International Journal of Clinical Oncology最新文献

{"title":"Conditions for effective use of liposomal irinotecan with fluorouracil and leucovorin in unresectable pancreatic cancer after FOLFIRINOX treatment.","authors":"Yasuyuki Okada, Yasushi Sato, Ryo Shinomiya, Takanori Miyake, Taku Takahashi, Reiko Yokoyama, Yasuhiro Mitsui, Tetsu Tomonari, Koichi Okamoto, Masahiro Sogabe, Hiroshi Miyamoto, Yutaka Kawano, Tetsuji Takayama","doi":"10.1007/s10147-024-02677-y","DOIUrl":"10.1007/s10147-024-02677-y","url":null,"abstract":"<p><strong>Background: </strong>Liposomal irinotecan + fluorouracil/leucovorin (nal-IRI + 5FU/LV) is commonly used as a second- or later-line treatment for pancreatic ductal adenocarcinoma (PDAC) and offers survival benefits. However, its efficacy and safety in patients previously treated with FOLFIRINOX, which includes irinotecan, remain unclear. We evaluated the efficacy and safety of nal-IRI + 5FU/LV in patients with unresectable PDAC who received previous FOLFIRINOX therapy and those who did not.</p><p><strong>Methods: </strong>This retrospective observational study included 42 patients with PDAC who were treated with nal-IRI + 5FU/LV (October 2020-November 2023). Patients were grouped based on prior FOLFIRINOX treatment.</p><p><strong>Results: </strong>The progression-free survival (PFS) in patients who previously received modified FOLFIRINOX (mFFX) therapy was shorter than that in patients who did not (2.5 vs. 3.5 months, P = 0.07). When patients with greater than- and less than the cut-off value of irinotecan-free interval (IFI) were classified into the long and short IFI groups, respectively, PFS was significantly longer in the long-IFI group than that in the short IFI group (4.0 vs. 2.1 months, P = 0.01). Moreover, the C-reactive protein/albumin ratio (CAR) was also a significant predictor of PFS (P = 0.03). Furthermore, both factors were found to be independent factors influencing PFS in the univariate Cox regression analysis (P = 0.02 and P = 0.04).</p><p><strong>Conclusion: </strong>Nal-IRI + 5FU/LV therapy may be a safe and effective option as a second- or later-line treatment, particularly for patients who have not previously received mFFX therapy. For patients who received prior mFFX exposure, a longer IFI and lower CAR may indicate greater potential benefit, thus aiding in more personalized treatment approaches.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"1201-1210"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143999423","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":"Prognostic factors and effect of existing predictive models in oligo-metastatic urothelial carcinoma (YUSHIMA study).","authors":"Kenji Tanabe, Soichiro Yoshida, Tomoki Kimura, Yuya Maezawa, Kensaku Ishihara, Naoki Inoue, Keita Izumi, Motohiro Fujiwara, Masahiro Toide, Takanobu Yamamoto, Sho Uehara, Saori Araki, Masaharu Inoue, Ryoji Takazawa, Noboru Numao, Yukihiro Ohtsuka, Hajime Tanaka, Yasuhisa Fujii","doi":"10.1007/s10147-025-02759-5","DOIUrl":"10.1007/s10147-025-02759-5","url":null,"abstract":"<p><strong>Background: </strong>Oligo-metastatic urothelial carcinoma (OMUC), characterized by a limited number of metastases, demonstrates better survival outcomes compared to poly-metastatic urothelial carcinoma (PMUC), but some patients with OMUC exhibit poor prognosis. However, a comprehensive analysis of prognostic factors in OMUC remains lacking. This study aimed to determine prognostic factors in patients with OMUC from a multicenter dataset and evaluate the effect of existing predictive models.</p><p><strong>Methods: </strong>This retrospective study included 443 patients with metastatic urothelial carcinoma (MUC) from 15 institutions (YUSHIMA study). OMUC involved cases with three or fewer metastases. Clinical data were analyzed for associations with overall survival (OS) utilizing Cox regression models. The effect of existing predictive models (Bajorin, Bellmunt, and Apolo) on OMUC prognosis was evaluated.</p><p><strong>Results: </strong>Patients with OMUC (n = 182) demonstrated better Eastern Cooperative Oncology Group-performance status (ECOG-PS) and lower visceral metastasis frequency compared to PMUC (n = 261). Patients with OMUC exhibited a median OS of 26.1 months vs. 13.7 months for PMUC (p < 0.01). Poor ECOG-PS, liver metastasis, and hypoalbuminemia appeared as independent poor prognostic factors for OS in OMUC. The Bajorin, Bellmunt, and Apolo models significantly correlated with OS in patients with OMUC (p < 0.01, for all).