International Journal of Clinical Oncology最新文献

{"title":"Return to work after upper gastrointestinal cancer surgery: questionnaire-based observational study.","authors":"Tatsuma Sakaguchi, Takuya Fukushima, Nobuyuki Yamamoto, Satoshi Toshiyama, Shota Eguchi, Shuta Takaishi, Hanako Koda, Nozomi Matsushita, Takashi Harino, Yuki Hashimoto, Masaya Kotsuka, Takuji Sato, Hiromi Mukaide, Takuya Saito, Kentaro Inoue, Jiro Nakano, Makoto Yamasaki","doi":"10.1007/s10147-026-03156-2","DOIUrl":"10.1007/s10147-026-03156-2","url":null,"abstract":"<p><strong>Background: </strong>Return to work (RTW) is an important component of cancer survivorship. However, evidence on RTW after upper gastrointestinal cancer surgery remains limited.</p><p><strong>Methods: </strong>We performed a questionnaire-based observational study between August 2023 and August 2025. Patients who underwent surgery with curative intent for upper gastrointestinal cancer, attended postoperative outpatient follow-up visits, and had been employed at the time of cancer diagnosis were eligible for this analysis.</p><p><strong>Results: </strong>Among 410 patients who completed the questionnaire, 207 had been employed at the time of cancer diagnosis. Of these 207 patients, 144 had returned to work (70%). Patients who returned to work were younger than those who did not (median age, 62.5 vs. 65.0 years; P = 0.013). In multivariable logistic regression analysis, older age was associated with a lower likelihood of RTW; however, this association was attenuated and no longer statistically significant after further adjustment for employment status (full-time or part-time worker). The cumulative probability of self-reported RTW was significantly higher in patients aged < 65 years than in those aged ≥ 65 years (P = 0.011). Approximately 85% of patients who ultimately returned to work had resumed work by 6 months after surgery.</p><p><strong>Conclusions: </strong>Most patients who ultimately returned to work did so within 6 months after surgery. RTW after upper gastrointestinal cancer surgery appears to be influenced by occupational and social circumstances; older age may serve as a proxy for these circumstances rather than an independent determinant of RTW, highlighting the potential value of individualized survivorship care and timely RTW support.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"2492-2501"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148653681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical utility and cost-effectiveness of universal tumor screening to identify Lynch syndrome in patients with stage II/III colorectal cancer: a prospective observational study in Japan.","authors":"Takahiro Yoshioka, Yasuaki Yamamoto, Yuichiro Tsukada, Ataru Igarashi, Takeshi Kuwata, Motohiro Kojima, Yumie Hiraoka, Koji Ikeda, Yuji Nishizawa, Hideaki Bando, Kiwamu Akagi, Takayuki Yoshino, Masaaki Ito","doi":"10.1007/s10147-026-03153-5","DOIUrl":"10.1007/s10147-026-03153-5","url":null,"abstract":"<p><strong>Background: </strong>Universal tumor screening (UTS) for Lynch syndrome (LS) is cost-effective in Western countries; however, cost-effectiveness varies based on the frequency of hereditary diseases and testing costs. This study aimed to clarify the clinical utility and cost-effectiveness of UTS in identifying LS in patients with stage II/III colorectal cancer (CRC) in Japan.</p><p><strong>Methods: </strong>This single-center, prospective cohort study evaluated 591 consecutive patients who underwent surgical resection for Stage II/III colorectal adenocarcinoma between 2016 and 2018. Immunohistochemistry (IHC) was used to evaluate mismatch repair (MMR) proteins. In patients with MMR deficiency, BRAF V600E mutational testing and genetic counseling/testing were performed to identify LS based on MMR deficiency patterns. Genetic counseling/testing was also conducted for blood relatives upon request. The cost-effectiveness of implementing UTS was evaluated from the perspective of healthcare payers using a Markov state-transition model, with the incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) gained as the reference value.</p><p><strong>Results: </strong>A total of 40 cases (6.8%) exhibited MMR deficiency; 12 cases (2.0%) had LS, of whom 2 (16.7%) did not meet Amsterdam criteria II or any criteria of the revised Bethesda guidelines. Eleven relatives of five LS probands underwent genetic testing, and six (54.5%) were diagnosed with LS. The ICER for UTS was JPY 0.6 million per QALY gained, substantially below the Japanese threshold of JPY 5.0-6.0 million per QALY.