Three hundred and ninety women participated in the quality of life (QL) study of ACCOG1, a high-dose vs conventional adjuvant chemotherapy breast cancer trial, for patients with a high risk of relapse. Patients completed the European Organisation for Research and Treatment of Cancer QLQ-C30, questions on menopausal symptoms and the Sexual Activity Questionnaire. Pretreatment, 6,12, 24, 36, 48 and 60-month assessments were conducted. For the high dose group the median decrease in global QL at 6 months was significantly greater than in the conventional group. At 12 months, however, the median change had returned to 0 for both groups. Social functioning was also significantly lower in the high-dose group at 6 months, again returning to prebaseline levels for both groups after 12 months. The most persistent changes appear to be in the effect of treatment in both arms on sexual outcomes, reflected in problems with discomfort and pleasure. Both high-dose and conventional chemotherapy showed persisting negative effects on sexual health. This has not been previously reported as a long-term complication of high-dose chemotherapy. However, it did not have longterm affects on sexual habit, which appeared to return to pretreatment frequency and similar to that of conventional chemotherapy by about 12 months from treatment. Breast cancer patients with four or more positive axillary lymph nodes have historically had a poor prognosis (Jatoi et al, 1999), even with conventional adjuvant chemotherapy (EBCTCG, 2005). A series of uncontrolled studies of high-dose chemotherapy in the 1990s, mainly using an induction/intensification strategy, in which patients received conventional chemotherapy followed by highdose chemotherapy as a late intensification regimen, produced results that showed a substantial benefit for high-dose regimens (Antman et al, 1992;Peters et al, 1993). High-dose therapy soon became a widely used treatment option for women with bad-risk breast cancer, even without supporting evidence from randomised controlled trials.The Anglo Celtic 1 trial was set up to examine the potential benefit, if any, of employing high-dose chemotherapy in the treatment of early stage bad-risk breast cancer based on the involvement of the axillary nodes at diagnosis. One of the prospective substudies within the Anglo-Celtic 1 trial was to examine the impact of late intensification high-dose chemotherapy on QL. The purpose of this report is to review the detailed analysis of patient QL. Ethical approval for all parts of the study was given from the MREC for Scotland.
PATIENTS AND METHODSBetween February 1995 and June 1999, 605 patients with newly diagnosed breast cancer with four or more positive lymph nodes were randomly assigned to either conventional (n ¼ 298) or highdose treatment (n ¼ 307). Both treatment arms initially received four cycles of doxorubicin 75 mg m À2 . Patients in the conventional arm then received eight further cycles of CMF (cyclophosphamide (600 mg m À2 ), methotrexate (50 mg m À2 ) and 5-fluorouracil (600 mg m...
