{"title":"Evaluating the impact of atezolizumab on febrile neutropenia occurrence in patients with NSCLC undergoing chemotherapy in Japan: a real-world post-marketing database study.","authors":"Sayuri Nakane, Akinori Yuri, Yuki Miyano, Kana Yamada, Erika Nakatsuji, Nobuki Takei, Yasuhiro Igarashi, Ryousuke Harada","doi":"10.1007/s10147-024-02669-y","DOIUrl":"10.1007/s10147-024-02669-y","url":null,"abstract":"<p><strong>Background: </strong>Febrile neutropenia (FN) is a recognised adverse event associated with chemotherapy. This study investigates the impact of atezolizumab, an immune checkpoint inhibitor, on the incidence of FN in patients with non-small cell lung cancer receiving concurrent chemotherapy in Japan.</p><p><strong>Methods: </strong>This post-marketing database study was conducted using data from patients with non-small cell lung cancer provided by Medical Data Vision Co., Ltd. covering April 2008 to present. The primary outcome measured was FN incidence, and its causal association with atezolizumab use was examined by comparing the atezolizumab plus bevacizumab plus carboplatin plus paclitaxel [ABCP])-containing regimen to the BCP control group. The data period was from 1 September, 2015, to 31 December, 2021, including approval date of this drug, 21 December, 2018.</p><p><strong>Results: </strong>The database identified 301 subjects for the ABCP regimen (exposure) group, 44 for the BCP regimen (cohort design control) group during the same period, and 207 for BCP regimen (historical cohort design control) group before the approval of atezolizumab. For historical cohort design, the incidence and adjusted incidence ratios of febrile neutropenia in the exposure group to the control group were 6.13 (95% CI 2.78-13.49) and 8.19 (95% CI 3.79-25.33), respectively. Sensitivity analysis showed FN occurred in 17% (52/301) of the exposure group, 4.5% (2/44) of the cohort design control group, and 3% (7/207) of the historical cohort design control group.</p><p><strong>Conclusions: </strong>The incidence of FN was higher in the exposure group. Considering the study results, special caution is needed for FN occurrence in patients receiving atezolizumab.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"298-308"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11785710/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827789","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}
Jin Li, Junli Xue, Tianshu Liu, Yi Feng, Nong Xu, Jianjin Huang, Yongmei Yin, Jun Zhang, Haibo Mou, Jiangzhong Shentu, Hanying Bao, Zusheng Xu, Zuhong Xu
{"title":"Phase Ib study of the oral PI3Kδ inhibitor linperlisib in patients with advanced solid tumors.","authors":"Jin Li, Junli Xue, Tianshu Liu, Yi Feng, Nong Xu, Jianjin Huang, Yongmei Yin, Jun Zhang, Haibo Mou, Jiangzhong Shentu, Hanying Bao, Zusheng Xu, Zuhong Xu","doi":"10.1007/s10147-024-02657-2","DOIUrl":"10.1007/s10147-024-02657-2","url":null,"abstract":"<p><strong>Background: </strong>Patients with advanced solid tumors have a suboptimal prognosis. This study investigated the safety and feasibility of linperlisib, a selective phosphatidylinositol 3-kinase delta isoform (PI3Kδ) inhibitor, for treating patients with advanced solid tumors.</p><p><strong>Methods: </strong>In this phase Ib, single-arm, open-label, multi-center clinical trial, patients with histologically confirmed advanced solid tumors from eight centers in China were enrolled to receive oral linperlisib (80 mg/day). The primary endpoint was safety.</p><p><strong>Results: </strong>Between August 2019 and June 2022, 94 patients were enrolled in the trial and received the study treatment. The most common (≥ 20%) treatment emergent adverse events (TEAEs) of all grades irrespective of causality were increased aspartate aminotransferase (AST) (26.6%), proteinuria (26.6%), decreased appetite (25.5%), increased alanine aminotransferase (ALT) (22.3%), weight loss (21.3%), and anemia (21.3%). The most common grade ≥ 3 TEAEs were diarrhea (4.3%), increased AST (3.2%), increased ALT (3.2%), neutropenia (3.2%), anemia (3.2%), increased blood alkaline phosphatase (3.2%). The objective response rate (ORR) was 1.1% (95% confidence interval [CI] 0.0-5.8), and the disease control rate (DCR) was 37.2% (95% CI 27.5-47.8). As of the data cutoff, the median follow-up time was 4.2 months (95% CI 2.8-6.9). The median progression-free survival (PFS) was 1.85 months (95% CI 1.79-1.88). The median overall survival (OS) was not reached.</p><p><strong>Conclusion: </strong>Linperlisib showed an acceptable safety profile and preliminary clinical benefit in patients with a range of advanced solid tumors. Further studies of linperlisib safety and efficacy are warranted.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"241-251"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11785675/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142619625","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}