</p><p><strong>Conclusions: </strong>The UTS of LS in patients with stage II/III CRC is a useful and cost-effective tool in Japan.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"2449-2459"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148673579","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recommendations for generating real-world evidence with regulatory-grade relevance and reliability.","authors":"Yasutoshi Sakamoto, Hideaki Bando, Yoshihiro Aoyagi, Hiroki Sokuoka, Toshihiro Misumi, Koji Oba, Yukiko Mori, Jun Okui, Makoto Miyazaki, Yasunari Sadatsuki, Kazuma Koizumi, Rie Otake, Akinori Yuri, Eri Tajima, Taro Ueno, Takayuki Nakamura, Hiroki Yoshihara, Keisuke Itoya, Ryosuke Annaka, Harumasa Nakamura, Natsuko Okita, Hideaki Takahashi, Tomohiro Kuroda, Kenichi Nakamura, Takayuki Yoshino, Atsushi Ohtsu","doi":"10.1007/s10147-026-03160-6","DOIUrl":"10.1007/s10147-026-03160-6","url":null,"abstract":"<p><p>Real-world data (RWD) and real-world evidence (RWE) are increasingly incorporated into regulatory decision-making to complement randomized controlled trials (RCTs), particularly in settings where conventional trial designs are infeasible, such as rare diseases, rare molecular subtypes, and post-marketing evaluation. Across regulatory authorities, the use of RWD/RWE is consistently framed by the fit-for-purpose principle, centered on two foundational concepts: relevance and reliability. However, the absence of operational guidance has created uncertainty regarding how academic registries and healthcare databases can be designed or upgraded to meet regulatory expectations. Drawing on practical experience with disease registries in Japan and their regulatory applications, this review proposes a purpose-oriented framework clarifying the levels of relevance and reliability required according to specific regulatory objectives. We categorize considerations into three use cases: (1) drug development for rare diseases and rare molecular subtypes; (2) Pharmacovigilance; and (3) evidence generation for clinical questions that cannot be sufficiently evaluated through randomized controlled trials (RCTs). For each category, we outline essential requirements related to study design, data elements, quality management, governance, statistical planning, and operational feasibility. We further compare regulatory expectations across the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Pharmaceuticals and Medical Devices Agency (PMDA), and the International Council for Harmonisation (ICH). While international convergence is evident at the level of principles, operational thresholds and implementation frameworks differ. By articulating relevance and reliability as a shared regulatory language and emphasizing purpose-driven design and early regulatory engagement, this review provides practical recommendations for generating regulatory-grade RWE that meaningfully informs regulatory decision-making while complementing conventional clinical trials.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"2075-2086"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13615135/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148792679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Racial disparities in time to treatment initiation and survival outcomes in patients with vulvar cancer: a national cancer database analysis.","authors":"Abdelrahman Yousif, Hatem S Mohamed, Mohanad Elchouemi, Sanjana Reddy Mada, Ilana Chefetz","doi":"10.1007/s10147-026-03111-1","DOIUrl":"10.1007/s10147-026-03111-1","url":null,"abstract":"<p><strong>Background: </strong>Racial and ethnic disparities in gynecologic cancer care are well documented, yet inequities in treatment timeliness and outcomes for vulvar squamous cell carcinoma (VSCC) have not been examined in large national cohorts. Treatment delay is a potentially modifiable disparity, and the role of neighborhood socioeconomic status (nSES) in shaping racial and ethnic differences in care remains unclear.</p><p><strong>Methods: </strong>We conducted a retrospective cohort study using the National Cancer Database of women aged ≥ 18 years diagnosed with FIGO stage I-IVA VSCC from 2004 to 2020. Race/ethnicity was categorized as non-Hispanic (NH) White, NH Black, Hispanic, and Asian/Pacific Islander. The primary outcome was treatment delay, defined as time to treatment initiation (TTI) > 30 days from diagnosis. Overall survival (OS) was secondary. Multivariable logistic and Cox regression models adjusted for demographic, clinical, socioeconomic, insurance, facility, and treatment factors. Interaction terms assessed whether nSES modified associations.