{"title":"Avelumab维持对晚期尿路上皮癌的影响：一项真实世界的多中心研究","authors":"Noritaka Ishii, Yuya Sekine, Masanao Shinohara, Yohei Kawashima, Kanami Mori, Mizuki Kobayashi, Kazuyuki Numakura, Jotaro Mikami, Naoki Fujita, Teppei Okamoto, Takahiro Yoneyama, Ryuji Tabata, Satoshi Sato, Tomonori Habuchi, Chikara Ohyama, Shingo Hatakeyama","doi":"10.1002/cam4.71241","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Objectives</h3>\n \n <p>Oncological outcomes in patients with urothelial carcinoma treated with avelumab maintenance therapy or conventional platinum-based first-line chemotherapy were compared in real-world practice.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>Outcomes in patients with advanced urothelial carcinoma treated with platinum-based first-line chemotherapy without avelumab (chemo group, <i>n</i> = 300) or avelumab maintenance therapy (avelumab group, <i>n</i> = 85) between March 2004 and September 2024 were retrospectively evaluated. Overall survival (OS) in the chemo and avelumab groups was stratified by the number of cycles of first-line chemotherapy. The primary outcome was OS among patients without progressive disease (non-PD) at the cycle-4 assessment (the standard-switch cohort). The secondary outcome was OS among patients with non-PD at the cycles-2 to 3 assessment (the early-switch cohort).</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>In the standard-switch cohort (non-PD at cycle 4), the chemo and avelumab groups comprised 122 and 47 patients, respectively; median OS was significantly longer with avelumab than with chemo (70 vs. 26 months; <i>p</i> = 0.015). In the early-switch cohort (non-PD at cycles 2–3), the chemo and avelumab groups comprised 104 and 35 patients, respectively; median OS was significantly longer with avelumab than with chemo (33 vs. 13 months; <i>p</i> = 0.002). A multivariable Cox regression analysis revealed that avelumab administration was significantly associated with a reduced risk of OS (hazard ratio, 0.37; <i>p</i> < 0.001). The retrospective design is a limitation of this study.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>Avelumab maintenance appeared to improve outcomes across cycles 2–3 and ≥ 4, though residual confounding cannot be excluded.</p>\n </section>\n </div>","PeriodicalId":139,"journal":{"name":"Cancer Medicine","volume":"14 18","pages":""},"PeriodicalIF":3.1000,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cam4.71241","citationCount":"0","resultStr":"{\"title\":\"Effects of Avelumab Maintenance on Advanced Urothelial Carcinoma: A Real-World Multicenter Study\",\"authors\":\"Noritaka Ishii, Yuya Sekine, Masanao Shinohara, Yohei Kawashima, Kanami Mori, Mizuki Kobayashi, Kazuyuki Numakura, Jotaro Mikami, Naoki Fujita, Teppei Okamoto, Takahiro Yoneyama, Ryuji Tabata, Satoshi Sato, Tomonori Habuchi, Chikara Ohyama, Shingo Hatakeyama\",\"doi\":\"10.1002/cam4.71241\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Objectives</h3>\\n \\n <p>Oncological outcomes in patients with urothelial carcinoma treated with avelumab maintenance therapy or conventional platinum-based first-line chemotherapy were compared in real-world practice.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>Outcomes in patients with advanced urothelial carcinoma treated with platinum-based first-line chemotherapy without avelumab (chemo group, <i>n</i> = 300) or avelumab maintenance therapy (avelumab group, <i>n</i> = 85) between March 2004 and September 2024 were retrospectively evaluated. Overall survival (OS) in the chemo and avelumab groups was stratified by the number of cycles of first-line chemotherapy. The primary outcome was OS among patients without progressive disease (non-PD) at the cycle-4 assessment (the standard-switch cohort). The secondary outcome was OS among patients with non-PD at the cycles-2 to 3 assessment (the early-switch cohort).