International Journal of Clinical Oncology最新文献

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Cost-effectiveness analysis of chemoradiotherapy compared to surgery in patients with stage I esophageal squamous cell carcinoma in Japan. 日本一期食管鳞状细胞癌患者放化疗与手术的成本-效果分析
IF 3 3区 医学
International Journal of Clinical Oncology Pub Date : 2026-10-01 Epub Date: 2026-07-23 DOI: 10.1007/s10147-026-03145-5
Takuro Ariga, Kensuke Moriwaki, Kousuke Morimoto, Katsuyuki Sakanaka, Yoshinori Ito, Tetsuo Saito, Atsuto Katano, Satoru Matsuda, Ken Kato, Hiroya Takeuchi, Hiroshi Onishi
{"title":"Cost-effectiveness analysis of chemoradiotherapy compared to surgery in patients with stage I esophageal squamous cell carcinoma in Japan.","authors":"Takuro Ariga, Kensuke Moriwaki, Kousuke Morimoto, Katsuyuki Sakanaka, Yoshinori Ito, Tetsuo Saito, Atsuto Katano, Satoru Matsuda, Ken Kato, Hiroya Takeuchi, Hiroshi Onishi","doi":"10.1007/s10147-026-03145-5","DOIUrl":"10.1007/s10147-026-03145-5","url":null,"abstract":"<p><strong>Purpose: </strong>We performed a model-based cost-effectiveness analysis of the use of surgical treatment (ST) versus chemoradiotherapy (CRT) for stage I esophageal cancer in Japan.</p><p><strong>Materials and methods: </strong>A model for partitioned survival analysis was developed to estimate the long-term medical costs and quality-adjusted life years (QALYs) for patients who had received either ST or CRT. Data on survival times were taken from the JCOG0502 trial. Utility values were estimated by applying a mapping algorithm based on Japanese data from the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire. From the perspective of public healthcare, only direct medical costs were considered. A discount rate of 2% per year was applied to long-term costs and QALYs to estimate the incremental cost-effectiveness ratio (ICER) of CRT compared to ST.</p><p><strong>Results: </strong>The incremental cost of CRT versus ST was estimated to be $26,313 (USD), the incremental QALY was 0.630, and the ICER was $41,742/QALY. Sensitivity analysis showed that the parameter with a relatively large effect on the ICER was the utility weight of progressive disease with esophagus preserved patients in CRT. The variations in ICERs ranged from approximately $37,113/QALY to $47,690/QALY. With willingness-to-pay thresholds ranging from $50,000/QALY to $100,000/QALY, CRT was more cost-effective than ST, with the probability of being cost-effective estimated to range from 59.3% to 76.3%.</p><p><strong>Conclusions: </strong>In Japan, CRT for stage I esophageal cancer may be more cost-effective than ST, if the acceptable ICER is $50,000/QALY.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"2394-2404"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13615109/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148561765","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}
引用次数: 0
Forecasting colorectal cancer screening in Japan: regional and sex disparities threaten national targets. 预测日本结直肠癌筛查:地区和性别差异威胁到国家目标。
IF 3 3区 医学
International Journal of Clinical Oncology Pub Date : 2026-10-01 Epub Date: 2026-07-27 DOI: 10.1007/s10147-026-03150-8
Hasan Jamil, Aminu Kende Abubakar, Takao Suzuki, Tshewang Gyeltshen, Hellen Wairimu Babu, Phuong The Nguyen
{"title":"Forecasting colorectal cancer screening in Japan: regional and sex disparities threaten national targets.","authors":"Hasan Jamil, Aminu Kende Abubakar, Takao Suzuki, Tshewang Gyeltshen, Hellen Wairimu Babu, Phuong The Nguyen","doi":"10.1007/s10147-026-03150-8","DOIUrl":"10.1007/s10147-026-03150-8","url":null,"abstract":"<p><strong>Objective: </strong>To forecast prefecture-level progress toward Japan's 60% colorectal cancer (CRC) screening target by 2028 and quantify regional and sex-based disparities.</p><p><strong>Methods: </strong>We extracted CRC screening rates (ages 40-69) for all 47 prefectures from 2013 to 2022 using the Comprehensive Survey of Living Conditions. Sex-stratified Bayesian linear regression models were applied to logit-transformed rates. Prefectures were considered likely to achieve the target if the probability of ≥ 60% uptake by 2028 was ≥ 80%.