Impact of age on the safety and efficacy of bevacizumab (BEV)-containing therapy in patients (pts) with primary ovarian cancer (OC): Analyses of the OTILIA German non-interventional study on behalf of the North-Eastern German Society of Gynaecological Oncology Ovarian Cancer Working Group

Date

08 Oct 2016

Session

Poster Display

Presenters

Alexander Mustea

Citation

Annals of Oncology (2016) 27 (6): 296-312. 10.1093/annonc/mdw374

Authors

A. Mustea1, P. Wimberger2, G. Oskay-Oezcelik3, P. Jungberg4, W. Meinerz5, D. Reichert6, J. Janssen7, M. Keller8, R. Richter9, J. Harde10, S. Klawitter11, A. Wegenaer12, M. Mueller13, J. Sehouli9

Author affiliations

  • 1 Gynecology, University Medicine Greifswald, 17475 - Greifswald/DE
  • 2 Gynecology And Obstetrics, Carl-Gustav-Carus University Dresden, TU Dresden, Dresden/DE
  • 3 Gynecologic Oncology, Praxisklinik Krebsheilkunde fuer Frauen, Berlin/DE
  • 4 Gynecologic Oncology, Private Practice, Chemnitz/DE
  • 5 Gynecology And Obstetrics, St. Vincenz-Krankenhaus, Paderborn/DE
  • 6 Oncology And Hematology, Medizinische Studiengesellschaft Nord-West GmbH, Westerstede/DE
  • 7 Oncology, Private Practice, Westerstede/DE
  • 8 C/o Charité Medical University Of Berlin, North-Eastern-German Society of Gynaecological Oncology (NOGGO e.V.), Berlin/DE
  • 9 Department Of Gynecology, Charité / University Hospital Berlin, Berlin/DE
  • 10 Statistics, Data Management And Medical Informatics, iOMEDICO AG, Freiburg/DE
  • 11 Biostatistics And Epidemiology, Roche Pharma AG, Grenzach-Wyhlen/DE
  • 12 Medical Affairs, Roche Pharma AG, Grenzach-Wyhlen/DE
  • 13 Hematology / Oncology, Outpatient Therapy Centre Offenburg, Offenburg/DE
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Background

The efficacy and tolerability of front-line BEV combined with carboplatin–paclitaxel (CP) for OC has been demonstrated in randomised phase III trials. To assess the safety and effectiveness of front-line BEV-containing therapy in the real-world setting in Germany, we initiated the single-arm non-interventional OTILIA study. The latter part of OTILIA focused on elderly pts. We report the second interim analysis.

Methods

Pts with FIGO stage IIIB–IV OC received front-line BEV + CP according to the EU label. Adverse events were recorded at each cycle and graded using CTCAE v4.0. Investigators assessed response according to local practice. Exploratory analyses compared safety and efficacy according to age.

Results

Between Feb 2012 and Jan 2016, 713 pts from 200 centres received BEV-containing treatment per the EU label. More pts aged

Conclusions

Exploratory analyses of OTILIA showed no evidence that age is associated with worse outcome (preliminary efficacy or tolerability) in pts receiving BEV for primary OC. BEV is an active and tolerable front-line treatment option that should be considered irrespective of age.

Clinical trial identification

NCT01697488

Legal entity responsible for the study

Roche Pharma AG, Germany

Funding

Roche Pharma AG, Germany

Disclosure

A. Mustea, R. Richter: Membership of Advisory Board: Roche. P. Wimberger: Member of Advisory Board: Roche, Novartis, Amgen, MSD, AstraZeneca, Teva, PharmaMar, Fresenius Biotech; Corporate-sponsored research: Roche, Novartis, Amgen, Fresenius Biotech, MSD. J. Harde, S. Klawitter, A. Wegenaer: Employee: Roche Pharma AG. J. Sehouli: Member of Advisory Board: Roche, AstraZeneca. All other authors have declared no conflicts of interest.

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