Evidence map›Paper›PMID 27718781›Full record

Trial reportThe New England journal of medicine2016

Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy.

Alain Ravaud, Robert J Motzer, Hardev S Pandha, Daniel J George, Allan J Pantuck, Anup Patel, Yen-Hwa Chang, Bernard Escudier, Frede Donskov, Ahmed Magheli and 13 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 344 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
344citing papers in PubMed, 7 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00375674 phase3completednot on this map

Sunitinib Treatment Of Renal Adjuvant Cancer (S-trac): A Randomized Double-blind Phase 3 Study Of Adjuvant Sunitinib Vs. Placebo In Subjects At High Risk Of Recurrent Rcc

TypeinterventionalSponsorPfizerRan2007 to 2017Enrolled674ConditionsKidney NeoplasmsArmsSunitinib malate, Placebo
NCT07172386 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

A Study on the Safety and Efficacy of Super-selective Tumour Arterial Embolisation in Combination With Toripalimab and Axitinib as a Preoperative Treatment for Advanced Renal Cell Carcinoma

TypeinterventionalSponsorTianjin Medical University Second HospitalRan2025 to 2027Enrolled40ConditionsRenal Cell Carcinoma (RCC)ArmsToripalimab and axitinib
3 · Its place in the literature

Who cites it

344 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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  20. Plasma KIM-1 Is Associated with Recurrence Risk after Nephrectomy for Localized Renal Cell Carcinoma: A Trial of the ECOG-ACRIN Research Group (E2805).Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
    Trial

284 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors.

