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 can-cer 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 trastu- zumab-containing regimens: adjuvant doxorubicin and cyclophos- phamidefollowed bydocetaxel plustrastuzumabadministeredfor1 year (AC-TH) or six cycles of docetaxel pluscarboplatin combined with trastuzumab administered for 1 year (TCH). The European Or-ganization for Research andTreatment of Cancer (EORTC)Qualityof Life Questionnaire C30 and BR-23 were administered at baseline, thestartofcycle4(mid),andtheendofchemotherapy(EOC),aswell 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 com-pared 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 re-covered 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 fol-low-up. Conclusion. HRQL outcomes for adjuvant docetaxel and trastu- zumab-based regimens are favorable and support TCH as a more tolerable treatment option. © AlphaMed Press 2013.