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Pretreatment quality of life, performance status and their relation to treatment discontinuation and treatment changes in high-risk breast cancer patients receiving chemotherapy: results from the prospective randomized ADEBAR trial

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Abstract

Background

Health-related quality of life (QoL) is a self-assessed construct indicating how people feel in regard to aspects of their health. Performance status (PS) is evaluated by the treating physician. We examined whether pretreatment QoL and PS are related to subsequent treatment discontinuation and treatment changes in high-risk breast cancer patients receiving chemotherapy.

Methods

We conducted a prospective cohort study with data from a randomized phase III trial comparing FEC- and EC-DOC-chemotherapy in patients with primary breast cancer (ADEBAR). We examined the patient’s request to discontinue the study, discontinuation due to toxicity, the prolongation of therapy, and dose reduction. Baseline QoL was assessed using the EORTC QLQ-C30. PS was evaluated using the Eastern Cooperative Oncology Group Scale (ECOG). Four QoL scales were selected prior to analysis as outcomes: global health, physical functioning, emotional functioning, and fatigue. Multivariate binary logistic regression analyses were used to test for differences within the independent variables.

Main results

1322 patients were included. 1094 (82.8 %) patients completed therapy according to protocol. 6.3 % stopped therapy due to toxicity and 4.4 % refused treatment. Global health was not related to any of the four QoL outcomes. Physical functioning had the strongest impact on QoL, when comparing the fittest group to the lowest quintile [OR 2.14 (95 % CI 1.00–4.60)]. ECOG 0 compared to worse than 1 was strongly correlated to therapy discontinuation due to toxicity [OR 20.15 (95 % CI 9.48–42.83)] and treatment refusal [OR 8.32 (95 % CI 3.81–18.14)].

Conclusions

Pretreatment QoL, especially physical functioning, is associated with subsequent therapy discontinuation due to toxicity and with changes of the treatment protocol. Pretreatment performance status is strongly associated with therapy discontinuation due to toxicity and with treatment refusal.

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References

  1. Quinten C, Coens C, Mauer M, Comte S, Sprangers MAG, Cleeland C, et al. Baseline quality of life as a prognostic indicator of survival: a meta-analysis of individual patient data from EORTC clinical trials. Lancet Oncol. 2009;10(9):865–71.

    Article  PubMed  Google Scholar 

  2. Seidman AD, Portenoy R, Yao TJ, Lepore J, Mont EK, Kortmansky J, et al. Quality of life in phase II trials: a study of methodology and predictive value in patients with advanced breast cancer treated with paclitaxel plus granulocyte colony-stimulating factor. J Natl Cancer Inst. 1995;87(17):1316–22.

    Article  CAS  PubMed  Google Scholar 

  3. Coates AS, Hürny C, Peterson HF, Bernhard J, Castiglione-Gertsch M, Gelber RD, International Breast Cancer Study Group, et al. Quality-of-life scores predict outcome in metastatic but not early breast cancer. J Clin Oncol Off J Am Soc Clin Oncol. 2000;18(22):3768–74.

    CAS  Google Scholar 

  4. Kramer JA, Curran D, Piccart M, de Haes JC, Bruning P, Klijn J, et al. Identification and interpretation of clinical and quality of life prognostic factors for survival and response to treatment in first-line chemotherapy in advanced breast cancer. Eur J Cancer Oxf Engl. 2000;36(12):1498–506.

    Article  CAS  Google Scholar 

  5. Montazeri A. Quality of life data as prognostic indicators of survival in cancer patients: an overview of the literature from 1982 to 2008. Health Qual Life Outcomes. 2009;7(1):102.

    Article  PubMed  PubMed Central  Google Scholar 

  6. Buccheri G, Ferrigno D, Tamburini M. Karnofsky and ECOG performance status scoring in lung cancer: a prospective, longitudinal study of 536 patients from a single institution. Eur J Cancer. 1996;32(7):1135–41.

    Article  Google Scholar 

  7. Lee CK, Stockler MR, Coates AS, Gebski V, Lord SJ, Simes RJ. Self-reported health-related quality of life is an independent predictor of chemotherapy treatment benefit and toxicity in women with advanced breast cancer. Br J Cancer. 2010;102(9):1341–7.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  8. Richardson LC, Wang W, Hartzema AG, Wagner S. The role of health-related quality of life in early discontinuation of chemotherapy for breast cancer. Breast J. 2007;13(6):581–7.