</p><p><strong>Results: </strong>Among 9,023 women, Hispanic patients had higher odds of treatment delay compared with NH White patients (aOR 1.31, 95% CI 1.03-1.67). No significant differences were observed for NH Black or Asian/Pacific Islander patients. nSES did not modify these associations (P = 0.44). Although NH Black patients had improved unadjusted OS, this difference was not significant after adjustment. Race/ethnicity was not independently associated with OS.</p><p><strong>Conclusions: </strong>Hispanic women with VSCC experience persistent treatment delays not explained by socioeconomic or clinical factors. Efforts to reduce delays through culturally responsive interventions are needed to advance equity in vulvar cancer care.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"2102-2113"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13615111/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148396625","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Primary site- and metastasis-directed therapies in patients with metastatic prostate cancer: A narrative review.","authors":"Takayuki Goto, Kei Mizuno, Takayuki Sumiyoshi, Yuki Kita, Kimihiko Masui, Takashi Ogata, Rihito Aizawa, Atsuro Sawada, Ryoichi Saito, Takashi Mizowaki, Takashi Kobayashi","doi":"10.1007/s10147-026-03061-8","DOIUrl":"10.1007/s10147-026-03061-8","url":null,"abstract":"<p><p>Metastatic prostate cancer (mPC) is primarily managed with systemic therapy based on androgen deprivation therapy, often combined with androgen receptor pathway inhibitors or chemotherapy. However, mPC is a biologically and clinically heterogeneous disease, ranging from low-volume or oligometastatic states with relatively favorable outcomes to widely disseminated disease associated with poor prognosis. In this context, primary site-directed therapy (PDT) and metastasis-directed therapy (MDT) have emerged as complementary strategies for selected patients, aiming to address both local and metastatic disease control. PDT, including prostate radiotherapy and cytoreductive radical prostatectomy, may improve outcomes by reducing tumor burden and preventing local complications. Randomized evidence supports prostate radiotherapy in low-volume metastatic hormone-sensitive PC, although its survival benefit in the setting of intensified systemic therapy remains unclear. MDT, delivered via stereotactic body radiotherapy or metastasectomy, has demonstrated clinical benefit in oligometastatic diseases-particularly metachronous oligo-recurrence-by prolonging progression-free survival, delaying systemic treatment escalation, and potentially deferring castration resistance. In oligometastatic castration-resistant PC, early randomized studies suggest that combining MDT with systemic therapy may improve progression-related outcomes. Advances in prostate-specific membrane antigen positron emission tomography have enhanced lesion detection and patient selection, although they also complicate cross-trial comparisons. Despite these advances, high-level evidence demonstrating an overall survival benefit remains limited. Ongoing clinical trials are expected to clarify the optimal integration of PDT and MDT with contemporary systemic therapies and to better define appropriate patient selection. This narrative review summarizes the current evidence and explores future perspectives on incorporating local treatment strategies into mPC management.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"2133-2149"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148101470","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Burden of bladder cancer in China from 1990 to 2023: temporal trends, modifiable risk factors, and implications for prevention.","authors":"Zhiyuan Bai, Shuai Wang, Hongjie Wang, Zijia Liu, Siyu Hou, Gengchen Huang, Yuchuan Hou","doi":"10.1007/s10147-026-03139-3","DOIUrl":"10.1007/s10147-026-03139-3","url":null,"abstract":"<p><strong>Background: </strong>Bladder cancer (BC) is one of the leading causes of cancer death in China. This study analyzed the long-term trends in the disease burden of BC in China from 1990 to 2023, the attributable burden of modifiable risk factors, and conducted a stratified analysis by gender and age.</p><p><strong>Methods: </strong>Based on China data from the Global Burden of Disease Study (GBD) 2023, age-standardized rates and absolute numbers of indicators, such as incidence and mortality of BC were extracted. The Joinpoint regression model was used to calculate the average annual percentage change (AAPC) of indicators for different populations and age groups.