Japanese journal of clinical oncology最新文献

{"title":"Current surgical treatment strategies and ongoing issues for locally recurrent rectal cancer.","authors":"Yasuyuki Yokoyama, Kay Uehara, Takeshi Yamada, Aitsariya Monkhonsupphawan, Seiichi Shinji, Akihisa Matsuda, Goro Takahashi, Woramin Riansuwan, Hiroshi Yoshida","doi":"10.1093/jjco/hyaf127","DOIUrl":"https://doi.org/10.1093/jjco/hyaf127","url":null,"abstract":"<p><p>Locally recurrent rectal cancer (LRRC) remains one of the most challenging problems in the rectal cancer management, despite advances in multimodal treatments. R0 resection remains the cornerstone of curative therapy and the most critical prognostic factor. However, achieving R0 resection is technically demanding, with outcomes heavily influenced by tumor location, institutional expertise, and careful patient selection. This narrative review summarizes current surgical strategies for LRRC, emphasizing the importance of accurate anatomical classification, multidisciplinary collaboration, and individualized planning. Extended resections-including bony pelvis, pelvic sidewall, and vascular dissections-have expanded surgical indications but require specialized expertise and carry risks of functional impairment. Minimally invasive approaches, such as laparoscopic or robotic pelvic exenteration, may offer potential advantages in selected cases but remain technically challenging. Carbon ion radiotherapy, which demonstrates superior local control compared to conventional radiotherapy, is expected to be a promising treatment for unresectable LRRCs. Its future role as an alternative or perioperative treatment for resectable or borderline cases is under investigation. Preoperative chemoradiotherapy may play an important role in radiation-naïve patients, while re-irradiation strategies remain controversial for previously irradiated cases. In patients with resectable distant metastases, aggressive combined surgical approaches may be pursued if curative resection is feasible. Ultimately, shared decision-making with patients is essential for optimal management of LRRC, based on a highly individualized, evidence-based approach that balances oncological prognosis and postoperative quality of life.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144835032","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tasurgratinib (E7090) for cholangiocarcinoma with fibroblast growth factor receptor 2 fusions/rearrangements: a multicenter, open-label, Phase 2 study.","authors":"Lin Shen, Huaxin Duan, Takamichi Kuwahara, Taroh Satoh, Xuelei Ma, Sheng Yan, Haitao Zhao, Masafumi Ikeda, Tongjian Cui, Takashi Sasaki, Zhiqiang Meng, Yousuke Nakai, Makoto Ueno, Yoshito Komatsu, Hiroaki Nagano, Chigusa Morizane, Setsuo Funasaka, Hiroki Ikezawa, Takuya Nakada, Junji Furuse","doi":"10.1093/jjco/hyaf119","DOIUrl":"https://doi.org/10.1093/jjco/hyaf119","url":null,"abstract":"<p><strong>Background: </strong>This Phase 2 study (NCT04238715) evaluated the efficacy/safety of tasurgratinib 140 mg daily in patients with cholangiocarcinoma (CCA) and fibroblast growth factor receptor (FGFR) 2 fusions/rearrangements.</p><p><strong>Methods: </strong>Eligible Japanese and Chinese patients who had surgically unresectable, advanced, or metastatic CCA and had received ≥1 prior gemcitabine-based combination chemotherapy regimen were included and treated with oral tasurgratinib 140 mg daily. The primary endpoint was objective response rate (ORR); the study was considered successful if the lower limit of the ORRs 90% CI was >15%. Secondary endpoints included duration of response and safety. FGFR2 fusions/rearrangements were confirmed by fluorescence in situ hybridization performed in central laboratories. Tumor responses were measured every 8 weeks by Response Evaluation Criteria in Solid Tumors version 1.1 per independent imaging review.</p><p><strong>Results: </strong>Sixty-three patients were treated; 23 (37%) had received 1 prior regimen, all others had received ≥2. By the data cutoff date (15 March 2023), the ORR was 30.2% (two-sided 90% CI: 20.7-41.0). The median duration of response for responders was 5.6 months (95% CI: 3.7-9.3; range: 1.0+ to 14.8+). Sixty-one patients (97%) had ≥1 treatment-related treatment-emergent adverse event; 18 patients (29%) had ≥1 grade ≥3 treatment-related treatment-emergent adverse events. Four patients (6%) had a fatal adverse event, none were considered treatment-related. Tasurgratinib had promising antitumor activity in patients with CCA harboring FGFR2 fusions or rearrangements after ≥1 prior gemcitabine-based chemotherapy regimen.