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01.09.2011 | Original Article

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

verfasst von: Elfriede R. Greimel, Vesna Bjelic-Radisic, Jacobus Pfisterer, Felix Hilpert, Fedor Daghofer, Eric Pujade-Lauraine, Andreas du Bois, 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)

Erschienen in: Supportive Care in Cancer | Ausgabe 9/2011

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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.

National Cancer Institute (1999) Common Toxicity Criteria version 2.o (CTC). http://www.77ctep.cancer.gov/reporing/CTC-3.html

Bentzen SM, Dorr W, Anscher MS et al (2003) Normal tissue effects: reporting and analysis. Semin Radiat Oncol 13:189–202PubMedCrossRef

Trotti A, Colevas AD, Setser A et al (2007) Patient-reported outcomes and the evolution of adverse event reporting in oncology. J Clin Oncol 25:5121–5127PubMedCrossRef

Velikova G, Wright P, Smith AB et al (2001) Self-reported quality of life of individual cancer patients: concordance of results with disease course and medical records. J Clin Oncol 19:2064–2073PubMed

Strömgren AS, Groenvold M, Pedersen L (2002) Symptomatology of cancer patients in palliative care: content validation of self-assessment questionnaires against medical records. Eur J Cancer 38:788–794PubMedCrossRef

Geels P, Eisenhauer E, Bezjak A (2000) Palliative effects of chemotherapy: objective tumor response is associated with symptom improvement in patients with metastatic breast cancer. J Clin Oncol 18:2395–2405PubMed

Petersen M, Larsen H, Pedersen L et al (2006) Assessing health-related quality of life in palliative care: comparing patient and physician assessments. Eur J Cancer 42:1159–1166PubMedCrossRef

Basch E, Iasonos A, McDonough T et al (2006) Patient versus clinician symptoms reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire based study. Lancet Oncol 7:903–908PubMedCrossRef

Varricchio CG, Sloan JA (2002) The need for and characteristics of randomized, phase III trials to evaluate symptom management in patients with cancer. J Natl Cancer Inst 94:1184–1184PubMed

10.

Wilson KA, Dowling AJ, Abdolell M et al (2000) Perception of quality of life by patients, partners and treating physicians. Qual Life Res 9:1041–1052PubMedCrossRef

11.

Butler L, Bacon M, Carey M et al (2004) Determining the relationship between toxicity and quality of life in an ovarian cancer chemotherapy clinical trial. J Clin Oncol 22:2461–2468PubMedCrossRef

12.

Fromme EK, Eilers KM, Mori M et al (2004) How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the quality of life questionnaire C30. J Clin Oncol 22:3485–3490PubMedCrossRef

13.

Huschka MM, Mandrekar SJ, Jett JR et al (2007) A pooled analysis of quality of life measures and adverse events data in North Central Cancer Treatment Group lung cancer clinical trials. Cancer 109:787–795PubMedCrossRef

14.

Basch E, Jia X, Heller G et al (2009) Adverse symptom reporting by patients vs clinicians: relationships with clinical outcomes. J Natl Cancer Inst 101:1624–1632PubMedCrossRef

15.

U.S. Department of Health and Human Services Food and Drug Administration (2007) Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims. Available at: http://www.fda.gov/cder/guidance/5460dft.htm

16.

Aaronson NK, Ahmedzai SM, Bergmann B et al (1993) The European Organisation 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 85:365–376PubMedCrossRef

17.

Huschka M, Burger K (2006) Does QOL provide the same information as toxicity data? Curr Probl Cancer 30:244–254PubMedCrossRef

18.

du Bois A, Lück HJ, Meier W et al (2003) Randomized clinical trial of Cisplatin/Paclitaxel versus Carboplatin/Paclitaxel as first-line treatment of ovarian cancer. J Natl Cancer Inst 95:1320–1330PubMed

19.

du Bois A, Weber B, Rochon J et al (2006) Addition of Epirubicin as a third drug to Carboplatin-Paclitaxel in first-line treatment of advanced ovarian cancer: a prospectively randomized Gynecologic Cancer Intergroup trial by the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group and The Groupe d’Investigateurs Nationaux pour L’Etude des Cancers Ovariens. J Clin Oncol 24:1127–1135PubMedCrossRef

20.

Pfisterer J, Weber B, Reuss A et al (2006) Randomized phase III Trial of Topotecan following Carboplatin and Paclitaxel in first-Line treatment of advanced ovarian cancer: a gynecologic Intergroup trial of the AGO-OVAR and GINECO. J Natl Cancer Inst 98:1036–1045PubMedCrossRef

21.

Fayers P, Aaronson N, Bjordal K et al (2001) EORTC QLQ-C30 scoring manual, 3rd edn. EORTC publications, Brussels

22.

Cohen J (1988) Statistical power analysis for the behavioral sciences, 2nd edn. Lawerence Earlbaum Associates, Hillsdale

23.

Greimel E, Bjelic-Radisic V, Pfisterer J et al (2006) Randomized study of the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group comparing quality of life in patients with ovarian cancer treated with Cisplatin/Paclitaxel versus Carboplatin/Paclitaxel. J Clin Oncol 24:579–586PubMedCrossRef

Titel: Toxicity and quality of life outcomes in ovarian cancer patients participating in randomized controlled trials
verfasst von: Elfriede R. Greimel
Vesna Bjelic-Radisic
Jacobus Pfisterer
Felix Hilpert
Fedor Daghofer
Eric Pujade-Lauraine
Andreas du Bois
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)
Publikationsdatum: 01.09.2011
Verlag: Springer-Verlag
Erschienen in: Supportive Care in Cancer / Ausgabe 9/2011
Print ISSN: 0941-4355
Elektronische ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-010-0969-8

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