</p><p><strong>Results: </strong>In 2023, there were 105,632 new cases and 44,729 deaths of BC in China. Compared with 1990, the absolute numbers of incidence and mortality both increased, while the age-standardized mortality and incidence rates showed a decreasing trend, and the prevalence rate slightly rose. Males and individuals aged ≥ 75 years bore the highest disease burden; among the GBD-reported risk factors, smoking contributed the largest attributable burden, and high fasting plasma glucose(FPG) also contributed a measurable burden, with the age-standardized disease burden attributable to them showing a downward trend.</p><p><strong>Conclusion: </strong>Although the age-standardized incidence, mortality, and DALY rates of BC in China have declined, the absolute burden has increased and remains concentrated among older males. These findings support prioritizing evidence-based primary prevention, especially tobacco control and reduction of carcinogen exposure, while improving risk-adapted awareness and timely diagnostic evaluation in high-burden populations.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"2342-2352"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148446062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk of second primary malignancies after bladder cancer diagnosed at a young age: a SEER population-based analysis.","authors":"Etan Eigner, Nicola Fazaa, Ameer Nsair, Melissa Atallah, Gilad E Amiel, Azik Hoffman, Kamil Malshy","doi":"10.1007/s10147-026-03140-w","DOIUrl":"10.1007/s10147-026-03140-w","url":null,"abstract":"<p><strong>Background: </strong>Bladder cancer diagnosed at a young age is uncommon, but survivors often have long life expectancy, making long-term risks such as second primary malignancies (SPMs) clinically relevant. However, the incidence and patterns of SPMs in young-onset bladder cancer survivors remain poorly characterized. We aimed to quantify the risk and distribution of SPMs in this population.</p><p><strong>Methods: </strong>We conducted a retrospective cohort study using data from 17 registries in the Surveillance, Epidemiology, and End Results (SEER) program (2000-2022). Patients diagnosed with a first primary urothelial carcinoma of the bladder before age 50 were included. Follow-up for SPMs began two months after diagnosis. Standardized incidence ratios (SIRs) and absolute excess risks (AERs) were calculated overall, by sex, and by cancer site. Age-related trends were assessed using Poisson regression, and sensitivity analyses were performed.</p><p><strong>Results: </strong>A total of 13,378 eligible patients contributed 140,014 person-years at risk to the SPM analysis. During follow-up, 1,272 SPMs were identified, excluding bladder and non-melanoma skin cancers, corresponding to a significantly elevated overall risk compared with the general U.S. population (SIR 1.67; 95% CI 1.58-1.76). Increased risk was observed in both men (SIR 1.81) and women (SIR 1.27). The largest elevations occurred for urinary tract malignancies outside the bladder, followed by colorectal, respiratory, renal cell carcinoma, and prostate cancers among men. No significant age-related trend was observed.</p><p><strong>Conclusions: </strong>Young-onset bladder cancer survivors experience a sustained elevation in second primary malignancy risk, underscoring the importance of long-term survivorship awareness and informing counseling and follow-up strategies in this population.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"2353-2362"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148497351","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-world safety and effectiveness of nivolumab in patients with cancer of unknown primary: results from a nationwide post-marketing surveillance in Japan.","authors":"Akira Kawasaki, Akito Kakuuchi, Ayumi Akamatsu, Misato Nakanishi, Chikara Honda","doi":"10.1007/s10147-026-03147-3","DOIUrl":"10.1007/s10147-026-03147-3","url":null,"abstract":"<p><strong>Background: </strong>Cancer of unknown primary (CUP) is associated with poor prognosis. In December 2021, nivolumab was approved in Japan for the treatment of CUP based on a small phase II trial. This post-marketing surveillance (PMS) evaluated the real-world safety and effectiveness of nivolumab in Japanese patients with CUP.</p><p><strong>Methods: </strong>This prospective, observational, PMS enrolled patients with CUP who initiated nivolumab between April 2022 and June 2023 at 66 institutions. Patients were observed for 6 months. Safety outcomes were treatment-related adverse events (TRAEs), and effectiveness outcomes included overall response rate (ORR) and overall survival (OS). Analyses were descriptive.