Japanese journal of clinical oncology最新文献

{"title":"Age-standardized mortality-to-incidence ratio for female breast cancer in the world.","authors":"Kumiko Saika, Sumiyo Okawa","doi":"10.1093/jjco/hyaf117","DOIUrl":"https://doi.org/10.1093/jjco/hyaf117","url":null,"abstract":"","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":"55 8","pages":"982-983"},"PeriodicalIF":2.2,"publicationDate":"2025-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144775409","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":"High real-world incidence of hepatic dysfunction from cabozantinib plus nivolumab for Japanese patients with metastatic renal cell carcinoma.","authors":"Toshihide Horiuchi, Koichi Nishimura, Kazutaka Nakamura, Yuki Nemoto, Yudai Ishiyama, Nanaka Katsurayama, Daisuke Toki, Hirohito Kobayashi, Tsunenori Kondo","doi":"10.1093/jjco/hyaf070","DOIUrl":"10.1093/jjco/hyaf070","url":null,"abstract":"<p><strong>Objective: </strong>The real-world incidence of hepatic dysfunction after combination therapy with cabozantinib plus nivolumab (CABO+NIVO) in Japanese patients with metastatic renal cell carcinoma remains undetermined; hence, this study aimed to determine the incidence of hepatotoxicity in these patients.</p><p><strong>Methods: </strong>A total of 48 patients treated with CABO+NIVO were enrolled in this study. Alanine aminotransferase (ALT) levels were used to evaluate liver dysfunction because of its liver specificity.</p><p><strong>Results: </strong>ALT elevation of any grade was found in 30 patients (63%), and grade 3 elevation was found in eight patients (17%). No grade 4 or 5 elevations were observed. Female gender and a higher body mass index were independent predictive factors for ALT elevation. All patients were managed with dose reduction or interruption of cabozantinib and concomitant use of hepatoprotective agents without high-dose corticosteroids. Of the seven patients that underwent cabozantinib rechallenge after grade 3 ALT elevation, only two (23%) required re-interruption due to repeat grade 3 ALT elevation.</p><p><strong>Conclusions: </strong>This is the first study to examine hepatic dysfunction caused by CABO+NIVO in Japanese patients. The incidence of hepatic dysfunction was higher in real-world patients than in global patients found in pivotal phase 3 trials. Cabozantinib appeared to be a major cause of hepatic dysfunction since dose reduction or interruption of cabozantinib without the use of corticosteroids resolved hepatotoxicity. In addition, additional care should be taken when treating female or obese patients with CABO+NIVO.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"947-953"},"PeriodicalIF":2.2,"publicationDate":"2025-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144019715","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":"Skin rash induced by apalutamide correlated with age and relative dose intensity adjusted by body surface area in Japanese patients with prostate cancer.","authors":"Naoki Akagi, Riki Obayashi, Akihiro Yamamoto, Akihiko Nagoshi, Tasuku Fujiwara, Atsushi Igarashi, Yuto Hattori, Noboru Shibasaki, Mutsushi Kawakita, Toshinari Yamasaki","doi":"10.1093/jjco/hyaf082","DOIUrl":"10.1093/jjco/hyaf082","url":null,"abstract":"<p><strong>Objective: </strong>Common adverse events associated with apalutamide include skin rashes and occur more frequently in Japanese patients. This study used relative dose intensity (RDI) and body surface area (BSA) to investigate the risk of skin adverse events and the efficacy of apalutamide in patients with prostate cancer.</p><p><strong>Methods: </strong>We retrospectively reviewed data from 63 patients with prostate cancer who were treated with an initial dose of 240 mg apalutamide, and RDI (%) was calculated. Patient backgrounds were compared, and factors contributing to rash development were analyzed. Progression-free survival (PFS), defined as the time to castration-resistant prostate cancer, was analyzed using overall RDI/BSA in metastatic castration-sensitive prostate cancer (mCSPC) patients.