{"title":"The clinical significance of signal regulatory protein alpha expression in the immune environment of gastric cancer.","authors":"Yasushi Tanaka, Qingjiang Hu, Tetsuro Kawazoe, Hirotada Tajiri, Ryota Nakanishi, Yoko Zaitsu, Yuichiro Nakashima, Mitsuhiko Ota, Eiji Oki, Yoshinao Oda, Tomoharu Yoshizumi","doi":"10.1007/s10147-024-02666-1","DOIUrl":"10.1007/s10147-024-02666-1","url":null,"abstract":"<p><strong>Background: </strong>Signal regulatory protein alpha (SIRPα) inhibits phagocytosis by macrophages by interacting with CD47. Despite its known role in various cancers, the clinical significance of SIRPα in gastric cancer (GC) remains unclear. This study aimed to elucidate the clinical implications of SIRPα in GC, exploring its relevance to immunotherapy efficacy and the tumor microenvironment.</p><p><strong>Methods: </strong>Two cohorts were studied: a gastrectomy cohort (137 patients) and an immune checkpoint inhibitor (ICI)-treated cohort (19 patients with unresectable advanced GC who received nivolumab). Immunohistochemistry was used to assess SIRPα, CD80, CD163, CD8, and PD-L1 expressions. Kaplan-Meier curves and Cox models were used to analyze the clinical outcomes. In vitro experiments used peripheral blood mononuclear cells and THP-1 macrophage cell lines to examine SIRPα responses to interferon-γ (IFN-γ).</p><p><strong>Results: </strong>In the gastrectomy cohort, high SIRPα expression correlated with advanced tumor invasion, distant metastasis, and poor recurrence-free and overall survival. SIRPα expression was also significantly associated with macrophage and CD8 + T cells infiltration and PD-L1 expression. In the ICI-treated cohort, high SIRPα expression was associated with better overall survival after nivolumab induced. Moreover, in vitro IFN-γ stimulation upregulated SIRPα expression on monocytes in peripheral blood mononuclear cells and THP-1 cells, suggesting high SIRPα expression may reflect an active immune microenvironment.</p><p><strong>Conclusion: </strong>SIRPα expression is not only a poor prognostic factor for GC, possibly through inhibition of the CD47-SIRP⍺ pathway, but may also be involved in the efficacy of ICI therapy in GC.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"330-339"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142716172","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}
Ami Jo, Tadahiro Shoji, Haruka Otsuka, Marina Abe, Shunsuke Tatsuki, Yohei Chiba, Sho Sato, Eriko Takatori, Yoshitaka Kaido, Takayuki Nagasawa, Masahiro Kagabu, Tsukasa Baba
{"title":"Treatment strategies for advanced and recurrent endometrial cancer using immune checkpoint inhibitors.","authors":"Ami Jo, Tadahiro Shoji, Haruka Otsuka, Marina Abe, Shunsuke Tatsuki, Yohei Chiba, Sho Sato, Eriko Takatori, Yoshitaka Kaido, Takayuki Nagasawa, Masahiro Kagabu, Tsukasa Baba","doi":"10.1007/s10147-024-02689-8","DOIUrl":"10.1007/s10147-024-02689-8","url":null,"abstract":"<p><p>Doxorubicin + cisplatin and paclitaxel + carboplatin are standard chemotherapy regimens for endometrial cancer. The development of PD-1 and PDL-1 antibody drugs has led to the use of these agents for endometrial cancer in other countries. The KEYNOTE-775 trial for advanced or recurrent endometrial cancer demonstrated the benefits of pembrolizumab and lenvatinib combination therapy, and the results of this trial led to the approval of its coverage for recurrent cancer by the Japanese health insurance system. Currently, treatment with immune checkpoint inhibitors is transitioning from second-line to first-line therapy. In a global randomized phase III study, the drugs dostarlimab, durvalumab, and atezolizumab, which are not yet approved in Japan, showed better results in the study arms than in the control arm. Additionally, biomarkers have been developed for endometrial cancer, enabling gynecologists to pursue treatment options based on the biomarkers detected for better treatment outcomes. In this article, we review the clinical trials of immune checkpoint inhibitors for advanced or recurrent endometrial cancer.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"229-240"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142983397","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}
