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Poster Discussion session - Sarcoma

4912 - Health-related Quality of Life (HR-QoL) in elderly soft tissue sarcoma (STS) patients from the randomized phase II EPAZ study comparing pazopanib (PAZ) and doxorubicin (DOX) in first line

Date

22 Oct 2018

Session

Poster Discussion session - Sarcoma

Topics

Cytotoxic Therapy;  Geriatric Oncology

Tumour Site

Soft Tissue Sarcomas

Presenters

Viktor Grünwald

Citation

Annals of Oncology (2018) 29 (suppl_8): viii576-viii595. 10.1093/annonc/mdy299

Authors

V. Grünwald1, M. Schuler2, P. Schöffski3, H. Kopp4, S. Bauer5, B. Kasper6, L.H. Lindner7, J.M. Chemnitz8, M. Crysandt9, A. Stein10, B. Steffen11, S. Richter12, M. Kneba13, G. Egerer14, S. Zimmermann15, A. Karch16, A. Kunitz17

Author affiliations

  • 1 Department Of Hematology, Hemostasis, Oncology, And Stem Cell Transplantation,, Hannover Medical School, 30625 - Hannover/DE
  • 2 Medical Oncology, Helios Klinikum Emil von Behring, 14165 - Berlin/DE
  • 3 General Medical Oncology, University Hospitals Leuven, 3000 - Leuven/BE
  • 4 Molecualr Oncology And Pneumatological Oncology, Robert-Bosch-Krankenhaus, 70376 - Stuttgart/DE
  • 5 Medical Oncology, University Hospital Essen Westdeutsches Tumorzentrum, 45122 - Essen/DE
  • 6 Interdisciplinary Tumro Center Mannheim, Universitätsklinikum Mannheim, 68167 - Mannheim/DE
  • 7 Medical Clinic Iii, Ludwig Maximilians University - Grosshadern, 81377 - Munich/DE
  • 8 Hematology, Oncology And Palliative Medicine, Ev. Stift St. Martin, 56068 - Koblenz/DE
  • 9 Hematology And Oncology, UNiversity Hospital Aachen, 52074 - Aachen/DE
  • 10 Ucch, UKE Universitätsklinikum Hamburg-Eppendorf KMTZ, 20246 - Hamburg/DE
  • 11 Hematolgoy/oncology, University Hospital Frankfurt, 60590 - Frankfurt/DE
  • 12 Internal Medicine I, University Hospital Carl Gustav Carus, 01307 - Dresden/DE
  • 13 Hematology And Oncology, University Hospital Kiel, 24105 - Kiel/DE
  • 14 Hematology, Oncology, Rheumatology, University Hospital Heidelberg, 69120 - Heidelberg/DE
  • 15 Hctc, Hannover Clinical trial center, 30625 - Hannover/DE
  • 16 Institute For Biometry, Hannover Medical School, 30625 - Hannover/DE
  • 17 Oncolgoy, Vivantes Netzwerk für Gesundheit GmbH, 13047 - Berlin/DE
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Abstract 4912

Background

The EPAZ study (NCT01861951) showed that pazopanib was non-inferior to doxorubicin in advanced, inoperable STS in elderly pts. We report an analysis on HR-QoL of EPAZ.

Methods

STS patients ³60 years were randomly assigned to receive either DOX 75 mg/m2 q3wks for a total of 6 cycles or PAZ 800 mg OD continuously in a 1:2 fashion. EORTC QLQ C30 and elderly minimal comprehensive geriatric assessment (consisting of G8 screening tool, Charlson Comorbidity Index (CCI), instrumental activities of daily living (IADL) and social situation) were utilized for HR-QoL evaluation. All tools were applied at baseline and end of treatment. Subsequent measures were as follows: QLQ C30 weeks 3, 6, 9, 12, 15, 19, and 26; geriatric assessment weeks 12, 26 and then every 12 weeks thereafter.

Results

A total of 39 pts were randomly assigned to DOX and 81 to PAZ and PFS was 5.3 vs. 4.4 mo (HR 1.00; 95%CI 0.65-1.53; P=.993), respectively. The median age was 71 years (range: 60-88). Frequent AEs for DOX were fatigue (64.9%), alopecia (56.8%), nausea (48.6%) and constipation (13.5%), and for PAZ fatigue (58.0%), nausea (43.2%) and diarrhea (43.2%). QLQ C30 global scale and geriatric assessment were not significantly different at baseline nor at time points during the study. For DOX and PAZ 9 (25.0%) and 25 (32.5%) pts. were dependent (P=.4200) and 36 (100%) and 71 (97.3%) pts. remained at home (P=.6018), respectively. Overall the CCI was low for DOX 0 (IQR 0-1) and PAZ 0 (IQR 0-1) (P=.7244). However, differences were detected in QLQ C30 symptom scales at week 9, indicating more symptoms from diarrhea for PAZ (P = 0.0274) and more symptoms from constipation for DOX (P = 0.0409). The remaining functional and symptom scales remained without significant difference between treatment groups.

Conclusions

EPAZ recruited mainly independent and fit elderly patients with STS. While achieving non-inferior PFS, no apparent difference in HR-QoL measures was seen between treatment groups, except for symptom scales addressing specific adverse events of DOX (constipation) and PAZ (diarrhea).

Clinical trial identification

NCT01861951. EudraCT: 2011-004168-30

Legal entity responsible for the study

Medical School Hannover.

Funding

Novartis.

Editorial Acknowledgement

NA

Disclosure

V. Grünwald: Consulting: BMS, MSD, Merck Kga, AstraZeneca, Novartis, Pfizer, Ipsen, Cerulean, EUSA-Pharma, Roche; Shares: BMS, MSD, AstraZeneca; Honoraria: BMS, MSD, Merck Kga, AstraZeneca, Novartis, Pfizer, Ipsen, Eisai, Roche; Research funding: AstraZeneca, BMS, MSD, Pfizer; Travel: MSD, BMS, Roche. M. Schuler: Research funding: Novartis. P. Schöffski: Honoraria: Daiichi, Eisai, Lilly, Medscape, Novartis, Swedish Orphan Biovitrium; Consulting: 6th Element capital, Adaptimmune, Amcure, AstraZeneca, Bayer, Blueprint, BMS, Boehringer Ingelheim, Cristal Therapeutics, Daiichi, Lilly, Epizyme, Genzyme, Ipsen, Loxo Oncology, Medscape, Nektar, Novartis, Philogen, Piquir Ther., Plexxikon; Speaker's bureau: Bayer, Eisai, Lilly, GSK, Novartis, PharmaMar, Swedich Orphan Biovitum; Research: Bayer, Blueprint, Cobiores. H-G. Kopp: Consulting: MSD, BMS, Sanofi; Expert testimony: Novartis, Pfizer, IcoPharma; Travel: Sanofi, Lilly, Amgen, Novartis, MSD. B. Kasper: Honoraria: Bayer, Lilly, Novartis, PharmaMar; Consulting: Bayer, Lilly, Eisai; Rsearch funding: PharmaMar. L.H. Lindner: Reasearch funding: Sennewald Medizintechnik; Travel: PharmaMar; Consulting: Novartis, Lilly, Eisai, EZ Medconsult; Speaker Bureau: PharmaMar. J.M. Chemnitz: Honoraria: Ablynx; Consulting: Amgen, Ablynx; Travel: Amgen, PharmaMar. G. Egerer: Consulting: MSD; Speaker Bureau: MSD, PharmaMar; Travel: MSD, Astellas. All other authors have declared no conflicts of interest.

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