Health-related quality of life with adjuvant docetaxel- and trastuzumab-based regimens in patients with node-positive and high-risk node-negative, HER2-positive early breast cancer: results from the BCIRG 006 Study

Abstract

Background: This study aims to describe and compare health-related quality of life (HRQL) in patients with node-positive and high-risk node-negative HER2-positive early breast cancer receiving adjuvant docetaxel and trastuzumab-based or docetaxel-based regimens alone.

Methods: Eligible patients (n = 3,222) were randomly assigned to either four cycles of adjuvant doxorubicin and cyclophosphamide followed by four cycles of docetaxel (AC→T) or one of two trastuzumab-containing regimens: adjuvant doxorubicin and cyclophosphamide followed by docetaxel plus trastuzumab administered for 1 year (AC→TH) or six cycles of docetaxel plus carboplatin combined with trastuzumab administered for 1 year (TCH). The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 and BR-23 were administered at baseline, the start of cycle 4 (mid), and the end of chemotherapy (EOC), as well as at 6, 12, and 24 months after chemotherapy.

Results: Compliance rates for the EORTC questionnaires were acceptable at 72%-93% of eligible patients out to the 12-month assessment. Systemic side effect (SE) change scores were significantly improved for TCH-treated patients compared with AC→TH and AC→T at EOC, suggesting improved tolerability. Physical functioning (PF) was only slightly worse at midpoint for those receiving TCH, compared with patients who were just starting on taxane in an AC→TH regimen, but was otherwise similar between arms. All treatment arms recovered from the deterioration in SE, PF, and Global Health Scale scores by 1 year and median future perspective change scores continued to improve throughout treatment and follow-up.

Conclusion: HRQL outcomes for adjuvant docetaxel and trastuzumab-based regimens are favorable and support TCH as a more tolerable treatment option.

Keywords: Adjuvant therapy; Anthracycline-induced cardiotoxicity; BCIRG 006; Breast cancer; Chemotherapy; Docetaxel; Quality of life; Trastuzumab.

Figure 1.

Consolidated Standards of Reporting Trials diagram for BCIRG 006 HRQL assessment. *Based on validation of questionnaire in patients' first language. **Numerators give total number of assessments completed; denominators give total number of eligible patients at that stage of treatment. Abbreviations: AC→T, doxorubicin plus cyclophosphamide for four cycles followed by docetaxel for four cycles; AC→TH, doxorubicin plus cyclophosphamide for four cycles followed by docetaxel with trastuzumab for 1 year; EOC, end of chemotherapy; HRQL, health-related quality of life; mid, 9 weeks (cycle 4); TCH, docetaxel plus carboplatin for six cycles with trastuzumab for 1 year.

Figure 2.

Baseline health-related quality-of-life scores. (A): Mean European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 scores at baseline. Data for single items of dyspnea, constipation, diarrhea, and sleep disturbance are not shown. (B): Mean EORTC BR-23 scores at baseline. Data for side effects of systemic therapy and upset by hair loss are not shown. Abbreviations: AC→T, doxorubicin plus cyclophosphamide for four cycles followed by docetaxel for four cycles; AC→TH, doxorubicin plus cyclophosphamide for four cycles followed by docetaxel with trastuzumab for 1 year; TCH, docetaxel plus carboplatin for six cycles with trastuzumab for 1 year.

Figure 3.

Mean change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 and BR23 scores. (A): Mean change from baseline in physical functioning scale. Higher score represents better physical functioning. (B): Mean change from baseline for global health scale. Higher score represents better global health. (C): Mean change from baseline in systemic side effects. Lower scores represent fewer side effects. (D): Mean change from baseline for future perspectives scale. Higher scores represent less worry about health in the future. Abbreviations: AC→T, doxorubicin plus cyclophosphamide for four cycles followed by docetaxel for four cycles; AC→TH, doxorubicin plus cyclophosphamide for four cycles followed by docetaxel with trastuzumab for 1 year; EOC, end of chemotherapy; FU, follow-up; Mid, 9 weeks (cycle 4); TCH, docetaxel plus carboplatin for six cycles with trastuzumab for 1 year.

Figure 4.

Health-related quality-of-life (HRQL) response analysis. (A): Proportion of patients whose HRQL improved by at least 10 units. (B): Proportion of patients whose HRQL worsened by at least 10 units. Abbreviations: AC→T, doxorubicin plus cyclophosphamide for four cycles followed by docetaxel for four cycles; AC→TH, doxorubicin plus cyclophosphamide for four cycles followed by docetaxel with trastuzumab for 1 year; TCH, docetaxel plus carboplatin for six cycles with trastuzumab for 1 year.