International Journal of Clinical Oncology最新文献

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Evaluation of drug lag and drug loss in Japan: participation in global phase III oncology trials. 日本药物滞后性和药物损失的评估:参与全球III期肿瘤试验。
IF 2.4 3区 医学
International Journal of Clinical Oncology Pub Date : 2025-04-11 DOI: 10.1007/s10147-025-02756-8
Kaname Shiga, Taro Shibata, Toshio Miyata
{"title":"Evaluation of drug lag and drug loss in Japan: participation in global phase III oncology trials.","authors":"Kaname Shiga, Taro Shibata, Toshio Miyata","doi":"10.1007/s10147-025-02756-8","DOIUrl":"https://doi.org/10.1007/s10147-025-02756-8","url":null,"abstract":"<p><strong>Background: </strong>Despite efforts to mitigate drug lag, discrepancies in drug approval timelines persist between Japan and the US, and increase in unapproved drugs has become a significant challenge. This study aimed to evaluate potential drug lag and drug loss by assessing Japan's participation in global phase III multinational/multiregional clinical trials (MRCTs) targeted cancers.</p><p><strong>Methods: </strong>Phase III MRCTs of anticancer drugs initiated between 2008 and 2022 were collected. Information of participant countries, study sponsor, study design, and cancer type were collected and analyzed by logistic regression analysis to identify factors affected Japan's participation.</p><p><strong>Results: </strong>Of 999 phase III MRCTs, Japan's participation every 5 years increased over 15 years (2008-2012: 34.3%, 2013-2017: 51.6%, 2018-2022: 60.2%), while Japan's non-participation numbers did not change (2008-2012: 157, 2013-2017: 167, 2018-2022: 165). In the multivariate logistic regression analysis, the absence of an operational base in Japan and minor cancers were negatively associated with Japan's participation in phase III MRCTs. Japan's participation was also associated with some cancer organs and drug modalities.</p><p><strong>Conclusion: </strong>Potential future drug lag and increases of unapproved drugs were expected to increase. Since the inclusion of Japan in MRCTs results in shorter or no approval lag, Japan should promote to make circumstances where small overseas companies can include Japan in MRCTs.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143985834","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
PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs; approval of amivantamab plus lazertinib for non-small cell lung cancer, durvalumab for small cell lung cancer, tislelizumab for esophageal cancer, tisotumab vedotin for cervical cancer, ivosidenib for leukemia, and venetoclax for lymphoma in Japan. PMDA关于抗癌药物使用注意事项批准和修订的监管更新;amivantamab联合lazertinib治疗非小细胞肺癌、durvalumab治疗小细胞肺癌、tislelizumab治疗食管癌、tisotumab vedotin治疗宫颈癌、ivosidenib治疗白血病和venetoclax治疗淋巴瘤在日本获批。
IF 2.4 3区 医学
International Journal of Clinical Oncology Pub Date : 2025-04-11 DOI: 10.1007/s10147-025-02758-6
Noriomi Matsumura, Masaki Mandai
{"title":"PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs; approval of amivantamab plus lazertinib for non-small cell lung cancer, durvalumab for small cell lung cancer, tislelizumab for esophageal cancer, tisotumab vedotin for cervical cancer, ivosidenib for leukemia, and venetoclax for lymphoma in Japan.","authors":"Noriomi Matsumura, Masaki Mandai","doi":"10.1007/s10147-025-02758-6","DOIUrl":"https://doi.org/10.1007/s10147-025-02758-6","url":null,"abstract":"","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143986063","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
Concordance of BRAF V600E mutation between immunohistochemistry and genomic testing for thyroid cancer. 甲状腺癌BRAF V600E突变免疫组化与基因组检测的一致性