</p><p><strong>Conclusion: </strong>Known prognostic factors for MUC were confirmed as significant prognostic factors for OS in OMUC, and existing prognostic models applied to OMUC. These results are expected to contribute to developing more effective treatment strategies for OMUC.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"1237-1246"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144010642","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":"Serum amylase level as a predictive biomarker for persistent grade 1 chemotherapy-associated oral mucositis: a retrospective cross-sectional study.","authors":"Nursema Ozdemir, Ali Alkan, Ozgur Tanriverdi","doi":"10.1007/s10147-025-02749-7","DOIUrl":"10.1007/s10147-025-02749-7","url":null,"abstract":"<p><strong>Background: </strong>This study aims to determine the relationship between persistent grade 1 chemotherapy-related oral mucositis and serum amylase level.</p><p><strong>Methods: </strong>The study was conducted as a retrospective cross-sectional study. Among the patients diagnosed with cancer whose file information was available, the files of those whose chemotherapy-related oral mucositis status was recorded after the first cycle treatment were examined. Among these patients, those whose serum amylase levels were checked for any reason and those who did not meet the exclusion criteria were included in the study.</p><p><strong>Results: </strong>A total of 376 patients were analyzed. It was observed that grade 1 oral mucositis persisted in 44% of the patients. With the ROC curve, the cut-off value for serum amylase level before the second cycle treatment was determined to be 69.5 U/L (AUC 0.771, 95% CI 0.720-0.821, p = 0.00011). The sensitivity rate of serum amylase levels above this value in predicting chemotherapy-associated oral mucositis was 68.29% and the specificity rate was 100%. In univariate and multivariate logistic (binary) regression analysis, it was concluded that high serum amylase level was an independent factor affecting the presence of oral mucositis (OR 3.37, 95% CI 1.94-9.66; p = 0.00014).</p><p><strong>Conclusion: </strong>It was concluded that serum amylase level may be an independent predictive factor for determining persistent grade 1 chemotherapy-induced oral mucositis. Original.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"1098-1108"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143779869","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Concordance of BRAF V600E mutation between immunohistochemistry and genomic testing for thyroid cancer.","authors":"Ryutaro Onaga, Tomohiro Enokida, Shingo Sakashita, Nobukazu Tanaka, Yuta Hoshi, Takuma Kishida, Ryo Kuboki, Takao Fujisawa, Susumu Okano, Hiroshi Nishino, Makoto Ito, Genichiro Ishii, Shumpei Ishikawa, Makoto Tahara","doi":"10.1007/s10147-025-02760-y","DOIUrl":"10.1007/s10147-025-02760-y","url":null,"abstract":"<p><strong>Background: </strong>BRAF V600E mutation is a significant therapeutic target for thyroid cancer, including anaplastic thyroid cancer (ATC). Although targeted therapy for this mutation requires genomic testing in Japan, turnaround time (TAT) is often unacceptably long, especially for certain conditions, such as ATC, which is one of the most aggressive cancers. Here, we evaluated concordance between immunohistochemistry (IHC) with a relatively short TAT of a few days and genomic testing in thyroid cancer.</p><p><strong>Methods: </strong>Immunohistochemical staining was performed with BRAF (VE1) antibody (Ventana) using the OptiView method on samples already undergoing genomic testing. A pathologist blindly annotated each staining expression with a cut-off of 1% in the cytoplasm. We then calculated the positive percent agreement (PPA), negative percent agreement (NPA), and overall percent agreement (OPA).</p><p><strong>Results: </strong>We identified 62 samples, including 12 of ATC, that underwent genomic testing using different methods: Oncomine Dx Target Test (ODxTT) (n = 32), MEBGEN BRAF 3 Kit (MEBGEN3) (n = 14), FoundationOne CDx (F1CDx) (n = 13), and GenMineTOP (TOP) (n = 1). Annotation results of IHC were positive for 31, negative for 29, and undeterminable for 2 samples due to low tumor content. PPA, NPA, and OPA were 100%, 91.7%, 96.9% for ODxTT; 100%, 100%, 100% for MEBGEN3; 100%, 80.0%, 93.9% for F1CDx; and incalculable, 100%, 100% for TOP, respectively. Discordance was found in the two undeterminable samples only.