Quality of life of older patients with early-stage breast cancer receiving adjuvant chemotherapy: a companion study to cancer and leukemia group B 49907

Abstract

Purpose: A phase III trial (Cancer and Leukemia Group B CALGB-49907) was conducted to test whether older patients with early-stage breast cancer would have equivalent relapse-free and overall survival with capecitabine compared with standard chemotherapy. The quality of life (QoL) substudy tested whether capecitabine treatment would be associated with a better QoL than standard chemotherapy.

Patients and methods: QoL was assessed in 350 patients randomly assigned to either standard chemotherapy (cyclophosphamide, methotrexate, and fluorouracil [CMF] or doxorubicin and cyclophosphamide [AC]; n = 182) or capecitabine (n = 168). Patients were interviewed by telephone before treatment (baseline), midtreatment, within 1 month post-treatment, and at 12, 18, and 24 months postbaseline by using questionnaires from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), a breast systemic adverse effects scale (EORTC BR23), and the Hospital Anxiety and Depression Scale (HADS).

Results: Compared with patients who were treated with standard chemotherapy, patients who were treated with capecitabine had significantly better QoL, role function, and social function, fewer systemic adverse effects, less psychological distress, and less fatigue during and at the completion of treatment (P ≤ .005). Capecitabine treatment was associated with less nausea, vomiting, and constipation and with better appetite than standard treatment (P ≤ .004), but worse hand-foot syndrome and diarrhea (P < .005). These differences all resolved by 12 months.

Conclusion: Standard chemotherapy was superior to capecitabine in improving relapse-free and overall survival for older women with early-stage breast cancer. Although capecitabine was associated with better QoL during treatment, QoL was similar for both groups at 1 year. The brief period of poorer QoL with standard treatment is a modest price to pay for a chance at improved survival.

Fig 1.

CONSORT diagram shows assessment over the study period. Deaths are cumulative. Standard therapy consists of cyclophosphamide, methotrexate, and fluorouracil (CMF) or doxorubicin and cyclophosphamide (AC). Midtreatment: CMF, day 77; AC, day 29; capecitabine, day 63. End of treatment: CMF, 6-7 months; AC, 4-5 months; capecitabine, 4-5 months. BOMC, Blessed Orientation-Memory-Concentration test.

Fig 2.

Global quality of life (QoL) by treatment arm over time according to European Organisation for Research and Treatment of Cancer (EORTC; predicted mean scores). Standard therapy consists of cyclophosphamide, methotrexate, and fluorouracil (CMF) or doxorubicin and cyclophosphamide (AC). Midtreatment: CMF, day 77; AC, day 29; capecitabine, day 63. End of treatment: CMF, 6-7 months; AC, 4-5 months; capecitabine, 4-5 months.

Fig 3.

Systemic adverse effects by treatment arm over time according to European Organisation for Research and Treatment of Cancer (EORTC; predicted mean scores). Standard therapy consists of cyclophosphamide, methotrexate, and fluorouracil (CMF) or doxorubicin and cyclophosphamide (AC). Midtreatment: CMF, day 77; AC, day 29; capecitabine, day 63. End of treatment: CMF, 6-7 months; AC, 4-5 months; capecitabine, 4-5 months.

Fig 4.

Psychological distress by treatment arm over time according to Hospital Anxiety and Depression Scale (HADS; predicted mean scores). Standard therapy consists of cyclophosphamide, methotrexate, and fluorouracil (CMF) or doxorubicin and cyclophosphamide (AC). Midtreatment: CMF, day 77; AC, day 29; capecitabine, day 63. End of treatment: CMF, 6-7 months; AC, 4-5 months; capecitabine, 4-5 months.

Fig A1.

Fatigue by treatment arm over time according to European Organisation for Research and Treatment of Cancer (EORTC; predicted mean scores). Standard therapy consists of cyclophosphamide, methotrexate, and fluorouracil (CMF) or doxorubicin and cyclophosphamide (AC). Midtreatment: CMF, day 77; AC, day 29; capecitabine, day 63. End of treatment: CMF, 6-7 months; AC, 4-5 months; capecitabine, 4-5 months.

Fig A2.

Role functioning by treatment arm over time according to European Organisation for Research and Treatment of Cancer (EORTC; predicted mean scores). Standard therapy consists of cyclophosphamide, methotrexate, and fluorouracil (CMF) or doxorubicin and cyclophosphamide (AC). Midtreatment: CMF, day 77; AC, day 29; capecitabine, day 63. End of treatment: CMF, 6-7 months; AC, 4-5 months; capecitabine, 4-5 months.

Fig A3.

Social functioning by treatment arm over time according to European Organisation for Research and Treatment of Cancer (EORTC; predicted mean scores). Standard therapy consists of cyclophosphamide, methotrexate, and fluorouracil (CMF) or doxorubicin and cyclophosphamide (AC). Midtreatment: CMF, day 77; AC, day 29; capecitabine, day 63. End of treatment: CMF, 6-7 months; AC, 4-5 months; capecitabine, 4-5 months.

Fig A4.

Neurobehavioral functioning by treatment arm over time according to Neurobehavioral Functioning and Activities of Living Scale (predicted mean scores). Standard therapy consists of cyclophosphamide, methotrexate, and fluorouracil (CMF) or doxorubicin and cyclophosphamide (AC). Midtreatment: CMF, day 77; AC, day 29; capecitabine, day 63. End of treatment: CMF, 6-7 months; AC, 4-5 months; capecitabine, 4-5 months.

Fig A5.

Clinically important psychological problems by treatment arm over time. Percent of patients with Hospital Anxiety and Depression Scale (HADS) score > 15. Standard therapy consists of cyclophosphamide, methotrexate, and fluorouracil (CMF) or doxorubicin and cyclophosphamide (AC). Midtreatment: CMF, day 77; AC, day 29; capecitabine, day 63. End of treatment: CMF, 6-7 months; AC, 4-5 months; capecitabine, 4-5 months.