Alain RavaudFrom the Department of Medical Oncology, Bordeaux University Hospital, Bordeaux (A.R.), Department of Medical Oncology, Institut Gustave Roussy, Villejuif (B.E.), Medical Oncology, Centre Eugene Marquis, Rennes (B.L.), and Department of Urology, Bicêtre Hospital, Paris-Saclay University, Le Kremlin Bicêtre (J.-J.P.) - all in France; Department of Medicine, Memorial Sloan Kettering Cancer Center (R.J.M.), and Pfizer (K.R.) - both in New York; Department of Clinical and Experimental Medicine, University of Surrey, Surrey, United Kingdom (H.S.P.); Division of Medical Oncology, Duke Cancer Institute, Durham, NC (D.J.G.); Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles (A.J.P.), and Pfizer, La Jolla (X.L., J.-F.M.) - both in California; Spire Roding Hospital, London (A.P.); Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Department of Oncology, Aarhus University Hospital, Aarhus, Denmark (F.D.); Department of Urology, Charité Universitätsmedizin Berlin, Berlin (A.M.), and Department of Urology, University Hospital of Munich, Munich (M.S.) - both in Germany; Divisions of Oncology and Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy (G.C.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Department of Urology, Slovak Medical University, Bratislava, Slovakia (J.B.); and Pfizer, Milan (P.G., M.L.), and Collegeville, PA (M.C.).
Robert J MotzerFrom the Department of Medical Oncology, Bordeaux University Hospital, Bordeaux (A.R.), Department of Medical Oncology, Institut Gustave Roussy, Villejuif (B.E.), Medical Oncology, Centre Eugene Marquis, Rennes (B.L.), and Department of Urology, Bicêtre Hospital, Paris-Saclay University, Le Kremlin Bicêtre (J.-J.P.) - all in France; Department of Medicine, Memorial Sloan Kettering Cancer Center (R.J.M.), and Pfizer (K.R.) - both in New York; Department of Clinical and Experimental Medicine, University of Surrey, Surrey, United Kingdom (H.S.P.); Division of Medical Oncology, Duke Cancer Institute, Durham, NC (D.J.G.); Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles (A.J.P.), and Pfizer, La Jolla (X.L., J.-F.M.) - both in California; Spire Roding Hospital, London (A.P.); Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Department of Oncology, Aarhus University Hospital, Aarhus, Denmark (F.D.); Department of Urology, Charité Universitätsmedizin Berlin, Berlin (A.M.), and Department of Urology, University Hospital of Munich, Munich (M.S.) - both in Germany; Divisions of Oncology and Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy (G.C.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Department of Urology, Slovak Medical University, Bratislava, Slovakia (J.B.); and Pfizer, Milan (P.G., M.L.), and Collegeville, PA (M.C.).
Hardev S PandhaFrom the Department of Medical Oncology, Bordeaux University Hospital, Bordeaux (A.R.), Department of Medical Oncology, Institut Gustave Roussy, Villejuif (B.E.), Medical Oncology, Centre Eugene Marquis, Rennes (B.L.), and Department of Urology, Bicêtre Hospital, Paris-Saclay University, Le Kremlin Bicêtre (J.-J.P.) - all in France; Department of Medicine, Memorial Sloan Kettering Cancer Center (R.J.M.), and Pfizer (K.R.) - both in New York; Department of Clinical and Experimental Medicine, University of Surrey, Surrey, United Kingdom (H.S.P.); Division of Medical Oncology, Duke Cancer Institute, Durham, NC (D.J.G.); Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles (A.J.P.), and Pfizer, La Jolla (X.L., J.-F.M.) - both in California; Spire Roding Hospital, London (A.P.); Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Department of Oncology, Aarhus University Hospital, Aarhus, Denmark (F.D.); Department of Urology, Charité Universitätsmedizin Berlin, Berlin (A.M.), and Department of Urology, University Hospital of Munich, Munich (M.S.) - both in Germany; Divisions of Oncology and Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy (G.C.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Department of Urology, Slovak Medical University, Bratislava, Slovakia (J.B.); and Pfizer, Milan (P.G., M.L.), and Collegeville, PA (M.C.).
Daniel J GeorgeFrom the Department of Medical Oncology, Bordeaux University Hospital, Bordeaux (A.R.), Department of Medical Oncology, Institut Gustave Roussy, Villejuif (B.E.), Medical Oncology, Centre Eugene Marquis, Rennes (B.L.), and Department of Urology, Bicêtre Hospital, Paris-Saclay University, Le Kremlin Bicêtre (J.-J.P.) - all in France; Department of Medicine, Memorial Sloan Kettering Cancer Center (R.J.M.), and Pfizer (K.R.) - both in New York; Department of Clinical and Experimental Medicine, University of Surrey, Surrey, United Kingdom (H.S.P.); Division of Medical Oncology, Duke Cancer Institute, Durham, NC (D.J.G.); Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles (A.J.P.), and Pfizer, La Jolla (X.L., J.-F.M.) - both in California; Spire Roding Hospital, London (A.P.); Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Department of Oncology, Aarhus University Hospital, Aarhus, Denmark (F.D.); Department of Urology, Charité Universitätsmedizin Berlin, Berlin (A.M.), and Department of Urology, University Hospital of Munich, Munich (M.S.) - both in Germany; Divisions of Oncology and Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy (G.C.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Department of Urology, Slovak Medical University, Bratislava, Slovakia (J.B.); and Pfizer, Milan (P.G., M.L.), and Collegeville, PA (M.C.).