IF 2.4 3区 医学
International Journal of Clinical Oncology Pub Date : 2025-04-10 DOI: 10.1007/s10147-025-02760-y
Ryutaro Onaga, Tomohiro Enokida, Shingo Sakashita, Nobukazu Tanaka, Yuta Hoshi, Takuma Kishida, Ryo Kuboki, Takao Fujisawa, Susumu Okano, Hiroshi Nishino, Makoto Ito, Genichiro Ishii, Shumpei Ishikawa, Makoto Tahara
{"title":"Concordance of BRAF V600E mutation between immunohistochemistry and genomic testing for thyroid cancer.","authors":"Ryutaro Onaga, Tomohiro Enokida, Shingo Sakashita, Nobukazu Tanaka, Yuta Hoshi, Takuma Kishida, Ryo Kuboki, Takao Fujisawa, Susumu Okano, Hiroshi Nishino, Makoto Ito, Genichiro Ishii, Shumpei Ishikawa, Makoto Tahara","doi":"10.1007/s10147-025-02760-y","DOIUrl":"https://doi.org/10.1007/s10147-025-02760-y","url":null,"abstract":"<p><strong>Background: </strong>BRAF V600E mutation is a significant therapeutic target for thyroid cancer, including anaplastic thyroid cancer (ATC). Although targeted therapy for this mutation requires genomic testing in Japan, turnaround time (TAT) is often unacceptably long, especially for certain conditions, such as ATC, which is one of the most aggressive cancers. Here, we evaluated concordance between immunohistochemistry (IHC) with a relatively short TAT of a few days and genomic testing in thyroid cancer.</p><p><strong>Methods: </strong>Immunohistochemical staining was performed with BRAF (VE1) antibody (Ventana) using the OptiView method on samples already undergoing genomic testing. A pathologist blindly annotated each staining expression with a cut-off of 1% in the cytoplasm. We then calculated the positive percent agreement (PPA), negative percent agreement (NPA), and overall percent agreement (OPA).</p><p><strong>Results: </strong>We identified 62 samples, including 12 of ATC, that underwent genomic testing using different methods: Oncomine Dx Target Test (ODxTT) (n = 32), MEBGEN BRAF 3 Kit (MEBGEN3) (n = 14), FoundationOne CDx (F1CDx) (n = 13), and GenMineTOP (TOP) (n = 1). Annotation results of IHC were positive for 31, negative for 29, and undeterminable for 2 samples due to low tumor content. PPA, NPA, and OPA were 100%, 91.7%, 96.9% for ODxTT; 100%, 100%, 100% for MEBGEN3; 100%, 80.0%, 93.9% for F1CDx; and incalculable, 100%, 100% for TOP, respectively. Discordance was found in the two undeterminable samples only.</p><p><strong>Conclusion: </strong>Concordance between IHC and genomic testing in assessing BRAF V600E was encouragingly high; its reliability and potentially short TAT should benefit patients, especially those with ATC.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143995664","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
Serum amylase level as a predictive biomarker for persistent grade 1 chemotherapy-associated oral mucositis: a retrospective cross-sectional study. 血清淀粉酶水平作为持续1级化疗相关口腔黏膜炎的预测性生物标志物:一项回顾性横断面研究
IF 2.4 3区 医学
International Journal of Clinical Oncology Pub Date : 2025-04-03 DOI: 10.1007/s10147-025-02749-7
Nursema Ozdemir, Ali Alkan, Ozgur Tanriverdi
{"title":"Serum amylase level as a predictive biomarker for persistent grade 1 chemotherapy-associated oral mucositis: a retrospective cross-sectional study.","authors":"Nursema Ozdemir, Ali Alkan, Ozgur Tanriverdi","doi":"10.1007/s10147-025-02749-7","DOIUrl":"https://doi.org/10.1007/s10147-025-02749-7","url":null,"abstract":"<p><strong>Background: </strong>This study aims to determine the relationship between persistent grade 1 chemotherapy-related oral mucositis and serum amylase level.</p><p><strong>Methods: </strong>The study was conducted as a retrospective cross-sectional study. Among the patients diagnosed with cancer whose file information was available, the files of those whose chemotherapy-related oral mucositis status was recorded after the first cycle treatment were examined. Among these patients, those whose serum amylase levels were checked for any reason and those who did not meet the exclusion criteria were included in the study.</p><p><strong>Results: </strong>A total of 376 patients were analyzed. It was observed that grade 1 oral mucositis persisted in 44% of the patients. With the ROC curve, the cut-off value for serum amylase level before the second cycle treatment was determined to be 69.5 U/L (AUC 0.771, 95% CI 0.720-0.821, p = 0.00011). The sensitivity rate of serum amylase levels above this value in predicting chemotherapy-associated oral mucositis was 68.29% and the specificity rate was 100%. In univariate and multivariate logistic (binary) regression analysis, it was concluded that high serum amylase level was an independent factor affecting the presence of oral mucositis (OR 3.37, 95% CI 1.94-9.66; p = 0.00014).</p><p><strong>Conclusion: </strong>It was concluded that serum amylase level may be an independent predictive factor for determining persistent grade 1 chemotherapy-induced oral mucositis. Original.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143779869","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
Real-world outcomes with avelumab + axitinib in patients with advanced renal cell carcinoma in Japan: subgroup analyses from the J-DART2 study by International Metastatic Renal Cell Carcinoma Database Consortium risk classification. 日本晚期肾癌患者使用avelumab + axitinib的真实结果:来自国际转移性肾癌数据库联盟风险分类J-DART2研究的亚组分析。
IF 2.4 3区 医学
International Journal of Clinical Oncology Pub Date : 2025-04-01 Epub Date: 2025-02-11 DOI: 10.1007/s10147-024-02655-4
Junya Furukawa, Taigo Kato, Toshinari Yamasaki, Keisuke Monji, Toshiaki Tanaka, Norihiko Tsuchiya, Tomoaki Miyagawa, Hiroshi Yaegashi, Tomoyasu Sano, Takashi Karashima, Kazutoshi Fujita, Jun-Ichi Hori, Takayuki Ito, Masahiro Kajita, Yoshihiko Tomita, Nobuo Shinohara, Masatoshi Eto, Mototsugu Oya, Hirotsugu Uemura
{"title":"Real-world outcomes with avelumab + axitinib in patients with advanced renal cell carcinoma in Japan: subgroup analyses from the J-DART2 study by International Metastatic Renal Cell Carcinoma Database Consortium risk classification.","authors":"Junya Furukawa, Taigo Kato, Toshinari Yamasaki, Keisuke Monji, Toshiaki Tanaka, Norihiko Tsuchiya, Tomoaki Miyagawa, Hiroshi Yaegashi, Tomoyasu Sano, Takashi Karashima, Kazutoshi Fujita, Jun-Ichi Hori, Takayuki Ito, Masahiro Kajita, Yoshihiko Tomita, Nobuo Shinohara, Masatoshi Eto, Mototsugu Oya, Hirotsugu Uemura","doi":"10.1007/s10147-024-02655-4","DOIUrl":"10.1007/s10147-024-02655-4","url":null,"abstract":"<p><strong>Background: </strong>Avelumab + axitinib was approved for the treatment of advanced renal cell carcinoma (aRCC) in Japan in December 2019. We report long-term real-world subgroup analyses with first-line avelumab + axitinib in patients with aRCC by International Metastatic RCC Database Consortium (IMDC) risk classification from the J-DART2 study in Japan.</p><p><strong>Methods: </strong>J-DART2 was a multicenter, noninterventional, retrospective study examining characteristics, treatment patterns, and outcomes in patients with aRCC who started first-line avelumab + axitinib in Japan between December 2019 and October 2022.</p><p><strong>Results: </strong>Data from 150 patients across 19 sites were analyzed. IMDC risk was favorable in 39 patients (26.0%), intermediate (1 risk factor) in 46 (30.7%), intermediate (2 risk factors) in 36 (24.0%), and poor in 29 (19.3%). Baseline characteristics were generally consistent across IMDC risk subgroups. In subgroups with favorable, intermediate (1 risk factor), intermediate (2 risk factors), and poor risk, median progression-free survival was 31.0, 15.3, 16.4, and 8.1 months; median overall survival (OS) was not reached, but 24-month OS rates were 95.2%, 91.3%, 85.3%, and 57.6%, respectively. Objective response rates were 54.5%, 56.8%, 47.1%, and 54.2%, respectively. High-dose corticosteroid treatment for immune-related adverse events was administered in 5.1%, 8.7%, 8.3%, and 6.9% of patients, respectively.</p><p><strong>Conclusion: </strong>Subgroup analyses from J-DART2 confirm the long-term real-world effectiveness of first-line avelumab + axitinib across IMDC risk groups in patients with aRCC in Japan. Our findings were consistent with previous analyses by IMDC risk and support the favorable benefit-risk profile of avelumab + axitinib in clinical practice in Japan.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"749-760"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11946980/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143399076","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
Efficacy and safety of dose-dense chemotherapy for early-stage breast cancer under prophylactic pegfilgrastim administration: a systematic review and meta-analysis from clinical practice guidelines for the use of G-CSF 2022. 预防性给药pegfilgrastim对早期乳腺癌剂量密集化疗的疗效和安全性:来自G-CSF 2022临床实践指南的系统评价和荟萃分析
IF 2.4 3区 医学
International Journal of Clinical Oncology Pub Date : 2025-04-01 Epub Date: 2025-02-12 DOI: 10.1007/s10147-025-02716-2
Takamichi Yokoe, Tetsuhiro Yoshinami, Kazuki Nozawa, Yukinori Ozaki, Hiroshi Nishio, Kenji Tsuchihashi, Eiki Ichihara, Yuji Miura, Makoto Endo, Shingo Yano, Dai Maruyama, Nobuyuki Susumu, Munetaka Takekuma, Takashi Motohashi, Mamoru Ito, Eishi Baba, Nobuaki Ochi, Toshio Kubo, Keita Uchino, Takahiro Kimura, Yutaro Kamiyama, Shinji Nakao, Shinobu Tamura, Hitomi Nishimoto, Yasuhisa Kato, Atsushi Sato, Toshimi Takano
{"title":"Efficacy and safety of dose-dense chemotherapy for early-stage breast cancer under prophylactic pegfilgrastim administration: a systematic review and meta-analysis from clinical practice guidelines for the use of G-CSF 2022.","authors":"Takamichi Yokoe, Tetsuhiro Yoshinami, Kazuki Nozawa, Yukinori Ozaki, Hiroshi Nishio, Kenji Tsuchihashi, Eiki Ichihara, Yuji Miura, Makoto Endo, Shingo Yano, Dai Maruyama, Nobuyuki Susumu, Munetaka Takekuma, Takashi Motohashi, Mamoru Ito, Eishi Baba, Nobuaki Ochi, Toshio Kubo, Keita Uchino, Takahiro Kimura, Yutaro Kamiyama, Shinji Nakao, Shinobu Tamura, Hitomi Nishimoto, Yasuhisa Kato, Atsushi Sato, Toshimi Takano","doi":"10.1007/s10147-025-02716-2","DOIUrl":"10.1007/s10147-025-02716-2","url":null,"abstract":"<p><strong>Background: </strong>In early-stage breast cancer, dose-dense chemotherapy, which involves the administration of standard doses at shorter intervals, is safer when administered with granulocyte colony-stimulating factor (G-CSF) to mitigate chemotherapy-induced neutropenia. This study aimed to thoroughly evaluate the advantages and disadvantages of dose-dense regimens based on the use of G-CSF.</p><p><strong>Methods: </strong>A systematic review was conducted according to the \"Minds Handbook for Clinical Practice Guideline Development\" using PubMed, Ichushi-Web, and the Cochrane Library databases. Randomized controlled trials (RCTs) and cohort studies assessing dose-dense chemotherapy with prophylactic pegfilgrastim administration in early-stage breast cancer were included. Outcomes included overall survival, event-free survival, incidence of febrile neutropenia, quality of life (QOL), and pain. Meta-analyses were performed on outcomes with sufficient data.