Exploratory biomarker analysis in patients treated with vinorelbine plus everolimus or vinorelbine monotherapy as second-line treatment for HER2-ne...

Date 22 October 2018
Event ESMO 2018 Congress
Session Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care
Topics Breast Cancer
Translational Research
Presenter Thomas Decker
Citation Annals of Oncology (2018) 29 (suppl_8): viii90-viii121. 10.1093/annonc/mdy272
Authors T. Decker1, A. Mündlein2, N. Marschner3, A. Welt4, T. Riedt5, V. Hagen6, J. Rauh7, D. Klein8, K. Potthoff5, P. Jähnig9, H. Schröder10, S. Hegewisch-Becker11, C. Lerchenmüller12
  • 1Gemeinschaftspraxis Für Hämatologie Und Onkologie, Onkologie Ravensburg, 88212 - Ravensburg/DE
  • 2Labor, VIVIT Molekularbiologisches Labor, 6850 - Dornbirn/AT
  • 3Medical Oncology, Praxis für Interdisziplinaere Onkologie, 79110 - Freiburg/DE
  • 4Klinik F. Innere Medizin/ Tumorforschung, Universitätsklinikum Essen (AöR), 45147 - Essen/DE
  • 5Clinical Operations, iOMEDICO AG, 79108 - Freiburg/DE
  • 6Onko Zentrum, St.-Johannes-Hospital Dortmund, 44137 - Dortmund/DE
  • 7Praxis, GIM - Gemeinschaftspraxis Innere Medizin, 58455 - Witten/DE
  • 8Medical Team, iOMEDICO AG, 79108 - Freiburg/DE
  • 9Statistik, ICRC Weyer GmbH, 12587 - Berlin/DE
  • 10Clinical Operations, AIO-Studien-gGmbH, 14057 - Berlin/DE
  • 11Hope, Hämatologisch-Onkologische Praxis Eppendorf, 20249 - Hamburg/DE
  • 12Praxis, Hämatologisch-Onkologische Gemeinschaftspraxis, 48149 - Münster/DE

Abstract

Background

The purpose of the VicTORia trial was to evaluate efficacy and safety of the combined treatment of everolimus (EVE) and vinorelbine (VIN) compared to VIN monotherapy as second-line treatment for HER2-negative advanced breast cancer. The study was accompanied by an exploratory analysis of phosphoinositide 3 kinase subunit (PIK3CA) as potential predicitve marker for response.

Methods

Patients were randomized 1:1 to receive i.v. VIN at a dose of 25 mg/m2 on days 1, 8 and 15 q3w plus 5 mg EVE once daily or i.v. VIN at a dose of 25 mg/m2 on days 1, 8 and 15 q3w. The primary objective was progression-free survival (PFS). Safety and tolerability, overall survival (OS) and overall response rates were secondary objectives. The mutational status of PIK3CA was determined at baseline from plasma samples.The study was initially planned to enroll 166 patients.

Results

Between December 2011 and February 2016 138 patients were enrolled from 32 sites across Germany. Of 69 patients randomized to receive VIN plus EVE, 68 received treatment and 65 of 69 patients randomized to VIN monotherapy received treatment. Baseline characteristics were balanced. Median age was 63 and 62 years, ECOG 0-1 98.5% and 90.7%, postmenopausal status 79.4% and 80.0%, and visceral metastases 89.7% and 87.7%, respectively. Median PFS was 4.01 months [95% CI, 2.40-6.09] for the combination vs. 4.08 months [95% CI, 2.80-5.33] for VIN monotherapy (HR = 1.05 [0.730-1.512], log rank p = 0.7908). The median OS was not statistically different between treatment arms (VIN+EVE: 16.25 months [95% CI, 11.38-18.95] vs. VIN: 13.78 months [95% CI, 10.23-19.05]), log rank p = 0.9361). PIK3CA mutational status was neither associated with PFS nor with OS in the total patient cohort, in patients treated with VIN+EVE and in patients treated with VIN monotherapy, respectively.

Conclusions

The addition of EVE to VIN was not associated with a benefit in PFS. Overall survival also did not significantly differ between treatment arms. No correlation between PIK3CA mutation status and outcome was detected.

Clinical trial identification

EudraCT: 2011-001024-38.

Legal entity responsible for the study

AIO-Studien-gGmbH.

Funding

Novartis.

Editorial Acknowledgement

Disclosure

T. Decker: Advisory role or expert testimony: Novartis; Advisory boards, other financial relationships, travel expenses: Novartis. N. Marschner: Advisory role or expert testimony: Novartis; Advisory boards, honoraria: Novartis; Other financial relationships, travel expenses: Novartis. A. Welt: Advisory role or expert testimony: Novartis; Advisory boards, financing of scientific research: Novartis. J. Rauh: Other financial relationships: Honoraria for documentation in clinical studies: Novartis. All other authors have declared no conflicts of interest.