Evidence map›Paper›PMID 21784672›Full record

Trial reportUrologic oncology2013

Eastern Cooperative Oncology Group Phase II Trial of lapatinib in men with biochemically relapsed, androgen dependent prostate cancer.

Glenn Liu, Yu-Hui Chen, Jill Kolesar, Wei Huang, Robert Dipaola, Michael Pins, Michael Carducci, Mark Stein, Glenn J Bubley, George Wilding

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Urologic oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00103194 (Phase II Trial of GW572016 in Patients With Recurrent Prostate Cancer as Evident by a Rising PSA), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.0field-weighted citation impact, top 13% 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.

NCT00103194 phase2completednot on this map

Phase II Trial of GW572016 in Patients With Recurrent Prostate Cancer as Evident by a Rising PSA

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2005 to 2013Enrolled49ConditionsRecurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate CancerArmslapatinib ditosylate, laboratory biomarker analysis
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 26 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Review
  5. Article
  6. Article
  7. Androgen Deprivation Therapy Potentiates the Efficacy of Vascular Targeted Photodynamic Therapy of Prostate Cancer Xenografts.Clinical cancer research : an official journal of the American Association for Cancer Research · 2018
    Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Novel therapeutic approaches for the treatment of castration-resistant prostate cancer.The Journal of steroid biochemistry and molecular biology · 2013
    Review
  13. Review
  14. Review
  15. Review
  16. Review
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

10 authors at 6 institutions in 1 country.

Glenn LiuUniversity of Wisconsin Carbone Cancer Center, Madison, WI 53705, USA. gxl@medicine.wisc.edu
Yu-Hui Chen
Jill Kolesar
Wei Huang
Robert Dipaola
Michael Pins
Michael Carducci
Mark Stein
Glenn J Bubley
George Wilding
University of Wisconsin Carbone Cancer Center · USRutgers Cancer Institute of New JerseyDana-Farber Cancer Institute · USHarvard University Press · USIllinois College · USJohns Hopkins University · US

Funding

UW COMPREHENSIVE CANCER CENTER SUPPORTP30CA014520 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI AMY TRENTHAM-DIETZ · 1985 to 2026
$142.6M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
ECOG Statistical Office Data Management GrantU10CA066636 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI GRAY, ROBERT J · 1994 to 2013
$39.5M
PROVIDE STATISTICAL SERVICESU10CA023318 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRAY, ROBERT J · 1985 to 2013
$33.4M
ECOG Specimen BankingU24CA114737 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI COMIS, ROBERT L · 2005 to 2014
$9.3M
EASTERN COOPERATIVE ONCOLOGY GROUP--WISCONSIN STUDIESU10CA021076 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI KAHL, BRAD · 1985 to 2013
$8.2M
EASTERN COOPERATIVE ONCOLOGY GROUPU10CA016116 · NCI · JOHNS HOPKINS UNIVERSITY · PI FORASTIERE, ARLENE ANN · 1985 to 2013
$4.0M
Participation in the Eastern Cooperative Oncology GroupU10CA107868 · NCI · UNIV OF MED/DENT NJ-R W JOHNSON MED SCH · PI AISNER, JOSEPH · 2004 to 2013
$2.3M
EASTERN COOPERATIVE ONCOLOGY GROUPU10CA080775 · NCI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI BUBLEY, GLENN J · 1999 to 2013
$1.7M
NCI NIH HHS CA107868NCI NIH HHS CA16116NCI NIH HHS CA21076NCI NIH HHS CA21115NCI NIH HHS CA23318NCI NIH HHS CA66636NCI NIH HHS CA80775NCI NIH HHS P30 CA014520NCI NIH HHS U10 CA016116NCI NIH HHS U10 CA021076NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA023318NCI NIH HHS U10 CA066636NCI NIH HHS U10 CA080775NCI NIH HHS U10 CA107868NCI NIH HHS U24 CA114737
6 · The paper itself

Abstract

purposeActivation of the epidermal growth factor pathway is important in prostate cancer development and the transcription of androgen receptor regulated genes. This study evaluated the potential activity of lapatinib in men with biochemically-relapsed androgen-dependent (stage D0) prostate cancer. PATIENTS AND

methodsPatients with a rising PSA after primary therapy for prostate cancer were enrolled. A PSA doubling time (PSADT) <12 months was required. Lapatinib was administered at 1,500 mg orally daily. Outcome measures were changes in PSA kinetics. Primary tumor blocks were obtained and assessed for EGFR expression, EGFR Q787Q polymorphism, and Kras 38 mutational status.

resultsForty-nine patients were enrolled (14 ineligible), resulting in 35 patients for analysis. No PSA response was observed; best response was stable disease (n = 28, 80.0%). Pretreatment average slope was 0.19 log (PSA)/month (PSADT = 3.70 months), in contrast to on-treatment average slope of 0.13 log (PSA)/month (PSADT = 5.44 months) using linear mixed effects models (P = 0.006). Median progression-free survival (PFS) was 17.4 months for the high EGFR group and 6.0 months for the low EGFR group (P = 0.50). Patients with Kras 38 mutation had shorter PFS than those without Kras 38 mutation (P = 0.09).

conclusionAlthough no PSA responses (primary endpoint) was observed, lapatinib may have biologic activity in men with stage D0 prostate cancer as evidenced by a decrease in PSA slope in this non-randomized study. Additional trials assessing the role of EGFR overexpression and Kras wild type status in prostate cancer should be investigated.

Indexed as

AgedAged, 80 and overAntineoplastic AgentsDisease-Free SurvivalErbB ReceptorsHumansKaplan-Meier EstimateLapatinibMaleMiddle AgedMutationNeoplasm Recurrence, LocalNeoplasm StagingPolymorphism, Single NucleotideProstate-Specific AntigenProstatic NeoplasmsAntineoplastic AgentsErbB ReceptorsKRAS protein, humanLapatinibProstate-Specific AntigenProto-Oncogene ProteinsProto-Oncogene Proteins p21(ras)Quinazolinesras Proteins

Identifiers

PMID21784672
PMCPMC3223557
OpenAlexW2084853079

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Registered trials

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.