in patients with cancer.
Materials and Methods
After a systematic literature search from January 2014 to December 2024 on PubMed and Medline several consensus meetings were held by an expert panel of the AGIHO to evaluate, discuss and consent on the level of evidence and strength of recommendation for the use of G-CSF in patients with cancer based on ESCMID criteria.
Results
Results from eligible (randomized) studies were grouped in evidence tables. Recommendations for different entities, risk groups, new G-CSF formulations and emerging strategies in immunotherapy were set up and put into comparison to 2014.
Discussion
Comprehensive literature search and expert panel consensus confirm most of the key recommendations of 2014. New recommendations on the use of G-CSF in immunotherapy settings provide insight and support for day-by-day clinical decision making in the care of patients with cancer.
{"title":"Evidence-based AGIHO guideline update on prophylaxis of infectious complications with granulocyte-stimulating factors (G-CSF) for the treatment of adult patients with cancer","authors":"Michael Sandherr , Enrico Schalk , Werner J. Heinz , Philipp Köhler , Stefan W. Krause , Blasius Liss , Lea Kausche , Hartmut Link , Sibylle C. Mellinghoff , Martin Schmidt-Hieber , Nikolai Schuelper , Karsten Spiekermann , Rosanne Sprute , Ruth Seggewiss-Bernhardt","doi":"10.1016/j.ejca.2026.116244","DOIUrl":"10.1016/j.ejca.2026.116244","url":null,"abstract":"<div><h3>Introduction</h3><div>Febrile neutropenia, a common complication of systemic antineoplastic therapy, varies in risk depending on malignant disease, treatment, and patient factors. The risk increases with the depth and duration of neutropenia and can be reduced with prophylactic use of G-CSF. International guidelines are conflicting in several aspects and do not reflect all patient groups. We therefore updated the 2014 Infectious Diseases Working Party (AGIHO) guideline of the German Society of Hematology and Medical Oncology (DGHO) on evidence-based recommendations for the use of G-CSF in patients with cancer.</div></div><div><h3>Materials and Methods</h3><div>After a systematic literature search from January 2014 to December 2024 on PubMed and Medline several consensus meetings were held by an expert panel of the AGIHO to evaluate, discuss and consent on the level of evidence and strength of recommendation for the use of G-CSF in patients with cancer based on ESCMID criteria.</div></div><div><h3>Results</h3><div>Results from eligible (randomized) studies were grouped in evidence tables. Recommendations for different entities, risk groups, new G-CSF formulations and emerging strategies in immunotherapy were set up and put into comparison to 2014.</div></div><div><h3>Discussion</h3><div>Comprehensive literature search and expert panel consensus confirm most of the key recommendations of 2014. New recommendations on the use of G-CSF in immunotherapy settings provide insight and support for day-by-day clinical decision making in the care of patients with cancer.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"235 ","pages":"Article 116244"},"PeriodicalIF":7.1,"publicationDate":"2026-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146028964","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-16DOI: 10.1016/j.ejca.2026.116245
Lise J. van de Velde , W.F. Julius Scheurleer , Michal D. Czerwinski , Lia G. Verhoef , Marco Ferrari , Rita De Berardinis , Mohssen Ansarin , Tamer Soror , Laura Motisi , Christian M. Meerwein , Bruno Fionda , Vittorio Rampinelli , Maurizio Bignami , Paolo Battaglia , Giampiero Parrinello , Florian Chatelet , Alessandro Vinciguerra , Zoltán Takácsi-Nagy , Monik Patel , Tsu-Hui (Hubert) Low , Francesco Bussu
Study aim
Cancer of the nasal vestibule (CNV) is an underrecognized head and neck malignancy, lacking a distinct ICD-O-3 topography code, and a specific T classification. The goal of this study was to assess which of the currently used T classifications provides the most accurate predictive and discriminatory accuracy.
Methods
The four currently used classifications (UICC Sinonasal, UICC NMSC, Wang and Rome) were assessed in a retrospective multicenter cohort established within the Head & Neck and Skin Groupe Européen de Curiethérapie / European SocieTy for Radiotherapy & Oncology Working Group. Through multivariable disease-specific and recurrence-free survival analyses, it was evaluated which staging system was most valuable.
Results
609 CNV cases were retrieved from 21 tertiary care centers. Only the Wang and New Rome systems provided accurate prognostic stratification as they showed diminishing survival rates and increasing hazards of disease-specific death and disease recurrence with each successive T category. Compared to Wang, the New Rome system employs more objective criteria and, since it includes four T categories, it can easily be integrated with cN stage to obtain a specific clinical staging for the CNV, which has also resulted superior compared to the current UICC/AJCC systems in this study.
Conclusion
The New Rome classification exhibits a superior predictive and descriptive precision compared to the Wang and both UICC/AJCC systems. The New Rome’s T category structure would allow an integration into the wider UICC/AJCC system once the nasal vestibule is acknowledged as a different subsite.