    Article  CAS  PubMed  Google Scholar 

  9. Combination chemotherapy in treating women with breast cancer, ClinicalTrials.gov Identifier: NCT00047099.

  10. Janni W, et al. Sequential treatment with epirubicin/cyclophosphamide, followed by docetaxel versus FEC120 in the adjuvant treatment of node-positive breast cancer patients: final survival analysis of the German ADEBAR phase III study. J Clin Oncol. 2012;30(suppl):abstr 1081.

    Google Scholar 

  11. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365–76.

    Article  CAS  PubMed  Google Scholar 

  12. Fayers P, Aaronson N, Bjordal K, Groenvold M. The EORTC QLQ-C30 scoring manual. 3rd ed. Brussels: European Organisation for Research and Treatment of Cancer; 2001.

  13. IBM Corp. IBM SPSS Statistics for Windows, Version 22.0. Armonk: IBM Corp; 2013.

  14. Scott NW, Fayers PM, Aaronson NK, Bottomley A, de Graeff A. EORTC QLQ-C30 reference values. Brussels: European Organisation for Research and Treatment of Cancer; 2008.

  15. You J, Shi Z. Study on the relationship among the international scales for quality of life evaluation in patients with lung cancer, the East Cooperative Oncology Group Status and Lung Cancer Symptoms Lists of TCM. Zhongguo Zhong Xi Yi Jie He Za Zhi Zhongguo Zhongxiyi Jiehe Zazhi Chin J Integr Tradit West Med Zhongguo Zhong Xi Yi Jie He Xue Hui Zhongguo Zhong Yi Yan Jiu Yuan Zhu Ban. 2005;25(7):595–9.

    Google Scholar 

  16. Suh S-Y, LeBlanc TW, Shelby RA, Samsa GP, Abernethy AP. Longitudinal patient-reported performance status assessment in the cancer clinic is feasible and prognostic. J Oncol Pract. 2011;7(6):374–81.

    Article  PubMed  PubMed Central  Google Scholar 

  17. Levine MN, Guyatt GH, Gent M, De Pauw S, Goodyear MD, Hryniuk WM, et al. Quality of life in stage II breast cancer: an instrument for clinical trials. J Clin Oncol Off J Am Soc Clin Oncol. 1988;6(12):1798–810.

    CAS  Google Scholar 

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Acknowledgments

The overhead of the study was partly supported by the pharmaceutical companies Aventis, Pharmacia, Amgen, Novartis, Astra Zeneca and Wilex.

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Authors and Affiliations

  1. Institute for Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany

    Martin Eichler & Susanne Singer

  2. Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany

    Wolfgang Janni, Christoph Scholz, Visnja Fink & Lukas Schwentner

  3. Breast Center, Department of Gynecology and Obstetrics, Ludwig-Maximilian-University Munich, Munich, Germany

    Nadia Harbeck & Brigitte Rack

  4. Clinics Deggendorf Mammacenter Ostbayern, Deggendorf, Germany

    Doris Augustin

  5. Breast Center, Clinics Augsburg, Augsburg, Germany

    Arthur Wischnik

  6. Department of Gynecology and Obstetrics, Klinikum Rechts der Isar, Technical University Munich, Munich, Germany

    Marion Kiechle & Johannes Ettl

Authors
  1. Martin Eichler
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  2. Susanne Singer
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  3. Wolfgang Janni
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  4. Nadia Harbeck
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  5. Brigitte Rack
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  6. Doris Augustin
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  7. Arthur Wischnik
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  8. Marion Kiechle
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  9. Johannes Ettl
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  10. Christoph Scholz
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  11. Visnja Fink
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  12. Lukas Schwentner
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Corresponding author

Correspondence to Martin Eichler.

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Conflict of interest

Martin Eichler, Wolfgang Janni, Nadia Harbeck, Doris Augustin, Arthur Wischnik, Marion Kiechle, Johannes Ettl, Visnja Fink and Lukas Schwentner declare that they have no conflict of interest. Christoph Scholz received honoraria from Roche Pharma AG. Susanne Singer received research funding from Fitzer. Brigitte Rack served as a consultant for Novartis and Amgen, received honoraria and a research grant from Sanofi-Aventis, Novartis and Amgen and got travel expenses from Sanofi-Aventis, Amgen and Novartis.

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Eichler, M., Singer, S., Janni, W. et al. Pretreatment quality of life, performance status and their relation to treatment discontinuation and treatment changes in high-risk breast cancer patients receiving chemotherapy: results from the prospective randomized ADEBAR trial. Breast Cancer 24, 319–325 (2017). https://doi.org/10.1007/s12282-016-0706-3

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  • DOI: https://doi.org/10.1007/s12282-016-0706-3

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