title: Discrepancy between the NCI-CTCAE and DEB-NTC scales in the evaluation of oxaliplatin-related neurotoxicity in patients with metastatic colorectal cancer.
abstract: BACKGROUND
  Several oxaliplatin-specific scales have been proposed in clinical practice to evaluate oxaliplatin-related neurotoxicity. We investigated whether there might be a discrepancy between the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) and the Neurotoxicity Criteria of Debiopharm (DEB-NTC), the commonly used oxaliplatin-specific scales, in the evaluation of peripheral neurotoxicity.
  
  
  METHODS
  The subjects were 42 patients with metastatic colorectal cancer who received more than 6 cycles of first-line therapy with modified FOLFOX6 and more than 6 cycles of second-line therapy with FOLFIRI. The median number and cumulative dose of oxaliplatin administrations were 10.5 (range 6-22) and 889.4 mg/m(2) (range 484.5-1875.0 mg/m(2)), respectively. The peripheral neurotoxicity was evaluated during mFOLFOX6 therapy and after its discontinuation using NCI-CTCAE ver. 3.0 and DEB-NTC. Data were collected prospectively and analyzed retrospectively.
  
  
  RESULTS
  The concordance rate of the peripheral neurotoxicity grade determined by these criteria was low: 48.8% during mFOLFOX6 and 47.3% after discontinuation of therapy. The cumulative dose of oxaliplatin-related peripheral neurotoxicity in 50% of the patients was lower when evaluated by DEB-NTC for both grades 1 (P = 0.09) and 2 (P < 0.001). The cumulative rate of improvement from grade 2 to 1 (P < 0.001) and from grade 2 to 0 (P < 0.05) after discontinuation of mFOLFOX6 therapy was higher when NCI-CTCAE was used for the evaluation.
  
  
  CONCLUSIONS
  We found a discrepancy between the NCI-CTCAE and DEB-NTC scales in the evaluation of oxaliplatin-related neurotoxicity and suggest that the concomitant use of NCI-CTCAE and DEB-NTC would be useful to maintain oxaliplatin-based chemotherapy at higher quality.
authors.affiliation: Department of Pharmacy Services, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan.
authors.forename: Naohiko
authors.initials: N
authors.lastname: Inoue
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Ishida
authors.forename: Motohiko
authors.initials: M
authors.lastname: Sano
authors.forename: Tohru
authors.initials: T
authors.lastname: Kishino
authors.forename: Norimichi
authors.initials: N
authors.lastname: Okada
authors.forename: Kensuke
authors.initials: K
authors.lastname: Kumamoto
authors.forename: Keiichiro
authors.initials: K
authors.lastname: Ishibashi
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000633:toxicity*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D054547:National Cancer Institute (U.S.); D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000633:toxicity*; D000077150:Oxaliplatin; D012015:Reference Standards; D014481:United States
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin