209P - Quality-of-life results from a randomized, phase-II-study of the therapeutic cancer vaccine L-BLP25 (Stimuvax®) in the preoperative treatment of wo...

Date 11 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Breast Cancer, Early Stage
Breast Cancer
Cancer Immunology and Immunotherapy
Presenter Vesna Bjelic-Radisic
Citation Annals of Oncology (2017) 28 (suppl_5): v43-v67. 10.1093/annonc/mdx362
Authors V. Bjelic-Radisic1, C.F. Singer2, G. Pfeiler2, M. Hubalek3, R. Bartsch4, H. Stöger5, A. Pichler6, E. Petru1, R. Greil7, V. Wette8, A. Petzer9, P. Sevelda10, D. Egle11, P. Dubsky12, F. Fitzal12, R. Jakesz13, M. Balic14, S. Frantal15, L. Sölkner15, M. Gnant13
  • 1Gyneology And Obstet, Medical Univeristy Graz, 8036 - Graz/AT
  • 2Gyneology And Obstet, Medizinische Universitaet Wien (Medical University of Vienna), 1090 - Vienna/AT
  • 3Gyneology And Obstet, Brustzentrum Schwaz, Schwaz/AT
  • 4Oncology, Medizinische Universitaet Wien (Medical University of Vienna), 1090 - Vienna/AT
  • 5Oncology, LKH-Univ. Klinikum Graz, 8036 - Graz/AT
  • 6Department Of Hematology And Oncology, Landeskrankenhaus LKH Leoben, 8700 - Leoben/AT
  • 7Oncology, Landeskrankenhaus Salzburg - Universitätsklinikum der PMU,, 5020 - Salzburg/AT
  • 8Chirurgie, LKH Veit an der Glan, St Veit an der Glan/AT
  • 9Oncology, Krankenhaus der Barmherzigen Schwestern Linz (bhslinz), 4040 - Linz/AT
  • 10Gyneology And Obstet, Krankenhaus Hietzing, 1130 - Vienna/AT
  • 11Department Of Gynecology, Univ. hospital Innsbruck, Innsbruck/AT
  • 12Chirurgie, Vienna General Hospital (AKH) - Medizinische Universität Wien, 1090 - Vienna/AT
  • 13Surgery, Vienna General Hospital (AKH) - Medizinische Universität Wien, 1090 - Vienna/AT
  • 14Department Of Hematology And Oncology, LKH-Univ. Klinikum Graz, 8036 - Graz/AT
  • 15Abcsg, ABCSG, Vienna/AT

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

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 ± TL-BPL25 showed more impairment in the QoL scales role and social functioning, financial problems and body image than the patients receiving endocrine therapy ± 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.

Clinical trial identification

Legal entity responsible for the study

ABCSG

Funding

This study was supported by Merck KGaA, Darmstadt, Germany Role of the Funder/Sponsor: ABCSG was the regulatory sponsor of this trial. Merck provided financial funding and the study drug (IMP). The study was designed and conducted by ABCSG. Merck was not involved in collection, management, analysis, and interpretation of the data. ABCSG prepared and approved the manuscript. All co-authors have decided to submit the manuscript for publication. This study was supported by Merck KGaA, Darmstadt, Germany Role of the Funder/Sponsor: ABCSG was the regulatory sponsor of this trial. Merck provided financial funding and the study drug (IMP). The study was designed and conducted by ABCSG. Merck was not involved in collection, management, analysis, and interpretation of the data. ABCSG prepared and approved the manuscript. All co-authors have decided to submit the manuscript for publication. This study was supported by Merck KGaA, Darmstadt, Germany Role of the Funder/Sponsor: ABCSG was the regulatory sponsor of this trial. Merck provided financial funding and the study drug (IMP). The study was designed and conducted by ABCSG. Merck was not involved in collection, management, analysis, and interpretation of the data. ABCSG prepared and approved the manuscript. All co-authors have decided to submit the manuscript for publication. ABCSG was the regulatory Sponsor of this Trial. Merck KGaA provided financial funding and teh study drug (IMP). The study was designed and conducted by ABCSG.

Disclosure

All authors have declared no conflicts of interest.