</p><p><strong>Results: </strong>The receiver operating characteristic curve analysis showed that RDI/BSA had a slightly stronger association with rash occurrence than RDI/kg. Univariate analysis identified age and RDI/BSA as significant risk factors for rash occurrence, particularly when both an age cutoff of 72 years and a RDI/BSA cutoff of 56 were met. PFS in mCSPC patients showed no significant differences among tRDI/BSA groups (<36, 36-55, >55) or between patients with and without dose reductions. Cutoff points (36 and 55) were based on the maximum tRDI/BSA values assuming continuous administration of 120 mg or 180 mg apalutamide in patients with a minimum BSA of 1.36 m2.</p><p><strong>Conclusions: </strong>Age and RDI/BSA were associated with rash occurrence, suggesting a need for dose reduction of apalutamide. A dose reduction to 180 or 120 mg may be appropriate in such cases when considering efficacy.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"963-969"},"PeriodicalIF":2.2,"publicationDate":"2025-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144110719","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":"Efficacy of nivolumab + ipilimumab ± chemotherapy versus pembrolizumab + chemotherapy in patients with PD-L1-negative non-small cell lung cancer (START001 PART-B): a multicenter retrospective observational study.","authors":"Yutaro Nagano, Mamoru Takahashi, Toshiyuki Sumi, Keiki Yokoo, Tatsuru Ishikawa, Osamu Honjo, Sayaka Kudo, Shun Kondo, Yusuke Tanaka, Makoto Shioya, Midori Hashimoto, Mitsuo Otsuka, Yuta Sudo, Masahiro Yanagi, Hayato Yabe, Hirotaka Nishikiori, Masami Yamazoe, Yuichiro Asai, Yasuko Fukataki, Shiro Hinotsu, Hirofumi Chiba","doi":"10.1093/jjco/hyaf073","DOIUrl":"10.1093/jjco/hyaf073","url":null,"abstract":"<p><strong>Background: </strong>Programmed death ligand 1 (PD-L1) serves as a crucial biomarker for predicting the efficacy of immune checkpoint inhibitors in patients with non-small cell lung cancer (NSCLC). This study aimed to identify the most suitable first-line treatment regimen for patients with PD-L1 expression <1% (PD-L1-negative) NSCLC by comparing nivolumab plus ipilimumab (NI), NI combined with chemotherapy (NICT), and pembrolizumab and chemotherapy (PCT).</p><p><strong>Methods: </strong>We analyzed data from 141 patients with PD-L1-negative NSCLC treated with NI, NICT, or PCT at 14 Japanese institutions between December 2020 and November 2022. Propensity score analysis was employed to minimize selection bias, and Kaplan-Meier analysis and Cox proportional hazards regression were used to evaluate progression-free survival (PFS) and overall survival (OS).</p><p><strong>Results: </strong>Neither NI nor NICT demonstrated superior PFS or OS than PCT. Subgroup analyses revealed no significant differences between treatment groups across age, histological subtypes, or clinical features. Results from propensity score matching and inverse probability of treatment weighting were consistent with those observed in the overall cohort. Moreover, safety profiles showed that PCT was associated with the lowest rates of treatment discontinuation and immune-related adverse events requiring systemic corticosteroid therapy.</p><p><strong>Conclusions: </strong>In patients with PD-L1-negative NSCLC, the efficacy of NI and NICT was not superior to that of PCT. Thus, we concluded that PCT could be a favorable treatment option for this patient population.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"933-940"},"PeriodicalIF":2.2,"publicationDate":"2025-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144018142","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":"Therapeutic strategy for scirrhous type gastric cancer.","authors":"Izuma Nakayama","doi":"10.1093/jjco/hyaf081","DOIUrl":"10.1093/jjco/hyaf081","url":null,"abstract":"<p><p>Scirrhous-type gastric cancer (SGC) is a rare but well-recognized subset of resectable gastric cancer (GC), accounting for ⁓10% of cases. Despite its long history of clinical recognition dating back to the pre-1900s, SGC remains one of the most challenging GC subtypes to treat. Traditionally, SGC has been clinically defined as Borrmann type 4 GC, with histological classifications such as signet ring cell carcinoma or diffuse-type histology serving as alternative diagnostic criteria. Therapeutic advancements for SGC have largely focused on locally advanced or oligometastatic disease, yet no SGC-specific treatment has been established. The phase III JCOG0501 trial failed to demonstrate a survival benefit of neoadjuvant S-1 plus cisplatin for Borrmann type 4 and large type 3 GC. Recent developments in biomarker-driven therapies may redefine SGC by molecular subtypes, with CLDN18.2-targeted therapy emerging as a potential option for some SGC cases. However, as the landscape of medical oncology evolves, SGC may not remain a distinct therapeutic entity. The focus should shift toward understanding the intrinsic biology of SGC. Treatment development for SGC is expected to continue advancing, becoming increasingly stratified based on molecular abnormalities while maintaining a commitment to addressing unmet needs, such as early-onset GC and GC with symptomatic peritoneal dissemination.