</p><p><strong>Results: </strong>Our literature search identified 23 RCTs. Overall survival and event-free survival showed a trend favoring dose-dense therapy (hazard ratio, 0.90, 0.90; 95% confidence interval [CI] 0.78 - 1.03, 0.80 - 1.01; p = 0.13; 0.07, respectively). The incidence of febrile neutropenia was similar between the groups (odds ratio, 0.90; 95% CI 0.58 - 1.40; p = 0.65). Mortality due to infection could not be compared owing to the small number of events. Pain increased with dose-dense therapy (odds ratio 2.57; 95% CI 1.00 - 6.62; p = 0.05), likely from G-CSF-induced bone pain. Only one study examined QOL, showing a decline with chemotherapy that recovered after treatment.</p><p><strong>Conclusions: </strong>Dose-dense chemotherapy trended toward improved survival outcomes without increasing the risk of infection, although pain increased. Further research should identify the specific subgroups that most benefit from dose-dense regimens. More data are needed on the impact on QOL.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"674-683"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143399146","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
Lenvatinib enhances antitumor immunity of anti-PD-1 antibody. Lenvatinib增强抗pd -1抗体的抗肿瘤免疫。
IF 2.4 3区 医学
International Journal of Clinical Oncology Pub Date : 2025-04-01 Epub Date: 2025-02-22 DOI: 10.1007/s10147-025-02721-5
Yu Kato
{"title":"Lenvatinib enhances antitumor immunity of anti-PD-1 antibody.","authors":"Yu Kato","doi":"10.1007/s10147-025-02721-5","DOIUrl":"10.1007/s10147-025-02721-5","url":null,"abstract":"<p><p>Lenvatinib is an orally available multi-tyrosine kinase inhibitor that mainly targets vascular endothelial growth factor (VEGF) and fibroblast growth factor (FGF) signaling. These inhibitory activities of lenvatinib exhibit antitumor efficacy, mainly due to their repressive effects on angiogenesis. In addition, a recent non-clinical evaluation using mouse tumor models revealed that lenvatinib causes immunomodulatory effects, including activation of effector T-cells and regulation of tumor-associated macrophages (TAMs). Combined treatment with lenvatinib and anti-programmed cell death-1 antibody (anti-PD-1) resulted in enhanced antitumor activity relative to monotreatment with anti-PD-1 or lenvatinib. This review summarizes the antitumor mechanisms of lenvatinib and of lenvatinib plus anti-PD-1 combination therapy.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"666-673"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11946938/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476563","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
Prospective observational study on the relationships between genetic alterations and survival in Japanese patients with metastatic castration-sensitive prostate cancer: the impact of IDC-P. 日本转移性去势敏感前列腺癌患者基因改变与生存关系的前瞻性观察研究:IDC-P的影响。
IF 2.4 3区 医学
International Journal of Clinical Oncology Pub Date : 2025-04-01 Epub Date: 2025-02-12 DOI: 10.1007/s10147-025-02707-3
Masashi Kato, Hiroyuki Sato, Yushi Naito, Akiyuki Yamamoto, Hideji Kawanishi, Yojiro Nakano, Toshinori Nishikimi, Masataka Kobayashi, Atsuya Kondo, Hiroki Hirabayashi, Satoshi Katsuno, Fumitoshi Sakamoto, Tohru Kimura, Shigeki Yamamoto, Hidemori Araki, Kosuke Tochigi, Fumihiro Ito, Hatsuro Hatsuse, Naoto Sassa, Akihiro Hirakawa, Shusuke Akamatsu, Toyonori Tsuzuki