</p><p><strong>Results: </strong>Nationwide coverage is projected to reach 51.9% (95% CrI 44.9-58.8%) by 2028, falling 8.1 percentage points short of the 60% target. Forty of 47 prefectures (85%) had less than a 20% posterior probability of meeting the target, and 14 were projected below 50% coverage. Only Yamagata exceeded the 80% probability threshold for the total population (probability 0.988). For men, three prefectures did (Yamagata, Yamanashi, Miyagi), versus one for women. Men outperformed women in 41 of 47 prefectures, with a median sex gap in target probability of 8.0 percentage points and a median lag of 6 years in projected achievement.</p><p><strong>Conclusions: </strong>Based on 2013-2022 trends, Japan is projected to miss the 60% CRC screening target by over a decade. Most prefectures had less than a 5% estimated probability of reaching 60% by 2028, and women lag men by a median of 6 years. Incremental progress under the current system appears insufficient. Reaching the target will require accelerated, prefecture-specific, and sex-sensitive interventions beyond what the current system delivers.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"2415-2425"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13615035/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148591411","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}
引用次数: 0
Timing-dependent skin toxicity phenotypes during enfortumab vedotin plus pembrolizumab therapy for advanced urothelial carcinoma. 治疗晚期尿路上皮癌时依时皮肤毒性表型
IF 3 3区 医学
International Journal of Clinical Oncology Pub Date : 2026-10-01 Epub Date: 2026-07-27 DOI: 10.1007/s10147-026-03148-2
Mamoru Hashimoto, Lan Inoki, Yutaka Yamamoto, Wataru Fukuokaya, Takafumi Yanagisawa, Keiichiro Mori, Ryoichi Maenosono, Yuki Yoshikawa, Takuya Tsujino, Masanobu Saruta, Takuhisa Nukaya, Yuya Oishi, Keita Tamura, Seitetsu Sugiyama, Hirofumi Morinaka, Kazumasa Komura, Kiyoshi Takahara, Teruo Inamoto, Kazutoshi Fujita
{"title":"Timing-dependent skin toxicity phenotypes during enfortumab vedotin plus pembrolizumab therapy for advanced urothelial carcinoma.","authors":"Mamoru Hashimoto, Lan Inoki, Yutaka Yamamoto, Wataru Fukuokaya, Takafumi Yanagisawa, Keiichiro Mori, Ryoichi Maenosono, Yuki Yoshikawa, Takuya Tsujino, Masanobu Saruta, Takuhisa Nukaya, Yuya Oishi, Keita Tamura, Seitetsu Sugiyama, Hirofumi Morinaka, Kazumasa Komura, Kiyoshi Takahara, Teruo Inamoto, Kazutoshi Fujita","doi":"10.1007/s10147-026-03148-2","DOIUrl":"10.1007/s10147-026-03148-2","url":null,"abstract":"<p><strong>Background: </strong>Enfortumab vedotin plus pembrolizumab (EV/Pem) has improved the survival of patients with advanced urothelial carcinoma; however, many patients suffer treatment-related adverse events, particularly skin toxicity. This study aimed to clarify the clinical impact of skin-toxicity timing on treatment outcomes.</p><p><strong>Methods: </strong>We retrospectively analyzed patients with advanced urothelial carcinoma treated with EV/Pem. Patients were categorized into three groups according to skin-toxicity timing: no rash, early-onset rash (< 1 month), and late-onset rash (≥ 1 month). Baseline clinical and laboratory characteristics were compared among groups and incorporated into multivariable Cox proportional hazards analyses. Kaplan-Meier analyses with pairwise log-rank tests were performed to evaluate progression-free survival (PFS) and overall survival (OS). The 1-month cutoff was selected for clinical interpretability.</p><p><strong>Results: </strong>The three-group analysis included 210 patients: no rash (n = 87), early-onset rash (n = 84), and late-onset rash (n = 39). Late-onset rash was associated with significantly prolonged PFS and OS in conventional analyses. In multivariable analysis, late-onset rash was significantly associated with prolonged PFS (HR 0.34, 95% CI 0.15-0.74, p = 0.007) and OS (HR 0.25, 95% CI 0.07-0.81, p = 0.02). Because late-onset rash could only be assigned after continued observation, these associations should be interpreted as exploratory and potentially affected by immortal time bias. In the 3-month landmark analysis, PFS remained significantly longer in the late-onset than early-onset rash group, whereas OS did not differ significantly.</p><p><strong>Conclusions: </strong>Skin toxicity during EV/Pem therapy appears to have timing-dependent prognostic implications. Late-onset rash showed favorable outcomes in conventional analyses, but these findings should be considered hypothesis-generating.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"2441-2448"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13615075/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148602512","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}
