Skip to main content
Top
Published in: Supportive Care in Cancer 9/2011

01-09-2011 | Original Article

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

Authors: 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)

Published in: Supportive Care in Cancer | Issue 9/2011

Login to get access

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.
Literature
2.
go back to reference Bentzen SM, Dorr W, Anscher MS et al (2003) Normal tissue effects: reporting and analysis. Semin Radiat Oncol 13:189–202PubMedCrossRef Bentzen SM, Dorr W, Anscher MS et al (2003) Normal tissue effects: reporting and analysis. Semin Radiat Oncol 13:189–202PubMedCrossRef
3.
go back to reference 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 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
4.
go back to reference 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 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
5.
go back to reference 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 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
6.
go back to reference 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 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
7.
go back to reference 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 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
8.
go back to reference 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 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
9.
go back to reference 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 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.
go back to reference 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 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.
go back to reference 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 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.
go back to reference 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 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.
go back to reference 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 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.
go back to reference 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 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
16.
go back to reference 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 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.
go back to reference Huschka M, Burger K (2006) Does QOL provide the same information as toxicity data? Curr Probl Cancer 30:244–254PubMedCrossRef Huschka M, Burger K (2006) Does QOL provide the same information as toxicity data? Curr Probl Cancer 30:244–254PubMedCrossRef
18.
go back to reference 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 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.
go back to reference 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 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.
go back to reference 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 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.
go back to reference Fayers P, Aaronson N, Bjordal K et al (2001) EORTC QLQ-C30 scoring manual, 3rd edn. EORTC publications, Brussels Fayers P, Aaronson N, Bjordal K et al (2001) EORTC QLQ-C30 scoring manual, 3rd edn. EORTC publications, Brussels
22.
go back to reference Cohen J (1988) Statistical power analysis for the behavioral sciences, 2nd edn. Lawerence Earlbaum Associates, Hillsdale Cohen J (1988) Statistical power analysis for the behavioral sciences, 2nd edn. Lawerence Earlbaum Associates, Hillsdale
23.
go back to reference 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 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
Metadata
Title
Toxicity and quality of life outcomes in ovarian cancer patients participating in randomized controlled trials
Authors
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)
Publication date
01-09-2011
Publisher
Springer-Verlag
Published in
Supportive Care in Cancer / Issue 9/2011
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI
https://doi.org/10.1007/s00520-010-0969-8

Other articles of this Issue 9/2011

Supportive Care in Cancer 9/2011 Go to the issue
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine