Japanese journal of clinical oncology最新文献

{"title":"Efficacy and safety of immunotherapy plus chemotherapy in elderly patients with advanced gastric cancer: a retrospective study.","authors":"Naoya Ishibashi, Takeshi Kawakami, Kunihiro Fushiki, Kotoe Oshima, Satoshi Hamauchi, Takahiro Tsushima, Tomoya Yokota, Yusuke Onozawa, Hirofumi Yasui, Kentaro Yamazaki","doi":"10.1093/jjco/hyag176","DOIUrl":"https://doi.org/10.1093/jjco/hyag176","url":null,"abstract":"<p><strong>Background: </strong>This study investigated the efficacy and safety of immunotherapy plus chemotherapy in elderly patients with human epidermal growth factor receptor 2 (HER2)-negative advanced gastric cancer (AGC).</p><p><strong>Methods: </strong>This single-center retrospective study included patients with HER2-negative AGC who received nivolumab or pembrolizumab plus chemotherapy between November 2021 and October 2025. Patients were classified as non-elderly (<75 years) or elderly (≥75 years). Endpoints included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and safety.</p><p><strong>Results: </strong>A total of 164 patients were selected (117 non-elderly, 47 elderly). The median PFS was 6.4 and 7.4 months (Hazard Ratio (HR) 0.79; 95% confidence interval (CI), 0.52-1.19), and median OS was 14.8 and 15.9 months (HR 0.89; 95% CI 0.57-1.38). Initial dose reduction was significantly more frequent in elderly patients (35.9% vs. 83.0%, P < .001). Any grade AEs occurred in 97.4% and 97.9%, grade 3-4 AEs in 51.3% and 40.4%. Any grade immune-related adverse events (irAEs) in 31.6% and 27.7%, and grade 3-4 irAEs in 6.8% and 6.4% in non-elderly and elderly patients, respectively. Treatment discontinuation due to AEs was observed more frequent in the elderly group (3.4% vs. 17.0%). Fewer elderly patients received subsequent therapy (72.6% vs. 48.5%, P = .01).</p><p><strong>Conclusions: </strong>No clear age-related differences in survival outcomes or safety were observed with first-line immunotherapy plus chemotherapy in this study. However, elderly patients had higher treatment discontinuation and lower subsequent therapy rates, highlighting the importance of individualized dose adjustment and timely disease assessment and close monitoring.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149215689","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":"Integrated host vulnerability assessment using prognostic nutritional index and psoas muscle index for predicting chemotherapy-related toxicity in ovarian cancer: a multicenter JGOG9005S cohort analysis.","authors":"Daisuke Inoue, Makoto Yamamoto, Kazuto Tasaki, Hitomi Sakai, Mikiko Asai-Sato, Tomohiko Tsuruta, Shiho Kuji, Shoji Nagao, Yoichi Kobayashi, Sari Nakao, Atsuko Kawamura, Haruka Imai, Kiyoshi Hasegawa, Natsuko Kamiya, Tomoka Usami, Nao Suzuki, Makoto Orisaka, Ken Yamaguchi, Yoshio Yoshida","doi":"10.1093/jjco/hyag175","DOIUrl":"https://doi.org/10.1093/jjco/hyag175","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate associations of prechemotherapy prognostic nutritional index (PNI) and computed tomography (CT)-derived muscle measures with severe chemotherapy-related toxicity in ovarian cancer and explore their combined assessment.</p><p><strong>Methods: </strong>This multicenter retrospective cohort included 109 patients treated with platinum-taxane chemotherapy. PNI was calculated from laboratory values obtained immediately before the first chemotherapy cycle, irrespective of treatment sequence. Psoas muscle index (PMI) was measured centrally on baseline CT images. Associations with grade ≥ 3 chemotherapy-related adverse events were estimated using separate age- and stage-adjusted logistic models. Discrimination was compared among nested models in the same complete-case cohort. Cutoff-based and treatment-sequence analyses were exploratory.</p><p><strong>Results: </strong>Grade ≥ 3 toxicity occurred in 63 patients (57.8%). Higher PNI and PMI were associated with lower odds of severe toxicity (adjusted odds ratios, 0.966 per PNI unit; 95% CI, 0.935-0.994; P = 0.024; and 0.598 per cm2/m2; 0.379-0.899; P = 0.018, respectively). The combined PNI-PMI model showed numerically improved discrimination compared with individual parameters (area under the curve, 0.694). In exploratory cohort-defined groups, toxicity occurred in 36.4%, 58.3%, and 75.7% of patients with zero, one, and two vulnerability domains, respectively; the adjusted odds ratio was 2.38 per domain (95% CI, 1.41-4.20, P = 0.0018).</p><p><strong>Conclusions: </strong>Lower prechemotherapy PNI and lower baseline PMI were associated with severe chemotherapy-related toxicity. The combined model showed modest discrimination, and cohort-derived classifications require prospective external validation before clinical implementation.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149165543","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":"Primary feasibility analysis of neoadjuvant chemotherapy with bevacizumab for resectable stage II/IIIA non-squamous non-small cell lung cancer: the NAVAL phase II study.","authors":"Norifumi Tsubokawa, Yasuhiro Tsutani, Yoshihiro Miyata, Kenji Suzuki, Kazuya Takamochi, Fumihiro Tanaka, Hiroyuki Ito, Yoshinori Yamashita, Makoto Oda, Takahiro Mimae, Morihito Okada","doi":"10.1093/jjco/hyag174","DOIUrl":"https://doi.org/10.1093/jjco/hyag174","url":null,"abstract":"<p><strong>Objectives: </strong>Bevacizumab (Bev) improves the response and survival rates in patients with advanced non-small cell lung cancer (NSCLC). This phase II trial aimed to assess the feasibility of adding Bev to preoperative chemotherapy in resectable non-squamous NSCLC.</p><p><strong>Methods: </strong>Patients with clinical stage II/IIIA non-squamous NSCLC (n = 30) received three cycles of cisplatin (Cis), pemetrexed (Pem), and Bev, followed by surgical resection. The primary endpoint was the complete resection rate (CRR), defined as the proportion of all eligible enrolled patients who ultimately underwent complete (R0) resection. The sample size was set at 30 patients. Treatment was considered feasible if the CRR exceeded the predefined acceptable threshold of 65%.</p><p><strong>Results: </strong>Radiological tumour reduction was observed in 29 of 30 patients (97%). Twenty-eight patients (93%) completed all three cycles of chemotherapy, and 25 patients (83%) underwent surgery. Five patients discontinued treatment due to adverse events (n = 3), disease progression (n = 1), or patient refusal (n = 1). Complete resection was achieved in all resected patients, yielding an 83% CRR (two-sided 80% confidence interval, 71.3%-91.7%). The objective response rate was 37%, and pathological complete response of the primary tumour was achieved in 3 patients (12%). Grade 3 toxicities included neutropenia (7%), nausea (7%), hypertension (23%), and pulmonary embolism (3%). No grade 4/5 adverse events occurred within 28 days, and no treatment-related deaths occurred within 84 days.</p><p><strong>Conclusions: </strong>Preoperative Cis, Pem, and Bev for clinical stage II/IIIA non-squamous NSCLC met the predefined feasibility criterion, with acceptable safety in this selected population. These findings provide historical insights supporting perioperative anti-vascular endothelial growth factor-based systemic intensification.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149167647","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":"Real-world trends in anti-androgen prescribing and associated costs for prostate cancer in Japan: a nationwide analysis.","authors":"Sosuke Omizo, Takuma Narita, Tomoko Hamaya, Kyo Togashi, Izuki Ogawa, Shunsuke Tazawa, Keita Ishimoto, Miki Sakao, Jotaro Mikami, Naoki Fujita, Teppei Okamoto, Atsushi Imai, Hayato Yamamoto, Chikara Ohyama, Shingo Hatakeyama","doi":"10.1093/jjco/hyag105","DOIUrl":"10.1093/jjco/hyag105","url":null,"abstract":"<p><strong>Objective: </strong>Anti-androgen therapy is central to prostate cancer management, but nationwide real-world trends in prescribing and costs remain insufficiently characterized in aging societies. We evaluated temporal trends in anti-androgen prescriptions and associated medical costs for prostate cancer in Japan using the National Database (NDB) Open Data.</p><p><strong>Methods: </strong>This retrospective study analysed outpatient prescription data from the NDB Open Data from 2016 to 2023. Prescription trends were assessed for bicalutamide (BIC), estramustine phosphate (EMP), flutamide (FLU), enzalutamide (ENZ), abiraterone, apalutamide, and darolutamide. Costs were estimated using an exchange rate of 150 JPY per USD. Trends were further stratified by age group and region.