Allan J PantuckFrom the Department of Medical Oncology, Bordeaux University Hospital, Bordeaux (A.R.), Department of Medical Oncology, Institut Gustave Roussy, Villejuif (B.E.), Medical Oncology, Centre Eugene Marquis, Rennes (B.L.), and Department of Urology, Bicêtre Hospital, Paris-Saclay University, Le Kremlin Bicêtre (J.-J.P.) - all in France; Department of Medicine, Memorial Sloan Kettering Cancer Center (R.J.M.), and Pfizer (K.R.) - both in New York; Department of Clinical and Experimental Medicine, University of Surrey, Surrey, United Kingdom (H.S.P.); Division of Medical Oncology, Duke Cancer Institute, Durham, NC (D.J.G.); Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles (A.J.P.), and Pfizer, La Jolla (X.L., J.-F.M.) - both in California; Spire Roding Hospital, London (A.P.); Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Department of Oncology, Aarhus University Hospital, Aarhus, Denmark (F.D.); Department of Urology, Charité Universitätsmedizin Berlin, Berlin (A.M.), and Department of Urology, University Hospital of Munich, Munich (M.S.) - both in Germany; Divisions of Oncology and Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy (G.C.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Department of Urology, Slovak Medical University, Bratislava, Slovakia (J.B.); and Pfizer, Milan (P.G., M.L.), and Collegeville, PA (M.C.).
Anup PatelFrom the Department of Medical Oncology, Bordeaux University Hospital, Bordeaux (A.R.), Department of Medical Oncology, Institut Gustave Roussy, Villejuif (B.E.), Medical Oncology, Centre Eugene Marquis, Rennes (B.L.), and Department of Urology, Bicêtre Hospital, Paris-Saclay University, Le Kremlin Bicêtre (J.-J.P.) - all in France; Department of Medicine, Memorial Sloan Kettering Cancer Center (R.J.M.), and Pfizer (K.R.) - both in New York; Department of Clinical and Experimental Medicine, University of Surrey, Surrey, United Kingdom (H.S.P.); Division of Medical Oncology, Duke Cancer Institute, Durham, NC (D.J.G.); Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles (A.J.P.), and Pfizer, La Jolla (X.L., J.-F.M.) - both in California; Spire Roding Hospital, London (A.P.); Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Department of Oncology, Aarhus University Hospital, Aarhus, Denmark (F.D.); Department of Urology, Charité Universitätsmedizin Berlin, Berlin (A.M.), and Department of Urology, University Hospital of Munich, Munich (M.S.) - both in Germany; Divisions of Oncology and Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy (G.C.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Department of Urology, Slovak Medical University, Bratislava, Slovakia (J.B.); and Pfizer, Milan (P.G., M.L.), and Collegeville, PA (M.C.).
Yen-Hwa ChangFrom the Department of Medical Oncology, Bordeaux University Hospital, Bordeaux (A.R.), Department of Medical Oncology, Institut Gustave Roussy, Villejuif (B.E.), Medical Oncology, Centre Eugene Marquis, Rennes (B.L.), and Department of Urology, Bicêtre Hospital, Paris-Saclay University, Le Kremlin Bicêtre (J.-J.P.) - all in France; Department of Medicine, Memorial Sloan Kettering Cancer Center (R.J.M.), and Pfizer (K.R.) - both in New York; Department of Clinical and Experimental Medicine, University of Surrey, Surrey, United Kingdom (H.S.P.); Division of Medical Oncology, Duke Cancer Institute, Durham, NC (D.J.G.); Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles (A.J.P.), and Pfizer, La Jolla (X.L., J.-F.M.) - both in California; Spire Roding Hospital, London (A.P.); Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Department of Oncology, Aarhus University Hospital, Aarhus, Denmark (F.D.); Department of Urology, Charité Universitätsmedizin Berlin, Berlin (A.M.), and Department of Urology, University Hospital of Munich, Munich (M.S.) - both in Germany; Divisions of Oncology and Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy (G.C.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Department of Urology, Slovak Medical University, Bratislava, Slovakia (J.B.); and Pfizer, Milan (P.G., M.L.), and Collegeville, PA (M.C.).
