title: Comparison of the NCI-CTCAE version 4.0 and version 3.0 in assessing chemoradiation-induced oral mucositis for locally advanced nasopharyngeal carcinoma.
abstract: To compare the role of CTCAE version 4.0 (v4.0) and version 3.0 (v3.0) in assessing chemoradiation-induced oral mucositis (OM) for locally advanced nasopharyngeal carcinoma (LA-NPC). Patients with LA-NPC were recruited into the study. All eligible participants received docetaxel and cisplatin-based induction chemotherapy followed by intensity modulated radiation therapy concurrent with cisplatin. OM was assessed before and weekly during radiotherapy (RT), using CTCAE v3.0 (clinical exam) and v4.0 separately. OM-related quality of life (QOL) was also evaluated in these patients with the EORTC Quality of Life Questionnaire - Head and Neck module (QLQ-H&N35). From June 2010 to February 2011, 23 eligible patients were enrolled. A highly significant correlation (rho=0.838, p=0.000) and a non-significant difference (p=0.167) in OM grades were found between the two CTCAE versions. However, the trend lines showed that the mean grade determined by CTCAE v3.0 reached a plateau while the mean grade determined by v4.0 continued to increase after the fourth week during RT. Changing trends of several QOL subscale mean scores were similar to that of OM mean grade evaluated by CTCAE v4.0. Both grades of the two CTCAE versions were significantly and positively correlated with scores of several QOL subscales. Nonetheless, the correlation coefficients related to CTCAE v4.0 were higher than those related to v3.0 (rho: 0.727-0.865 versus 0.727-0.778). CTCAE v4.0 could serve as a good surrogate for v3.0 (clinical exam) in assessing chemoradiation-induced oral mucositis. Moreover, CTCAE v4.0 has a few subtle advantages over v3.0 under some circumstances such as delegating QOL. However, there is still no "gold standard" assessment scale for oral mucositis. Therefore, the appropriate tool should be carefully chosen according to the purpose of assessment.
authors.affiliation: Department of Radiation Oncology, Shanghai Cancer Center, Shanghai Medical College, Fudan University, Shanghai 200032, China.
authors.forename: Yu-Jie
authors.initials: YJ
authors.lastname: Liu
authors.forename: Guo-Pei
authors.initials: GP
authors.lastname: Zhu
authors.forename: Xi-Yin
authors.initials: XY
authors.lastname: Guan
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000009:adverse effects; D059248:Chemoradiotherapy / Q000009:adverse effects; D002945:Cisplatin / Q000009:adverse effects; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009303:Nasopharyngeal Neoplasms / Q000628:therapy; D011788:Quality of Life; D011832:Radiation Injuries / Q000139:chemically induced / Q000175:diagnosis*; D011838:Radiation-Sensitizing Agents / Q000009:adverse effects; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D013280:Stomatitis / Q000139:chemically induced / Q000175:diagnosis*; D011795:Surveys and Questionnaires / Q000592:standards*; D043823:Taxoids / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D011838:Radiation-Sensitizing Agents; D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin