{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T19:37:10Z","timestamp":1790797030450,"version":"4.1.0"},"reference-count":58,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"4","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:sec>\n            <jats:title>PURPOSE<\/jats:title>\n            <jats:p>Surrogate end points are commonly used to estimate treatment efficacy in clinical studies of chronic lymphocytic leukemia (CLL). This patient- and trial-level analysis describes the correlation between progression-free survival (PFS) and minimal residual disease (MRD) with overall survival (OS) in first-line trials for CLL.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>PATIENTS AND METHODS<\/jats:title>\n            <jats:p>First, patient-level correlation was confirmed using source data from 12 frontline German CLL Study Group (GCLLSG)-trials. Additionally, a joint-frailty copula model was fitted to validate correlation in the setting of targeted therapies (TT). Second, a meta-analysis of first-line phase III trials in CLL from 2008 to 2024 was performed. Treatment effect correlation was quantified from seven GCLLSG and nine published trials, using hazard ratios (HRs) for time-to-event and odds ratios for binary end points.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>RESULTS<\/jats:title>\n            <jats:p>\n              The GCLLSG analysis set comprised 4,237 patients. Patient-level correlation for PFS\/OS was strong with Spearman Rho &gt;0.9. The joint-frailty copula indicated a weak correlation for chemotherapy\/chemoimmunotherapy (C\/CIT) with a tau of 0.52 (95% CI, 0.49 to 0.55) while the correlation was strong for TT (tau, 0.91 [95% CI, 0.89 to 0.93). The meta-analysis set contained a total of 8,065 patients including 5,198 (64%) patients treated with C\/CIT and 2,867 (36%) treated with TT. Treatment-effect correlation of the HRs for PFS and OS was\n              <jats:italic>R<\/jats:italic>\n              = 0.75 (95% CI, 0.74 to 0.76,\n              <jats:italic>R<\/jats:italic>\n              <jats:sup>2<\/jats:sup>\n              = 0.56) while correlation of end-of-treatment MRD with PFS and OS was\n              <jats:italic>R<\/jats:italic>\n              = 0.88 (95% CI, \u20130.87 to 0.89;\n              <jats:italic>R<\/jats:italic>\n              <jats:sup>2<\/jats:sup>\n              = 0.78) and 0.71 (95% CI, 0.69 to 0.73;\n              <jats:italic>R<\/jats:italic>\n              <jats:sup>2<\/jats:sup>\n              = 0.5), respectively.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>CONCLUSION<\/jats:title>\n            <jats:p>Patient-level correlation was confirmed in the setting of TTs while treatment-effect correlation between PFS and OS remains uncertain. MRD response status showed a high treatment-effect correlation with PFS but not OS, with the caveat of a limited number of randomized trials with available MRD data.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1200\/jco.24.01192","type":"journal-article","created":{"date-parts":[[2024,8,30]],"date-time":"2024-08-30T19:59:05Z","timestamp":1725047945000},"page":"381-391","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":29,"title":["End Point Surrogacy in First-Line Chronic Lymphocytic Leukemia"],"prefix":"10.1200","volume":"43","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2700-3717","authenticated-orcid":true,"given":"Florian","family":"Simon","sequence":"first","affiliation":[{"name":"Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; German CLL Study Group, University of Cologne, Cologne, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6546-0911","authenticated-orcid":true,"given":"Rudy","family":"Ligtvoet","sequence":"additional","affiliation":[{"name":"Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; German CLL Study Group, University of Cologne, Cologne, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"Robrecht","sequence":"additional","affiliation":[{"name":"Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; German CLL Study Group, University of Cologne, Cologne, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4046-9922","authenticated-orcid":true,"given":"Paula","family":"Cramer","sequence":"additional","affiliation":[{"name":"Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; German CLL Study Group, University of Cologne, Cologne, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9559-8575","authenticated-orcid":true,"given":"Nadine","family":"Kutsch","sequence":"additional","affiliation":[{"name":"Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; 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