Bernard EscudierFrom the Department of Medical Oncology, Bordeaux University Hospital, Bordeaux (A.R.), Department of Medical Oncology, Institut Gustave Roussy, Villejuif (B.E.), Medical Oncology, Centre Eugene Marquis, Rennes (B.L.), and Department of Urology, Bicêtre Hospital, Paris-Saclay University, Le Kremlin Bicêtre (J.-J.P.) - all in France; Department of Medicine, Memorial Sloan Kettering Cancer Center (R.J.M.), and Pfizer (K.R.) - both in New York; Department of Clinical and Experimental Medicine, University of Surrey, Surrey, United Kingdom (H.S.P.); Division of Medical Oncology, Duke Cancer Institute, Durham, NC (D.J.G.); Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles (A.J.P.), and Pfizer, La Jolla (X.L., J.-F.M.) - both in California; Spire Roding Hospital, London (A.P.); Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Department of Oncology, Aarhus University Hospital, Aarhus, Denmark (F.D.); Department of Urology, Charité Universitätsmedizin Berlin, Berlin (A.M.), and Department of Urology, University Hospital of Munich, Munich (M.S.) - both in Germany; Divisions of Oncology and Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy (G.C.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Department of Urology, Slovak Medical University, Bratislava, Slovakia (J.B.); and Pfizer, Milan (P.G., M.L.), and Collegeville, PA (M.C.).
Frede DonskovFrom the Department of Medical Oncology, Bordeaux University Hospital, Bordeaux (A.R.), Department of Medical Oncology, Institut Gustave Roussy, Villejuif (B.E.), Medical Oncology, Centre Eugene Marquis, Rennes (B.L.), and Department of Urology, Bicêtre Hospital, Paris-Saclay University, Le Kremlin Bicêtre (J.-J.P.) - all in France; Department of Medicine, Memorial Sloan Kettering Cancer Center (R.J.M.), and Pfizer (K.R.) - both in New York; Department of Clinical and Experimental Medicine, University of Surrey, Surrey, United Kingdom (H.S.P.); Division of Medical Oncology, Duke Cancer Institute, Durham, NC (D.J.G.); Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles (A.J.P.), and Pfizer, La Jolla (X.L., J.-F.M.) - both in California; Spire Roding Hospital, London (A.P.); Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Department of Oncology, Aarhus University Hospital, Aarhus, Denmark (F.D.); Department of Urology, Charité Universitätsmedizin Berlin, Berlin (A.M.), and Department of Urology, University Hospital of Munich, Munich (M.S.) - both in Germany; Divisions of Oncology and Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy (G.C.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Department of Urology, Slovak Medical University, Bratislava, Slovakia (J.B.); and Pfizer, Milan (P.G., M.L.), and Collegeville, PA (M.C.).
Ahmed MagheliFrom the Department of Medical Oncology, Bordeaux University Hospital, Bordeaux (A.R.), Department of Medical Oncology, Institut Gustave Roussy, Villejuif (B.E.), Medical Oncology, Centre Eugene Marquis, Rennes (B.L.), and Department of Urology, Bicêtre Hospital, Paris-Saclay University, Le Kremlin Bicêtre (J.-J.P.) - all in France; Department of Medicine, Memorial Sloan Kettering Cancer Center (R.J.M.), and Pfizer (K.R.) - both in New York; Department of Clinical and Experimental Medicine, University of Surrey, Surrey, United Kingdom (H.S.P.); Division of Medical Oncology, Duke Cancer Institute, Durham, NC (D.J.G.); Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles (A.J.P.), and Pfizer, La Jolla (X.L., J.-F.M.) - both in California; Spire Roding Hospital, London (A.P.); Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Department of Oncology, Aarhus University Hospital, Aarhus, Denmark (F.D.); Department of Urology, Charité Universitätsmedizin Berlin, Berlin (A.M.), and Department of Urology, University Hospital of Munich, Munich (M.S.) - both in Germany; Divisions of Oncology and Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy (G.C.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Department of Urology, Slovak Medical University, Bratislava, Slovakia (J.B.); and Pfizer, Milan (P.G., M.L.), and Collegeville, PA (M.C.).
Giacomo CarteniFrom the Department of Medical Oncology, Bordeaux University Hospital, Bordeaux (A.R.), Department of Medical Oncology, Institut Gustave Roussy, Villejuif (B.E.), Medical Oncology, Centre Eugene Marquis, Rennes (B.L.), and Department of Urology, Bicêtre Hospital, Paris-Saclay University, Le Kremlin Bicêtre (J.-J.P.) - all in France; Department of Medicine, Memorial Sloan Kettering Cancer Center (R.J.M.), and Pfizer (K.R.) - both in New York; Department of Clinical and Experimental Medicine, University of Surrey, Surrey, United Kingdom (H.S.P.); Division of Medical Oncology, Duke Cancer Institute, Durham, NC (D.J.G.); Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles (A.J.P.), and Pfizer, La Jolla (X.L., J.-F.M.) - both in California; Spire Roding Hospital, London (A.P.); Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Department of Oncology, Aarhus University Hospital, Aarhus, Denmark (F.D.); Department of Urology, Charité Universitätsmedizin Berlin, Berlin (A.M.), and Department of Urology, University Hospital of Munich, Munich (M.S.) - both in Germany; Divisions of Oncology and Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy (G.C.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Department of Urology, Slovak Medical University, Bratislava, Slovakia (J.B.); and Pfizer, Milan (P.G., M.L.), and Collegeville, PA (M.C.).