研究目的鼻前庭癌（CNV）是一种未被充分认识的头颈部恶性肿瘤，缺乏明确的ICD-O-3地形编码和特定的T分类。本研究的目的是评估目前使用的T分类中哪一种提供了最准确的预测和区分准确性。方法对目前使用的四种分类（UICC Sinonasal、UICC NMSC、Wang和Rome）进行回顾性多中心队列评估，该队列由欧洲颈部和皮肤组织(Head & Neck and Skin Group) /欧洲放射与肿瘤学会（European SocieTy for radiation & Oncology Working Group）建立。通过多变量疾病特异性和无复发生存分析，评估哪种分期系统最有价值。结果21个三级医疗中心共收集到609例CNV病例。只有Wang和New Rome系统提供了准确的预后分层，因为它们显示每一个连续的T分类生存率降低，疾病特异性死亡和疾病复发的风险增加。与Wang相比，新罗马系统采用了更客观的标准，由于它包括四个T类别，它可以很容易地与cN分期相结合，以获得CNV的特定临床分期，这也导致了本研究中与当前UICC/AJCC系统相比的优势。结论与Wang和UICC/AJCC系统相比，New Rome分类系统具有更高的预测和描述精度。一旦鼻前庭被确认为不同的子站点，新罗马的T类结构将允许集成到更广泛的UICC/AJCC系统中。
{"title":"International multicentric validation of a novel T classification system for cancer of the nasal vestibule","authors":"Lise J. van de Velde , W.F. Julius Scheurleer , Michal D. Czerwinski , Lia G. Verhoef , Marco Ferrari , Rita De Berardinis , Mohssen Ansarin , Tamer Soror , Laura Motisi , Christian M. Meerwein , Bruno Fionda , Vittorio Rampinelli , Maurizio Bignami , Paolo Battaglia , Giampiero Parrinello , Florian Chatelet , Alessandro Vinciguerra , Zoltán Takácsi-Nagy , Monik Patel , Tsu-Hui (Hubert) Low , Francesco Bussu","doi":"10.1016/j.ejca.2026.116245","DOIUrl":"10.1016/j.ejca.2026.116245","url":null,"abstract":"<div><h3>Study aim</h3><div>Cancer of the nasal vestibule (CNV) is an underrecognized head and neck malignancy, lacking a distinct ICD-O-3 topography code, and a specific T classification. The goal of this study was to assess which of the currently used T classifications provides the most accurate predictive and discriminatory accuracy.</div></div><div><h3>Methods</h3><div>The four currently used classifications (UICC Sinonasal, UICC NMSC, Wang and Rome) were assessed in a retrospective multicenter cohort established within the Head & Neck and Skin Groupe Européen de Curiethérapie / European SocieTy for Radiotherapy & Oncology Working Group. Through multivariable disease-specific and recurrence-free survival analyses, it was evaluated which staging system was most valuable.</div></div><div><h3>Results</h3><div>609 CNV cases were retrieved from 21 tertiary care centers. Only the Wang and New Rome systems provided accurate prognostic stratification as they showed diminishing survival rates and increasing hazards of disease-specific death and disease recurrence with each successive T category. Compared to Wang, the New Rome system employs more objective criteria and, since it includes four T categories, it can easily be integrated with cN stage to obtain a specific clinical staging for the CNV, which has also resulted superior compared to the current UICC/AJCC systems in this study.</div></div><div><h3>Conclusion</h3><div>The New Rome classification exhibits a superior predictive and descriptive precision compared to the Wang and both UICC/AJCC systems. The New Rome’s T category structure would allow an integration into the wider UICC/AJCC system once the nasal vestibule is acknowledged as a different subsite.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"235 ","pages":"Article 116245"},"PeriodicalIF":7.1,"publicationDate":"2026-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146035857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-15DOI: 10.1016/j.ejca.2026.116246
Thomas Budolfsen , Rene Horsleben Petersen , Lars Borgbjerg Møller , Jette Brabrand , Zaigham Saghir , Morten Quist
Background
Surgical resection is first-line treatment for patients with stage I–IIIA non-small cell lung cancer (NSCLC), yet a substantial proportion are managed without surgery. The reasons for non-operative management and the role of objective functional assessment are insufficiently described.
Methods
This retrospective registry-based cohort study included patients diagnosed with stage I–IIIA NSCLC in 2022 in the Capital Region of Denmark. Data were retrieved from the Danish Lung Cancer Registry and electronic medical records. Patients were categorized into “Surgery” and “No surgery” groups. Demographic variables, lung function, ECOG performance status, comorbidities, and MDT justifications were extracted. Multivariable logistic regression identified factors associated with not receiving surgery, and one-year overall survival (OS) was estimated using Kaplan–Meier methods.
Results
Among 524 patients, 178 (34 %) did not undergo surgery. Non-surgical management was independently associated with age ≥ 80 years, stage IIIA disease, poorer ECOG performance status, comorbidities, and reduced or unregistered DLco, whereas FEV1 and DLco ≥ 80 % predicted were negatively associated. MDT justifications were low lung function or poor performance status (29.2 %), comorbidities (18.0 %), and N2 disease (11.8 %); in 19.7 % no justification was documented. No documentation of preoperative exercise testing was identified. One-year OS was higher after surgery than no surgery (95.7 % vs. 82.0 %), unadjusted.
Conclusions
One third of patients with stage I–IIIA NSCLC were treated without surgery, mainly due to impaired functional status, comorbidity, or advanced stage. The absence of documented exercise testing highlights a gap between guideline recommendations and clinical practice.