</p><p><strong>Results: </strong>Among 653.42 billion oral doses recorded during the study period, dose-adjusted prescriptions included 374.6 million for BIC, 25.2 million for EMP/FLU, and 57.6 million for androgen receptor signaling inhibitors (ARSIs). The share of ARSI prescriptions increased from 6.1% in 2016 to 19.4% in 2023, with ENZ being the most prescribed ARSI (9.5%). Although overall anti-androgen use increased among men aged ≥80 years, ARSI use in this group remained relatively stable at 12%-18%. Total anti-androgen-related medical costs increased 2.12-fold, and ARSIs accounted for 94.5% of these costs in 2023. Limitations include the lack of clinical details and the inability to distinguish disease states.</p><p><strong>Conclusions: </strong>In Japan, ARSI use and related expenditures increased substantially between 2016 and 2023. Despite modest prescription volumes, ARSIs accounted for most anti-androgen-related costs.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"1240-1247"},"PeriodicalIF":2.5,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148382066","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":"Crude incidence rates of Tier 2 rare cancers within the RARECAREnet HEAD and NECK Family in Japan and the United States (2016-2020).","authors":"Kumiko Saika, Tomohiro Matsuda","doi":"10.1093/jjco/hyag156","DOIUrl":"https://doi.org/10.1093/jjco/hyag156","url":null,"abstract":"","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":"56 10","pages":"1288-1289"},"PeriodicalIF":2.5,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149136720","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":"Characterization of distant metastases in salivary gland cancer patients undergoing upfront surgery followed by postoperative radiation therapy: a multicenter analysis.","authors":"Dong Soo Lee, Min Kyu Kang, Chang Geol Lee, Ki Chang Keum, Seung Yeun Chung, Tae Hyung Kim, Hong-Gyun Wu, Jin Ho Kim, Sung Ho Moon, Ki Mun Kang, Young-Taek Oh, Jin Hee Kim","doi":"10.1093/jjco/hyag106","DOIUrl":"10.1093/jjco/hyag106","url":null,"abstract":"<p><strong>Background: </strong>This study aimed to clarify the incidence and outcomes of distant metastasis (DM) in patients with major salivary gland cancer who received upfront surgery followed by adjuvant postoperative radiation therapy (PORT).</p><p><strong>Methods: </strong>We analyzed 214 patients from a multicenter study. The importance of histologic subtypes on distant metastasis-free survival (DMFS) was analyzed, along with other clinicopathologic prognostic factors. Median total doses and fractional doses were 61 (range, 26-70) Gy and 1.8 (range, 1.8-2.5) Gy, respectively.</p><p><strong>Results: </strong>With a median follow-up of 74 (range, 4-174) months, DM developed as a first (n = 44) or second relapse event (n = 4) in a total of 48 (22.4%) patients. In univariate analysis, histologic subtype (P < .001), salivary gland subsite (P = .002), pT stage (P = .001), pN stage (P < .001), perineural invasion (P = .001), extracapsular extension (P = .001), lymphovascular invasion (P = .001), resection margin status (P = .009), and tumor grade (P = .005) significantly affected DMFS. The 5-year DMFS rates were as follows: 100% (acinic cell carcinoma), 100% (basal cell carcinoma), 100% (epithelial myoepithelial carcinoma), and 96.6% (mucoepidermoid carcinoma) in the low-risk group and 62.5% (adenoid cystic carcinoma), 62.5% (adenocarcinoma), 72.6% (carcinoma-ex-pleomorphic adenoma), 68% (salivary duct carcinoma), and 54.5% (squamous cell carcinoma) in the high-risk group.</p><p><strong>Conclusion: </strong>DM risk after PORT varies substantially by histologic subtype in salivary gland cancer patients. High-risk subtypes demonstrate inferior DMFS, indicating a potential need for improved systemic treatment strategies.