</p><p><strong>Conclusions: </strong>The primary endpoint (ORR) met the study's predefined success criteria. Tasurgratinib had a manageable safety profile consistent with previous reports and the known pharmacological profile of FGFR inhibitors.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144835035","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recurrence risk following rectal cancer surgery: a survival analysis of key predictors.","authors":"Neda Gorjizadeh, Reza Hajebi, Matin Vahedi, Mahsa Mottahedi, Elham Nazar","doi":"10.1093/jjco/hyaf080","DOIUrl":"10.1093/jjco/hyaf080","url":null,"abstract":"<p><strong>Background: </strong>Identifying predictors of postsurgical recurrence in patients with rectal cancer is critical for optimizing postoperative management and improving patient outcomes. We aimed to assess the effects of demographic, clinical, and pathological factors on recurrence risk after rectal cancer surgery.</p><p><strong>Methods: </strong>We conducted a secondary analysis of data from patients who underwent curative rectal cancer surgery between 2004 and 2018. A Cox proportional hazards regression model was applied to examine the influence of variables on recurrence risk. Kaplan-Meier curves were used to visualize cumulative hazards.</p><p><strong>Results: </strong>Among 961 patients (62.7% male, mean age 63.1 years), 127 (13.2%) experienced recurrence over a median follow-up of 60 months. Based on the Cox model (C-index = 0.770, likelihood ratio test χ2(19) = 127.5, P < 0.001), significant predictors of increased recurrence risk included pathologic node stage N1 (hazard ratio 2.92, 95% CI: 1.84-4.63, P < 0.001) and N2 (4.05, 2.36-6.94, P < 0.001), as well as fewer than 12 harvested lymph nodes (1.95, 1.31-2.90, P = 0.001). Moderately differentiated histology reduced recurrence risk (0.49, 0.27-0.89, P = 0.018), and age (0.98, 0.96-0.99, P = 0.004) was inversely correlated with recurrence risk. Sex, chemotherapy, pathologic tumor stage, and lymphovascular invasion were not significant predictors of recurrence.</p><p><strong>Conclusion: </strong>This study identified key factors associated with recurrence risk after rectal cancer surgery, highlighting the importance of pathologic node stage, lymph node metrics, and histological differentiation. These findings provide a foundation for personalized postoperative management strategies and improving long-term outcomes in rectal cancer patients.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"880-888"},"PeriodicalIF":2.2,"publicationDate":"2025-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078178","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness and safety of pembrolizumab for the treatment of Japanese patients with microsatellite instability-high tumors excluding colorectal cancer: a post-marketing surveillance.","authors":"Daisuke Aoki, Mai Yamauchi, Makiko Izawa, Yuichiro Ito, Masahiro Hamada, Masahiko Ozaki, Shinichiroh Maekawa, Kei Muro","doi":"10.1093/jjco/hyaf064","DOIUrl":"10.1093/jjco/hyaf064","url":null,"abstract":"<p><strong>Background: </strong>We aimed to assess the real-world effectiveness and safety of pembrolizumab monotherapy in Japanese patients with high-frequency microsatellite instability (MSI-H) solid tumors except colorectal cancer.</p><p><strong>Methods: </strong>This multicenter, observational, post-marketing surveillance had a 12-month observation period. We included all patients with locally advanced or metastatic MSI-H solid tumors, except colorectal cancer, in whom standard treatment was difficult or who had shown tumor progression after conventional chemotherapies and had started treatment with pembrolizumab by 31 December 2019.</p><p><strong>Results: </strong>In total, 403 patients were enrolled, and 396 and 376 patients were included in the safety and effectiveness analysis sets, respectively. The numbers of patients and frequencies of tumor types occurring in ≥20 cases were: endometrial, 162/403 (40.2%); gastric, 61/403 (15.1%); biliary tract, 42/403 (10.4%); pancreatic, 29/403 (7.2%); and ovarian, 20/403 (5.0%). The objective response rate was 50.3% (189/376) and the disease control rate was 71.5% (269/376). The 12-month progression-free survival (PFS) rate was 42.1% and the median PFS was 8.8 months (95% confidence interval, 6.4-11.5). The 12-month overall survival (OS) rate was 75.1%, and median OS was not reached. Treatment-related adverse events (AEs) of special interest of any grade occurred in 128/396 (32.3%) patients, and those of Grade ≥ 3, in 54/396 (13.6%) patients. One patient with esophageal cancer experienced a Grade 5 AE. No new safety signals were observed.</p><p><strong>Conclusions: </strong>This study confirmed the real-world effectiveness and safety of pembrolizumab monotherapy in patients with MSI-H solid tumors except colorectal cancer in Japan.