{"title":"Why are patients with non-small cell lung cancer in stage I-IIIA considered inoperable? A registry-based study from the capital region of Denmark","authors":"Thomas Budolfsen , Rene Horsleben Petersen , Lars Borgbjerg Møller , Jette Brabrand , Zaigham Saghir , Morten Quist","doi":"10.1016/j.ejca.2026.116246","DOIUrl":"10.1016/j.ejca.2026.116246","url":null,"abstract":"<div><h3>Background</h3><div>Surgical resection is first-line treatment for patients with stage I–IIIA non-small cell lung cancer (NSCLC), yet a substantial proportion are managed without surgery. The reasons for non-operative management and the role of objective functional assessment are insufficiently described.</div></div><div><h3>Methods</h3><div>This retrospective registry-based cohort study included patients diagnosed with stage I–IIIA NSCLC in 2022 in the Capital Region of Denmark. Data were retrieved from the Danish Lung Cancer Registry and electronic medical records. Patients were categorized into “Surgery” and “No surgery” groups. Demographic variables, lung function, ECOG performance status, comorbidities, and MDT justifications were extracted. Multivariable logistic regression identified factors associated with not receiving surgery, and one-year overall survival (OS) was estimated using Kaplan–Meier methods.</div></div><div><h3>Results</h3><div>Among 524 patients, 178 (34 %) did not undergo surgery. Non-surgical management was independently associated with age ≥ 80 years, stage IIIA disease, poorer ECOG performance status, comorbidities, and reduced or unregistered DLco, whereas FEV1 and DLco ≥ 80 % predicted were negatively associated. MDT justifications were low lung function or poor performance status (29.2 %), comorbidities (18.0 %), and N2 disease (11.8 %); in 19.7 % no justification was documented. No documentation of preoperative exercise testing was identified. One-year OS was higher after surgery than no surgery (95.7 % vs. 82.0 %), unadjusted.</div></div><div><h3>Conclusions</h3><div>One third of patients with stage I–IIIA NSCLC were treated without surgery, mainly due to impaired functional status, comorbidity, or advanced stage. The absence of documented exercise testing highlights a gap between guideline recommendations and clinical practice.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"235 ","pages":"Article 116246"},"PeriodicalIF":7.1,"publicationDate":"2026-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145975632","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-14DOI: 10.1016/j.ejca.2026.116224
A. Addeo , M. Früh
{"title":"Corrigendum to “Thoracic radiotherapy plus maintenance durvalumab after first line carboplatin and etoposide plus durvalumab in extensive-stage disease small cell lung cancer (ES-SCLC) - A multicenter single arm open label phase II trial (SAKK 15/19)” [Eur J Cancer 2025 Nov 29:232:116138]","authors":"A. Addeo , M. Früh","doi":"10.1016/j.ejca.2026.116224","DOIUrl":"10.1016/j.ejca.2026.116224","url":null,"abstract":"","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"235 ","pages":"Article 116224"},"PeriodicalIF":7.1,"publicationDate":"2026-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146035856","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-12DOI: 10.1016/j.ejca.2026.116230
Alessandra Spata , Joana M. Ribeiro , Paolo Vigneri , Alberto Zambelli , Jean Zeghondy , Chayma Bousrih , Thomas Grinda , Alessandro Viansone , Alexandre J. Vivanti , Michaël Grynberg , Bruno Achutti Duso , Fabrice André , Barbara Pistilli , Elie Rassy
Pregnancy-Associated Breast Cancer (PABC) accounts for pregnancy-related breast cancer (PrBC), occurring during pregnancy and the first postpartum year, and postpartum breast cancer (PPBC), arising up to 5–10 years after childbirth. It represents an increasingly oncological challenge as delayed childbearing trends extend maternal reproductive age. Occurring in approximately 1:3000 pregnancies, PABC accounts for 0.2–3.8 % of all breast cancer cases. PABC is often associated with aggressive clinic-biological characteristics, including higher prevalence of triple-negative subtypes, increased lymph node involvement, and more frequent advanced-stage presentation compared to age-matched non-pregnant controls. The complex mammary microenvironment during pregnancy, lactation, and postpartum involution undergoes extensive hormonal-driven remodeling that creates a biphasic landscape, initially providing a permissive environment for carcinogenesis while conferring long-term protective effects. The molecular mechanisms underlying this transformation remain incompletely understood and represent an active area of investigation. Molecular profiling of PABC reveals enhanced proliferative signaling pathways, metabolic reprogramming, tumor-promoting inflammatory responses, and compromised DNA damage repair mechanisms. While PABC shares similar genomic architecture with non-pregnancy-associated breast cancers, distinct gene expression signatures have been identified that may contribute to its aggressive phenotype. This comprehensive review examines the physiological breast changes occurring throughout the reproductive cycle and their relationship to PABC carcinogenesis. We analyze the molecular profile and clinicopathological features that distinguish PABC from conventional breast cancer, while addressing the therapeutic challenges posed by fetal safety considerations. Additionally, we evaluate the safety profiles of novel therapeutic agents during pregnancy and lactation, highlighting the critical need for new pregnancy-compatible treatment strategies.
