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
Heather-Jane Au, Wolfgang Eiermann, Nicholas J Robert, Tadeusz Pienkowski, John Crown, Miguel Martin, Marek Pawlicki, Arlene Chan, John Mackey, John Glaspy, Tamás Pintér, Mei-Ching Liu, Tommy Fornander, Sandeep Sehdev, Jean-Marc Ferrero, Valerie Bée, Maria J Santana, Dave P Miller, Deepa Lalla, Dennis J Slamon, Translational Research in Oncology BCIRG 006 Trial Investigators, Heather-Jane Au, Wolfgang Eiermann, Nicholas J Robert, Tadeusz Pienkowski, John Crown, Miguel Martin, Marek Pawlicki, Arlene Chan, John Mackey, John Glaspy, Tamás Pintér, Mei-Ching Liu, Tommy Fornander, Sandeep Sehdev, Jean-Marc Ferrero, Valerie Bée, Maria J Santana, Dave P Miller, Deepa Lalla, Dennis J Slamon, Translational Research in Oncology BCIRG 006 Trial Investigators
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.
Conflict of interest statement
Disclosures of potential conflicts of interest may be found at the end of this article.
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Source: PubMed