A debate on health-related quality of life (HRQoL) by patients’ assessment and the assessment of toxicity by physicians in clinical trials is ongoing. The relations between these two assessments is therefore of importance. The aim of this study was to investigate the relations between toxicity items (Common Terminology Criteria for Adverse Events, version 3.0.) and items in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
Data was collected in a randomised phase 3 trial, comparing dose dense vs standard administration of adjuvant chemotherapy in high-risk breast cancer patients with mostly node positive disease (Foukakis et al., 2016). Data from the assessment at the end of treatment was used. Items from the EORTC QLQ-C30, considered to be associated with CTCAE, were chosen individually by three researchers. Relations based on ordinal data were analysed by Goodman and Kruskal gamma.
A total of 1428 event-free patients were included. Relations between 13 toxicities and 36 EORTC QLQ-C30 items (some with more than one toxicity) were investigated.Table:
1422O Strong or moderate relation between toxicity and HRQoL item
|Diahorrea||q17. Have you had diarrhoea||0.53S (0.47 to 0.59)|
|Vomiting||q15. Have you vomited?||0.50S (0.39 to 0.62)|
|Fatigue||q10. Did you need to rest?||0.35M (0.28 to 0.41)|
|q12. Have you felt weak?||0.35M (0.28 to 0.41)|
|q18. Were you tired?||0.41M (0.36 to 0.47)|
S = Strong relation (0.50-1.00) M= Moderate relation (0.30-0.49) There were no or weak relations between all the other toxicities and HRQoL items.
Few relations were found between CTCAE and HRQoL items, indicating that CTCAE does not mirror the total patient experience. Some toxicities, however, are not related to patients scoring of HRQoL and therefore have to be reported by physicians. These findings should raise concerns on how to best evaluate HRQoL/toxicities in clinical trials.
Clinical trial identification
NCT00798070 and ISRCTN39017665
Legal entity responsible for the study
Department of Oncology-Pathology, Karolinska Institutet
Swedish Cancer Society
T. Foukakis: Honoraria for lectures from Novartis, Pfizer, Roche and Eisai. Royalty from UpToDate. Institutional grant to the Karolinska University Hospital from Roche and Pfizer. M. Gnant: Institutional research support from AstraZeneca, Roche, Novartis, Pfizer. Lecture fees & honoraria for advisory boards from Roche, AstraZeneca, Celgene, Novartis, OBI-Pharma, Amgen. Consultant for Accelsiors. An immediate family member employed by Sandoz. G. von Minckwitz: Institutional research support from Pfizer, Sanofi, Amgen, Roche, Novartis, Celgene, Teva, AstraZeneca, Myriad Genetics, Abbvie, Vifor Pharma. N-O. Bengtsson: Advisory board Amgen Biosimilars for Trastuzumab. G. Steger: Lecture honoraria and travel support from Amgen and Roche. J. Bergh: Grants from Amgen, AstraZeneca, Bayer, Merck, Pfizer, Roche and Sanofi-Aventis to Karolinska Institutet and University Hospital. No personal payments. Honoraria from UpToDate for a chapter in breast cancer diagnostics to Asklepios Medicine HB. All other authors have declared no conflicts of interest.