{"title":"Comprehensive review of pregnancy associated breast cancer: Clinical features, molecular characteristics and novel therapies","authors":"Alessandra Spata , Joana M. Ribeiro , Paolo Vigneri , Alberto Zambelli , Jean Zeghondy , Chayma Bousrih , Thomas Grinda , Alessandro Viansone , Alexandre J. Vivanti , Michaël Grynberg , Bruno Achutti Duso , Fabrice André , Barbara Pistilli , Elie Rassy","doi":"10.1016/j.ejca.2026.116230","DOIUrl":"10.1016/j.ejca.2026.116230","url":null,"abstract":"<div><div>Pregnancy-Associated Breast Cancer (PABC) accounts for pregnancy-related breast cancer (PrBC), occurring during pregnancy and the first postpartum year, and postpartum breast cancer (PPBC), arising up to 5–10 years after childbirth. It represents an increasingly oncological challenge as delayed childbearing trends extend maternal reproductive age. Occurring in approximately 1:3000 pregnancies, PABC accounts for 0.2–3.8 % of all breast cancer cases. PABC is often associated with aggressive clinic-biological characteristics, including higher prevalence of triple-negative subtypes, increased lymph node involvement, and more frequent advanced-stage presentation compared to age-matched non-pregnant controls. The complex mammary microenvironment during pregnancy, lactation, and postpartum involution undergoes extensive hormonal-driven remodeling that creates a biphasic landscape, initially providing a permissive environment for carcinogenesis while conferring long-term protective effects. The molecular mechanisms underlying this transformation remain incompletely understood and represent an active area of investigation. Molecular profiling of PABC reveals enhanced proliferative signaling pathways, metabolic reprogramming, tumor-promoting inflammatory responses, and compromised DNA damage repair mechanisms. While PABC shares similar genomic architecture with non-pregnancy-associated breast cancers, distinct gene expression signatures have been identified that may contribute to its aggressive phenotype. This comprehensive review examines the physiological breast changes occurring throughout the reproductive cycle and their relationship to PABC carcinogenesis. We analyze the molecular profile and clinicopathological features that distinguish PABC from conventional breast cancer, while addressing the therapeutic challenges posed by fetal safety considerations. Additionally, we evaluate the safety profiles of novel therapeutic agents during pregnancy and lactation, highlighting the critical need for new pregnancy-compatible treatment strategies.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"235 ","pages":"Article 116230"},"PeriodicalIF":7.1,"publicationDate":"2026-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145975631","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Non-small cell lung cancer (NSCLC) patients with comorbid interstitial pneumonia (IP) are at high risk for drug-induced pneumonitis, and previous reports suggest a lower frequency of common driver mutations such as EGFR. This may discourage genetic testing, potentially overlooking prevalent, targetable mutations like KRAS, BRAF, and MET. This study aimed to elucidate the real-world status of genetic testing, the frequency of oncogenic drivers, and the safety and efficacy of targeted therapies in patients with NSCLC and comorbid IP.
Methods
This multicenter, retrospective study analyzed 1256 patients with advanced or recurrent NSCLC and comorbid chronic fibrosing IP from 37 Japanese institutions (Registry number: UMIN000055609).
Results
The rate of any genetic testing was 59.2 % (95 % confidence interval [CI], 56.5–62.0), with multigene testing performed in only 41.0 % (95 %CI, 38.3–43.8). Among patients with NSCLC undergoing multigene testing (N = 515), the most frequent mutations were KRAS (4.7 %; G12C, 1.9 %), followed by EGFR (2.9 %), BRAF V600E (1.6 %), and MET exon 14 skipping (1.6 %). The incidence of drug-induced pneumonitis was 0 % (0/6) for sotorasib, 50 % (4/8) for osimertinib, 33 % (1/3) for alectinib, and 25 % (1/4) for both dabrafenib plus trametinib and tepotinib. Patients with actionable oncogenic drivers receiving targeted therapy had the longest overall survival, followed by those not receiving it, and then driver-negative/unknown patients (median: 39.2, 24.0, and 13.8 months, respectively).
Conclusions
Multigene testing is underutilized in this population. While many targeted therapies carry a high risk of pneumonitis, sotorasib appeared relatively safe. Despite the risks, identifying and treating actionable oncogenic drivers may improve survival.
