Evidence map›Paper›PMID 24323035›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2014

Randomized, placebo-controlled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castration-resistant prostate cancer.

M Dror Michaelson, Stephane Oudard, Yen-Chuan Ou, Lisa Sengeløv, Fred Saad, Nadine Houede, Peter Ostler, Arnulf Stenzl, Gedske Daugaard, Robert Jones and 11 more

Abstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 94 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
94citing papers in PubMed, 5 pooled it
19.0field-weighted citation impact, top 1% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

94 citing papers in PubMed, 5 syntheses or guidelines pooled it, 189 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Review
  19. Review
  20. Review

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 1 institution in 1 country.

M Dror MichaelsonM. Dror Michaelson, Massachusetts General Hospital Cancer Center, Boston, MA; Stephane Oudard, George Pompidou European Hospital, Rene Descartes University, Paris; Nadine Houede, Institut Bergonie, Bordeaux; Tristan Maurina, CHU de Besançon, Hôpital Jean Minjoz, Besançon, France; Yen-Chuan Ou, Taichung Veterans General Hospital, Taichung, Taiwan; Lisa Sengeløv, Herlev Hospital, Herlev; Gedske Daugaard, Rigshospitalet, Copenhagen, Denmark; Fred Saad, University of Montreal, Montreal, Canada; Peter Ostler, Mount Vernon Hospital, Northwood, Middlesex; Robert Jones, Beatson West of Scotland Cancer Centre, Glasgow; Amit Bahl, Bristol Haematology and Oncology Centre, Bristol, UK; Arnulf Stenzl, Eberhard-Karls-University Medical School, Tübingen; Juergen Gschwend, Technical University of Munich, Munich, Germany; Fredrik Laestadius and Anders Ullèn, Karolinska University Hospital, Stockholm, Sweden; Daniel Castellano, I_12 Research Institute, University Hospital 12 de Octubre, Madrid, Spain; Edna Chow Maneval, Shaw-Ling Wang, and Isan Chen, Pfizer Oncology, La Jolla, CA; and Maria Jose Lechuga and Jolanda Paolini, Pfizer Oncology, Milan, Italy.
Stephane Oudard
Yen-Chuan Ou
Lisa Sengeløv
Fred Saad
Nadine Houede
Peter Ostler
Arnulf Stenzl
Gedske Daugaard
Robert Jones
Fredrik Laestadius
Anders Ullèn
Amit Bahl
Daniel Castellano
Juergen Gschwend
Tristan Maurina
Edna Chow Maneval
Shaw-Ling Wang
Maria Jose Lechuga
Jolanda Paolini
Isan Chen
Taichung Veterans General Hospital · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe evaluated angiogenesis-targeted sunitinib therapy in a randomized, double-blind trial of metastatic castration-resistant prostate cancer (mCRPC). PATIENTS AND

methodsMen with progressive mCRPC after docetaxel-based chemotherapy were randomly assigned 2:1 to receive sunitinib 37.5 mg/d continuously or placebo. Patients also received oral prednisone 5 mg twice daily. The primary end point was overall survival (OS); secondary end points included progression-free survival (PFS). Two interim analyses were planned.

resultsOverall, 873 patients were randomly assigned to receive sunitinib (n = 584) or placebo (n = 289). The independent data monitoring committee stopped the study for futility after the second interim analysis. After a median overall follow-up of 8.7 months, median OS was 13.1 months and 11.8 months for sunitinib and placebo, respectively (hazard ratio [HR], 0.914; 95% CI, 0.762 to 1.097; stratified log-rank test, P = .168). PFS was significantly improved in the sunitinib arm (median 5.6 v 4.1 months; HR, 0.725; 95% CI, 0.591 to 0.890; stratified log-rank test, P < .001). Toxicity and rates of discontinuations because of adverse events (AEs; 27% v 7%) were greater with sunitinib than placebo. The most common treatment-related grade 3/4 AEs were fatigue (9% v 1%), asthenia (8% v 2%), and hand-foot syndrome (7% v 0%). Frequent treatment-emergent grade 3/4 hematologic abnormalities were lymphopenia (20% v 11%), anemia (9% v 8%), and neutropenia (6% v < 1%).

conclusionThe addition of sunitinib to prednisone did not improve OS compared with placebo in docetaxel-refractory mCRPC. The role of antiangiogenic therapy in mCRPC remains investigational.

Indexed as

AdultAgedAged, 80 and overAnemiaAntineoplastic Combined Chemotherapy ProtocolsAstheniaDisease-Free SurvivalDisease ProgressionDocetaxelDouble-Blind MethodDrug Administration ScheduleDrug Resistance, NeoplasmFatigueHumansIndolesKaplan-Meier EstimateDocetaxelIndolesPrednisonePyrrolesSunitinibTaxoids

Identifiers

PMID24323035
OpenAlexW2161306413

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.