{"title":"Prospective observational study on the relationships between genetic alterations and survival in Japanese patients with metastatic castration-sensitive prostate cancer: the impact of IDC-P.","authors":"Masashi Kato, Hiroyuki Sato, Yushi Naito, Akiyuki Yamamoto, Hideji Kawanishi, Yojiro Nakano, Toshinori Nishikimi, Masataka Kobayashi, Atsuya Kondo, Hiroki Hirabayashi, Satoshi Katsuno, Fumitoshi Sakamoto, Tohru Kimura, Shigeki Yamamoto, Hidemori Araki, Kosuke Tochigi, Fumihiro Ito, Hatsuro Hatsuse, Naoto Sassa, Akihiro Hirakawa, Shusuke Akamatsu, Toyonori Tsuzuki","doi":"10.1007/s10147-025-02707-3","DOIUrl":"10.1007/s10147-025-02707-3","url":null,"abstract":"<p><strong>Background: </strong>Intraductal Carcinoma of the Prostate (IDC-P) is a significant prognostic indicator for prostate cancer, which demonstrates significant associations with homologous recombination repair gene mutations (HRRm) and alterations in tumor suppressor genes. However, no study in Japan has investigated the association between IDC-P and genetic mutations in men with metastatic castration-sensitive prostate cancer (mCSPC).</p><p><strong>Methods: </strong>This prospective observational study enrolled 102 de novo mCSPC (LATITUDE high-risk) patients diagnosed between 2018 and 2021, with subsequent monitoring of survival outcomes. A single genitourinary pathologist evaluated all needle biopsy slides. Genetic analyses were performed using the Myriad myChoice HRD plus™. These genetic analyses covered 108 genetic loci, including 15 HRRm genes, with a success rate of 91%.</p><p><strong>Results: </strong>Genetic alterations were observed in 79 patients (77.5%), with 20 exhibiting HRRm (19.6%). Common genetic alterations included FOXA1 (29.4%) and TP53 (17.6%) mutations; BRCA (9.8%) mutations were the most frequent HRRm (BRCA1:2 cases, BRCA2:8 cases, including 6 biallelic). IDC-P-positive patients demonstrated a significantly higher frequency of genetic aberrations (82.6% vs. 50%, p = 0.0082). Patients with biallelic BRCA2, TP53, and PTEN mutations exhibited significantly poorer cancer-specific survival. Multivariate analysis identified lactate dehydrogenase (LDH) (HR 1.005, p = 0.035), TP53 mutations (HR 5.196, p < 0.001), biallelic BRCA2 mutations (HR 10.686, p = 0.005), and IDC-P as independent predictors of poor cancer-specific survival. No cancer-related deaths occurred in IDC-P-negative cases.</p><p><strong>Conclusion: </strong>Our study emphasizes the significant association between IDC-P and an elevated incidence of genetic alterations in Japanese mCSPC patients, emphasizing the need for early genetic testing to guide therapeutic decision-making.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"789-796"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11947062/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143399073","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
Characteristics of patients with metastatic renal cell carcinoma who do not respond to axitinib treatment. 对阿西替尼治疗无效的转移性肾细胞癌患者的特征。
IF 2.4 3区 医学
International Journal of Clinical Oncology Pub Date : 2025-04-01 Epub Date: 2025-02-14 DOI: 10.1007/s10147-025-02715-3
Kojiro Ohba, Takahiro Osawa, Takahiro Kojima, Tomohiko Hara, Mikio Sugimoto, Masatoshi Eto, Keita Minami, Yasutomo Nakai, Kosuke Ueda, Sei Naito, Norio Nonomura, Sachiyo Murai, Hiroyuki Nishiyama, Hiromi Nakanishi, Yuta Mukae, Kensuke Mitsunari, Tomohiro Matsuo, Ryoichi Imamura, Nobuo Shinohara