{"title":"Targeting driver mutations in lung cancer with interstitial pneumonia: A nationwide study in Japan","authors":"Satoshi Ikeda , Takashi Ogura , Toshihiro Misumi , Yasuhiko Nishioka , Seishu Hashimoto , Kazuya Ichikado , Aya Fukuizumi , Saori Takata , Taku Itoh , Yuki Sato , Kyoichi Okishio , Kazuhiro Yatera , Noriho Sakamoto , Motoyasu Kato , Ryota Kikuchi , Takayuki Honda , Naozumi Hashimoto , Koji Murakami , Takuma Isshiki , Mayuka Yamane , Kazuma Kishi","doi":"10.1016/j.ejca.2026.116232","DOIUrl":"10.1016/j.ejca.2026.116232","url":null,"abstract":"<div><h3>Introduction</h3><div>Non-small cell lung cancer (NSCLC) patients with comorbid interstitial pneumonia (IP) are at high risk for drug-induced pneumonitis, and previous reports suggest a lower frequency of common driver mutations such as <em>EGFR</em>. This may discourage genetic testing, potentially overlooking prevalent, targetable mutations like <em>KRAS</em>, <em>BRAF</em>, and <em>MET</em>. This study aimed to elucidate the real-world status of genetic testing, the frequency of oncogenic drivers, and the safety and efficacy of targeted therapies in patients with NSCLC and comorbid IP.</div></div><div><h3>Methods</h3><div>This multicenter, retrospective study analyzed 1256 patients with advanced or recurrent NSCLC and comorbid chronic fibrosing IP from 37 Japanese institutions (Registry number: UMIN000055609).</div></div><div><h3>Results</h3><div>The rate of any genetic testing was 59.2 % (95 % confidence interval [CI], 56.5–62.0), with multigene testing performed in only 41.0 % (95 %CI, 38.3–43.8). Among patients with NSCLC undergoing multigene testing (N = 515), the most frequent mutations were <em>KRAS</em> (4.7 %; G12C, 1.9 %), followed by <em>EGFR</em> (2.9 %), <em>BRAF V600E</em> (1.6 %), and <em>MET exon 14 skipping</em> (1.6 %). The incidence of drug-induced pneumonitis was 0 % (0/6) for sotorasib, 50 % (4/8) for osimertinib, 33 % (1/3) for alectinib, and 25 % (1/4) for both dabrafenib plus trametinib and tepotinib. Patients with actionable oncogenic drivers receiving targeted therapy had the longest overall survival, followed by those not receiving it, and then driver-negative/unknown patients (median: 39.2, 24.0, and 13.8 months, respectively).</div></div><div><h3>Conclusions</h3><div>Multigene testing is underutilized in this population. While many targeted therapies carry a high risk of pneumonitis, sotorasib appeared relatively safe. Despite the risks, identifying and treating actionable oncogenic drivers may improve survival.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"235 ","pages":"Article 116232"},"PeriodicalIF":7.1,"publicationDate":"2026-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145975633","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-11DOI: 10.1016/j.ejca.2026.116231
Rachel Woodford , Sally Lord , Annelise Decaria , John Simes , Michael Friedlander , Ian C. Marschner , Chee Khoon Lee
Introduction
A considerable proportion of patients in ovarian cancer maintenance trials may be censored in progression-free survival (PFS) analyses, the primary study endpoint. Such censoring is often informative, reflecting discontinuation due to toxicity, preference, or early switch to alternative therapies, potentially biasing results toward overestimating PFS benefit. We aimed to quantify the impact of informative censoring on PFS in these trials.
Methods
Double-blind, placebo-controlled maintenance therapy trials were selected, and individual patient data reconstructed from published survival curves. A sensitivity analysis reclassified varying proportions of all censored events as progressions to model scenarios from 0 % to 100 % informative censoring. Hazard ratios (HRs) were re-estimated and compared with the originally reported values. Duration of therapy was compared with PFS.
Results
Twenty-two trial units (N = 8256) were included. Nineteen reported statistically significant results, falling to 14 (74 %) at the upper limit of analysis. HRs diminished progressively, with a 6 % reduction at 10 % censoring and 29 % at 100 %. In nine PARP inhibitor trials, treatment duration was shorter than PFS (mean of medians = 12.5 vs 17.6 months). Results were consistent when limited to PARP inhibitor studies. No correlation was observed between adverse events and censoring.
Conclusions
Informative censoring can substantially distort PFS benefit estimates in ovarian cancer maintenance trials. Transparent reporting of censoring rates and their causes is essential for meaningful clinical interpretation and should be standard in all randomised maintenance therapy trials.
{"title":"Informative censoring in maintenance therapy trials for advanced ovarian cancer: An empirical assessment of its impact on treatment benefit","authors":"Rachel Woodford , Sally Lord , Annelise Decaria , John Simes , Michael Friedlander , Ian C. Marschner , Chee Khoon Lee","doi":"10.1016/j.ejca.2026.116231","DOIUrl":"10.1016/j.ejca.2026.116231","url":null,"abstract":"<div><h3>Introduction</h3><div>A considerable proportion of patients in ovarian cancer maintenance trials may be censored in progression-free survival (PFS) analyses, the primary study endpoint. Such censoring is often informative, reflecting discontinuation due to toxicity, preference, or early switch to alternative therapies, potentially biasing results toward overestimating PFS benefit. We aimed to quantify the impact of informative censoring on PFS in these trials.</div></div><div><h3>Methods</h3><div>Double-blind, placebo-controlled maintenance therapy trials were selected, and individual patient data reconstructed from published survival curves. A sensitivity analysis reclassified varying proportions of all censored events as progressions to model scenarios from 0 % to 100 % informative censoring. Hazard ratios (HRs) were re-estimated and compared with the originally reported values. Duration of therapy was compared with PFS.</div></div><div><h3>Results</h3><div>Twenty-two trial units (N = 8256) were included. Nineteen reported statistically significant results, falling to 14 (74 %) at the upper limit of analysis. HRs diminished progressively, with a 6 % reduction at 10 % censoring and 29 % at 100 %. In nine PARP inhibitor trials, treatment duration was shorter than PFS (mean of medians = 12.5 vs 17.6 months). Results were consistent when limited to PARP inhibitor studies. No correlation was observed between adverse events and censoring.</div></div><div><h3>Conclusions</h3><div>Informative censoring can substantially distort PFS benefit estimates in ovarian cancer maintenance trials. Transparent reporting of censoring rates and their causes is essential for meaningful clinical interpretation and should be standard in all randomised maintenance therapy trials.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"235 ","pages":"Article 116231"},"PeriodicalIF":7.1,"publicationDate":"2026-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145975635","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-11DOI: 10.1016/j.ejca.2026.116229
Nai-Jung Chiang , Yung-Yeh Su , I.-Wei Ho , Li-Yuan Bai , Chung-Pin Li , Jen-Shi Chen , Chin-Fu Hsiao , Hsiao-Hui Tsou , Chiun Hsu , Tai-Jan Chiu , Yao-Yu Hsieh , Kun-Ming Rau , Ching-Liang Ho , Yan-Shen Shan , Li-Tzong Chen
Objective
A multicenter, randomized phase II trial to compare two first-line triplet treatments for advanced pancreatic ductal adenocarcinoma (PDAC).
