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01-07-2013 | Original Article

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

Authors: Béatrice Weber, Rémy Largillier, Isabelle Ray-Coquard, Gabriel Yazbek, Jérôme Meunier, Jérôme Alexandre, Jérôme Dauba, Dominique Spaeth, Rémy Delva, Florence Joly, Eric Pujade-Lauraine, Laure Copel, on behalf of the GINECO group, France

Published in: Supportive Care in Cancer | Issue 7/2013

Abstract

Purpose

A 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.

Methods

Patients 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.

Results

Patients 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.

Conclusions

The 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.

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Title: A potentially neuroprotective role for erythropoietin with paclitaxel treatment in ovarian cancer patients: a prospective phase II GINECO trial
Authors: Béatrice Weber
Rémy Largillier
Isabelle Ray-Coquard
Gabriel Yazbek
Jérôme Meunier
Jérôme Alexandre
Jérôme Dauba
Dominique Spaeth
Rémy Delva
Florence Joly
Eric Pujade-Lauraine
Laure Copel
on behalf of the GINECO group, France
Publication date: 01-07-2013
Publisher: Springer-Verlag
Published in: Supportive Care in Cancer / Issue 7/2013
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-013-1748-0

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