Quality-of-life results from a randomized, phase-II-study of the therapeutic cancer vaccine L-BLP25 (Stimuvax®) in the preoperative treatment of women with primary breast cancer (ABCSG-34)

Abstract

Background: In ABCSG-34, patients with HER2-negative breast cancer were randomized to preoperative standard of care therapy (SoC) with or without L-BLP25 (Stimuvax). This report describes the quality-of-life (QoL) results of the trial. Methods: 400 patients were randomized to receive SoC with or without BLP25. Postmenopausal women with low-risk disease (ER+++/++, Ki67 <14%, G1/2) received 6 months of letrozole; premenopausal and postmenopausal patients with triple-negative, ER-/+/++, Ki67 ≥14%, or G3 tumors received 4 cycles of epirubicin/ cyclophosphamide plus 4 cycles of docetaxel with or without L-BLP25. Primary end point results RCB and pCR rates were presented previously (SABCS 2016; Abstract Nr 850339). QoL was assessed with the EORTC QLQ-C30 and EORTC QLQ-BR 23 at baseline, before surgery, and up to 4 weeks thereafter. The objective was to evaluate differences of QoL in women treated with or without L-BLP25, as well as between the two regimens. Results: 385 patients from 17 centers were included in the QoL analysis. There were no differences in QoL between patients receiving SoC only and those receiving additional L-BLP25. Impact on QoL was determined by the SoC therapy and by the timepoint of the assessment. Before surgery and 4 weeks thereafter patients receiving chemotherapy 6TL-BPL25 showed more impairment in the QoL scales role and social functioning, financial problems and body image than the patients receiving endocrine therapy6 TL-BPL25. Fatigue and hair loss were significantly more common in the chemotherapy than in the endocrine arm. At the time of surgery and thereafter, patients in both SoC arms had significantly negatively impacted QoL (physical, role, emotional, cognitive, social, sexual functioning, body image domains) as well as more fatigue, pain, dyspnoea, breast and arm symptoms. There were no differences in global health status between the arms at the different time points. Conclusions: Addition of L-BLP25 (Stimuvax) to SoC in HER2-negative EBC patients does not impair QoL.