</p><p><strong>Conclusion: </strong>Concordance between IHC and genomic testing in assessing BRAF V600E was encouragingly high; its reliability and potentially short TAT should benefit patients, especially those with ATC.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"1143-1151"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143995664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Utility of circulating human papillomavirus DNA as a biomarker for detection and prognosis of cervical cancer in Japanese patients.","authors":"Tomoko Taguchi, Minako Yokoyama, Toshitsugu Fujita, Satoka Tanba, Hiroe Oikiri, Yuki Osawa, Yukiko Matsumura, Tatsuhiko Shigeto, Yoshihito Yokoyama, Hodaka Fujii","doi":"10.1007/s10147-025-02762-w","DOIUrl":"10.1007/s10147-025-02762-w","url":null,"abstract":"<p><strong>Background: </strong>Cervical cancer (CC), the fourth most common cancer in women, is caused predominantly by human papillomavirus (HPV). Although measuring serum squamous cell carcinoma antigen (SCC Ag) can be useful for detecting recurrence of SCC, a major type of CC, its prognostic value remains unclear. This study focuses on the utility of circulating cell-free HPV (ccfHPV) DNA in plasma as a biomarker, with particular emphasis on its relevance to high-risk HPV subtypes prevalent in Japan.</p><p><strong>Methods: </strong>A prospective study of 26 CC patients and 23 females diagnosed with pre-cancerous lesions was conducted. Patients were selected carefully to include only those with single high-risk HPV subtypes (i.e., HPV16, 18, 52, or 58), reflecting regional HPV epidemiology. ccfHPV DNA was isolated from plasma and analyzed by droplet digital PCR targeting the HPV E7 genes.</p><p><strong>Results: </strong>The detection rate of ccfHPV DNA in CC patients before clinical treatment was 57.7%. The detection rate correlated significantly with tumor size (r = 0.624, P < 0.01) and clinical stage (r = 0.844, P < 0.01). No ccfHPV DNA was detected in the females with pre-cancerous lesions. By contrast, of the 13 concurrent chemoradiotherapy cases, two relapsed within 6 months post-treatment. In those cases, ccfHPV DNA levels rose earlier than SCC Ag levels. The 11 CC cases in which no ccfHPV DNA was detected within 1 month post-treatment did not relapse.</p><p><strong>Conclusion: </strong>ccfHPV DNA is a useful biomarker for advanced-stage CC and for predicting prognosis, particularly in the Japanese clinical setting.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"1247-1257"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144010923","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":"Survival paradox and effect of adjuvant chemotherapy for high-risk Stage II and low-risk Stage III colorectal cancer.","authors":"Keisuke Noda, Tetsuro Tominaga, Takashi Nonaka, Rika Ono, Kaido Oishi, Yuma Takamura, Toshio Shiraishi, Shintaro Hashimoto, Makoto Hisanaga, Hiroaki Takeshita, Mitsutoshi Ishii, Shosaburo Oyama, Kazuhide Ishimaru, Terumitsu Sawai, Keitaro Matsumoto","doi":"10.1007/s10147-025-02743-z","DOIUrl":"10.1007/s10147-025-02743-z","url":null,"abstract":"<p><strong>Purpose: </strong>High-risk Stage II may have a worse prognosis than low-risk Stage III colorectal cancer and there are limited reports examining the efficacy of adjuvant chemotherapy in Stage II and III subgroups.</p><p><strong>Methods: </strong>Using a multicenter database, 598 colorectal cancer patients who underwent laparoscopic colorectal resection and were pathologically diagnosed with high-risk Stage II (T4N0) or low-risk Stage III (T1-2N1, T1-2N2, T3N1) between April 2016 and December 2022 were retrospectively reviewed.</p><p><strong>Results: </strong>Fewer patients received adjuvant chemotherapy in the T4N0 group (54.7/45.0/44.7/27.7%, p < 0.001). The T4N0 group had significantly worse 5-year relapse-free survival (RFS) (67.0 vs. 95.5%, p < 0.01) and than the T1-2N1 group. The T4N0 group had significantly worse 5-year RFS (67.0% vs. 95.5%, p < 0.01) than the T1-2N1 group. Five-year OS was significantly better in the T1-2N1 and T3N1 groups with than without adjuvant chemotherapy (p < 0.032, p < 0.001, respectively), but not in the T4N0 group.</p><p><strong>Conclusions: </strong>The present multicenter study showed that high-risk Stage II colorectal cancer may have a worse prognosis than low-risk Stage III colorectal cancer. Preoperative treatment may be considered for T4N0 colorectal cancer.