PMID- 30412222
OWN - NLM
STAT- MEDLINE
DCOM- 20191125
LR  - 20210109
IS  - 1569-8041 (Electronic)
IS  - 0923-7534 (Print)
IS  - 0923-7534 (Linking)
VI  - 29
IP  - 10
DP  - 2018 Oct 1
TI  - Adjuvant sunitinib in patients with high-risk renal cell carcinoma: safety, 
      therapy management, and patient-reported outcomes in the S-TRAC trial.
PG  - 2098-2104
LID - S0923-7534(19)34202-4 [pii]
LID - 10.1093/annonc/mdy329 [doi]
AB  - BACKGROUND: Adjuvant sunitinib has significantly improved disease-free survival 
      versus placebo in patients with renal cell carcinoma at high risk of recurrence 
      post-nephrectomy (hazard ratio 0.76; 95% confidence interval, 0.59-0.98; 
      two-sided P = 0.03). We report safety, therapy management, and patient-reported 
      outcomes for patients receiving sunitinib and placebo in the S-TRAC trial. 
      PATIENTS AND METHODS: Patients were stratified by the University of California, 
      Los Angeles Integrated Staging System and Eastern Cooperative Oncology Group 
      performance status score, and randomized (1 : 1) to receive sunitinib (50 mg/day) 
      or placebo. Single dose reductions to 37.5 mg, dose delays, and dose 
      interruptions were used to manage adverse events (AEs). Patients' health-related 
      quality of life, including key symptoms typically associated with sunitinib, were 
      evaluated with the European Organisation for Research and Treatment of Cancer 
      Quality of Life Questionnaire (EORTC QLQ-C30). RESULTS: Patients maintained 
      treatment for 9.5 (mean, SD 4.4) and 10.3 (mean, SD 3.7) months in the sunitinib 
      and placebo arms, respectively. In the sunitinib arm, key AEs occurred  approximately 1 month 
      (median) after start of treatment and resolved within  approximately 3.5 weeks (median). Many 
      (40.6%) AEs leading to permanent discontinuation were grade 1/2, and most (87.2%) 
      resolved or were resolving by 28 days after last treatment. Patients taking 
      sunitinib showed a significantly lower EORTC QLQ-C30 overall health status score 
      versus placebo, although this reduction was not clinically meaningful. Patients 
      reported symptoms typically related to sunitinib treatment with diarrhea and loss 
      of appetite showing clinically meaningful increases. CONCLUSIONS: In S-TRAC, AEs 
      were predictable, manageable, and reversible via dose interruptions, dose 
      reductions, and/or standard supportive medical therapy. Patients on sunitinib did 
      report increased symptoms and reduced HRQoL, but these changes were generally not 
      clinically meaningful, apart from appetite loss and diarrhea, and were expected 
      in the context of known sunitinib effects. CLINICAL TRIAL REGISTRATION: 
      ClinicalTrials.gov, NCT00375674.
FAU - Staehler, M
AU  - Staehler M
AD  - Department of Urology, University Hospital of Munich, Munich, Germany. Electronic 
      address: michael.staehler@med.uni-muenchen.de.
FAU - Motzer, R J
AU  - Motzer RJ
AD  - Department of Oncology, Memorial Sloan Kettering Cancer Center, New York, USA.
FAU - George, D J
AU  - George DJ
AD  - Division of Oncology, Duke Cancer Center, Durham, USA.
FAU - Pandha, H S
AU  - Pandha HS
AD  - Department of Clinical and Experimental Medicine, University of Surrey, Surrey, 
      UK; Department of Microbial Sciences, University of Surrey, Surrey, UK.
FAU - Donskov, F
AU  - Donskov F
AD  - Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.
FAU - Escudier, B
AU  - Escudier B
AD  - Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France.
FAU - Pantuck, A J
AU  - Pantuck AJ
AD  - Department of Urology, Ronald Reagan UCLA Medical Center, Los Angeles, USA.
FAU - Patel, A
AU  - Patel A
AD  - Spire Roding Hospital, London, UK.
FAU - DeAnnuntis, L
AU  - DeAnnuntis L
AD  - Pfizer Inc., Collegeville, USA.
FAU - Bhattacharyya, H
AU  - Bhattacharyya H
AD  - Pfizer Inc., New York, USA.
FAU - Ramaswamy, K
AU  - Ramaswamy K
AD  - Pfizer Inc., New York, USA.
FAU - Zanotti, G
AU  - Zanotti G
AD  - Pfizer Inc., New York, USA.
FAU - Lin, X
AU  - Lin X
AD  - Pfizer Inc., La Jolla, USA.
FAU - Lechuga, M
AU  - Lechuga M
AD  - Pfizer S.r.L, Milan, Italy.
FAU - Serfass, L
AU  - Serfass L
AD  - Pfizer Oncology, Paris, France.
FAU - Paty, J
AU  - Paty J
AD  - Quintiles IMS, Pittsburg, USA.
FAU - Ravaud, A
AU  - Ravaud A
AD  - Department of Medical Oncology, Bordeaux University Hospital, Bordeaux, France.
LA  - eng
SI  - ClinicalTrials.gov/NCT00375674
GR  - P30 CA008748/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Antineoplastic Agents)
RN  - V99T50803M (Sunitinib)
SB  - IM
CIN - Ann Oncol. 2018 Oct 1;29(10):2030-2032. PMID: 30184148
MH  - Antineoplastic Agents/*therapeutic use
MH  - Carcinoma, Renal Cell/*drug therapy/pathology
MH  - Chemotherapy, Adjuvant
MH  - Disease Management
MH  - Double-Blind Method
MH  - Follow-Up Studies
MH  - Humans
MH  - International Agencies
MH  - Kidney Neoplasms/*drug therapy/pathology
MH  - Neoplasm Recurrence, Local/*drug therapy/pathology
MH  - *Patient Reported Outcome Measures
MH  - Prognosis
MH  - Prospective Studies
MH  - *Quality of Life
MH  - Sunitinib/*therapeutic use
MH  - Survival Rate
PMC - PMC6247664
EDAT- 2018/11/10 06:00
MHDA- 2019/11/26 06:00
PMCR- 2018/08/23
CRDT- 2018/11/10 06:00
PHST- 2018/11/10 06:00 [entrez]
PHST- 2018/11/10 06:00 [pubmed]
PHST- 2019/11/26 06:00 [medline]
PHST- 2018/08/23 00:00 [pmc-release]
AID - S0923-7534(19)34202-4 [pii]
AID - mdy329 [pii]
AID - 10.1093/annonc/mdy329 [doi]
PST - ppublish
SO  - Ann Oncol. 2018 Oct 1;29(10):2098-2104. doi: 10.1093/annonc/mdy329.