SPECIAL DEPARTMENTS
Authors: Paul L. R. Mitchell, Alan Sandler
Journal: Journal of Clinical Oncology (2000)

Article Tools SPECIAL DEPARTMENTS Article Tools OPTIONS & TOOLS Export Citation Track Citation Add To Favorites Rights & Permissions COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/JCO.2000.18.14.2791 Journal of Clinical Oncology - published online before print September 21, 2016 PMID: 10894882 Paul L. R. MitchellxPaul L. R. MitchellSearch for articles by this author Alan SandlerxAlan SandlerSearch for articles by this author Show More Austin & Repatriation Medical Centre MelbourneAustraliaIndiana Cancer Pavilion IndianapolisIN https://doi.org/10.1200/JCO.2000.18.14.2791 First Page Full Text PDF Figures and Tables © 2000 by American Society of Clinical OncologyjcoJ Clin OncolJournal of Clinical OncologyJCO0732-183X1527-7755American Society of Clinical OncologyResponse14072000In Reply:Dr Mitchell raises valid points on the reporting of health-related quality of life (HRQoL) data. It is extremely challenging to provide a thorough description of longitudinal data, especially in an article that addresses numerous other end points.1 Moreover, it is even more difficult considering the multiple domains of HRQoL (eg, physical well-being, social/family well-being).There is no ideal single time point at which to report the HRQoL data given the multiple patient outcomes (eg, objective tumor response, progressive disease, death, discontinuation due to toxicity) that occur at varying times throughout a clinical trial. The number of patients completing questionnaires at each cycle did decrease more rapidly on the cisplatin arm (Table 1). Patients on the cisplatin arm received a median of two cycles of therapy and completed a median of three questionnaires, which would correspond to a baseline assessment plus assessments after each of two cycles of therapy. Because the intended course of therapy was six cycles, reporting of data after two cycles was believed to be premature. By presenting data from the last observation of each patient, we attempted to report data on all patients, regardless of actual time point or outcome. Furthermore, a specific time point would provide data on only a subset of patients, and the reduced sample size might limit the detection of statistical differences. Number of Patients Completing HRQoL QuestionnairesNumber of Patients Completing HRQoL QuestionnairesCisplatin AloneGemcitabine + CisplatinBaseline visit149161Cycle 1138153Cycle 2105125Cycle 371100Cycle 45378Cycle 53756Cycle 62226Per protocol, the HRQoL data were only collected while patients were on study, and, as Mitchell notes, may fail to represent those patients who have deteriorated. The patients who completed questionnaires were those whose disease at least remained stable, making it difficult to distinguish between the treatment arms. Collection of poststudy HRQoL data is demanding and may be confounded by subsequent therapies. Statistical and HRQoL experts are developing methods to model these missing data in order to better illustrate the impact of therapy on HRQoL. However, it is likely that an entire article will need to be dedicated to HRQoL so as to adequately explain the data.REFERENCE6. Sandler AB, Nemunaitis J, Denham C, et al: Phase III trial of gemcitabine plus cisplatin versus cisplatin alone in patients with locally advanced or metastatic non–small-cell lung cancer. J Clin Oncol 18::122,2000-130, Link, Google Scholar