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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

4156 - Palbociclib in combination with letrozole as first or later line therapy for patients with locally advanced, inoperable or metastatic HR+/HER2- breast cancer in Germany: Interim results of the INGE-B phase 2 study

Date

22 Oct 2018

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

Cytotoxic Therapy

Tumour Site

Breast Cancer

Presenters

Manfred Welslau

Citation

Annals of Oncology (2018) 29 (suppl_8): viii90-viii121. 10.1093/annonc/mdy272

Authors

M.K. Welslau1, M. Zaiss2, U. Söling3, M. Untch4, L. Müller5, D. Lüftner6, J. Meiler7, A. Welt8, J. Sahlmann9, L. Houet10, E. Runkel10, N.W. Marschner10

Author affiliations

  • 1 Medical Oncology, MVZ am Klinikum Aschaffenburg GmbH, 63739 - Aschaffenburg/DE
  • 2 Medical Oncology, Praxis für Interdisziplinaere Onkologie, 79110 - Freiburg/DE
  • 3 Medical Oncology, Onkologische Gemeinschaftspraxis, 34119 - Kassel/DE
  • 4 Clinic For Gynecology, Gynecologic Oncology And Obstetrics, Helios Klinikum Berlin Buch, 13125 - Berlin/DE
  • 5 Medical Oncology, Onkologie UnterEms, 26789 - Leer/DE
  • 6 Klinik Für Hämatologie, Onkologie Und Tumorimmunologie, Charité Campus Benjamin Franklin, 12200 - Berlin/DE
  • 7 Medical Oncology, Klinik Dr. Hancken GmbH, 21680 - Stade/DE
  • 8 Klinik F. Innere Medizin/ Tumorforschung, Universitätsklinikum Essen (AöR), 45147 - Essen/DE
  • 9 Datamanagement, Statistics And Medical Informatics, iOMEDICO, 79108 - Freiburg/DE
  • 10 Medical Department, iOMEDICO, 79108 - Freiburg/DE

Resources

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Abstract 4156

Background

Based on the pivotal PALOMA trials investigating the combination of the CDK4/6 inhibitor palbociclib with letrozole or with fulvestrant after prior endocrine therapy, extended European approval was granted for this patient population to receive palbociclib in combination with any aromatase inhibitor or with fulvestrant after prior endocrine therapy. The prospective multi-centre phase 2 study INGE-B was designed to a) investigate the combination of palbociclib with letrozole or with fulvestrant in accordance with the PALOMA trials in Germany and b) to obtain so far lacking data on the combination of palbociclib with the aromatase inhibitors exemestane or anastrozole.

Methods

In total, 360 patients with locally advanced, inoperable or metastatic HR+/HER2- breast cancer were recruited at 82 sites across Germany. Eligible patients are treated with palbociclib either in combination with letrozole, anastrozole, exemestane or fulvestrant as first-line therapy or in combination with letrozole or fulvestrant as later-line therapy. Primary objective is the clinical benefit rate (CBR), defined as the percentage of patients with response or stable disease at week 24. Key secondary endpoints include progression-free survival (PFS), overall survival (OS), overall response rate (ORR) and safety. Quality of life, fatigue, anxiety and depression are assessed with validated questionnaires. Data were analysed for each treatment group separately with descriptive statistics.

Results

The first interim analysis of the INGE-B study was scheduled to analyse data of patients receiving palbociclib and letrozole in first or later line. Between 09/2016 and 01/2018, 63 first- and 59 later-line patients were enrolled at 38 sites and observed for at least 6 months of treatment, unless discontinued earlier for disease progression or any other reason. Baseline patient and tumour characteristics will be presented. Efficacy in terms of CBR and best response and treatment-emergent adverse events will be described.

Conclusions

The results of the first interim analysis of the INGE-B study will be discussed with respect to data from the PALOMA 1/2 trials.

Clinical trial identification

NCT02894398.

Legal entity responsible for the study

iOMEDICO AG.

Funding

Pfizer.

Editorial Acknowledgement

Disclosure

D. Lüftner: Membership on an advisory board or board of directors, remunerations: Amgen, Pfizer, Eli Lilly, Celgene, Loreal. A. Welt: Membership on an advisory board or board of directors: Roche, Pfizer, Novartis. All other authors have declared no conflicts of interest.

Resources from the same session

4697 - Genetic signatures always suggest undertreatment? Experience with PAM51

Presenter: Carolina Sales

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

Resources:

Abstract

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