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>In the standard-switch cohort (non-PD at cycle 4), the chemo and avelumab groups comprised 122 and 47 patients, respectively; median OS was significantly longer with avelumab than with chemo (70 vs. 26 months; <i>p</i> = 0.015). In the early-switch cohort (non-PD at cycles 2–3), the chemo and avelumab groups comprised 104 and 35 patients, respectively; median OS was significantly longer with avelumab than with chemo (33 vs. 13 months; <i>p</i> = 0.002). A multivariable Cox regression analysis revealed that avelumab administration was significantly associated with a reduced risk of OS (hazard ratio, 0.37; <i>p</i> < 0.001). The retrospective design is a limitation of this study.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusion</h3>\\n \\n <p>Avelumab maintenance appeared to improve outcomes across cycles 2–3 and ≥ 4, though residual confounding cannot be excluded.</p>\\n </section>\\n </div>\",\"PeriodicalId\":139,\"journal\":{\"name\":\"Cancer Medicine\",\"volume\":\"14 18\",\"pages\":\"\"},\"PeriodicalIF\":3.1000,\"publicationDate\":\"2025-09-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cam4.71241\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Cancer Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/cam4.71241\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancer Medicine","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/cam4.71241","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
Effects of Avelumab Maintenance on Advanced Urothelial Carcinoma: A Real-World Multicenter Study
Objectives
Oncological outcomes in patients with urothelial carcinoma treated with avelumab maintenance therapy or conventional platinum-based first-line chemotherapy were compared in real-world practice.
Methods
Outcomes in patients with advanced urothelial carcinoma treated with platinum-based first-line chemotherapy without avelumab (chemo group, n = 300) or avelumab maintenance therapy (avelumab group, n = 85) between March 2004 and September 2024 were retrospectively evaluated. Overall survival (OS) in the chemo and avelumab groups was stratified by the number of cycles of first-line chemotherapy. The primary outcome was OS among patients without progressive disease (non-PD) at the cycle-4 assessment (the standard-switch cohort). The secondary outcome was OS among patients with non-PD at the cycles-2 to 3 assessment (the early-switch cohort).
Results
In the standard-switch cohort (non-PD at cycle 4), the chemo and avelumab groups comprised 122 and 47 patients, respectively; median OS was significantly longer with avelumab than with chemo (70 vs. 26 months; p = 0.015). In the early-switch cohort (non-PD at cycles 2–3), the chemo and avelumab groups comprised 104 and 35 patients, respectively; median OS was significantly longer with avelumab than with chemo (33 vs. 13 months; p = 0.002). A multivariable Cox regression analysis revealed that avelumab administration was significantly associated with a reduced risk of OS (hazard ratio, 0.37; p < 0.001). The retrospective design is a limitation of this study.
Conclusion
Avelumab maintenance appeared to improve outcomes across cycles 2–3 and ≥ 4, though residual confounding cannot be excluded.
期刊介绍：
Cancer Medicine is a peer-reviewed, open access, interdisciplinary journal providing rapid publication of research from global biomedical researchers across the cancer sciences. The journal will consider submissions from all oncologic specialties, including, but not limited to, the following areas:
Clinical Cancer Research
Translational research ∙ clinical trials ∙ chemotherapy ∙ radiation therapy ∙ surgical therapy ∙ clinical observations ∙ clinical guidelines ∙ genetic consultation ∙ ethical considerations
Cancer Biology:
Molecular biology ∙ cellular biology ∙ molecular genetics ∙ genomics ∙ immunology ∙ epigenetics ∙ metabolic studies ∙ proteomics ∙ cytopathology ∙ carcinogenesis ∙ drug discovery and delivery.
Cancer Prevention:
Behavioral science ∙ psychosocial studies ∙ screening ∙ nutrition ∙ epidemiology and prevention ∙ community outreach.
Bioinformatics:
Gene expressions profiles ∙ gene regulation networks ∙ genome bioinformatics ∙ pathwayanalysis ∙ prognostic biomarkers.
Cancer Medicine publishes original research articles, systematic reviews, meta-analyses, and research methods papers, along with invited editorials and commentaries. Original research papers must report well-conducted research with conclusions supported by the data presented in the paper.
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