Evidence map›Paper›PMID 20837357›Full record

Trial reportGynecologic oncology2010

Erlotinib added to carboplatin and paclitaxel as first-line treatment of ovarian cancer: a phase II study based on surgical reassessment.

Stephanie V Blank, Paul Christos, John P Curtin, Noah Goldman, Carolyn D Runowicz, Joseph A Sparano, Leonard Liebes, Helen X Chen, Franco M Muggia

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Gynecologic oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00059787 (Phase II Study of Erlotinib Plus Carboplatin and Paclitaxel in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma), which is not on this map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
6.2field-weighted citation impact, top 4% 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.

NCT00059787 phase2completednot on this map

Phase II Study of Erlotinib Plus Carboplatin and Paclitaxel in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2003 to 2010Enrolled56ConditionsBrenner Tumor, Fallopian Tube Cancer, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid AdenocarcinomaArmspaclitaxel, carboplatin, erlotinib
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 1 synthesis or guideline pooled it, 57 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Review
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  9. Review
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  11. Article
  12. Review
  13. Article
  14. Integrative Kinome Profiling Identifies mTORC1/2 Inhibition as Treatment Strategy in Ovarian Clear Cell Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2018
    Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. The rise of genomic profiling in ovarian cancer.Expert review of molecular diagnostics · 2016
    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

9 authors at 5 institutions in 1 country.

Stephanie V BlankDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, New York University School of Medicine, New York, NY, USA.
Paul Christos
John P Curtin
Noah Goldman
Carolyn D Runowicz
Joseph A Sparano
Leonard Liebes
Helen X Chen
Franco M Muggia
New York University · USAlbert Einstein College of Medicine · USCornell University · USNational Institutes of Health · USUConn Health · US

Funding

ZOPOLRESTAT IN SUBJECTS W/ PERIPHERAL SYMMETRICAL DIABETIC POLYNEUROPATHYM01RR000096 · NCRR · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI NOVIK, YELENA · 1985 to 2008
$34.8M
NCI NIH HHS N01 CM017103NCI NIH HHS N01 CM062204NCI NIH HHS N01-CM-62204NCRR NIH HHS M01 RR000096NCRR NIH HHS M01-RR-00096
6 · The paper itself

Abstract

backgroundThe purpose of this study was to determine whether adding the anti-epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor erlotinib to carboplatin/paclitaxel improved pathologic complete response (pCR) at reassessment surgery in epithelial ovarian, fallopian tube, or primary peritoneal cancers (OFPC).

methodsPatients with stage III-IV OFPC initiated treatment within 12 weeks of initial cytoreductive surgery or, after histologic confirmation of diagnosis, neoadjuvantly. Treatment included paclitaxel (175 mg/m²) and carboplatin (AUC 6) every 3 weeks for up to 6 cycles, plus oral erlotinib 150 mg daily. The primary objective was to determine whether the pCR rate at reassessment surgery was at least 60% after optimal cytoreduction at initial surgery (< 1cm residual disease), or at least 40% after suboptimal cytoreduction (at least 1cm residual disease) using a two-stage design (alpha=0.10, beta=0.10).

resultsThe study population included 56 patients with stage III-IV OFPC. EGFR gene amplification was present in 15% of the 20 tumors evaluated. Twenty-eight patients had protocol therapy after optimal cytoreduction (stratum I), 23 had protocol therapy either after suboptimal cytoreduction (stratum II), and 5 received neoadjuvant therapy prior to cytoreduction (stratum III). Pathologic CR was confirmed in 8 patients (29%; 95% confidence intervals 13%, 49%) in stratum I and 3 patients (11%, 95% C.I. 2%, 28%) in stratum II, which did not meet the prespecified efficacy endpoint in either stratum.

conclusionsAmong unselected patients, erlotinib plus carboplatin-paclitaxel did not improve pCR rates compared with historical experience with carboplatin-paclitaxel alone in patients with stage III-IV OFPC.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinChemotherapy, AdjuvantDisease-Free SurvivalErbB ReceptorsErlotinib HydrochlorideFallopian Tube NeoplasmsFemaleGene AmplificationGenes, erbB-1HumansMiddle AgedNeoadjuvant TherapyNeoplasm StagingCarboplatinErbB ReceptorsErlotinib HydrochloridePaclitaxelQuinazolines

Identifiers

PMID20837357
PMCPMC3446254
OpenAlexW1974028385

What OpenQuestion holds

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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.