Methods
Patients with histologically confirmed advanced PDAC were randomized 1:1 to receive S-1/leucovorin plus oxaliplatin, and gemcitabine (SLOG) or modified FOLFIRINOX (mFOLFIRINOX). Tumor response was assessed every eight weeks. The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS), objective response rate (ORR), safety and biomarker studies.
Results
A total of 129 patients (65 SLOG, 64 mFOLFIRINOX) were enrolled. After a median follow-up of 37.7 months, no significant differences were observed between the SLOG and mFOLFIRINOX arms in median PFS (7.5 vs. 6.5 months; p = 0.88), median OS (12.9 vs. 12.1 months), or objective response rate (38.5 % vs. 26.6 %). HRD (homologous recombination deficiency) mutations were found in 14 of 108 profiled patients (12.9 %). Patients with HRD mutations had significantly longer median PFS (11.9 vs. 7.0 months; p = 0.008) and OS (17.7 vs. 11.7 months; p = 0.036). The safety profiles differed: grade 3/4 neutropenia was significantly less common with SLOG (15.4 % vs. 53.1 %; p < 0.001), while SLOG had more grade 3/4 non-hematological toxicities.
Conclusion
SLOG did not demonstrate superiority in PFS over mFOLFIRINOX, and mFOLFIRINOX therefore remains as one of the preferred first-line standards. Given its lower incidence of severe neutropenia and its convenience with oral S-1, SLOG may warrant further investigation in selected Asian patients with advanced PDAC.
{"title":"SLOG versus modified FOLFIRINOX as first-line treatment for advanced pancreatic cancer: A randomized phase II trial (TCOG T5217)","authors":"Nai-Jung Chiang , Yung-Yeh Su , I.-Wei Ho , Li-Yuan Bai , Chung-Pin Li , Jen-Shi Chen , Chin-Fu Hsiao , Hsiao-Hui Tsou , Chiun Hsu , Tai-Jan Chiu , Yao-Yu Hsieh , Kun-Ming Rau , Ching-Liang Ho , Yan-Shen Shan , Li-Tzong Chen","doi":"10.1016/j.ejca.2026.116229","DOIUrl":"10.1016/j.ejca.2026.116229","url":null,"abstract":"<div><h3>Objective</h3><div>A multicenter, randomized phase II trial to compare two first-line triplet treatments for advanced pancreatic ductal adenocarcinoma (PDAC).</div></div><div><h3>Methods</h3><div>Patients with histologically confirmed advanced PDAC were randomized 1:1 to receive S-1/leucovorin plus oxaliplatin, and gemcitabine (SLOG) or modified FOLFIRINOX (mFOLFIRINOX). Tumor response was assessed every eight weeks. The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS), objective response rate (ORR), safety and biomarker studies.</div></div><div><h3>Results</h3><div>A total of 129 patients (65 SLOG, 64 mFOLFIRINOX) were enrolled. After a median follow-up of 37.7 months, no significant differences were observed between the SLOG and mFOLFIRINOX arms in median PFS (7.5 vs. 6.5 months; p = 0.88), median OS (12.9 vs. 12.1 months), or objective response rate (38.5 % vs. 26.6 %). HRD (homologous recombination deficiency) mutations were found in 14 of 108 profiled patients (12.9 %). Patients with HRD mutations had significantly longer median PFS (11.9 vs. 7.0 months; p = 0.008) and OS (17.7 vs. 11.7 months; p = 0.036). The safety profiles differed: grade 3/4 neutropenia was significantly less common with SLOG (15.4 % vs. 53.1 %; p < 0.001), while SLOG had more grade 3/4 non-hematological toxicities.</div></div><div><h3>Conclusion</h3><div>SLOG did not demonstrate superiority in PFS over mFOLFIRINOX, and mFOLFIRINOX therefore remains as one of the preferred first-line standards. Given its lower incidence of severe neutropenia and its convenience with oral S-1, SLOG may warrant further investigation in selected Asian patients with advanced PDAC.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"235 ","pages":"Article 116229"},"PeriodicalIF":7.1,"publicationDate":"2026-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146035752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-10DOI: 10.1016/j.ejca.2026.116228
Goh Eun Chung , Su Jong Yu , Jeayeon Park , Yoon Jun Kim , Jung-Hwan Yoon , Kyungdo Han , Eun Ju Cho
Background
Metabolic dysfunction–associated steatotic liver disease (MASLD) is increasingly prevalent among young adults and may contribute to cancer development. However, the impact of longitudinal changes in MASLD status on cancer risk remains unclear. This study aimed to evaluate the association between changes in MASLD status and subsequent cancer incidence in young adults.
