Validation and reduction of FACT/GOG-Ntx subscale for platinum/paclitaxel-induced neurologic symptoms: a gynecologic oncology group study.
The FACT/GOG (Gynecologic Oncology Group) Neurotoxicity (Ntx) subscale for assessing platinum/paclitaxel-induced neurologic symptoms was evaluated. The 11-item questionnaire was administered to patients with advanced endometrial cancer treated with doxorubicin/cisplatin (AP) or doxorubicin/cisplatin/paclitaxel (TAP) prior to 1-7 cycles of treatment in GOG 177. The subscale was evaluated in 134 patients in the TAP group for internal reliability, construct validity, criteria validity, sensitivity to treatment differences, and change over time. Cronbach coefficients for internal consistency prior to cycles 1-7 were 0.85, 0.80, 0.84, 0.82, 0.82, 0.85, and 0.84, respectively. The area under the receiver operating characteristic curve was 0.81 for the Ntx score prior to cycle 3. The TAP arm Ntx scores increased significantly from 3.67 at baseline to 8.13 prior to cycle 7; these were higher than the AP arm Ntx scores, which increased from 3.54 at baseline to 4.72 prior to cycle 7. The four sensory items accounted for 80% of treatment differences and 63% of longitudinal changes in the observed subscale score. The 11-item Ntx subscale reliably and validly assesses platinum/paclitaxel-induced peripheral neuropathy. A reduced four-item version is an efficient alternative in measuring this toxicity in clinical trials without compromising its performance.
Huang
H Q
HQ
Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY 14263, USA. hhuang@gogstats.org
Brady
M F
MF
Cella
D
D
Fleming
G
G
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D002277:Carcinoma / Q000188:drug therapy / Q000523:psychology; D016889:Endometrial Neoplasms / Q000188:drug therapy* / Q000523:psychology*; D005260:Female; D006801:Humans; D009422:Nervous System Diseases / Q000139:chemically induced*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects*; D010984:Platinum / Q000008:administration & dosage / Q000009:adverse effects*; D011594:Psychometrics; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D010984:Platinum; D017239:Paclitaxel