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"1207-1214"},"PeriodicalIF":2.5,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148396787","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":"Screening for prognostic indicators in patients with metastatic castration-resistant prostate cancer after androgen receptor signaling inhibitor treatment for metastatic castration-sensitive prostate cancer.","authors":"Keita Hayakawa, Takashi Ueda, Yusuke Gabata, Junki Murashita, Hikaru Takahashi, Yumiko Saito, Masatsugu Miyashita, Takumi Shiraishi, Atsuko Fujihara, Masayoshi Okumi, Fumiya Hongo, Osamu Ukimura","doi":"10.1093/jjco/hyag107","DOIUrl":"10.1093/jjco/hyag107","url":null,"abstract":"<p><strong>Background: </strong>Androgen receptor signaling inhibitors (ARSI) and docetaxel (DTX) are standard treatments for metastatic castration-resistant prostate cancer (mCRPC). However, the differences in therapeutic efficacy between these treatments for mCRPC after upfront ARSI for metastatic castration-sensitive prostate cancer (mCSPC) remain unclear. In this study, we used real-world data to compare treatment efficacy and to identify prognostic indicators.</p><p><strong>Methods: </strong>We retrospectively analyzed 120 patients who progressed to mCRPC after receiving ARSI as a first-line therapy for mCSPC. Second-line progression-free survival (PFS) and second-line overall survival (OS) were compared between the DTX and non-DTX groups. Cox proportional hazards regression analysis was performed to identify the prognostic indicators of second-line OS in patients with mCRPC. Propensity score matching was used to adjust for differences in baseline clinical characteristics.</p><p><strong>Results: </strong>Among matched patients with mCRPC, no significant differences were observed in second-line PFS or OS between the non-DTX and DTX groups. Univariate and multivariate analyses demonstrated that pretreatment serum lactate dehydrogenase (LDH) levels (<220 vs. ≥220 U/l) and Gleason pattern 5 (GP5) status were significant prognostic indicators for second-line OS in patients with mCRPC.</p><p><strong>Conclusions: </strong>Pretreatment LDH levels and GP5 status may be useful prognostic indicators for patients with mCRPC following upfront ARSI therapy for mCSPC.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"1248-1254"},"PeriodicalIF":2.5,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148381927","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 Lynch syndrome patient with multiple cancers who was found to have a novel pathogenic variant generating aberrant splicing of MLH1.","authors":"Ayumi Abe, Hidetaka Eguchi, Kimio Matsumura, Yudai Fukui, Kosuke Hiramatsu, Takeshi Fujii, Masako Ikemura, Gaku Kuge, Hiroya Kuroyanagi, Yasushi Okazaki, Masami Arai","doi":"10.1093/jjco/hyag101","DOIUrl":"10.1093/jjco/hyag101","url":null,"abstract":"<p><p>Lynch syndrome is an autosomal dominant cancer predisposition syndrome caused by inactivating germline variants in DNA mismatch repair genes. Here, we describe a woman who developed colorectal, gastric, and endometrial cancers and was found to have a rare missense variant, MLH1:c.545G > T/p.Arg182Met. The variant, which was located at the last nucleotide of MLH1exon 6, was initially reported by a clinical testing laboratory as being a variant of uncertain significance. In silico analyses predicted that it would cause splicing aberration, and reverse-transcription polymerase chain reaction analysis of total RNA from the patient's peripheral blood cells identified an aberrant MLH1 transcript that skipped the entire exon 6 and caused generation of a premature stop codon (p.Glu153Phefs*8). In accordance with the American College of Medical Genetics and Genomics/Association for Molecular Pathology guidelines, we reclassified the variant as likely pathogenic. Further additional analysis enabled carrier diagnosis in the patient's relatives. Genetics summary Disorder: Lynch syndrome Ethnicity of the patient: Japanese Gene: MLH1 (19 exons) GenBank accession number: NM_000249.4 Chromosomal assignment: 3p21.3 Type of DNA variant: a germline splice aberration variant Mutation: c.545G > T in exon 6 of MLH1 Methods of mutation detection: PCR-sequencing, RT-PCR.