引用次数: 0
Local treatment for metastatic and primary sites in metastatic renal cell carcinoma in the combination immunotherapy era: a narrative review. 联合免疫治疗时代转移性肾细胞癌转移和原发部位的局部治疗:叙述性回顾。
IF 3 3区 医学
International Journal of Clinical Oncology Pub Date : 2026-10-01 Epub Date: 2026-02-13 DOI: 10.1007/s10147-026-02982-8
Junya Abe, Takaya Murashima, Shimpei Kojima, Takashi Ueno, Akinori Takei, Naoko Nakai, Takahiro Akioka, Toshiyuki Kamoto, Atsuro Sawada
{"title":"Local treatment for metastatic and primary sites in metastatic renal cell carcinoma in the combination immunotherapy era: a narrative review.","authors":"Junya Abe, Takaya Murashima, Shimpei Kojima, Takashi Ueno, Akinori Takei, Naoko Nakai, Takahiro Akioka, Toshiyuki Kamoto, Atsuro Sawada","doi":"10.1007/s10147-026-02982-8","DOIUrl":"10.1007/s10147-026-02982-8","url":null,"abstract":"<p><p>Advances in immuno-oncology (IO)-based systemic therapies have improved treatment outcomes for patients with metastatic renal cell carcinoma (mRCC). However, long-term survival of these patients remains challenging, highlighting the need to reassess the role of local and metastasis-directed treatments. Cytoreductive nephrectomy (CN) has traditionally been a part of the therapeutic armamentarium for mRCC, and evidence from the targeted therapy era-most notably the CARMENA and SURTIME trials-indicates that deferred CN after initial systemic therapy may benefit carefully selected patients. In the IO era, prospective evidence regarding CN is lacking, although ongoing trials, such as NORDIC-SUN and PROBE, are expected to refine patient selection and optimal timing. Real-world analysis reveals a significant decline in conducting CN since 2018. However, CN remains associated with improved overall survival of patients who received several IO-based first-line regimens after adjustment for baseline characteristics. Metastasis-directed treatments, including metastasectomy and local interventions for bone metastases, continue to exhibit potential survival benefits and may maintain functional status when complete resection of lesions is achievable. Considering the absence of definitive prospective data applicable to routine clinical practice, individualized treatment strategies should consider CN and local therapies alongside systemic treatment response, tumor biology, and patient-specific prognostic factors.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"2126-2132"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13615021/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146178570","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}
引用次数: 0
Nivolumab plus ipilimumab-based treatment in Japanese patients with metastatic non-small cell lung cancer and tumor PD-L1 < 1%: a pooled analysis. Nivolumab联合伊匹单抗治疗转移性非小细胞肺癌和肿瘤PD-L1 < 1%的日本患者:一项汇总分析
IF 3 3区 医学
International Journal of Clinical Oncology Pub Date : 2026-10-01 Epub Date: 2026-08-11 DOI: 10.1007/s10147-026-03116-w
Makoto Nishio, Hidetoshi Hayashi, Yasushi Goto, Satoshi Ikeda, Toshihide Yokoyama, Hiroshi Tanaka, Yuichi Tambo, Katsuyuki Hotta, Tatsuro Fukuhara, Haruko Daga, Ken Masubuchi, Takekazu Aoyama, Marina Tschaika, Nan Hu, Hideaki Mizutani
