{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T20:48:25Z","timestamp":1782247705613,"version":"3.54.5"},"reference-count":25,"publisher":"American Society of Clinical Oncology (ASCO)","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO Oncol Pract"],"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>\n                      Multiple reports have suggested that receiving immunotherapy infusions earlier in the day is associated with improved outcomes, including longer overall survival (OS) and lower toxicity rates. However, the definition of early varies between publications. Reports also fail to account for confounding factors (including distance to infusion center), are subject to survivor bias (analyzing postbaseline factors at baseline), and do not adjust\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      values for multiple comparisons when evaluating multiple potential thresholds for early versus late time of day of infusion.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>We analyzed a previously reported multicenter clinical trial evaluating pembrolizumab as adjuvant therapy for participants with resectable high-risk melanoma. Standard statistical methodologies that account for potential biasses were used to evaluate the association between time of day of infusion and clinical outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      A total of 628 participants received pembrolizumab and had time of first infusion recorded. The median age was 55 years, range, 20-82. Odds of infusion before 11:00 hours increased by 32% over 12 months of therapy (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .013). Participants living further from their treating institution had later infusion times on average: odds of infusion before 11:00 decreased by 9% for each additional 50 miles (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .017). The optimal cut point for first infusion time for OS was 15:48 with hazard ratio (HR) = 1.40; changing the cut point by 30 minutes earlier to 15:18 decreased HR to 0.98, indicating lack of robustness of the threshold. No significant association was identified between proportion of early infusions and outcomes in multivariable time-dependent Cox regression models.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>In this multicenter trial of adjuvant pembrolizumab for participants with high-risk melanoma, analyses that account for common sources of bias found no significant association between recurrence-free or OS and time of day of infusion.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/op-25-01413","type":"journal-article","created":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T19:59:17Z","timestamp":1782244757000},"update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":0,"title":["Addressing Biases in Analysis of Time of Infusion: NCI\/SWOG Trial S1404 Among Participants With High-Risk Resectable Melanoma Who Received Adjuvant Anti\u2013PD-1 Therapy"],"prefix":"10.1200","clinical-trial-number":[{"clinical-trial-number":"nct02506153","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8176-6371","authenticated-orcid":true,"given":"Megan","family":"Othus","sequence":"first","affiliation":[{"name":"Division of Public Health, Fred Hutchinson Cancer Center, Seattle WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6774-2557","authenticated-orcid":true,"given":"Thach-Giao","family":"Truong","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0044-9719","authenticated-orcid":true,"given":"Elad","family":"Sharon","sequence":"additional","affiliation":[{"name":"Department of Medicine, Dana Farber Cancer Institute, Boston, MA"},{"name":"Harvard Medical School, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5936-6689","authenticated-orcid":true,"given":"Kari","family":"Kendra","sequence":"additional","affiliation":[{"name":"Medical Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, OH"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8523-7407","authenticated-orcid":true,"given":"Kenneth","family":"Grossmann","sequence":"additional","affiliation":[{"name":"Medical Oncology, Providence Cancer Institute, Portland, OR"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7979-8953","authenticated-orcid":true,"given":"Elizabeth","family":"Buchbinder","sequence":"additional","affiliation":[{"name":"Medical Oncology, Mass General Brigham Cancer Institute, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3636-4143","authenticated-orcid":true,"given":"Nikhil I.","family":"Khushalani","sequence":"additional","affiliation":[{"name":"Department of Cutaneous Oncology, H Lee Moffitt Cancer Center, Tampa, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2307-7030","authenticated-orcid":true,"given":"Zeynep","family":"Eroglu","sequence":"additional","affiliation":[{"name":"Department of Cutaneous Oncology, H Lee Moffitt Cancer Center, Tampa, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7936-5069","authenticated-orcid":true,"given":"Sunandana","family":"Chandra","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology, Robert H Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9141-449X","authenticated-orcid":true,"given":"Gary C.","family":"Doolittle","sequence":"additional","affiliation":[{"name":"Division of Clinical Oncology, University of Kansas Medical Center, Kansas City, KS"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3570-4476","authenticated-orcid":true,"given":"John M.","family":"Kirkwood","sequence":"additional","affiliation":[{"name":"Melanoma Program, University of Pittsburgh Medical Center, Hillman Cancer Center, Pittsburgh, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"Ikeguchi","sequence":"additional","affiliation":[{"name":"Melanoma Medical Oncology, University of Texas, MD Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catalin","family":"Mihalcioiu","sequence":"additional","affiliation":[{"name":"Medical Oncology, McGill University Health Centre, Montreal, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C. 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