Evidence map›Paper›PMID 23420555›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2013

A potentially neuroprotective role for erythropoietin with paclitaxel treatment in ovarian cancer patients: a prospective phase II GINECO trial.

Béatrice Weber, Rémy Largillier, Isabelle Ray-Coquard, Gabriel Yazbek, Jérôme Meunier, Jérôme Alexandre, Jérôme Dauba, Dominique Spaeth, Rémy Delva, Florence Joly and 3 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.8field-weighted citation impact, top 27% 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

6 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
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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

13 authors at 9 institutions in 3 countries.

Béatrice WeberCentre Alexis Vautrin, 6 Avenue de Bourgogne Brabois, Vandœuvre-lès-Nancy, France.
Rémy Largillier
Isabelle Ray-Coquard
Gabriel Yazbek
Jérôme Meunier
Jérôme Alexandre
Jérôme Dauba
Dominique Spaeth
Rémy Delva
Florence Joly
Eric Pujade-Lauraine
Laure Copel
GINECO group, France
Délégation Paris 5 · FRCentre Léon Bérard · FRCentre d'expertise et de recherche en infrastructures urbaines · CACentre d’Investigation Clinique Innovation Technologique de Nancy · FRCentre François Baclesse · LUCentre hospitalier universitaire d'Orléans · FRDélégation Centre-Est · FRHôpital Marin de Hendaye · FRInstitut Claudius Regaud · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeA prospective phase II multicenter study was performed in two steps in paclitaxel-treated ovarian cancer patients in France. A French version of the four-item Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire was validated. This was then used to evaluate neurotoxicity in relation to erythropoietin treatment.

methodsPatients received standard second-line paclitaxel-based chemotherapy and erythropoietin for anemia. Neurotoxicity and hemoglobin levels were evaluated every cycle with the FACT/GOG-Ntx and NCI-CTCAE. The translated questionnaire was tested in 20 patients to confirm the translation accuracy. The final questionnaire was validated in 98 patients with internal consistency (Cronbach's coefficient) and item correlation (Pearson's r coefficient) tests. Neurotoxicity severity was analyzed according to erythropoietin intake (first three cycles versus no or late intake) and correlated with anemia.

resultsPatients received a median of six paclitaxel cycles (range 1-9). Neurotoxicity was validated in 484 questionnaires. Internal consistency was excellent with Cronbach's coefficients of ≥0.89 at inclusion, after 3 cycles and at study end. Inter-question correlation was high with Pearson's coefficients of 0.65-0.85. FACT/GOG-Ntx and NCI-CTCAE severity scoring was similar. Globally, the incidence of severe neurotoxicity (FACT/GOG-Ntx and NCI-CTCAE) was found significantly higher in patients with severe anemia. Of 98 evaluable patients, 31 received erythropoietin during the first three cycles. Mean hemoglobin level was significantly lower in this group from baseline to cycle 4; however, these anemic patients with early EPO intake did not develop an increase rate of severe neurotoxicity.

conclusionsThe French FACT/GOG-Ntx questionnaire is a reliable and valid tool for assessing chemotherapy-induced neuropathy. This study raises the possibility that erythropoietin might play a neuroprotective role when administered with paclitaxel.

Indexed as

AdultAgedAnemiaAntineoplastic Combined Chemotherapy ProtocolsErythropoietinFemaleFranceHumansMiddle AgedNeuroprotective AgentsNeurotoxicity SyndromesOvarian NeoplasmsPaclitaxelProspective StudiesSurveys and QuestionnairesTranslationsErythropoietinNeuroprotective AgentsPaclitaxel

Identifiers

PMID23420555
OpenAlexW2032103616

What OpenQuestion holds

Textmetadata
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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.