Brigitte LaguerreFrom the Department of Medical Oncology, Bordeaux University Hospital, Bordeaux (A.R.), Department of Medical Oncology, Institut Gustave Roussy, Villejuif (B.E.), Medical Oncology, Centre Eugene Marquis, Rennes (B.L.), and Department of Urology, Bicêtre Hospital, Paris-Saclay University, Le Kremlin Bicêtre (J.-J.P.) - all in France; Department of Medicine, Memorial Sloan Kettering Cancer Center (R.J.M.), and Pfizer (K.R.) - both in New York; Department of Clinical and Experimental Medicine, University of Surrey, Surrey, United Kingdom (H.S.P.); Division of Medical Oncology, Duke Cancer Institute, Durham, NC (D.J.G.); Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles (A.J.P.), and Pfizer, La Jolla (X.L., J.-F.M.) - both in California; Spire Roding Hospital, London (A.P.); Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Department of Oncology, Aarhus University Hospital, Aarhus, Denmark (F.D.); Department of Urology, Charité Universitätsmedizin Berlin, Berlin (A.M.), and Department of Urology, University Hospital of Munich, Munich (M.S.) - both in Germany; Divisions of Oncology and Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy (G.C.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Department of Urology, Slovak Medical University, Bratislava, Slovakia (J.B.); and Pfizer, Milan (P.G., M.L.), and Collegeville, PA (M.C.).
Piotr TomczakFrom the Department of Medical Oncology, Bordeaux University Hospital, Bordeaux (A.R.), Department of Medical Oncology, Institut Gustave Roussy, Villejuif (B.E.), Medical Oncology, Centre Eugene Marquis, Rennes (B.L.), and Department of Urology, Bicêtre Hospital, Paris-Saclay University, Le Kremlin Bicêtre (J.-J.P.) - all in France; Department of Medicine, Memorial Sloan Kettering Cancer Center (R.J.M.), and Pfizer (K.R.) - both in New York; Department of Clinical and Experimental Medicine, University of Surrey, Surrey, United Kingdom (H.S.P.); Division of Medical Oncology, Duke Cancer Institute, Durham, NC (D.J.G.); Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles (A.J.P.), and Pfizer, La Jolla (X.L., J.-F.M.) - both in California; Spire Roding Hospital, London (A.P.); Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Department of Oncology, Aarhus University Hospital, Aarhus, Denmark (F.D.); Department of Urology, Charité Universitätsmedizin Berlin, Berlin (A.M.), and Department of Urology, University Hospital of Munich, Munich (M.S.) - both in Germany; Divisions of Oncology and Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy (G.C.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Department of Urology, Slovak Medical University, Bratislava, Slovakia (J.B.); and Pfizer, Milan (P.G., M.L.), and Collegeville, PA (M.C.).
Jan BrezaFrom the Department of Medical Oncology, Bordeaux University Hospital, Bordeaux (A.R.), Department of Medical Oncology, Institut Gustave Roussy, Villejuif (B.E.), Medical Oncology, Centre Eugene Marquis, Rennes (B.L.), and Department of Urology, Bicêtre Hospital, Paris-Saclay University, Le Kremlin Bicêtre (J.-J.P.) - all in France; Department of Medicine, Memorial Sloan Kettering Cancer Center (R.J.M.), and Pfizer (K.R.) - both in New York; Department of Clinical and Experimental Medicine, University of Surrey, Surrey, United Kingdom (H.S.P.); Division of Medical Oncology, Duke Cancer Institute, Durham, NC (D.J.G.); Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles (A.J.P.), and Pfizer, La Jolla (X.L., J.-F.M.) - both in California; Spire Roding Hospital, London (A.P.); Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Department of Oncology, Aarhus University Hospital, Aarhus, Denmark (F.D.); Department of Urology, Charité Universitätsmedizin Berlin, Berlin (A.M.), and Department of Urology, University Hospital of Munich, Munich (M.S.) - both in Germany; Divisions of Oncology and Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy (G.C.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Department of Urology, Slovak Medical University, Bratislava, Slovakia (J.B.); and Pfizer, Milan (P.G., M.L.), and Collegeville, PA (M.C.).
Paola GerlettiFrom the Department of Medical Oncology, Bordeaux University Hospital, Bordeaux (A.R.), Department of Medical Oncology, Institut Gustave Roussy, Villejuif (B.E.), Medical Oncology, Centre Eugene Marquis, Rennes (B.L.), and Department of Urology, Bicêtre Hospital, Paris-Saclay University, Le Kremlin Bicêtre (J.-J.P.) - all in France; Department of Medicine, Memorial Sloan Kettering Cancer Center (R.J.M.), and Pfizer (K.R.) - both in New York; Department of Clinical and Experimental Medicine, University of Surrey, Surrey, United Kingdom (H.S.P.); Division of Medical Oncology, Duke Cancer Institute, Durham, NC (D.J.G.); Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles (A.J.P.), and Pfizer, La Jolla (X.L., J.-F.M.) - both in California; Spire Roding Hospital, London (A.P.); Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Department of Oncology, Aarhus University Hospital, Aarhus, Denmark (F.D.); Department of Urology, Charité Universitätsmedizin Berlin, Berlin (A.M.), and Department of Urology, University Hospital of Munich, Munich (M.S.) - both in Germany; Divisions of Oncology and Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy (G.C.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Department of Urology, Slovak Medical University, Bratislava, Slovakia (J.B.); and Pfizer, Milan (P.G., M.L.), and Collegeville, PA (M.C.).