{"title":"Nivolumab plus ipilimumab-based treatment in Japanese patients with metastatic non-small cell lung cancer and tumor PD-L1 < 1%: a pooled analysis.","authors":"Makoto Nishio, Hidetoshi Hayashi, Yasushi Goto, Satoshi Ikeda, Toshihide Yokoyama, Hiroshi Tanaka, Yuichi Tambo, Katsuyuki Hotta, Tatsuro Fukuhara, Haruko Daga, Ken Masubuchi, Takekazu Aoyama, Marina Tschaika, Nan Hu, Hideaki Mizutani","doi":"10.1007/s10147-026-03116-w","DOIUrl":"10.1007/s10147-026-03116-w","url":null,"abstract":"<p><strong>Background: </strong>Nivolumab plus ipilimumab-based therapies have shown long-term, durable clinical benefit in patients with metastatic non-small cell lung cancer (NSCLC), including those with tumor programmed death-ligand 1 (PD-L1) expression < 1%, a population with high unmet need. Here we report long-term clinical outcomes with first-line nivolumab plus ipilimumab with or without chemotherapy (2 cycles) versus chemotherapy (≤ 4 cycles) in a pooled population of Japanese patients with metastatic NSCLC and tumor PD-L1 < 1% from the randomized, phase 3 CheckMate 227 (NCT02477826) and CheckMate 9LA (NCT03215706) studies.</p><p><strong>Methods: </strong>Adults with stage IV/recurrent NSCLC without sensitizing EGFR/ALK alterations were included. Overall survival (OS), progression-free survival (PFS), objective response rate, duration of response, and safety were assessed.</p><p><strong>Results: </strong>Among the pooled population of Japanese patients with tumor PD-L1 < 1% in the nivolumab plus ipilimumab with or without chemotherapy (n = 34) versus chemotherapy (n = 41) arms, median OS was 41.0 (95% CI 19.4-not reached) versus 15.2 (95% CI 7.6-21.3) months (hazard ratio [HR] 0.46; 95% CI 0.27-0.78); 5-year OS rates were 38% (95% CI 22-54) versus 16% (95% CI 6-30). Median PFS was 8.2 (95% CI 4.1-19.3) versus 5.6 (95% CI 4.2-7.0) months (HR 0.57 [95% CI 0.31-1.03]). No new safety signals were observed.</p><p><strong>Conclusions: </strong>Consistent with results in the pooled global population, nivolumab plus ipilimumab with or without chemotherapy showed long-term, durable clinical benefit in Japanese patients with metastatic NSCLC and tumor PD-L1 < 1%, suggesting potential clinical benefit with its use as a first-line treatment for this hard-to-treat population.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"2179-2190"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13615008/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148706517","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}
引用次数: 0
Return to work after upper gastrointestinal cancer surgery: questionnaire-based observational study. 上消化道肿瘤手术后重返工作岗位:基于问卷的观察性研究。
IF 3 3区 医学
International Journal of Clinical Oncology Pub Date : 2026-10-01 Epub Date: 2026-08-01 DOI: 10.1007/s10147-026-03156-2
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
{"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}
引用次数: 0
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. 通用肿瘤筛查识别II/III期结直肠癌患者Lynch综合征的临床效用和成本效益:日本的一项前瞻性观察研究
IF 3 3区 医学
International Journal of Clinical Oncology Pub Date : 2026-10-01 Epub Date: 2026-08-04 DOI: 10.1007/s10147-026-03153-5
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
{"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}
引用次数: 0
Recommendations for generating real-world evidence with regulatory-grade relevance and reliability. 关于产生具有监管级相关性和可靠性的真实证据的建议。
IF 3 3区 医学
International Journal of Clinical Oncology Pub Date : 2026-10-01 Epub Date: 2026-08-20 DOI: 10.1007/s10147-026-03160-6
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
{"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}
引用次数: 0
Racial disparities in time to treatment initiation and survival outcomes in patients with vulvar cancer: a national cancer database analysis. 外阴癌患者治疗开始时间和生存结果的种族差异:一项国家癌症数据库分析。
IF 3 3区 医学
International Journal of Clinical Oncology Pub Date : 2026-10-01 Epub Date: 2026-07-06 DOI: 10.1007/s10147-026-03111-1
Abdelrahman Yousif, Hatem S Mohamed, Mohanad Elchouemi, Sanjana Reddy Mada, Ilana Chefetz
{"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}
引用次数: 0
Primary site- and metastasis-directed therapies in patients with metastatic prostate cancer: A narrative review. 转移性前列腺癌患者的原发部位和转移性治疗:叙述性回顾。
IF 3 3区 医学
International Journal of Clinical Oncology Pub Date : 2026-10-01 Epub Date: 2026-05-30 DOI: 10.1007/s10147-026-03061-8
Takayuki Goto, Kei Mizuno, Takayuki Sumiyoshi, Yuki Kita, Kimihiko Masui, Takashi Ogata, Rihito Aizawa, Atsuro Sawada, Ryoichi Saito, Takashi Mizowaki, Takashi Kobayashi
{"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}
引用次数: 0
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