{"title":"Characteristics of patients with metastatic renal cell carcinoma who do not respond to axitinib treatment.","authors":"Kojiro Ohba, Takahiro Osawa, Takahiro Kojima, Tomohiko Hara, Mikio Sugimoto, Masatoshi Eto, Keita Minami, Yasutomo Nakai, Kosuke Ueda, Sei Naito, Norio Nonomura, Sachiyo Murai, Hiroyuki Nishiyama, Hiromi Nakanishi, Yuta Mukae, Kensuke Mitsunari, Tomohiro Matsuo, Ryoichi Imamura, Nobuo Shinohara","doi":"10.1007/s10147-025-02715-3","DOIUrl":"10.1007/s10147-025-02715-3","url":null,"abstract":"<p><strong>Background: </strong>Axitinib is a widely used tyrosine kinase inhibitor (TKI) in metastatic renal cell carcinoma (mRCC) treatment. Here, we analyzed the characteristics of patients who did not respond to axitinib and evaluated alternative options for their treatment.</p><p><strong>Methods: </strong>We retrospectively analyzed data for 449 patients with mRCC who were administered axitinib following another TKI as initial therapy. Patients with progressive disease (PD) at their first assessment were defined as showing early-PD. We analyzed the characteristics of patients at risk of early-PD and evaluated the relationship between the treatment following axitinib and their prognosis.</p><p><strong>Results: </strong>Early-PD was diagnosed in 102 patients, and was more common in those who had not undergone nephrectomy (p < 0.001), those treated with a TKI for a short period (p < 0.001), and those in the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) poor risk category for mRCC (p < 0.001). Multivariate analysis showed that these were independent risk factors for early-PD (all p < 0.001). Of those with early-PD, 52 changed to next-line treatment. The progression-free survival periods were 5.5 (95% confidence interval (CI) 2.4-8.6) months for patients administered TKIs, 4.2 (95% CI 0.3-8.1) months for those on nivolumab, and 2.2 (1.8-2.6) months for those on mammalian target of rapamycin inhibitors (p = 0.030).</p><p><strong>Conclusion: </strong>Patients who have not undergone nephrectomy, those previously treated with another TKI for a short period, and those in the IMDC poor risk category are more likely to experience early-PD when taking axitinib. Furthermore, TKIs are the best treatment for patients with early-PD who have previously been administered axitinib.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"781-788"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11947068/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143414245","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
Correction: Therapeutic efficacy of immune-oncology combination therapy in advanced renal cell carcinoma without prior nephrectomy. 更正:免疫肿瘤联合疗法对未进行过肾切除术的晚期肾细胞癌的疗效。
IF 2.4 3区 医学
International Journal of Clinical Oncology Pub Date : 2025-04-01 DOI: 10.1007/s10147-025-02728-y
Kosuke Ueda, Naoki Ito, Yuya Sakai, Satoshi Ohnishi, Taishi Hirano, Hirofumi Kurose, Katsuaki Chikui, Keiichiro Uemura, Kiyoaki Nishihara, Makoto Nakiri, Shigetaka Suekane, Tsukasa Igawa
{"title":"Correction: Therapeutic efficacy of immune-oncology combination therapy in advanced renal cell carcinoma without prior nephrectomy.","authors":"Kosuke Ueda, Naoki Ito, Yuya Sakai, Satoshi Ohnishi, Taishi Hirano, Hirofumi Kurose, Katsuaki Chikui, Keiichiro Uemura, Kiyoaki Nishihara, Makoto Nakiri, Shigetaka Suekane, Tsukasa Igawa","doi":"10.1007/s10147-025-02728-y","DOIUrl":"10.1007/s10147-025-02728-y","url":null,"abstract":"","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"780"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143537101","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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