Methods
Adults aged 20–39 years who underwent two consecutive health screening examinations—one between 2009–2012 and another between 2011–2014—were identified from the Korean National Health Insurance Service database. Participants were classified into four groups based on changes in MASLD status: non-MASLD, resolved MASLD, incident MASLD, and persistent MASLD. Cox proportional hazards models were used to calculate adjusted hazard ratios (HRs) and 95 % confidence intervals (CIs) for the development of cancer.
Results
During a median follow-up of 10.6 years, 95,666 (2.7 %) of 3536,172 participants developed cancer. Compared with the non-MASLD group, the persistent MASLD group exhibited the highest overall cancer risk (HR = 1.15; 95 % CI = 1.13–1.18), followed by the incident MASLD group (HR = 1.03; 95 % CI = 1.00–1.06). The resolved MASLD group showed no significant difference in cancer risk (HR = 1.02; 95 % CI = 0.98–1.05). Persistent MASLD was further associated with elevated risks of laryngeal, biliary, renal, hepatic, pancreatic, and colorectal cancers. Among women, persistent MASLD was linked to higher risks of uterine corpus, cervical, and ovarian cancers.
Conclusions
Incident and persistent MASLD in young adults are associated with increased overall and site-specific cancer risks, whereas individuals whose MASLD improved showed no significant excess risk. Early identification and management of MASLD may help reduce future cancer burden.
代谢功能障碍相关的脂肪变性肝病（MASLD）在年轻人中越来越普遍，并可能导致癌症的发展。然而，MASLD状态的纵向变化对癌症风险的影响尚不清楚。本研究旨在评估年轻成人中MASLD状态变化与随后癌症发病率之间的关系。方法从韩国国民健康保险服务数据库中确定年龄在20-39岁的成年人，他们分别在2009-2012年和2011 - 2014年连续进行了两次健康筛查检查。参与者根据MASLD状态的变化分为四组：非MASLD、解决MASLD、事件MASLD和持续MASLD。采用Cox比例风险模型计算癌症发展的校正风险比（hr）和95% %置信区间（CIs）。在中位随访10.6年期间，3536,172名参与者中有95,666人（2.7% %）患上了癌症。与非MASLD组相比，持续性MASLD组的总体癌症风险最高（HR = 1.15; 95 % CI = 1.13-1.18），其次是偶发性MASLD组（HR = 1.03; 95 % CI = 1.00-1.06）。解决MASLD组的癌症风险无显著差异（HR = 1.02; 95 % CI = 0.98-1.05）。持续的MASLD与喉癌、胆癌、肾癌、肝癌、胰腺癌和结直肠癌的风险升高进一步相关。在女性中，持续的MASLD与子宫癌、宫颈癌和卵巢癌的高风险相关。结论：年轻成人的偶发性和持续性MASLD与整体和部位特异性癌症风险增加相关，而MASLD改善的个体没有明显的额外风险。早期发现和管理MASLD可能有助于减少未来的癌症负担。
{"title":"Associations between changes in MASLD status and cancer development in young adults: A nationwide cohort study","authors":"Goh Eun Chung , Su Jong Yu , Jeayeon Park , Yoon Jun Kim , Jung-Hwan Yoon , Kyungdo Han , Eun Ju Cho","doi":"10.1016/j.ejca.2026.116228","DOIUrl":"10.1016/j.ejca.2026.116228","url":null,"abstract":"<div><h3>Background</h3><div>Metabolic dysfunction–associated steatotic liver disease (MASLD) is increasingly prevalent among young adults and may contribute to cancer development. However, the impact of longitudinal changes in MASLD status on cancer risk remains unclear. This study aimed to evaluate the association between changes in MASLD status and subsequent cancer incidence in young adults.</div></div><div><h3>Methods</h3><div>Adults aged 20–39 years who underwent two consecutive health screening examinations—one between 2009–2012 and another between 2011–2014—were identified from the Korean National Health Insurance Service database. Participants were classified into four groups based on changes in MASLD status: non-MASLD, resolved MASLD, incident MASLD, and persistent MASLD. Cox proportional hazards models were used to calculate adjusted hazard ratios (HRs) and 95 % confidence intervals (CIs) for the development of cancer.</div></div><div><h3>Results</h3><div>During a median follow-up of 10.6 years, 95,666 (2.7 %) of 3536,172 participants developed cancer. Compared with the non-MASLD group, the persistent MASLD group exhibited the highest overall cancer risk (HR = 1.15; 95 % CI = 1.13–1.18), followed by the incident MASLD group (HR = 1.03; 95 % CI = 1.00–1.06). The resolved MASLD group showed no significant difference in cancer risk (HR = 1.02; 95 % CI = 0.98–1.05). Persistent MASLD was further associated with elevated risks of laryngeal, biliary, renal, hepatic, pancreatic, and colorectal cancers. Among women, persistent MASLD was linked to higher risks of uterine corpus, cervical, and ovarian cancers.</div></div><div><h3>Conclusions</h3><div>Incident and persistent MASLD in young adults are associated with increased overall and site-specific cancer risks, whereas individuals whose MASLD improved showed no significant excess risk. Early identification and management of MASLD may help reduce future cancer burden.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"235 ","pages":"Article 116228"},"PeriodicalIF":7.1,"publicationDate":"2026-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145950247","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-09DOI: 10.1016/j.ejca.2026.116227
Alice Boilève , Léa Mercier , Baptiste Bonnet , Anthony Tarabay , Sarah Blanchet-Deverly , Antoine Hollebecque , Cristina Smolenschi , Marine Valéry , Matthieu Delaye , Thomas Pudlarz , Alina Fuerea , Valérie Boige , Jérome Durand-Labrunie , Maximiliano Gelli , Paul Beunon , Rémy Barbe , Aurélien Lambert , Michel Ducreux
Background
A better prognosis is suggested for lung-only metastases patients with pancreatic ductal adenocarcinoma (PDAC), yet biological/clinical underpinnings of organotropism in PDAC remain unclear. Study objective was to compare PDAC patients depending on their metastatic site with a special focus on “lung-only” metastases patients.
