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Randomized Controlled Trial
. 2014 Sep;50(14):2375-89.
doi: 10.1016/j.ejca.2014.06.007. Epub 2014 Jul 24.

Comparison of patient reported quality of life and impact of treatment side effects experienced with a taxane-containing regimen and standard anthracycline based chemotherapy for early breast cancer: 6 year results from the UK TACT trial (CRUK/01/001)

E Hall  1 , D Cameron  2 , R Waters  3 , P Barrett-Lee  4 , P Ellis  5 , S Russell  6 , J M Bliss  3 , P Hopwood  3 ; TACT Trial Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Comparison of patient reported quality of life and impact of treatment side effects experienced with a taxane-containing regimen and standard anthracycline based chemotherapy for early breast cancer: 6 year results from the UK TACT trial (CRUK/01/001)

E Hall et al. Eur J Cancer. 2014 Sep.

Abstract

Background: The TACT trial (CRUK/01/001) compared adjuvant sequential FEC-docetaxel (FEC-D) chemotherapy with standard anthracycline-based chemotherapy of similar duration in women with early breast cancer. Results at a median of 5 years suggested no improvement in disease-free survival with FEC-D. Given differing toxicity profiles of the regimens, the impact on quality of life (QL) was explored.

Methods: Patients from 44 centres completed standardised QL questionnaires before chemotherapy, after cycles 4 and 8, at 9, 12, 18 and 24 months and at 6 years follow-up. Patient diaries assessed frequency, associated distress and impact on daily activity of 15 treatment related side effects.

Findings: 830 patients (415 FEC-D; 415 controls) contributed assessments during 0-24 months; 362 of whom participated again at 6 years. During chemotherapy, FEC-D impaired global health/QL and depression rates and significantly more QL domains than standard regimens. Novel diary card ratings highlighted significantly more distress and interference with daily activities due to FEC-D side effects compared with standard treatment. In both groups, most QL parameters returned to baseline levels by 2 years and were unchanged at 6 years.

Interpretation: Within expected negative effects of chemotherapy on wide ranging QL domains FEC-D patients reported greater toxicity, disruption and distress during treatment with no improvement in disease outcome at 5 years than patients receiving standard anthracycline-based chemotherapy. Findings should inform future patients of relative costs and benefits of adjuvant chemotherapy.

Keywords: Breast; Chemotherapy; Early; Patient reported outcomes; Quality of life; Randomised controlled trial.

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Figures

Fig. 1
Fig. 1
Study profile.
Fig. 2
Fig. 2
Change from baseline in EORTC QLQ-C30 and BR23 functional and symptom subscales scores at each time point. Text shows mean difference in change from baseline† (FEC-D minus control, with confidence interval‡ and p value) at cycle 8. Red = FEC-D, blue = control. †Change from baseline scores are adjusted for baseline score, chosen control and randomised treatment group using an analysis of covariance (ANCOVA) model. ∗Positive change from baseline indicates a worsening of symptoms; otherwise deterioration in function is shown by a negative change score. ‡95% confidence interval is given for the primary endpoint of global health/QL, 99% confidence intervals for all other subscales. (For interpretation of the references to colour in this figure legend, the reader is referred to the web version of this article.)
Fig. 3
Fig. 3
HADS anxiety and depression ratings (probable case disorder, borderline disorder, normal) by regimen at each time point. Graph shows predicted probabilities from generalised ordinal logistic regression models adjusting for baseline score, chosen control and randomised treatment. Number of observations at each time point are given in parentheses.
Fig. 4
Fig. 4
Diary card: Proportion experiencing side effect ‘quite a bit’ or ‘very much’ during treatment by regimen. P-values compare area under the curve by Mann–Whitney U test. Note scale of vertical axis differs on each row.
See this image and copyright information in PMC

References

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