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Poster Discussion session - Sarcoma

954 - Quality of Life in patients with soft tissue sarcoma undergoing palliative treatment - A multicenter, cluster-randomized trial within the Germany Interdisciplinary Sarcoma Group (GISG-12)

Date

22 Oct 2018

Session

Poster Discussion session - Sarcoma

Topics

End-of-life Care;  Soft Tissue Sarcomas

Presenters

Leopold Hentschel

Citation

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

Authors

L. Hentschel1, S. Richter2, H. Kopp3, B. Kasper4, A. Kunitz5, V. Grünwald6, T. Kessler7, J. Chemnitz8, U.-. Pelzer9, U.S. Schuler10, J. Freitag2, A. Schilling11, B. Hornemann1, K. Arndt12, G. Ehninger1, M. Bornhäuser1, M. Schuler2

Author affiliations

  • 1 University Cancer Center, University Hospital Carl Gustav Carus, 01307 - Dresden/DE
  • 2 Internal Medicine I, University Hospital Carl Gustav Carus, 01307 - Dresden/DE
  • 3 Internal Medicine Ii, Universitätsklinikum Tübingen Medizinische Universitätsklinik, 72076 - Tübingen/DE
  • 4 Interdisciplinary Tumor Center, Universitätsklinikum Mannheim, 68167 - Mannheim/DE
  • 5 Internal Medicine, Vivantes Clinic Spandau, Berlin/DE
  • 6 Clinic For Hematology, Hemostasis, Oncology And Stem Cell Transplantation, Medical School Hannover, Hannover/DE
  • 7 Hematology Oncology, University Hospital of Münster, 48149 - Münster/DE
  • 8 Internal Medicine, St. Martin Hospital, Koblenz/DE
  • 9 Medizinische Klinik Hämatologie, Onkologie Und Tumorimmunologie, Universitätsklinik Charité, Campus Virchow Klinikum, 13353 - Berlin/DE
  • 10 Palliative Care, Universitätsklinikum Dresden, 01307 - Dresden/DE
  • 11 Social Work, University Hospital Carl Gustav Carus, 01307 - Dresden/DE
  • 12 Das Lebenshaus E.v., Das Lebenshaus e.V., Wölfersheim/DE
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Resources

Abstract 954

Background

The choice of drug treatment in advanced soft tissue sarcoma (STS) continues to be a challenge considering efficacy, QoL and toxicity. Unlike other cancer types, where integrating patient reported outcomes (PRO) has proven to be beneficial for QoL, there is no such evidence in patients with STS yet.

Methods

This multi-center study explored the effect of a comprehensive intervention on QoL in patients with STS undergoing treatment with trabectedin (Yondelis®). Seven hospitals were cluster-randomized into control cluster (CC with electronic [e] assessment of PRO) or interventional cluster (IC including ePRO and expert-consensus based treatment suggestions). The center, where the multidisciplinary treatment suggestions were created, served as a reference center (RC). Outcomes included QoL (measured with FACT-G), symptoms (MDASI), anxiety and depression (HADS) and pain intensity and interference (BPI). The explorative primary endpoint was change of FACT-G total score (range 0-108) after nine weeks.

Results

80 patients (50% male; mean age: 58.1 years, range: 22-87 years) were included. After nine weeks, decrease in QoL was smaller in IC (-2.04) than in the CC (-5.5) and RC (-4.75). Nevertheless, this trend failed to reach statistical significance (p = 0.235). Improved, but not significant (p = 0.247) median progression free survival was observed in IC (277 days) and CC (279 days) than in RC (126 days). Other PRO showed non-significant, but yet medium to large effects.

Conclusions

This is the first study to include ePRO in patients with STS. The clinically important benefit in QoL observed in the IC could serve as a proof of principle to strengthen patient care. Beyond proofing statistical significance of the clinically meaningful effects, this study is an important prerequisite for future research in this area.

Clinical trial identification

NCT02204111.

Legal entity responsible for the study

GWT-TUD GmbH.

Funding

PharmaMar, Spain.

Editorial Acknowledgement

Disclosure

B. Kasper: Consultancy: Bayer, Clinigen, Eisai, Lilly; Honoraria: Bayer, Eisai, Lilly, Novartis, PharmaMar, Pfizer; Financing of research: PharmaMar. M. Schuler: Research Grant: PharmaMar. All other authors have declared no conflicts of interest.Table: 1606PD

Sociodemographic data at baseline

Interventional cluster (IC), n = 39Control cluster (CC), n = 29Reference center (RC), n = 12p-value
Age, mean (SD) Range (years)58.39 (11.68), 38-8755.80 (14.92), 22-8063.00 (15.63), 34 - 820.440
Tumor entity Leiomyosarcoma Liposarcoma Others18 10 159 10 155 3 7
ECOG 0 1 220 15 314 13 05 7 00.300
Patient Reported OutcomesIC, n = 3CC, n = 18RC, n = 8Cohens dp-value
FACT-G total Mean change after 9 weeks-2.04-5.50-4.750.720.235
HADS depression Mean change after 9 weeks0.651.44-0.250.910.181
HADS anxiety Mean change after 9 weeks0.000.78-0.880.720.235
BPI pain severity Mean change after 9 weeks0.480.01-0.470.720.235
BPI pain interference Mean change after 9 weeks0.620.15-0.230.700.241
MDASI, symptom severity Mean change after 9 weeks0.600.29-0.230.680.247
MDASI, symptom interference Mean change after 9 weeks1.031.000.210.040.482

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