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"860-870"},"PeriodicalIF":2.2,"publicationDate":"2025-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12319224/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144127630","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":"Near-infrared photoimmunotherapy: basics and clinical application.","authors":"Ryuhei Okada, Takahiro Asakage","doi":"10.1093/jjco/hyaf069","DOIUrl":"10.1093/jjco/hyaf069","url":null,"abstract":"<p><p>Use of antibody-drug conjugates (ADCs) is rapidly increasing in the field of oncology. While ADCs exhibit strong and cell-selective cytotoxicity, they do not show spatial selectivity. Near-infrared photoimmunotherapy (NIR-PIT, Alluminox™) utilizes photoactivatable ADCs, that is, antibody-photoabsorber conjugates (APCs). The photoabsorber used in NIR-PIT, IRDye700DX (IR700), is activated by light of ~690 nm wavelength. APCs, usually administered by intravenous injection, bind to the target cell surface, and subsequent excitation-light illumination dramatically changes the status of IR700 from hydrophilic to hydrophobic, inducing aggregation of the APC-target molecule complex and cell burst. Dying cells release neoantigens as well as damage-associated molecular patterns, resulting in immunogenic cell death (ICD). Based on the favorable results of clinical trials, epidermal growth factor-targeted NIR-PIT has been performed in Japan since 2021 for patients with unresectable head and neck cancers (HNCs). Since pain and local edema are frequent adverse events (AEs), various measures have been taken against these AEs. Because NIR-PIT induces ICD, combining NIR-PIT with immune checkpoint inhibitor (ICI) therapy is thought to be a rather effective strategy. NIR-PIT could also locally destroy immune suppressor cells, such as regulatory T cells, in the tumor microenvironment. Currently, numerous clinical trials are under way to evaluate the efficacy of NIR-PIT as well as of combined NIR-PIT plus ICI therapy. In this review article, we describe the basics of NIT-PIT, results of translational experiments, current clinical application of NIT-PIT in HNCs, and relevant ongoing clinical trials.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"843-851"},"PeriodicalIF":2.2,"publicationDate":"2025-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144002865","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":"Protocol digest of a single-arm confirmatory trial for less intensive postoperative surveillance in low-risk colorectal cancer patients: JCOG1915 (less study).","authors":"Yuta Sekino, Konosuke Moritani, Junki Mizusawa, Dai Shida, Tsukamoto Shunsuke, Tetsuya Hamaguchi, Atsuo Takashima, Akio Shiomi, Masaaki Ito, Yuichi Takayama, Makoto Kinouchi, Shin Fujita, Manabu Shiozawa, Hideki Ueno, Satoshi Ikeda, Yasumasa Takii, Yusuke Sano, Tomoko Kataoka, Haruhiko Fukuda, Yukihide Kanemitsu","doi":"10.1093/jjco/hyaf077","DOIUrl":"10.1093/jjco/hyaf077","url":null,"abstract":"<p><p>The Japanese Society for Cancer of the Colon and Rectum guidelines recommend intensive surveillance for curatively resected pathological stage I-III colorectal cancer. However, there is still no global consensus on the optimal method, duration, or frequency of surveillance, and no clinical trials have demonstrated the usefulness of surveillance. We are conducting a clinical trial to confirm the efficacy of less-intensive surveillance after R0 resection with lymph node dissection for stage I or low-risk stage II colorectal cancer in patients without risk factors for recurrence. If this less intensive surveillance method proves effective, medical costs will be considerably reduced. The primary endpoint is overall survival. A total of 680 patients will be enrolled from 59 institutions over 2 years. This trial has been registered at the Japan Registry of Clinical Trials (jRCT) as study number jRCT1030220350.