{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,18]],"date-time":"2026-10-18T08:45:50Z","timestamp":1792313150251,"version":"4.4.0"},"reference-count":11,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"2","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO Clin Cancer Inform"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>JAVELIN Renal 101 revealed that avelumab plus axitinib improved progression-free survival (PFS) compared with sunitinib in advanced renal cell carcinoma. However, Japanese subgroup estimates were imprecise. In this study, we evaluated how Bayesian borrowing assumptions translate into posterior probabilities for this subgroup.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>PATIENTS AND METHODS<\/jats:title>\n                    <jats:p>\n                      Using published summary data from JAVELIN Renal 101, we modeled PFS on the log hazard-ratio scale with a normal-normal framework, comparing a weakly informative neutral prior with informative borrowing priors centered on the global final estimate (with sensitivity to the third interim estimate). Outputs were posterior HRs, 95% credible intervals (CrIs),\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      (hazard ratio [HR] &lt;1), and\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      (HR &lt; 0.8). Sensitivity analyses evaluated alternative borrowing specifications. Adverse events (AEs) were assessed with a no-borrowing beta-binomial framework using noninformative Jeffreys priors for Japanese and global data sets, reporting Japanese posterior means, 95% CrIs, and probabilities of enrichment for any grade and grade \u22653.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      Under the neutral prior, evidence for PFS benefit in the Japanese subgroup was moderate (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      [HR &lt; 1] = .83;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      [HR &lt; 0.8] = .64), whereas informative borrowing priors yielded substantially higher probabilities. Borrowing in PD-L1\n                      <jats:sup>+<\/jats:sup>\n                      Japanese patients narrowed CrIs while preserving the favorable direction of effect. Any-grade AEs in Japanese patients were most often enriched in hepatic\/laboratory, thyroid, infusion-related, and hand-foot domains. For grade \u22653, enrichment mainly involved hepatic\/laboratory abnormalities, while rare severe events yielded imprecise posteriors.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>A paired Bayesian strategy, graded priors for efficacy and no-borrowing priors for safety, produced transparent posterior probability summaries for the Japanese subgroup. This framework illustrates how borrowing can narrow uncertainty when exchangeability is plausible, while clarifying toxicity domains that may warrant closer monitoring, using published trial data.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/cci-25-00307","type":"journal-article","created":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T20:00:53Z","timestamp":1782849653000},"update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":1,"title":["Bayesian Methods for Subgroup Efficacy and Safety: Application to Japanese Patients in JAVELIN Renal 101"],"prefix":"10.1200","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7548-1580","authenticated-orcid":true,"given":"Hiroshi","family":"Fukushima","sequence":"first","affiliation":[{"name":"Department of Urology, Institute of Science Tokyo, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2757-8083","authenticated-orcid":true,"given":"Soichiro","family":"Yoshida","sequence":"additional","affiliation":[{"name":"Department of Urology, Institute of Science Tokyo, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2300-8446","authenticated-orcid":true,"given":"Shugo","family":"Yajima","sequence":"additional","affiliation":[{"name":"Department of Urology, National Cancer Center Hospital East, Chiba, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2275-4527","authenticated-orcid":true,"given":"Wei","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Urology, Institute of Science Tokyo, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9507-9887","authenticated-orcid":true,"given":"Hiroyuki","family":"Sato","sequence":"additional","affiliation":[{"name":"Department of Clinical Biostatistics, Graduate School of Medical and Dental Sciences, Institute of Science Tokyo, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akihiro","family":"Hirakawa","sequence":"additional","affiliation":[{"name":"Department of Clinical Biostatistics, Graduate School of Medical and Dental Sciences, Institute of Science Tokyo, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9454-3345","authenticated-orcid":true,"given":"Motohiro","family":"Fujiwara","sequence":"additional","affiliation":[{"name":"Department of Urology, Teikyo University School of Medicine Mizonokuchi Hospital, Kanagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5285-0352","authenticated-orcid":true,"given":"Yuki","family":"Arita","sequence":"additional","affiliation":[{"name":"Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY"},{"name":"Department of Radiology and Biomedical Imaging, University of California, San Francisco, San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yosuke","family":"Yasuda","sequence":"additional","affiliation":[{"name":"Department of Urology, Institute of Science Tokyo, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3632-2901","authenticated-orcid":true,"given":"Hajime","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Department of Urology, Institute of Science Tokyo, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9182-8481","authenticated-orcid":true,"given":"Hitoshi","family":"Masuda","sequence":"additional","affiliation":[{"name":"Department of Urology, National Cancer Center Hospital East, Chiba, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuhisa","family":"Fujii","sequence":"additional","affiliation":[{"name":"Department of Urology, Institute of Science Tokyo, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"e_1_3_6_2_2","doi-asserted-by":"publisher","DOI":"10.1111\/cas.14294"},{"key":"e_1_3_6_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.esmoop.2023.101210"},{"key":"e_1_3_6_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2024.12.008"},{"key":"e_1_3_6_5_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1816047"},{"key":"e_1_3_6_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2020.04.010"},{"key":"e_1_3_6_7_2","first-page":"373","article-title":"The power prior: Theory and applications","volume":"30","author":"Ibrahim JG","year":"2015","unstructured":"Ibrahim JG, Chen MH, Gwon Y, et al: The power prior: Theory and applications. Statist Sci 30:373-395, 2015","journal-title":"Statist Sci"},{"key":"e_1_3_6_8_2","doi-asserted-by":"publisher","DOI":"10.1214\/ss\/1009212673"},{"key":"e_1_3_6_9_2","doi-asserted-by":"publisher","DOI":"10.1111\/biom.12242"},{"key":"e_1_3_6_10_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1541-0420.2011.01564.x"},{"key":"e_1_3_6_11_2","unstructured":"U.S. Food and Drug Administration (FDA): Guidance for the use of Bayesian statistics in medical device clinical trials 2010. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/guidance-use-bayesian-statistics-medical-device-clinical-trials"},{"key":"e_1_3_6_12_2","doi-asserted-by":"publisher","DOI":"10.1002\/pst.2192"}],"container-title":["JCO Clinical Cancer Informatics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/CCI-25-00307","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T20:00:59Z","timestamp":1782849659000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/CCI-25-00307"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4]]},"references-count":11,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2026,4]]}},"alternative-id":["10.1200\/CCI-25-00307"],"URL":"https:\/\/doi.org\/10.1200\/cci-25-00307","relation":{},"ISSN":["2473-4276"],"issn-type":[{"value":"2473-4276","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4]]},"assertion":[{"value":"2025-10-05","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-03-21","order":1,"name":"revised","label":"Revised","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-05-13","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-30","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e2500307"}}