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"1264-1271"},"PeriodicalIF":2.5,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148396807","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":"Progress in siRNA nucleic acid therapeutics and challenges in their application to cancer treatment.","authors":"Kumiko Ui-Tei","doi":"10.1093/jjco/hyag099","DOIUrl":"10.1093/jjco/hyag099","url":null,"abstract":"<p><p>Small interfering RNA (siRNA) therapeutics have emerged as a promising class of nucleic acid-based medicines that selectively suppress the expression of disease-associated genes by targeting messenger RNAs (mRNAs). Unlike conventional small-molecule drugs and antibody therapeutics, which primarily act on proteins, siRNAs function at the mRNA level through the mechanism of RNA interference (RNAi), enabling selective silencing of targets that are difficult to address using traditional therapeutic approaches. Over the past decade, substantial advances in siRNA design, chemical modification, and delivery technologies have markedly improved the stability, efficacy, and safety of siRNA therapeutics. In particular, liver-targeted lipid nanoparticle (LNP) and N-acetylgalactosamine (GalNAc)-based delivery platforms have enabled the successful clinical translation of several siRNA drugs, leading to multiple regulatory approvals for the treatment of metabolic and rare genetic diseases. Despite these achievements, no siRNA-based therapeutic has yet been approved for cancer treatment. Oncology applications face several unique challenges, including efficient and selective delivery to tumor tissues, intratumoral heterogeneity, off-target effects, endosomal escape, and the complex tumor microenvironment. In this review, we summarize recent progress in siRNA therapeutics, with particular emphasis on oncology. We discuss the molecular basis of RNAi, clinical development in cancer, and key barriers limiting broader application. We also highlight emerging strategies, including mutation-specific siRNA approaches, that may enable more precise and personalized cancer therapies. Overcoming these challenges will be critical for expanding the clinical utility of siRNA therapeutics in oncology.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"1189-1198"},"PeriodicalIF":2.5,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148382032","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":"Prognostic impact of lenvatinib dose intensity in previously untreated patients with advanced renal cell carcinoma receiving lenvatinib plus pembrolizumab.","authors":"Koichi Nishimura, Hiroki Ishihara, Katsurayama Nanaka, Takayuki Nakayama, Hironori Fukuda, Kazuhiko Yoshida, Yasunobu Hashimoto, Junpei Iizuka, Tsunenori Kondo, Toshio Takagi","doi":"10.1093/jjco/hyag173","DOIUrl":"https://doi.org/10.1093/jjco/hyag173","url":null,"abstract":"<p><strong>Background: </strong>Lenvatinib plus pembrolizumab is the standard of care as first-line systemic therapy for advanced renal cell carcinoma (RCC). However, the prognostic impact of the relative dose intensity (RDI) of lenvatinib remains unclear.</p><p><strong>Methods: </strong>Clinical data from 54 patients with advanced RCC who received lenvatinib plus pembrolizumab as first-line therapy were retrospectively evaluated. The RDI of lenvatinib within the initial 3 months (3m-RDI) was calculated, and tumor response and survival were compared according to 3m-RDI.</p><p><strong>Result: </strong>The 3m-RDI threshold was set at 70%, which was significantly associated with objective response during treatment. Patients with a high 3m-RDI (≥70%) had a higher objective response rate (ORR) than those with a low 3m-RDI (<70%) (69% vs. 36%, P = .014).Multivariable analysis identified 3m-RDI ≥70% as an independent predictor of higher ORR (odds ratio: 5.25, 95% CI: 1.55-20.36, P = .007). Among patients with synchronous metastasis (n = 24), patients with a high 3m-RDI had higher ORR (62% vs. 18%, P = .028) and longer progression-free survival (median: not reached vs. 4.8 months, P = .035) than those with a low 3m-RDI.</p><p><strong>Conclusions: </strong>Lenvatinib with 3m-RDI ≥70% may be a useful early treatment-related marker associated with clinical outcomes during first-line lenvatinib plus pembrolizumab for advanced RCC.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149136735","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}