Jinsong Zhou, Shuang Liu, Juwei Zhang, Qiaoyan Zeng, Zheng Lin, Rong Fu, Yulan Lin, Zhijian Hu
{"title":"Discovery and validation of Hsa-microRNA-3665 promoter methylation as a potential biomarker for the prognosis of esophageal squaous cell carcinoma.","authors":"Jinsong Zhou, Shuang Liu, Juwei Zhang, Qiaoyan Zeng, Zheng Lin, Rong Fu, Yulan Lin, Zhijian Hu","doi":"10.1007/s10147-024-02656-3","DOIUrl":"10.1007/s10147-024-02656-3","url":null,"abstract":"<p><strong>Background: </strong>Methylation of microRNA (miRNA) promoters associated with diseases is a common epigenetic mechanism in the development of various human cancers. However, its relationship with prognosis in esophageal squamous cell carcinoma (ESCC) remains unclear. This study aims to explore the association between the methylation level of has-miR-3665 promoter and prognosis in ESCC.</p><p><strong>Methods: </strong>Human miRNA data were downloaded from miRbase, and we identified CpG islands of these human miRNAs by genomics browser analysis. MiRNA methylation levels were detected by methylation-specific high-resolution melting. Gene ontology (GO), and Kyoto Encyclopedia of Genes and Genomes (KEGG) analyses were used to explore the molecular mechanism of hsa-miR-3665. Cox regression analysis was used to investigate prognostic factors. The overall survival rate was predicted by a nomogram.</p><p><strong>Results: </strong>We found that 88 human miRNAs had promoter methylatio, of which 15 miRNAs were found to be epigenetically regulated in ESCC cells compared with their normal counterparts, including hsa-miR-3665. Meanwhile, hsa-miR-3665 expression was significantly lower in ESCC tumour tissue than in adjacent tissue (P = 0.03). GO and KEGG analyses demonstrated that the target genes are involved in protein transport, transcription regulator activity, MAPK and RAS signaling pathway. High hsa-miR-3665 promoter methylation levels were associated with a poor prognosis (HR = 3.89, 95% CI 1.11 ~ 13.55). Moreover, a nomogram incorporating the hsa-miR-3665 methylation level and clinical factors presented a good performance for predicting survival in the training and validation tests, with C-indices of 0.748 and 0.751, respectively.</p><p><strong>Conclusions: </strong>High hsa-miR-3665 promoter methylation levels may be a potential biomarker for the progression of ESCC.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"309-319"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11785691/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142768683","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}
{"title":"Efficacy and safety of mosunetuzumab monotherapy for Japanese patients with relapsed/refractory follicular lymphoma: FLMOON-1.","authors":"Hideki Goto, Takahiro Kumode, Yuko Mishima, Keisuke Kataoka, Yoshiaki Ogawa, Nobuhiro Kanemura, Kazuyuki Shimada, Toshiki Uchida, Yukano Kuroe, Atsuko Kawasaki, Jotaro Sato, Takanori Teshima","doi":"10.1007/s10147-024-02662-5","DOIUrl":"10.1007/s10147-024-02662-5","url":null,"abstract":"<p><strong>Background: </strong>In a global phase I/II study (GO29781; NCT02500407), single-agent mosunetuzumab had a manageable safety profile and induced durable complete responses in patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma, including in patients with R/R follicular lymphoma (FL). In this analysis, the efficacy and safety of mosunetuzumab monotherapy were evaluated in an expansion cohort, FLMOON-1, in Japanese patients with R/R FL who had received ≥ 2 prior lines of therapy in a phase I study (JO40295, jRCT2080223801).</p><p><strong>Methods: </strong>Mosunetuzumab was administered intravenously at the recommended phase II dose (with cycle 1 step-up dosing) for eight cycles or up to 17 cycles, or until disease progression or unacceptable toxicity. The pre-specified primary endpoint was Independent Review Facility (IRF)-assessed complete response rate (CRR; as best overall response). Secondary objectives included investigator (INV)-assessed CRR, INV- and IRF-assessed objective response rate (ORR), and safety.