title: A potentially neuroprotective role for erythropoietin with paclitaxel treatment in ovarian cancer patients: a prospective phase II GINECO trial.
abstract: OBJECTIVE
  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.
authors: Centre Alexis Vautrin, 6 Avenue de Bourgogne Brabois, Vandœuvre-lès-Nancy, France.
authors: Béatrice
authors: B
authors: Weber
authors: Rémy
authors: R
authors: Largillier
authors: Isabelle
authors: I
authors: Ray-Coquard
authors: Gabriel
authors: G
authors: Yazbek
authors: Jérôme
authors: J
authors: Meunier
authors: Jérôme
authors: J
authors: Alexandre
authors: Jérôme
authors: J
authors: Dauba
authors: Dominique
authors: D
authors: Spaeth
authors: Rémy
authors: R
authors: Delva
authors: Florence
authors: F
authors: Joly
authors: Eric
authors: E
authors: Pujade-Lauraine
authors: Laure
authors: L
authors: Copel
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000097:blood / Q000188:drug therapy*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D004921:Erythropoietin / Q000627:therapeutic use*; D005260:Female; D005602:France; D006801:Humans; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000627:therapeutic use*; D020258:Neurotoxicity Syndromes / Q000209:etiology / Q000517:prevention & control*; D010051:Ovarian Neoplasms / Q000097:blood / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects*; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D014177:Translations
chemical_list: D018696:Neuroprotective Agents; D004921:Erythropoietin; D017239:Paclitaxel