Evidence map›Paper›PMID 25556916›Full record

Trial reportCancer medicine2015

Paclitaxel/carboplatin with or without sorafenib in the first-line treatment of patients with stage III/IV epithelial ovarian cancer: a randomized phase II study of the Sarah Cannon Research Institute.

John D Hainsworth, Dana S Thompson, John A Bismayer, Victor G Gian, William M Merritt, Robert C Whorf, Lindsey H Finney, B Stephens Dudley

Open access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 8 pooled it
8.8field-weighted citation impact, top 2% 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

35 citing papers in PubMed, 8 syntheses or guidelines pooled it, 58 citations in OpenAlex.

  1. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Guideline
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  9. Review
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  11. Article
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  15. International journal of oncology · 2022
    Article
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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

8 authors at 4 institutions in 1 country.

John D HainsworthSarah Cannon Research Institute, Nashville, Tennessee.
Dana S ThompsonSarah Cannon Research Institute, Nashville, Tennessee.
John A BismayerSarah Cannon Research Institute, Nashville, Tennessee.
Victor G GianSarah Cannon Research Institute, Nashville, Tennessee.
William M MerrittSarah Cannon Research Institute, Nashville, Tennessee.
Robert C WhorfSarah Cannon Research Institute, Nashville, Tennessee.
Lindsey H FinneySarah Cannon Research Institute, Nashville, Tennessee.
B Stephens DudleySarah Cannon Research Institute, Nashville, Tennessee.
Sarah Cannon · USTennessee Oncology · USFlorida Cancer Specialists & Research Institute · USSouth Carolina Oncology Associates · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This trial compared the efficacy and toxicity of standard first-line treatment with paclitaxel/carboplatin versus paclitaxel/carboplatin plus sorafenib in patients with advanced ovarian carcinoma. Patients with stage 3 or 4 epithelial ovarian cancer with residual measurable disease or elevated CA-125 levels after maximal surgical cytoreduction were randomized (1:1) to receive treatment with paclitaxel (175 mg/m(2) , 3 h infusion, day 1) and carboplatin (AUC 6.0, IV, day 1) with or without sorafenib 400 mg orally twice daily (PO BID). Patients were reevaluated for response after completing 6 weeks of treatment (two cycles); responding or stable patients received six cycles of paclitaxel/carboplatin. Patients receiving the sorafenib-containing regimen continued sorafenib (400 PO BID) for a total of 52 weeks. Eighty-five patients were randomized and received treatment.Efficacy was similar for patients receiving paclitaxel/carboplatin/sorafenib versus paclitaxel/carboplatin: overall response rates 69% versus 74%; median progression-free survival 15.4 versus 16.3 months; 2 year survival 76% versus 81%. The addition of sorafenib added substantially to the toxicity of the regimen; rash, hand-foot syndrome, mucositis, and hypertension were significantly more common in patients treated with sorafenib. The addition of sorafenib to standard paclitaxel/carboplatin did not improve efficacy and substantially increased toxicity in the first-line treatment of advanced epithelial ovarian cancer. Based on evidence from this study and other completed trials, sorafenib is unlikely to have a role in the treatment of ovarian cancer.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Ovarian EpithelialFemaleHumansMiddle AgedNeoplasm GradingNeoplasms, Glandular and EpithelialNeoplasm StagingNiacinamideOvarian NeoplasmsPaclitaxelPhenylurea CompoundsCarboplatinNiacinamidePaclitaxelPhenylurea CompoundsSorafenibCarboplatinfirst-line therapyovarian cancerpaclitaxelsorafenib

Identifiers

PMID25556916
PMCPMC4430260
OpenAlexW2034158072

What OpenQuestion holds

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LicenceCC BY
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.