Quality of life in patients with metastatic colorectal cancer receiving maintenance therapy after first-line inductive treatment: A quality of life sub-analysis of the AIO KRK 0207 phase III trial

Date

08 Oct 2016

Session

Poster Display

Presenters

Julia Quidde

Citation

Annals of Oncology (2016) 27 (6): 149-206. 10.1093/annonc/mdw370

Authors

J. Quidde1, S. Hegewisch Becker2, U. Graeven3, C. Lerchenmueller4, B. Killing5, R. Depenbusch6, C. Steffens7, T. Lange8, G. Dietrich9, J. Stoehlmacher10, A. Reinacher11, A. Tannapfel12, T. Trarbach13, N. Marschner14, H.J. Schmoll15, A. Hinke16, S. Al-Batran17, D. Arnold18

Author affiliations

  • 1 University Cancer Center Hamburg, University Hospital Hamburg, 20246 - Hamburg/DE
  • 2 Hope, Internal Medicine Oncology and Hematology, 20249 - Hamburg/DE
  • 3 Chefarzt Privatdozent, Kliniken Maria Hilf GmbH Klinik für Haematolgie/Onkologie, 41063 - Mönchengladbach/DE
  • 4 Haematologie Und Onkologie, Ueberoertliche Gemeinschaftspraxis, Münster/DE
  • 5 Department Of Hematology And Oncology, Lahn-Dill-Kliniken, Wetzlar/DE
  • 6 Medical Oncology, Practice for Oncology, Gütersloh/DE
  • 7 Medical Oncology, Onkologische Schwerpunktpraxis Stade, 21680 - Stade/DE
  • 8 Department Of Hematology And Oncology, Asklepios-Klinik Weißenfels, Weißenfels/DE
  • 9 Department Of Gastroenterology, Hematology And Oncology, Klinikum Bietigheim, Bietigheim/DE
  • 10 -, Tumorgenetik, Bonn/DE
  • 11 Medical Departement, Ruhr University Bochum Medizinische Universitätsklinik, Bochum/DE
  • 12 Department Of Pathology, Ruhr University Bochum Medizinische Universitätsklinik, Bochum/DE
  • 13 Medical Departement, iOMEDICO AG, Freiburg/DE
  • 14 Internal Medicine / Hematology, Praxis für Interdisziplinaere Onkologie, 79110 - Freiburg/DE
  • 15 Dept. Hematology/ Oncology Fg 16 / U1, Martin Luther University of Halle, 06120 - Halle/DE
  • 16 Research, WiSP GmbH, 40764 - Langenfeld/DE
  • 17 Medical Oncology, Nordwest-Krankenhaus, Frankfurt am Main/DE
  • 18 Cuf, CUF Hospitals Cancer Centre, Lisbon/PT
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Resources

Background

First-line maintenance strategies are a current matter of debate in the management of mCRC. Their impact on patient's health related quality of life (HRQOL) has not yet been evaluated. The objective of this study was to assess whether differences in HRQOL during any active maintenance treatment compared to no maintenance treatment exist.

Methods

837 patients with mCRC were enrolled in the AIO KRK 0207 trial. 472 underwent randomization after 24 weeks of induction treatment into one of the maintenance arms: FP plus Bev (arm A), Bev (arm B) or no active treatment (arm C). HRQOL were assessed every 6 weeks during induction and maintenance treatment independent from treatment stop, delay, or treatment modification (e.g. also including assessment after progression), using the EORTC QLQ-C30, QLQ-CR29. The mean value of the global quality of life dimension (GHS/QoL) of the EORTC QLQ-C30, calculated as the average of all available time points after randomization was considered as primary endpoint. Additionally, EORTC QLQ-C30 response scores were analyzed.

Results

For HRQOL analysis, 413 patients were eligible (arm A: 136; arm B: 142, arm C: 135). Compliance rate with HRQOL questionnaires was 95% at time of randomization and remained high during maintenance (98%, 99%, 97% and 97% at week 6, 12, 18 and 24). No significant difference in the mean GHS/QoL scores at week 6, 12, 18, and 24 were observed between treatment arms. GHS/QoL scores deterioration (decrease by 10 points or more) was observed in 20.5%; 17.2 % and 20.7% of the patients, whereas an improvement of at least 10 GHS/QOL scores occurred in 36.1%; 43.8% and 42.1% (arms A, B, C). Compared to PD, non-PD patients had a favorable GHS/Qol score in all arms.

Conclusions

Continuation of an active maintenance treatment with FP/Bev after intensively induction treatment was neither associated with a detrimental effect on GHS/QoL scores when compared to both, less active treatment with Bev alone or no active treatment.

Clinical trial identification

ClinicalTrials.gov NCT00973609

Legal entity responsible for the study

Susanne Hegewisch-Becker

Funding

AIO trail with foundation from Roche Pharma

Disclosure

All authors have declared no conflicts of interest.

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