</p><p><strong>Results: </strong>Among 151 patients in the safety set, the median age was 70 years and 79.5% had an Eastern Cooperative Oncology Group performance status (PS) 0-1. Any grade and Grade ≥ 3 TRAEs occurred in 25.2% and 11.9% of patients, respectively. Frequently reported TRAEs included interstitial lung disease (3.3%), hepatic function abnormal (2.6%), and hypothyroidism (2.6%). There was one TRAE (neutropenia) resulting in death. In the effectiveness set (n = 144), the ORR was 21.5%. ORR was higher in patients without prior systemic therapy (25.4% vs. 18.2%) and in those with lymph node-only involvement (36.6% vs. 15.5%). The 6-month OS rate was 71.0%, and median OS was not reached. The 6-month OS rates were greater in patients with PS 0-1 and lymph node-only involvement.</p><p><strong>Conclusions: </strong>Nivolumab was tolerated in patients with CUP in routine practice in Japan, with no new safety concerns, and indicated antitumor activity consistent with clinical trial results.</p><p><strong>Trial registration: </strong>Japan Registry of Clinical Trials (jRCT2041240121).</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"2363-2373"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13615158/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148828141","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction to: Real-world clinical outcomes and economic burden of discontinuation of taxane therapy among patients with metastatic castration-resistant prostate cancer.","authors":"Neal Shore, Jennifer Nguyen, Barinder Kang, Amrita Sawhney, Clare Byrne, Jackson Tang, Magdaliz Gorritz, Chi-Chang Chen, Jeetvan Patel","doi":"10.1007/s10147-026-03194-w","DOIUrl":"https://doi.org/10.1007/s10147-026-03194-w","url":null,"abstract":"","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149109305","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacotherapy for older adults with cancer: a digest of the Japanese clinical practice guidelines (2nd edition)-gastrointestinal cancers.","authors":"Naoya Ishibashi, Masayuki Ueno, Shigeki Kataoka, Ayako Doi, Chie Tanaka, Osamu Maeda, Tetsuya Hamaguchi, Junichi Nakazawa, Fumio Nagashima, Ayumu Matsuoka, Akitaka Makiyama","doi":"10.1007/s10147-026-03203-y","DOIUrl":"https://doi.org/10.1007/s10147-026-03203-y","url":null,"abstract":"<p><strong>Background: </strong>The number of older adults with gastrointestinal cancers is increasing in rapidly aging societies. However, optimal pharmacotherapy for this population remains challenging because of heterogeneity in functional status, comorbidities, and the limited representation of older patients in clinical trials.</p><p><strong>Methods: </strong>This article presents an English digest of the Japanese Clinical Practice Guidelines for Pharmacotherapy in Older Adults with Cancer (second edition) [5] with a focus on gastrointestinal cancers. The guidelines were developed in accordance with the Minds 2020 methodology, incorporating systematic reviews, the Evidence-to-Decision framework, and multidisciplinary consensus.</p><p><strong>Results: </strong>The guideline addresses key clinical questions regarding systemic therapy for older patients with gastric and colorectal cancers, including combination chemotherapy, biomarker-guided therapy, and adjuvant treatment strategies. All recommendations were conditional because of limited direct evidence in older populations. Specifically, in gastric cancer, oxaliplatin-containing combination therapy and biomarker-guided treatment may be considered for appropriately selected patients and are conditionally recommended. In colorectal cancer, routine treatment intensification with oxaliplatin- or irinotecan-containing regimens is not uniformly recommended. Treatment decisions should be individualized by weighing the expected benefit against the risk of increased toxicity, particularly in frail or very old patients.</p><p><strong>Conclusions: </strong>These guidelines provide practical evidence-informed recommendations for pharmacotherapy in older adults with gastrointestinal cancers. They emphasize individualized treatment strategies that integrate patient characteristics, treatment goals, and tolerability. Further research, specifically targeting older populations, is required to strengthen the evidence base in geriatric oncology.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149060497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}