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"901-912"},"PeriodicalIF":2.2,"publicationDate":"2025-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12319222/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093696","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of a dynamic prediction model with the inclusion of time-dependent inflammatory biomarker enhances recurrence prediction after curative surgery for stage II or III gastric cancer.","authors":"Larbi Aluariachy, Koji Oba, Yutaka Matsuyama, Akihiro Kuroda, Yasuhiro Okumura, Koichi Yagi, Yoko Oshima, Takeo Fukagawa, Hideaki Shimada, Yasuyuki Seto","doi":"10.1093/jjco/hyaf075","DOIUrl":"10.1093/jjco/hyaf075","url":null,"abstract":"<p><strong>Background: </strong>Postoperative recurrence prediction models for gastric cancer often rely on preoperative or immediate postoperative data, overlooking time-dependent biomarkers from follow-up visits. By incorporating longitudinal biomarker data through a landmarking approach, this study aims to enhance recurrence risk prediction.</p><p><strong>Methods: </strong>This multicenter study included patients who underwent curative surgery for stage II-III gastric cancer from January 2010 to December 2016 in three hospitals in Tokyo, Japan. Their demographic, clinical, and biomarker data were collected from medical records. Biomarkers were collected at surgery and 3, 6, 9, and 12 months postoperatively. Three prediction models-baseline model, landmarking 1.0, and landmarking 1.5-were developed and compared in terms of their prediction accuracy using four measures: concordance probability, calibration plot, Kaplan-Meier curves stratified with predicted risk, and Net Reclassification Improvement. The models aimed to predict recurrence within three years after surgery, with predictions made one year postsurgery.</p><p><strong>Results: </strong>The study included 274 patients with gastric cancer, with 62 (22.6%) events occurring within three years. As a result of the variable selection process, lymphatic venous Invasion (LVI), pathological T (pT) stage, pathological N (pN) stage, and baseline prognostic nutritional index (PNI) were chosen. Additionally, in landmarking 1.0 and 1.5, S1 treatment status and PNI-change were also selected as time-dependent predictors. Landmarking 1.5, which incorporates time-dependent biomarkers until one year postsurgery, showed superior performance to the other models in all four measures.</p><p><strong>Conclusions: </strong>Prediction models incorporating postoperative information could serve as a decision-making tool in clinical practice to more precisely distinguish between patients with high and low risk of recurrence.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"871-879"},"PeriodicalIF":2.2,"publicationDate":"2025-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12319220/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144127618","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of pectoralis major muscle mass decrease after lobectomy on the prognosis of lung cancer.","authors":"Risa Kuboi, Norifumi Tsubokawa, Atsushi Kamigaichi, Nobutaka Kawamoto, Takahiro Mimae, Yoshihiro Miyata, Morihito Okada","doi":"10.1093/jjco/hyaf072","DOIUrl":"10.1093/jjco/hyaf072","url":null,"abstract":"<p><strong>Background: </strong>Low preoperative skeletal muscle mass is a negative prognostic factor for non-small cell lung cancer. However, the clinical significance of postsurgical skeletal muscle loss remains unclear. We investigated the impact of a postoperative decrease in pectoralis major muscle mass on long-term outcomes.</p><p><strong>Methods: </strong>A retrospective evaluation was conducted on 460 patients with pathological stage I-II non-small cell lung cancer who underwent lobectomy. Patients were categorized into two groups based on whether they did or did not show a decrease in pectoralis major muscle mass 12 months postoperatively, using a muscle mass change rate of 0.94 as the cutoff.</p><p><strong>Results: </strong>The group showing a decrease in muscle mass (n = 126) exhibited a higher incidence of chronic obstructive pulmonary disease than the group showing no decrease in muscle mass (n = 334). The median rate of change in the muscle mass of the pectoralis major was 1.00. The median follow-up period was 42.8 months. Overall survival was significantly lower in the group showing a decrease in muscle mass than in the group showing no decrease in muscle mass (P < .001). Multivariable Cox regression analysis revealed that a decrease in pectoralis major muscle mass after surgery was an independent prognostic factor for overall survival (hazard ratio, 1.05; 95% confidence interval, 1.03-1.06; P < .001).