</p><p><strong>Results: </strong>At the data cutoff (October 13, 2023), 19 patients (median age 72 years) were evaluated. The IRF-assessed CRR and ORR were 68.4% and 78.9%, respectively; the INV-assessed CRR and ORR were 63.2% and 84.2%, respectively. Grade 3-4 adverse events (AEs) were observed in 89.5% of patients, with a low incidence of AEs leading to mosunetuzumab discontinuation (10.5%) and one fatal AE unrelated to mosunetuzumab. Cytokine release syndrome occurred in 47.4% of patients and were mostly Grade 1 in severity.</p><p><strong>Conclusion: </strong>These findings indicate mosunetuzumab has a consistent efficacy and manageable safety profile in Japanese patients with R/R FL compared with previously reported data from the global phase I/II study.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"389-396"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11785659/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142800515","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}
{"title":"The efficacy and safety of lenvatinib plus pembrolizumab in vulnerable patients with metastatic or recurrent endometrial cancer: a single institution experience.","authors":"Mayu Yunokawa, Akiko Abe, Xiaofei Wang, Yusuke Toyohara, Ryo Nimura, Takayuki Komoto, Satoki Misaka, Teruyuki Yoshimitsu, Ai Ikki, Mayumi Kamata, Shogo Nishino, Motoko Kanno, Atsushi Fusegi, Sachiho Netsu, Yoichi Aoki, Makiko Omi, Terumi Tanigawa, Sanshiro Okamoto, Hidetaka Nomura, Hiroyuki Kanao","doi":"10.1007/s10147-024-02667-0","DOIUrl":"10.1007/s10147-024-02667-0","url":null,"abstract":"<p><strong>Background: </strong>Effective management with second-line therapy with the lenvatinib + pembrolizumab regimen for patients with advanced endometrial cancer is necessary.</p><p><strong>Methods: </strong>This retrospective study enrolled patients with endometrial cancer treated with the lenvatinib + pembrolizumab regimen. We evaluated progression-free survival (PFS), overall survival (OS), safety for patients non-eligible for the KEYNOTE775 trial, aged ≥65 years, or with ECOG performance status 1-2.</p><p><strong>Results: </strong>Forty-five patients were analyzed: 21 (47%) were aged ˃ 65 years, 16 (36%) had performance status 1-2, and 15 (33%) were non-eligible for KEYNOTE775 trial participation. Overall, the median PFS was 8.5 months (95% confidence interval [CI] 4.6-12.4), and the median OS was 15.6 months (95% CI 9.4-NA). Median PFS was significantly shorter in patients not eligible for KEYNOTE775 participation and with performance status 1-2. The median OS was significantly shorter in patients with performance status 1-2. Grade ˃3 adverse events (AEs) occurred in 78% of patients who received the lenvatinib + pembrolizumab regimen. AEs resulted in lenvatinib dose reductions in 35 patients (78%) and lenvatinib and pembrolizumab discontinuation in 3 (7%) and 5 (11%), respectively. The median time to the first lenvatinib dose reduction was 1.5 (0.92-2.3) months in all patients and was significantly shorter in patients aged >65 years.</p><p><strong>Conclusions: </strong>The current regimen has favorable efficacy and manageable safety with appropriate dose reduction of lenvatinib in the real world. However, the efficacy may be inferior in patients with performance status 1 or 2, heavily treated patients, and those with organ dysfunction. The current treatment status should reflect real-world data relative to the medical environment and management.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"371-379"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142785641","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}
