{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T20:33:49Z","timestamp":1793306029223,"version":"4.5.0"},"reference-count":18,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"35","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2017,12,10]]},"abstract":"<jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>This phase III trial evaluated the efficacy and safety of pazopanib versus placebo in patients with locally advanced renal cell carcinoma (RCC) at high risk for relapse after nephrectomy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and Methods<\/jats:title>\n                    <jats:p>\n                      A total of 1,538 patients with resected pT2 (high grade) or \u2265 pT3, including N1, clear cell RCC were randomly assigned to pazopanib or placebo for 1 year; 403 patients received a starting dose of 800 mg or placebo. To address toxicity attrition, the 800-mg starting dose was lowered to 600 mg, and the primary end point analysis was changed to disease-free survival (DFS) for pazopanib 600 mg versus placebo (n = 1,135). Primary analysis was performed after 350 DFS events in the intent-to-treat (ITT) pazopanib 600 mg group (ITT\n                      <jats:sub>600mg<\/jats:sub>\n                      ), and DFS follow-up analysis was performed 12 months later. Secondary end point analyses included DFS with ITT pazopanib 800 mg (ITT\n                      <jats:sub>800mg<\/jats:sub>\n                      ) and safety.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The primary analysis results of DFS ITT\n                      <jats:sub>600mg<\/jats:sub>\n                      favored pazopanib but did not show a significant improvement over placebo (hazard ratio [HR], 0.86; 95% CI, 0.70 to 1.06; P = .165). The secondary analysis of DFS in ITT\n                      <jats:sub>800mg<\/jats:sub>\n                      (n = 403) yielded an HR of 0.69 (95% CI, 0.51 to 0.94). Follow-up analysis in ITT\n                      <jats:sub>600mg<\/jats:sub>\n                      yielded an HR of 0.94 (95% CI, 0.77 to 1.14). Increased ALT and AST were common adverse events leading to treatment discontinuation in the pazopanib 600 mg (ALT, 16%; AST, 5%) and 800 mg (ALT, 18%; AST, 7%) groups.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The results of the primary DFS analysis of pazopanib 600 mg showed no benefit over placebo in the adjuvant setting.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco.2017.73.5324","type":"journal-article","created":{"date-parts":[[2017,9,13]],"date-time":"2017-09-13T15:57:26Z","timestamp":1505318246000},"page":"3916-3923","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":330,"title":["Randomized Phase III Trial of Adjuvant Pazopanib Versus Placebo After Nephrectomy in Patients With Localized or Locally Advanced Renal Cell Carcinoma"],"prefix":"10.1200","volume":"35","author":[{"given":"Robert J.","family":"Motzer","sequence":"first","affiliation":[{"name":"Robert J. Motzer and Paul Russo, Memorial Sloan Kettering Cancer Center, New York, NY; Naomi B. Haas, University of Pennsylvania, Philadelphia, PA; Frede Donskov, Aarhus University Hospital, Aarhus, Denmark; Marine Gross-Goupil, Bordeaux University Hospital, Bordeaux, France; Sergei Varlamov, Altai Regional Cancer Center, Barnaul; Evgeny Kopyltsov, State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia; Jae Lyun Lee, University of Ulsan College of Medicine; Ho Yeong Lim,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naomi B.","family":"Haas","sequence":"additional","affiliation":[{"name":"Robert J. Motzer and Paul Russo, Memorial Sloan Kettering Cancer Center, New York, NY; Naomi B. Haas, University of Pennsylvania, Philadelphia, PA; Frede Donskov, Aarhus University Hospital, Aarhus, Denmark; Marine Gross-Goupil, Bordeaux University Hospital, Bordeaux, France; Sergei Varlamov, Altai Regional Cancer Center, Barnaul; Evgeny Kopyltsov, State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia; Jae Lyun Lee, University of Ulsan College of Medicine; Ho Yeong Lim,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frede","family":"Donskov","sequence":"additional","affiliation":[{"name":"Robert J. Motzer and Paul Russo, Memorial Sloan Kettering Cancer Center, New York, NY; Naomi B. Haas, University of Pennsylvania, Philadelphia, PA; Frede Donskov, Aarhus University Hospital, Aarhus, Denmark; Marine Gross-Goupil, Bordeaux University Hospital, Bordeaux, France; Sergei Varlamov, Altai Regional Cancer Center, Barnaul; Evgeny Kopyltsov, State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia; Jae Lyun Lee, University of Ulsan College of Medicine; Ho Yeong Lim,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marine","family":"Gross-Goupil","sequence":"additional","affiliation":[{"name":"Robert J. Motzer and Paul Russo, Memorial Sloan Kettering Cancer Center, New York, NY; Naomi B. Haas, University of Pennsylvania, Philadelphia, PA; Frede Donskov, Aarhus University Hospital, Aarhus, Denmark; Marine Gross-Goupil, Bordeaux University Hospital, Bordeaux, France; Sergei Varlamov, Altai Regional Cancer Center, Barnaul; Evgeny Kopyltsov, State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia; Jae Lyun Lee, University of Ulsan College of Medicine; Ho Yeong Lim,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sergei","family":"Varlamov","sequence":"additional","affiliation":[{"name":"Robert J. Motzer and Paul Russo, Memorial Sloan Kettering Cancer Center, New York, NY; Naomi B. 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