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"970-974"},"PeriodicalIF":2.2,"publicationDate":"2025-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12319228/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144127627","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":"Sentinel lymph node biopsy mapped with carbon nanoparticle suspensions in patients with cervical cancer: a systematic review and meta-analysis.","authors":"Ting Qu, Guangfu Zeng, Jinmei Yang, Kexin Tang, Ping Xie, Xiaohai Tang","doi":"10.1093/jjco/hyaf063","DOIUrl":"10.1093/jjco/hyaf063","url":null,"abstract":"<p><strong>Background: </strong>The mapping technique significantly influences the detection rate of sentinel lymph nodes in cervical cancer. This study aims to evaluate the clinical efficacy of carbon nanoparticle suspensions (CNSs) in guiding sentinel lymph node biopsy (SLNB) for cervical cancer patients.</p><p><strong>Methods: </strong>Systematic search of China National Knowledge Infrastructure, Cqvip, Wanfang, PubMed, EMBASE, Web of Science, and the Cochrane Library from inception until June 2024. Studies on cervical cancer patients receiving SLNB with CNSs are included. An individual participant data meta-analysis was conducted. The protocol was prospectively registered on the International Prospective Register of Systematic Reviews (PROSPERO: CRD42024569290).</p><p><strong>Results: </strong>In total, 26 publications involving 1671 patients were analyzed. The overall detection rate of CNSs in SLNB for cervical cancer was 0.92, with bilateral and unilateral detection rates of 0.74 and 0.20, respectively. This detection rate exhibited a correlation with lesion size and the administration of neoadjuvant chemotherapy. The pooled sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio were 0.93 (95% CI: 0.88-0.96, I2 = 35.89%), 1.00 (95% CI: 0.98-1.00, I2 = 90.01%), 216.84 (95% CI: 40.47-1161.85, I2 = 77.68%), and 0.07 (95% CI: 0.05-0.12, I2 = 54.96%), respectively. The area under the curve of the summary receiver operating characteristic curve was 0.97. No significant differences were found in subgroup analyses based on the method, time, and dose of CNS injection. However, significant publication bias was detected among the included studies based on Deeks' funnel plot [Slope (Bias) = -15.61, P = .001]. Nonetheless, sensitivity analysis confirmed the reliability and stability of the results.</p><p><strong>Conclusions: </strong>This meta-analysis highlights the accuracy and feasibility of using CNSs for SLNB in patients with cervical cancer, particularly for lesions <2.0 cm and patients untreated with neoadjuvant chemotherapy.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"889-900"},"PeriodicalIF":2.2,"publicationDate":"2025-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143992399","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":"Reliability and validity of the Japanese version of the palliative care phase in palliative care facilities.","authors":"Hironori Ohinata, Masanori Mori, Maho Aoyama, Nao Ito, Tomoko Shigeno, Tomoya Iida, Yuko Matsumura, Hiroaki Tsukuura, Akemi Shirado Naito, Kengo Imai, Naosuke Yokomichi, Tatsuya Morita, Mitsunori Miyashita","doi":"10.1093/jjco/hyaf076","DOIUrl":"10.1093/jjco/hyaf076","url":null,"abstract":"<p><strong>Background: </strong>Palliative care phase is a tool to assess five phases that reflect a patient's care needs: stable, unstable, deteriorating, terminal, and bereavement. The palliative care phase is routinely used to describe the clinical status of patients and their families. Australia has established nationwide benchmarks for comparing care services. However, the reliability of palliative care in Japan has not yet been verified. This study aimed to develop a Japanese version of the palliative care phase and examine its inter-rater reliability.</p><p><strong>Methods: </strong>This was a multicenter, cross-sectional study. Based on previous studies, two healthcare providers evaluated the single-patient phase and calculated kappa coefficients. The reliability was assessed between March 2024 and November 2024 in a palliative care facility in Japan.