Mariajose LechugaFrom the Department of Medical Oncology, Bordeaux University Hospital, Bordeaux (A.R.), Department of Medical Oncology, Institut Gustave Roussy, Villejuif (B.E.), Medical Oncology, Centre Eugene Marquis, Rennes (B.L.), and Department of Urology, Bicêtre Hospital, Paris-Saclay University, Le Kremlin Bicêtre (J.-J.P.) - all in France; Department of Medicine, Memorial Sloan Kettering Cancer Center (R.J.M.), and Pfizer (K.R.) - both in New York; Department of Clinical and Experimental Medicine, University of Surrey, Surrey, United Kingdom (H.S.P.); Division of Medical Oncology, Duke Cancer Institute, Durham, NC (D.J.G.); Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles (A.J.P.), and Pfizer, La Jolla (X.L., J.-F.M.) - both in California; Spire Roding Hospital, London (A.P.); Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Department of Oncology, Aarhus University Hospital, Aarhus, Denmark (F.D.); Department of Urology, Charité Universitätsmedizin Berlin, Berlin (A.M.), and Department of Urology, University Hospital of Munich, Munich (M.S.) - both in Germany; Divisions of Oncology and Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy (G.C.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Department of Urology, Slovak Medical University, Bratislava, Slovakia (J.B.); and Pfizer, Milan (P.G., M.L.), and Collegeville, PA (M.C.).
Xun LinFrom the Department of Medical Oncology, Bordeaux University Hospital, Bordeaux (A.R.), Department of Medical Oncology, Institut Gustave Roussy, Villejuif (B.E.), Medical Oncology, Centre Eugene Marquis, Rennes (B.L.), and Department of Urology, Bicêtre Hospital, Paris-Saclay University, Le Kremlin Bicêtre (J.-J.P.) - all in France; Department of Medicine, Memorial Sloan Kettering Cancer Center (R.J.M.), and Pfizer (K.R.) - both in New York; Department of Clinical and Experimental Medicine, University of Surrey, Surrey, United Kingdom (H.S.P.); Division of Medical Oncology, Duke Cancer Institute, Durham, NC (D.J.G.); Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles (A.J.P.), and Pfizer, La Jolla (X.L., J.-F.M.) - both in California; Spire Roding Hospital, London (A.P.); Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Department of Oncology, Aarhus University Hospital, Aarhus, Denmark (F.D.); Department of Urology, Charité Universitätsmedizin Berlin, Berlin (A.M.), and Department of Urology, University Hospital of Munich, Munich (M.S.) - both in Germany; Divisions of Oncology and Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy (G.C.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Department of Urology, Slovak Medical University, Bratislava, Slovakia (J.B.); and Pfizer, Milan (P.G., M.L.), and Collegeville, PA (M.C.).
Jean-Francois MartiniFrom the Department of Medical Oncology, Bordeaux University Hospital, Bordeaux (A.R.), Department of Medical Oncology, Institut Gustave Roussy, Villejuif (B.E.), Medical Oncology, Centre Eugene Marquis, Rennes (B.L.), and Department of Urology, Bicêtre Hospital, Paris-Saclay University, Le Kremlin Bicêtre (J.-J.P.) - all in France; Department of Medicine, Memorial Sloan Kettering Cancer Center (R.J.M.), and Pfizer (K.R.) - both in New York; Department of Clinical and Experimental Medicine, University of Surrey, Surrey, United Kingdom (H.S.P.); Division of Medical Oncology, Duke Cancer Institute, Durham, NC (D.J.G.); Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles (A.J.P.), and Pfizer, La Jolla (X.L., J.-F.M.) - both in California; Spire Roding Hospital, London (A.P.); Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Department of Oncology, Aarhus University Hospital, Aarhus, Denmark (F.D.); Department of Urology, Charité Universitätsmedizin Berlin, Berlin (A.M.), and Department of Urology, University Hospital of Munich, Munich (M.S.) - both in Germany; Divisions of Oncology and Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy (G.C.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Department of Urology, Slovak Medical University, Bratislava, Slovakia (J.B.); and Pfizer, Milan (P.G., M.L.), and Collegeville, PA (M.C.).
Krishnan RamaswamyFrom the Department of Medical Oncology, Bordeaux University Hospital, Bordeaux (A.R.), Department of Medical Oncology, Institut Gustave Roussy, Villejuif (B.E.), Medical Oncology, Centre Eugene Marquis, Rennes (B.L.), and Department of Urology, Bicêtre Hospital, Paris-Saclay University, Le Kremlin Bicêtre (J.-J.P.) - all in France; Department of Medicine, Memorial Sloan Kettering Cancer Center (R.J.M.), and Pfizer (K.R.) - both in New York; Department of Clinical and Experimental Medicine, University of Surrey, Surrey, United Kingdom (H.S.P.); Division of Medical Oncology, Duke Cancer Institute, Durham, NC (D.J.G.); Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles (A.J.P.), and Pfizer, La Jolla (X.L., J.-F.M.) - both in California; Spire Roding Hospital, London (A.P.); Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Department of Oncology, Aarhus University Hospital, Aarhus, Denmark (F.D.); Department of Urology, Charité Universitätsmedizin Berlin, Berlin (A.M.), and Department of Urology, University Hospital of Munich, Munich (M.S.) - both in Germany; Divisions of Oncology and Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy (G.C.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Department of Urology, Slovak Medical University, Bratislava, Slovakia (J.B.); and Pfizer, Milan (P.G., M.L.), and Collegeville, PA (M.C.).