</p><p><strong>Conclusions: </strong>A decrease in pectoralis major muscle mass following lobectomy is associated with poor prognosis in patients with non-small cell lung cancer.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"941-946"},"PeriodicalIF":2.2,"publicationDate":"2025-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143983722","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enhancing patient positioning accuracy: evaluating daily cone beam computed tomography in the halcyon system.","authors":"Duong Thanh Tai, Luong Tien Phat, Tran Trung Kien, Nguyen Ngoc Anh, Nguyen Xuan Hai, Peter Sandwall, David Bradley, James C L Chow","doi":"10.1093/jjco/hyaf067","DOIUrl":"10.1093/jjco/hyaf067","url":null,"abstract":"<p><strong>Background: </strong>Precise patient positioning is crucial for successful radiotherapy, ensuring accurate delivery of radiation to tumors while minimizing exposure to healthy tissues. Positional errors can significantly impact treatment efficacy and increase side effects. This study evaluates the effectiveness of daily cone beam computed tomography (CBCT) imaging in the Halcyon system for detecting and correcting patient misalignments across various cancer types and treatment sites.</p><p><strong>Methods: </strong>A retrospective analysis was conducted on 411 patients treated with the Varian Halcyon linear accelerator from August 2022 to August 2024. Patients were grouped based on tumor location: Head and Neck (118 patients), Chest (188 patients), and Pelvis (105 patients). Daily pre-treatment CBCT scans were performed to verify positioning, with shifts in the x, y, and z axes quantified and adjusted using automated couch corrections.</p><p><strong>Results: </strong>The study revealed average positional shifts along the x-axis of ~0.112 cm, while both the Chest and Pelvic groups recorded 0.194 cm. The y-axis deviations were 0.135 cm for Head and Neck, 0.206 cm for Chest, and 0.195 cm for the Pelvis. On the z-axis, a mean deviation of 0.07 cm was found for the Head and Neck group, while 0.11 cm for the Chest group, and 0.085 cm for the Pelvic group. The Head and Neck group exhibited the smallest standard deviations across all axes, indicating greater positional consistency. Normalized density distributions showed distinct emergent patterns, the Head and Neck group showing tighter distributions compared to the broader distributions observed in the Chest and Pelvic groups.</p><p><strong>Conclusions: </strong>Daily CBCT imaging in the Halcyon system significantly enhances patient positioning accuracy in radiotherapy. The findings demonstrate that this approach minimizes positional shifts, particularly in the Head and Neck region, essential for optimizing treatment outcomes and reducing the risk of adverse effects. Future studies should further explore the integration of advanced imaging techniques to improve precision in patient positioning.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"925-932"},"PeriodicalIF":2.2,"publicationDate":"2025-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12319221/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144013117","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Carotid body tumors-epidemiology and surgical resection.","authors":"Kiyoto Shiga, Katsunori Katagiri, Aya Ikeda, Daisuke Saito, Shin-Ichi Oikawa, Kodai Tshuchida, Jun Miyaguchi, Takahiro Kusaka, Akio Tamura","doi":"10.1093/jjco/hyaf074","DOIUrl":"10.1093/jjco/hyaf074","url":null,"abstract":"<p><p>Carotid body tumor originates from paraganglion cells of the carotid body and is a hypervascular tumor with multiple feeding arteries and uniquely located at the carotid bifurcation. Recently, it has been revealed that various types of gene alterations exist mainly in the succinate dehydrogenase (SDH) gene family. Although resection is a radical therapy for this tumor, complete resection is challenging. On the other hand, radiotherapy for carotid body tumors is insufficient as a radical therapy concerning the response rate. Here, we reviewed articles reporting carotid body tumor treatment and surgical resection focusing on choice of treatment, surgical difficulties, and preoperative embolization of feeding arteries. The effectiveness of preoperative embolization remains controversial due to the varied situations performing surgical resection among the institutions.