</p><p><strong>Results: </strong>A total of 419 phase evaluations were conducted. The inter-rater reliability was a kappa of 0.47 (95% confidence interval 0.40-0.54). Assessment disagreements were most common during the unstable and deteriorating phases (11.7%). There were no statistically significant differences in the matches or mismatches in the assessment of the adequacy of the phases (P = 0.338).</p><p><strong>Conclusion: </strong>The Japanese version of the palliative care phase was well-adapted for use in clinical palliative care. However, the concepts underlying these phases are not clearly distinguishable. In the future, we need to further educate healthcare providers and accumulate experience through on-the-job training to improve the quality of care through palliative care outcome measurements and benchmarking during the palliative care phase.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"913-919"},"PeriodicalIF":2.2,"publicationDate":"2025-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144012777","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":"A randomized, placebo-controlled phase III trial of an autologous, formalin-fixed tumor vaccine for newly diagnosed glioblastoma: trial protocol.","authors":"Yoshihiro Muragaki, Eiichi Ishikawa, Manabu Tamura, Takakazu Kawamata, Masahiko Gosho, Koichi Hashimoto, Takashi Komori, Hideaki Yokoo, Masao Matsutani, Katsuya Maebayashi, Toshihide Tanaka, Shigeru Yamaguchi, Masayuki Kanamori, Tetsuya Yamamoto, Mitsuto Hanihara, Yoshiki Arakawa, Takashi Sasayama, Tatsuya Abe, Hideo Nakamura, Akitake Mukasa, Takeo Uzuka, Kosuke Nakajo, Tadao Ohno","doi":"10.1093/jjco/hyaf078","DOIUrl":"10.1093/jjco/hyaf078","url":null,"abstract":"<p><p>This multi-institutional, double-blind, randomized, placebo-controlled phase III trial was designed to evaluate the efficacy and safety of Cellm-001, an autologous formalin-fixed brain tumor immunostimulant, for newly diagnosed glioblastoma with gross total resection to prolong overall survival (OS) and prevent recurrence after surgery. One hundred twelve patients are to be randomized 1:1 to either Cellm-001 with standard chemoradiotherapy (CRT) or saline solution with standard CRT. Randomization is based on the following stratified randomization criteria: age, Karnofsky Performance Status, and the presence or absence of photodynamic therapy (PDT). The primary endpoint is OS and secondary outcomes are progression-free survival (PFS), OS and PFS with and without radiographically residual lesions as subgroups, OS and PFS with and without PDT, p53-negative OS and PFS, high Cluster of Differentiation-8 score OS and PFS, OS associated with death in primary disease, and 24-month OS and PFS rates. All institutions received ethical committee approval and patient enrollment began in 2021.</p><p><strong>Importance of the study: </strong>Given the growing interest in immunotherapy (IMT), we developed an autologous formalin-fixed tumor vaccine (AFTV) manufactured from the patient's own glioblastoma multiforme (GBM) tissue in paraffin-embedded blocks made from the resected tumor and a double-blind, randomized phase IIB trial of AFTV with temozolomide in newly diagnosed GBM was conducted. The 3-year progression-free survival (PFS) rate for patients with gross total resection (GTR) on imaging tended toward improvement: 81% in the AFTV group versus 46% in the placebo group (P = .067). Based on these IIB results, the feasibility of conducting a phase III trial was confirmed for IIB-eligible patients with total resection. We here plan to conduct the world's first double-blind, randomized, placebo-controlled phase III trial using Cellm-001 to demonstrate autologous tumor immunostimulant efficacy. This IMT, in combination with sub-analyses (GTR, P53 status, CD8 score, and other factors) to be validated, is expected to be a breakthrough in effective standards of care for the treatment of GBM.</p><p><strong>Trial registration: </strong>Registry number: jRCT2031200153; Date of Registration: 20 /October, /2020; Date of First Patient Enrollment: 14 /January/, 2021.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"975-981"},"PeriodicalIF":2.2,"publicationDate":"2025-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078174","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}