Determining the relationship between toxicity and quality of life in an ovarian cancer chemotherapy clinical trial

Purpose This analysis of data from a randomized trial of chemotherapy in epithelial ovarian cancer sought to determine whether a relationship exists between the presence and severity of the most commonly observed toxic effects and the corresponding quality of life (QOL) items. Patients and Methods One hundred fifty-two eligible patients accrued from Canada by the National Cancer Institute of Canada Clinical Trials Group on a randomized trial of paclitaxel and cisplatin versus cyclophosphamide/cisplatin were included in the analysis. Toxicity to the chemotherapeutic treatments was subjectively evaluated using a trial-specific checklist for ovarian cancer and the European Organization for Research and Treatment of Cancer QLQ C30+3 questionnaire. Assessments were conducted at baseline, before each cycle of treatment (3 weeks), and at each 3-month follow-up during the next 2 years (or until progression). Results The most frequently observed symptoms experienced during or shortly following chemotherapy were neurosensory loss, lethargy, nausea, vomiting, and alopecia. Regression analyses revealed that change scores of QOL items related to motor weakness and gastrointestinal pain were common predictors for the change global QOL score during protocol treatment; and change scores of QOL items related to lethargy or fatigue and change toxicity grade of mood predicted the change global QOL score after patients were off treatment. Conclusion The use of the European Organization for Research and Treatment of Cancer QLQ C30+3 and trial-specific checklist was able to assess the effect of expected toxicities on patient's QOL during and following treatment, and so may be useful in addressing the concerns regarding methodological issues that have limited the acquisition of prospective, longitudinal treatment-related toxicity data. (C) 2004 by American Society of Clinical Oncology.