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"852-859"},"PeriodicalIF":2.2,"publicationDate":"2025-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078176","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mitochondrial DNA copy numbers in gastric cancer tissues: a possible biomarker for estimating cancer progression.","authors":"Hisanori Fukunaga, Mayuko Fukunaga","doi":"10.1093/jjco/hyaf066","DOIUrl":"10.1093/jjco/hyaf066","url":null,"abstract":"<p><strong>Background: </strong>Mitochondria have their own genome (mtDNA), which in humans is a circular multi-copy genome consisting of 16 569 base pairs. Abnormalities in the mtDNA have been reported to correlate with various age-related pathophysiologies.</p><p><strong>Methods: </strong>Based on a total of 182 DNA samples extracted from gastric cancer tissues, we measured mtDNA copy numbers (mtDNA-CN) using real-time polymerase chain reaction (PCR) and then examined alongside sex, age, tumor stage, Laurén classification, and the overexpression of Human Epidermal Growth Factor Receptor 2 (HER2).</p><p><strong>Results: </strong>We found no sex differences in mtDNA-CN and no correlation with age, but significant differences according to tumor stage. The mtDNAcn of intestinal type by Laurén classification was significantly larger than that of diffuse type. There was no significant difference in mtDNA-CN between HER2-positive and -negative tissues. Multiple regression analyses showed that only the tumor stage was a significant variable, while Laurén classification was not.</p><p><strong>Conclusion: </strong>These results indicate that mitochondrial genomic abnormalities contribute the progression of gastric cancer independently of HER2 overexpression, and may shed light on the emerging role of mtDNA-CN in situ as a possible biomarker for estimating cancer progression.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"920-924"},"PeriodicalIF":2.2,"publicationDate":"2025-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143965066","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical benefits of androgen receptor signaling inhibitors in patients with metastatic hormone-sensitive prostate cancer: real-world data from a multi-center study.","authors":"Yosuke Kinoshita, Yasutaka Yamada, Takuya Tsujino, Zhao Xue, Kodai Sato, Sinpei Saito, Kazuki Nishimura, Tatsuo Fukushima, Ko Nakamura, Satoshi Yamamoto, Takayuki Arai, Hiroaki Sato, Kosuke Higuchi, Akinori Takei, Manato Kanesaka, Keisuke Ando, Sangjon Pae, Sanji Kanaoka, Nobushige Takeshita, Kei Yoneda, Daichi Hino, Tomokazu Sazuka, Yusuke Imamura, Kazuo Mikami, Kazuyoshi Nakamura, Satoshi Fukasawa, Akira Kurozumi, Yukio Naya, Maki Nagata, Atsushi Komaru, Toyofusa Tobe, Noriyuki Suzuki, Haruhito Azuma, Tomohiko Ichikawa, Shinichi Sakamoto","doi":"10.1093/jjco/hyaf079","DOIUrl":"10.1093/jjco/hyaf079","url":null,"abstract":"<p><strong>Background: </strong>This study investigated clinical benefits of androgen receptor signaling inhibitor (ARSI) in patients with synchronous metastatic hormone-sensitive prostate cancer (mHSPC) based on real-world data from multiple centers.</p><p><strong>Methods: </strong>Clinical records of 1107 mHSPC patients who commenced vintage (bicalutamide) (n = 801) or ARSI (n = 306) treatment in addition to androgen deprivation therapy between 1999 and 2024 were reviewed. Progression-free and overall survival (OS) were examined, and prognostic factors were analyzed using multivariate cox proportional hazard modeling. Propensity score matching (PSM) analysis was performed to balance background characteristics.</p><p><strong>Results: </strong>Median age and initial prostate-specific antigen level were 73 years and 229 ng/ml, respectively. Kaplan-Meier analysis revealed that upfront ARSI treatment was associated with longer progression-free survival (P < 0.0001, hazard ratio [HR] = 0.37) and OS (P = 0.0088, HR = 0.58) than combined androgen blockade after PSM analysis. In particular, an OS benefit of upfront ARSI was observed in high-volume patients (P = 0.0052, HR = 0.56). ARSI use after castration-resistant prostate cancer (CRPC) development correlated with improved OS as compared to patients without ARSI use (P < 0.0001, HR = 0.52). Multivariate analysis identified ARSI therapy as an independent prognostic factor for OS both when used upfront (P = 0.0141, HR = 0.61) and after CRPC development (P < 0.0001, HR = 0.55). In addition, categorizing all patients into groups receiving no ARSI, ARSI after CRPC, or ARSI as upfront therapy revealed 5-year OS rates of 55.65%, 59.85%, and 65.01%, respectively.</p><p><strong>Conclusions: </strong>Early use of ARSI in Japanese patients with mHSPC appears clinically beneficial. Our findings suggest the prognostic importance for optimal treatment intensification.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"954-962"},"PeriodicalIF":2.2,"publicationDate":"2025-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}