Michelle CaseyFrom the Department of Medical Oncology, Bordeaux University Hospital, Bordeaux (A.R.), Department of Medical Oncology, Institut Gustave Roussy, Villejuif (B.E.), Medical Oncology, Centre Eugene Marquis, Rennes (B.L.), and Department of Urology, Bicêtre Hospital, Paris-Saclay University, Le Kremlin Bicêtre (J.-J.P.) - all in France; Department of Medicine, Memorial Sloan Kettering Cancer Center (R.J.M.), and Pfizer (K.R.) - both in New York; Department of Clinical and Experimental Medicine, University of Surrey, Surrey, United Kingdom (H.S.P.); Division of Medical Oncology, Duke Cancer Institute, Durham, NC (D.J.G.); Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles (A.J.P.), and Pfizer, La Jolla (X.L., J.-F.M.) - both in California; Spire Roding Hospital, London (A.P.); Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Department of Oncology, Aarhus University Hospital, Aarhus, Denmark (F.D.); Department of Urology, Charité Universitätsmedizin Berlin, Berlin (A.M.), and Department of Urology, University Hospital of Munich, Munich (M.S.) - both in Germany; Divisions of Oncology and Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy (G.C.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Department of Urology, Slovak Medical University, Bratislava, Slovakia (J.B.); and Pfizer, Milan (P.G., M.L.), and Collegeville, PA (M.C.).
Michael StaehlerFrom the Department of Medical Oncology, Bordeaux University Hospital, Bordeaux (A.R.), Department of Medical Oncology, Institut Gustave Roussy, Villejuif (B.E.), Medical Oncology, Centre Eugene Marquis, Rennes (B.L.), and Department of Urology, Bicêtre Hospital, Paris-Saclay University, Le Kremlin Bicêtre (J.-J.P.) - all in France; Department of Medicine, Memorial Sloan Kettering Cancer Center (R.J.M.), and Pfizer (K.R.) - both in New York; Department of Clinical and Experimental Medicine, University of Surrey, Surrey, United Kingdom (H.S.P.); Division of Medical Oncology, Duke Cancer Institute, Durham, NC (D.J.G.); Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles (A.J.P.), and Pfizer, La Jolla (X.L., J.-F.M.) - both in California; Spire Roding Hospital, London (A.P.); Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Department of Oncology, Aarhus University Hospital, Aarhus, Denmark (F.D.); Department of Urology, Charité Universitätsmedizin Berlin, Berlin (A.M.), and Department of Urology, University Hospital of Munich, Munich (M.S.) - both in Germany; Divisions of Oncology and Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy (G.C.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Department of Urology, Slovak Medical University, Bratislava, Slovakia (J.B.); and Pfizer, Milan (P.G., M.L.), and Collegeville, PA (M.C.).
Jean-Jacques PatardFrom the Department of Medical Oncology, Bordeaux University Hospital, Bordeaux (A.R.), Department of Medical Oncology, Institut Gustave Roussy, Villejuif (B.E.), Medical Oncology, Centre Eugene Marquis, Rennes (B.L.), and Department of Urology, Bicêtre Hospital, Paris-Saclay University, Le Kremlin Bicêtre (J.-J.P.) - all in France; Department of Medicine, Memorial Sloan Kettering Cancer Center (R.J.M.), and Pfizer (K.R.) - both in New York; Department of Clinical and Experimental Medicine, University of Surrey, Surrey, United Kingdom (H.S.P.); Division of Medical Oncology, Duke Cancer Institute, Durham, NC (D.J.G.); Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles (A.J.P.), and Pfizer, La Jolla (X.L., J.-F.M.) - both in California; Spire Roding Hospital, London (A.P.); Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Department of Oncology, Aarhus University Hospital, Aarhus, Denmark (F.D.); Department of Urology, Charité Universitätsmedizin Berlin, Berlin (A.M.), and Department of Urology, University Hospital of Munich, Munich (M.S.) - both in Germany; Divisions of Oncology and Urology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Naples, Italy (G.C.); Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland (P.T.); Department of Urology, Slovak Medical University, Bratislava, Slovakia (J.B.); and Pfizer, Milan (P.G., M.L.), and Collegeville, PA (M.C.).
S-TRAC Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSunitinib, a vascular endothelial growth factor pathway inhibitor, is an effective treatment for metastatic renal-cell carcinoma. We sought to determine the efficacy and safety of sunitinib in patients with locoregional renal-cell carcinoma at high risk for tumor recurrence after nephrectomy.

