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Toxicity and quality of life outcomes in ovarian cancer patients participating in randomized controlled trials

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Abstract

Main purpose

The objective of this study was to determine the relationship between clinician-graded symptoms based on the common toxicity criteria (CTC) and patient-reported quality of life (QoL). We hypothesized that toxicity symptoms that are objective or observable would have a higher correlation with QoL than subjective data.

Material and methods

A retrospective analyses of data from three closed randomized chemotherapy trials was performed. A total of 2,110 patients with ovarian cancer (stage IIB–IV) who had complete toxicity and QoL data at cycles 3 and 6 were included. Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria. Quality of life was assessed every other cycle by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).

Main results

Correlations between CTC grading and the QLQ-C30 functioning scales were weak (<0.30); correlation coefficients between CTC ratings and the QLQ-C30 symptom scales including nausea, vomiting, constipation, pain, and dyspnea ranged from 0.32 to 0.49 except for constipation (0.55). On a symptom level exact agreement between clinician and patient reporting ranged from 54.2% (pain) to 80.8% (emesis/vomiting). When symptom grading differed, patients reported greater severity for pain, constipation, and dyspnea, whereas clinicians graded emesis/vomiting and nausea as more severe than the grading by patients.

Conclusion

Patient experience is not routinely captured by CTC toxicity scales. Therefore, clinicians should not entirely rely on the CTC grading but consider patient-reported outcomes as well.

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Acknowledgments

We thank the following experts for their contribution: K. Baumann, A. Belau, H. Eidtmann, D. Elling, M. Gropp, P. Harter, J. Huober, Keil E, W. Kuhn, S. Loibl, W. Meier, G von Minckwitz, B. Schmalfeldt, J. Sehouli, A. Stähle, M. Untch, and K. Wollschlaeger. We thank all patients, the study office staff, and the statistical department of the AGO for their support. This work was not funded, but the original studies had been supported by Bristol-Myers-Squibb, Pfizer, and Glaxo-Smithkline.

Conflict of interest statement

The authors have no conflict of interest.

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Medical University Graz, Auenbruggerplatz 14, 8036, Graz, Austria

    Elfriede R. Greimel, Vesna Bjelic-Radisic & Fedor Daghofer

  2. Department of Gynecology and Obstetrics, Städtisches Klinikum Solingen, Solingen, Germany

    Jacobus Pfisterer

  3. Department of Gynecology and Obstetrics, University of Schleswig-Holstein, Campus Kiel, Kiel, Germany

    Felix Hilpert

  4. Department of Oncology, Hôpital Hôtel-Dieu (GINECO), Université Paris Descartes, AP-HP, Paris, France

    Eric Pujade-Lauraine

  5. Department of Gynecology and Gynecologic Oncology, Dr. Horst Schmidt Klinik (HSK), Wiesbaden, Germany

    Andreas du Bois

Authors
  1. Elfriede R. Greimel
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  2. Vesna Bjelic-Radisic
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  3. Jacobus Pfisterer
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  4. Felix Hilpert
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  5. Fedor Daghofer
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  6. Eric Pujade-Lauraine
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  7. Andreas du Bois
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for the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group (AGO-OVAR) and the Groupe d’Investigateurs Nationaux pour les Etudes des Cancers de l’Ovaire (GINECO)

Corresponding author

Correspondence to Elfriede R. Greimel.

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Greimel, E.R., Bjelic-Radisic, V., Pfisterer, J. et al. Toxicity and quality of life outcomes in ovarian cancer patients participating in randomized controlled trials. Support Care Cancer 19, 1421–1427 (2011). https://doi.org/10.1007/s00520-010-0969-8

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  • DOI: https://doi.org/10.1007/s00520-010-0969-8

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