High-Dose S equential C hemotherapy W ith R ecombinant Granulocyte C olony-Stimulati ng F actor a nd R epeated Stem-Cell S upport f or I nflammatory B reast C ancer Patients: D oes I mpact o n Q uality o f L ife J eopardize Feasibility a nd A cceptability o f T reatment?

Purpose: This study was designed to investigate the quality of life (QOL) of patients enrolled onto the HighDose Chemotherapy for Breast Cancer Study Group trial (PEGASE 02), a French pilot multicenter trial of the treatment of inflammatory breast cancer (IBC) aimed at evaluating (1) toxicity and feasibility of sequential high-dose chemotherapy (HDC) with recombinant human granulocyte colony-stimulating factor (filgrastim) and stem-cell support and (2) response to HDC in terms of pathologic response and survival. Patients and Methods: QOL measures were performed at inclusion and four times subsequently up to 1 year using an ad hoc side-effect questionnaire (19 physical symptoms) and the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30). Results: Of the 95 patients entered, the overall QOL questionnaire completion compliance was 75.6%. During cycle 3 of HDC, the number of symptoms was high (mean 6 SD QOL score, 10 6 3), with fatigue, hair loss, appetite loss, nausea, change in taste, vomiting, fever, and weight loss reported by more than 60% of patients. Toxicity and distress associated with HDC were reflected in the decline of four EORTC QLQ-C30 scores: global QOL (P 5 .001), and physical, role, and social functioning (P < .001 for all statistics). However, QOL deterioration disappeared after treatment completion, except for physical functioning (P 5 .025). One year after inclusion, most QOL scores returned to baseline, and both emotional functioning and global QOL scores were even higher than baseline (P 5 .030 and P 5 .009, respectively). Conclusion: If it is confirmed that improvements in pathologic response rates with HDC effectively translate into increased probabilities of survival for IBC patients, adoption of such treatment as PEGASE 02 will not involve crucial choices between length of life and QOL and should not be delayed for QOL arguments. J Clin Oncol 18:754-764. © 2000 by American Society of Clinical Oncology.