Methods
A retrospective analysis included all patients with metastatic PDAC between 2010 and 2022 in an academic-center. Lung-only patients were defined as patients with only lung metastases at diagnosis of metastases.
Results
Among 1012 patients, 109 (11 %) presented lung-only metastases, 506 patients (50 %) liver-only, 94 (9 %) peritoneal-only and 303 (30 %) other or multiple sites. Compared with others, lung-only patients were more frequently female (63 % vs. 46 %), older at metastatic diagnosis (median 66 vs. 63 years, p = 0.01), and less likely to have synchronous metastases (42 % vs. 69 %, p < 0.001).
ctDNA detection was lower in the lung-only group with less KRAS mutations and TP53 mutations detected with liquid biopsy (but no difference was observed using tumor tissue). Median OS was higher in the lung-only group with 28.7 months (95 %CI [23.3–38.6]) vs 13.5 months (95 %CI [12.4–14.6]) for liver-only group, 11.5 months (95 %CI [9.6–16.9]) for peritoneal-only group and 11.3 months (95 %CI [10.0–13.8]) for other patients (p < 0.0001). Among lung-only patients, local treatments (n = 15) had a positive prognostic impact.
Conclusions
Patients with lung-only metastases had a better OS than others, were more often women, and harbored less KRAS mutations. Our results argue in favor of PDAC with specific characteristics, especially a better prognosis, possibly further enhanced by the possibility to perform local treatments, and less detection of ctDNA.
{"title":"Lung-only metastatic pancreatic cancer: Differences in patients ‘characteristics, molecular profile and survival","authors":"Alice Boilève , Léa Mercier , Baptiste Bonnet , Anthony Tarabay , Sarah Blanchet-Deverly , Antoine Hollebecque , Cristina Smolenschi , Marine Valéry , Matthieu Delaye , Thomas Pudlarz , Alina Fuerea , Valérie Boige , Jérome Durand-Labrunie , Maximiliano Gelli , Paul Beunon , Rémy Barbe , Aurélien Lambert , Michel Ducreux","doi":"10.1016/j.ejca.2026.116227","DOIUrl":"10.1016/j.ejca.2026.116227","url":null,"abstract":"<div><h3>Background</h3><div>A better prognosis is suggested for lung-only metastases patients with pancreatic ductal adenocarcinoma (PDAC), yet biological/clinical underpinnings of organotropism in PDAC remain unclear. Study objective was to compare PDAC patients depending on their metastatic site with a special focus on “lung-only” metastases patients.</div></div><div><h3>Methods</h3><div>A retrospective analysis included all patients with metastatic PDAC between 2010 and 2022 in an academic-center. Lung-only patients were defined as patients with only lung metastases at diagnosis of metastases.</div></div><div><h3>Results</h3><div>Among 1012 patients, 109 (11 %) presented lung-only metastases, 506 patients (50 %) liver-only, 94 (9 %) peritoneal-only and 303 (30 %) other or multiple sites. Compared with others, lung-only patients were more frequently female (63 % vs. 46 %), older at metastatic diagnosis (median 66 vs. 63 years, p = 0.01), and less likely to have synchronous metastases (42 % vs. 69 %, p < 0.001).</div><div>ctDNA detection was lower in the lung-only group with less <em>KRAS</em> mutations and <em>TP53</em> mutations detected with liquid biopsy (but no difference was observed using tumor tissue). Median OS was higher in the lung-only group with 28.7 months (95 %CI [23.3–38.6]) vs 13.5 months (95 %CI [12.4–14.6]) for liver-only group, 11.5 months (95 %CI [9.6–16.9]) for peritoneal-only group and 11.3 months (95 %CI [10.0–13.8]) for other patients (p < 0.0001). Among lung-only patients, local treatments (n = 15) had a positive prognostic impact.</div></div><div><h3>Conclusions</h3><div>Patients with lung-only metastases had a better OS than others, were more often women, and harbored less <em>KRAS</em> mutations. Our results argue in favor of PDAC with specific characteristics, especially a better prognosis, possibly further enhanced by the possibility to perform local treatments, and less detection of ctDNA.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"235 ","pages":"Article 116227"},"PeriodicalIF":7.1,"publicationDate":"2026-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145975634","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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