Validation of a Self-Reported Neurotoxicity Scale in Patients With Operable Colon Cancer Receiving Oxaliplatin

Jacek A. Kopec, PhD, Stephanie R. Land, PhD, Reena S. Cecchini, MSc, Patricia A. Ganz, MD, David Cella, PhD, Joseph P. Costantino, PhD, H. Samuel Wieand, PhD, Roy E. Smith, MD, J. Philip Kuebler, MD, and Norman Wolmark, MD

University of British Columbia, Vancouver, Canada; National Surgical Adjuvant Breast and Bowel Project Biostatistical Center, Pittsburgh, Pennsylvania; Department of Biostatistics, University of Pittsburgh, Pittsburgh, Pennsylvania; the Schools of Medicine and Public Health and the Jonsson Comprehensive Cancer Center, University of California at Los Angeles, Los Angeles; Center on Outcomes, Research, and Education, Northwestern University, Chicago, Illinois; and the Clinical Community Oncology Program, Columbus, Ohio

Standardized questionnaires are important tools for evaluating adverse effects associated with new cancer treatments. This randomized trial, which assessed the measurement properties of the modified Functional Assessment of Cancer Therapy/Gynecologic Oncology Group–Neurotoxicity scale, was conducted in a subsample of patients participating in the National Surgical Adjuvant Breast and Bowel Project Protocol C-07. Investigators compared the efficacy of fluorouracil/leucovorin with and without oxaliplatin in patients with operable colon cancer. In all, 395 patients took part in the neurotoxicity study; 189 were randomized to the oxaliplatin arm of the trial. Self-reported neurotoxicity was assessed before, during, and after chemotherapy. The original 11-item scale was augmented with two oxaliplatin-specific items. The distribution of responses to all items, item-total correlations, and mean item scores, as well as reliability, validity, and responsiveness of the final scale, were assessed over time. One item was deleted after item analyses. The final 12-item neurotoxicity subscale (Ntx-12) was reliable; as expected, it correlated with clinical measurements of neurosensory toxicity. Adding an oxaliplatin-specific item improved the responsiveness of the scale. The team concluded that self-reports of neurologic symptoms obtained from a standardized patient-based questionnaire may be used for early detection and monitoring of neurotoxicity. The Ntx-12 is a valid, reliable, and responsive instrument for colon cancer patients receiving oxaliplatin- containing chemotherapy.

J Support Oncol 2006;4:W1–W8   print e-mail full text 230 kb