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"1183-1192"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143673645","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":"Evaluation of drug lag and drug loss in Japan: participation in global phase III oncology trials.","authors":"Kaname Shiga, Taro Shibata, Toshio Miyata","doi":"10.1007/s10147-025-02756-8","DOIUrl":"10.1007/s10147-025-02756-8","url":null,"abstract":"<p><strong>Background: </strong>Despite efforts to mitigate drug lag, discrepancies in drug approval timelines persist between Japan and the US, and increase in unapproved drugs has become a significant challenge. This study aimed to evaluate potential drug lag and drug loss by assessing Japan's participation in global phase III multinational/multiregional clinical trials (MRCTs) targeted cancers.</p><p><strong>Methods: </strong>Phase III MRCTs of anticancer drugs initiated between 2008 and 2022 were collected. Information of participant countries, study sponsor, study design, and cancer type were collected and analyzed by logistic regression analysis to identify factors affected Japan's participation.</p><p><strong>Results: </strong>Of 999 phase III MRCTs, Japan's participation every 5 years increased over 15 years (2008-2012: 34.3%, 2013-2017: 51.6%, 2018-2022: 60.2%), while Japan's non-participation numbers did not change (2008-2012: 157, 2013-2017: 167, 2018-2022: 165). In the multivariate logistic regression analysis, the absence of an operational base in Japan and minor cancers were negatively associated with Japan's participation in phase III MRCTs. Japan's participation was also associated with some cancer organs and drug modalities.</p><p><strong>Conclusion: </strong>Potential future drug lag and increases of unapproved drugs were expected to increase. Since the inclusion of Japan in MRCTs results in shorter or no approval lag, Japan should promote to make circumstances where small overseas companies can include Japan in MRCTs.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"1109-1117"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12122644/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143985834","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Genomic landscape of biliary tract cancer and corresponding targeted treatment strategies.","authors":"Daisaku Yamada, Shogo Kobayashi, Yuichiro Doki, Hidetoshi Eguchi","doi":"10.1007/s10147-025-02761-x","DOIUrl":"10.1007/s10147-025-02761-x","url":null,"abstract":"<p><p>Biliary tract cancers (BTCs) are classified on the basis of their anatomical origin, and the feasibility of surgical resection depends on the tumor location and extent of progression. However, for unresectable BTCs, systemic therapy has been uniformly applied. Gemcitabine and cisplatin (GC) therapy and GC-based therapies were established as the first-line standard BTC treatment. However, no highly effective second-line therapy has been established, and the prognosis remains poor, highlighting the need for further therapeutic advancements. Meanwhile, the era of precision medicine has expanded the use of genetic testing, leading to the identification of actionable molecular targets in BTC. Several targeted therapies, including FGFR inhibitors and IDH1 inhibitors, have been developed, offering new second-line treatment options and the potential for first-line use in appropriate cases. Notably, the frequency of these genetic alterations varies depending on the tumor location, demonstrating the molecular heterogeneity of BTC. Therefore, it has been recognized that a tailored treatment approach for each BTC patient may be more effective than uniform systemic therapy. Consequently, although routine genetic testing before initiating systemic treatment is currently limited by the medical environment (e.g., cost, accessibility, regional differences), it is recommended in ESMO guideline and might be increasingly advocated. However, BTC harbors a wide range of genetic alterations, and numerous targeted therapies are being developed accordingly. This review provides an overview of the reported genetic alterations in BTC, the frequencies of these alterations, and the corresponding targeted therapies, emphasizing the evolving role of precision medicine in BTC treatment.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"1069-1079"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12122590/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144012089","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":"Prognostic impact of dose reduced S-1 adjuvant chemotherapy in patients with pancreatic ductal adenocarcinoma: a retrospective multicenter study.","authors":"Kazuki Kobayashi, Takahiro Einama, Yoichi Miyata, Asuma Ide, Naoto Yonamine, Takazumi Tsunenari, Mikiya Takao, Masato Yamadera, Makoto Nishikawa, Akifumi Kimura, Eiji Shinto, Hideki Ueno, Yoshifumi Beck, Yoji Kishi","doi":"10.1007/s10147-025-02742-0","DOIUrl":"10.1007/s10147-025-02742-0","url":null,"abstract":"<p><strong>Background: </strong>The standard adjuvant chemotherapy for pancreatic ductal adenocarcinoma (PDAC) in Japan is S-1; however, the impact of dose reduction on prognosis remains unclear. We have reported that total dose intensity (TDI) ≥ 62.5% indicates good prognosis. This multicenter retrospective study evaluated the prognostic impact of TDI ≥ 62.5% and reduced dosing in patients who underwent radical resection for PDAC across three institutions.</p><p><strong>Method: </strong>Patients were grouped into high-TDI (≥ 62.5%) and low-TDI (< 62.5%) based on this cutoff. We performed an inverse probability of treatment weighting (IPTW)-adjusted analysis and calculated relapse-free survival (RFS) and overall survival (OS). OS was also calculated for high TDI with TDI < 100% and TDI = 100%.</p><p><strong>Result: </strong>Among 487 patients, 274 were included: 152 in the low-TDI and 122 in high-TDI groups. Patient background was adjusted using IPTW based on factors that might influence TDI. The median RFS for low- and high-TDI was 8 and 18 months, respectively (p = 0.004). The median OS of low- and high-TDI groups was 20 and 50 months, respectively (p < 0.001). Among patients with high TDI, OS did not differ between those with TDI < 100% and those with TDI = 100% (median, 47 vs. 72 months, p = 0.208).</p><p><strong>Conclusion: </strong>It has been suggested that a partial dose reduction of S-1 as adjuvant chemotherapy for PDAC does not significantly impact prognosis.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"1218-1228"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12122594/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144007194","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 cancer vaccine therapy in malignant melanoma: a systematic review.","authors":"Takeshi Seta, Shohei Nakamura, Mitsuaki Oura, Kazuki Yokoyama, Yoshitaka Nishikawa, Nobuaki Hoshino, Kiichiro Ninomiya, Tatsunori Shimoi, Katsuyuki Hotta, Takeo Nakayama","doi":"10.1007/s10147-025-02753-x","DOIUrl":"10.1007/s10147-025-02753-x","url":null,"abstract":"<p><strong>Introduction: </strong>Malignant melanoma is a cancer that develops from melanocytes in the skin and mucous membranes. Surgery, and chemotherapy, radiation therapy, or immunotherapy are also used in cases of distant metastasis. Immunotherapy includes immune checkpoint inhibitors and cancer vaccine therapy; however, their efficacy remains limited.</p><p><strong>Methods: </strong>A systematic review and meta-analysis of cancer vaccine therapies were conducted. PubMed was used to search the literature up to December 2023, and clinical trials were also identified for the same period. RCTs involving patients with resectable or unresectable malignant melanoma were included. The primary outcome was OS, and secondary outcomes were PFS, DFS, and RFS. Safety was assessed based on AEs. Integrated results were presented as risk ratio and risk difference.</p><p><strong>Results: </strong>The initial search identified 418 studies on cancer vaccine therapy and 44 studies on effector T-cell therapy. We supplemented this with our PubMed search, extracting 149 studies. After database searches and screening, 611 studies were initially considered. Following exclusions based on eligibility criteria, 20 RCTs using cancer vaccines remained. For the primary outcome, OS, the pooled RR was 1.11 (95% CI, 0.97-1.32, I² = 59.0%), and the pooled RD was 0.02 (-0.01 to 0.06, I² = 74.0%) at 12 months. PFS, DFS, and RFS did not show statistically significant differences, and AEs did not increase significantly.</p><p><strong>Conclusion: </strong>Cancer vaccine therapy, neither alone, or in combination with other agents for malignant melanoma did not show a significant improvement in OS, PFS, DFS, or RFS nor did it significantly increase AEs.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"1080-1097"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143995810","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}