Evidence map›Paper›PMID 21821830›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2012

Sunitinib in combination with docetaxel and prednisone in chemotherapy-naive patients with metastatic, castration-resistant prostate cancer: a phase 1/2 clinical trial.

A J Zurita, D J George, N D Shore, G Liu, G Wilding, T E Hutson, M Kozloff, P Mathew, C S Harmon, S L Wang and 3 more

Abstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
–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.

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

24 citing papers in PubMed.

  1. Trial
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  11. Review
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  15. Article
  16. Novel therapeutic approaches for the treatment of castration-resistant prostate cancer.The Journal of steroid biochemistry and molecular biology · 2013
    Review
  17. Review
  18. Review
  19. Targeting angiogenesis for the treatment of prostate cancer.Expert opinion on therapeutic targets · 2012
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

A J ZuritaDepartment of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston. Electronic address: azurita@mdanderson.org.
D J GeorgeDivisions of Medical Oncology and Urology, Duke University Medical Center, Durham.
N D ShoreCarolina Urologic Research Center, Myrtle Beach.
G LiuHematology/Oncology Division, University of Wisconsin Carbone Cancer Center, Madison.
G WildingHematology/Oncology Division, University of Wisconsin Carbone Cancer Center, Madison.
T E HutsonGenitourinary Oncology Program, Baylor Sammons Cancer Center-Texas Oncology, P.A., Dallas.
M KozloffCancer Research Center, Ingalls Memorial Hospital, Harvey.
P MathewDepartment of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston.
C S HarmonDepartments of Translational Oncology.
S L WangDepartments of Clinical Statistics.
I ChenDepartments of Clinical Development, Pfizer Oncology, La Jolla, USA.
E Chow ManevalDepartments of Clinical Development, Pfizer Oncology, La Jolla, USA.
C J LogothetisDepartment of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundThis phase 1/2 study assessed sunitinib combined with docetaxel (Taxotere) and prednisone in chemotherapy-naive metastatic, castration-resistant prostate cancer (mCRPC) patients. PATIENTS AND

methodsTo determine the recommended phase 2 dose (RP2D), 25 patients in four dose escalation cohorts received 3-week cycles of sunitinib (2 weeks on, 1 week off), docetaxel and prednisone, preceded by a 4-week sunitinib 50 mg/day lead in. RP2D was evaluated in 55 additional patients. The primary end point was prostate-specific antigen (PSA) response rate.

resultsOne phase 1 dose-limiting toxicity occurred (grade 3 hyponatremia). The RP2D was sunitinib 37.5 mg/day, docetaxel 75 mg/m(2) and prednisone 5 mg b.i.d. During phase 2, confirmed PSA responses occurred in 31 patients [56.4% (95% confidence interval 42.3-69.7)]. Median time to PSA progression was 9.8 months. Forty-one patients (75%) were treated >3 months, 12 (22%) completed the study (16 cycles) and 43 (78%) discontinued (36% for disease progression and 27% adverse events). The most frequent treatment-related grade 3/4 adverse events were neutropenia (53%; 15% febrile) and fatigue/asthenia (16%). Among 33 assessable patients, 14 (42.4%) had confirmed partial response. Median progression-free and overall survivals were 12.6 and 21.7 months, respectively.

conclusionThis combination was moderately well tolerated, with promising response rate and survival benefit, justifying further investigation in mCRPC.

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalDocetaxelDrug Resistance, NeoplasmHumansIndolesKaplan-Meier EstimateMaleMaximum Tolerated DoseMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalPrednisoneProstate-Specific AntigenDocetaxelIndolesPrednisoneProstate-Specific AntigenPyrrolesSunitinibTaxoids

Identifiers

PMID21821830
PMCPMC4415089

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.