{"title":"Comprehensive epidemiology of melanoma at all sites: insights from Japan's National Cancer Registry, 2016-2017.","authors":"Dai Ogata, Kenjiro Namikawa, Eiji Nakano, Maiko Fujimori, Yosuke Uchitomi, Takahiro Higashi, Tomoyuki Satake, Chigusa Morizane, Naoya Yamazaki, Akira Kawai","doi":"10.1007/s10147-024-02675-0","DOIUrl":"10.1007/s10147-024-02675-0","url":null,"abstract":"<p><strong>Background: </strong>Melanoma is a highly malignant cancer responsible for 55 000 deaths worldwide annually. Despite its severity, its epidemiology in Japan remains understudied owing to its rarity among Asians. This study aimed to determine the incidence of melanoma in Japan using data from the National Cancer Registry.</p><p><strong>Methods: </strong>We analyzed data from patients diagnosed with melanoma in 2016 and 2017, classifying cases according to subtype using the World Health Organization (WHO) and other tumor classifications. Tumor incidence was calculated as the number of new cases divided by the corresponding population per year.</p><p><strong>Results: </strong>A total of 6176 patients were included in the study. The subtypes were distributed as follows: cutaneous (76.2%), mucosal (19.6%), uveal (2.7%), and neural organ/unknown primary melanoma (1.3%). The overall age-adjusted incidence of melanoma was 2.57 per 100 000 persons in the Japanese and 1.15 per 100 000 persons in the WHO population models.</p><p><strong>Conclusions: </strong>This study provided comprehensive epidemiological data on melanoma in Japan using population-based registry data, highlighting the relatively low incidence of melanoma compared with that worldwide and emphasizing the need for further research into its unique epidemiology in Asian populations.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"194-198"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142921696","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}
{"title":"Celebrating 30 years of IJCO: shaping the future of clinical oncology.","authors":"Masaki Mandai","doi":"10.1007/s10147-025-02704-6","DOIUrl":"10.1007/s10147-025-02704-6","url":null,"abstract":"","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"169"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143038363","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}
{"title":"Efficacy and safety of multi-day antiemetic treatment for patients undergoing multi-day chemotherapy: a systematic review of Clinical Practice Guidelines for Antiemesis 2023 from Japan Society of Clinical Oncology.","authors":"Kazuhisa Nakashima, Saki Harashima, Rena Kaneko, Ryuhei Tanaka, Masakazu Abe, Makoto Wada, Keiko Iino, Tatsuo Akechi, Hirotoshi Iihara, Chiyo K Imamura, Ayako Okuyama, Keiko Ozawa, Yong-Il Kim, Eriko Satomi, Masayuki Takeda, Takako Eguchi Nakajima, Naoki Nakamura, Junichi Nishimura, Mayumi Noda, Kazumi Hayashi, Takahiro Higashi, Narikazu Boku, Koji Matsumoto, Yoko Matsumoto, Kenji Okita, Nobuyuki Yamamoto, Kenjiro Aogi, Hidenori Sasaki","doi":"10.1007/s10147-024-02652-7","DOIUrl":"10.1007/s10147-024-02652-7","url":null,"abstract":"<p><strong>Background: </strong>A standardized multi-day antiemetic regimen for multi-day chemotherapy remains elusive. This systematic review evaluated the efficacy and safety of multi-day antiemetic regimens in patients undergoing multi-day intravenous chemotherapy.</p><p><strong>Methods: </strong>We conducted a comprehensive search of PubMed, Cochrane Library, and Ichushi-Web databases for relevant studies published from January 1990 to December 2020. We included studies comparing multi-day and single-day antiemetic regimens for preventing chemotherapy-induced nausea and vomiting.</p><p><strong>Results: </strong>No studies directly comparing multi-day versus single-day antiemetic regimens were found. Despite expanding control group criteria beyond \"single-day antiemetic therapy\" limited high-quality studies and variations in cancer types, chemotherapy regimens, and antiemetic treatments precluded meta-analysis. Among the included studies, some randomized controlled trials (RCTs) focused on complete response and vomiting rates. Two studies comparing two- and three-drug combinations reported higher complete response and no-vomiting rates with the three-drug regimen. Limited RCTs explored \"nausea control\" and \"cost,\" and assessing \"adverse events\" proved challenging due to inconsistent reporting.</p><p><strong>Conclusion: </strong>The research on multi-day antiemetic therapy is limited, necessitating further investigation. Nonetheless, our findings suggest that three-drug combination therapy, including aprepitant, may offer superior antiemetic efficacy compared to two-drug regimens. Multi-day antiemetic therapy is strongly recommended during multi-day intravenous administration of cytotoxic anticancer drugs.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"17-26"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142619618","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}