methodsIn this randomized, double-blind, phase 3 trial, we assigned 615 patients with locoregional, high-risk clear-cell renal-cell carcinoma to receive either sunitinib (50 mg per day) or placebo on a 4-weeks-on, 2-weeks-off schedule for 1 year or until disease recurrence, unacceptable toxicity, or consent withdrawal. The primary end point was disease-free survival, according to blinded independent central review. Secondary end points included investigator-assessed disease-free survival, overall survival, and safety.

resultsThe median duration of disease-free survival was 6.8 years (95% confidence interval [CI], 5.8 to not reached) in the sunitinib group and 5.6 years (95% CI, 3.8 to 6.6) in the placebo group (hazard ratio, 0.76; 95% CI, 0.59 to 0.98; P=0.03). Overall survival data were not mature at the time of data cutoff. Dose reductions because of adverse events were more frequent in the sunitinib group than in the placebo group (34.3% vs. 2%), as were dose interruptions (46.4% vs. 13.2%) and discontinuations (28.1% vs. 5.6%). Grade 3 or 4 adverse events were more frequent in the sunitinib group (48.4% for grade 3 events and 12.1% for grade 4 events) than in the placebo group (15.8% and 3.6%, respectively). There was a similar incidence of serious adverse events in the two groups (21.9% for sunitinib vs. 17.1% for placebo); no deaths were attributed to toxic effects.

conclusionsAmong patients with locoregional clear-cell renal-cell carcinoma at high risk for tumor recurrence after nephrectomy, the median duration of disease-free survival was significantly longer in the sunitinib group than in the placebo group, at a cost of a higher rate of toxic events. (Funded by Pfizer; S-TRAC ClinicalTrials.gov number, NCT00375674 .).

Indexed as

NephrectomyAdolescentAdultAgedAged, 80 and overAntineoplastic AgentsCarcinoma, Renal CellChemotherapy, AdjuvantDouble-Blind MethodDrug Administration ScheduleFemaleHumansIndolesKidney NeoplasmsMaleMiddle AgedAntineoplastic AgentsIndolesPyrrolesSunitinib

Identifiers

PMID27718781

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