Table 3. Mean estimates of each QL indicator from the (a) IBCSG Core Form and (b) trial-specific module by treatment group at months 0, 3, 6, 9, 12, and 18 months from randomisationa.
Months from randomisation
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0
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3
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6
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9
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12
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18
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QL | SD-CT | DI-EC | P-value | SD-CT | DI-EC | P-value | SD-CT | DI-EC | P-value | SD-CT | DI-EC | P-value | SD-CT | DI-EC | P-value | SD-CT | DI-EC | P-value |
(a) | ||||||||||||||||||
Physical well-being | 84±2 | 87±2 | 0.24 | 73±3 | 52±4 | <0.01 | 75±3 | 84±3 | 0.01 | 88±2 | 87±2 | 0.76 | 89±2 | 89±2 | 0.90 | 88±2 | 90±2 | 0.30 |
Mood | 74±3 | 74±3 | 0.95 | 74±3 | 64±4 | 0.01 | 76±3 | 84±3 | 0.02 | 85±2 | 83±2 | 0.51 | 86±2 | 87±2 | 0.71 | 88±2 | 89±2 | 0.52 |
Tiredness | 76±3 | 78±3 | 0.42 | 56±4 | 46±5 | 0.05 | 59±4 | 73±4 | <0.01 | 69±3 | 75±3 | 0.12 | 76±3 | 76±3 | 0.94 | 74±3 | 81±3 | 0.03 |
Appetite | 89±2 | 90±2 | 0.60 | 81±3 | 58±4 | <0.01 | 85±2 | 88±2 | 0.27 | 92±2 | 92±2 | 0.84 | 94±2 | 93±2 | 0.97 | 94±1 | 94±2 | 0.94 |
Hot flushes | 93±2 | 94±2 | 0.65 | 84±3 | 90±3 | 0.05 | 76±4 | 79±4 | 0.60 | 68±4 | 71±4 | 0.44 | 68±4 | 77±4 | 0.05 | 63±5 | 70±5 | 0.16 |
Nausea/vomiting | 96±1 | 98±1 | 0.23 | 74±3 | 74±3 | 0.83 | 84±2 | 96±1 | <0.01 | 98±1 | 97±1 | 0.46 | 97±1 | 98±1 | 0.56 | 98±1 | 98±1 | 0.71 |
Coping effort | 60±4 | 61±4 | 0.94 | 60±4 | 51±4 | 0.06 | 62±4 | 76±3 | <0.01 | 73±3 | 78±3 | 0.12 | 77±3 | 78±3 | 0.83 | 78±3 | 83±3 | 0.09 |
Feel supported | 97±1 | 97±1 | 0.87 | 93±1 | 96±1 | 0.04 | 93±1 | 96±1 | 0.07 | 94±1 | 94±1 | 0.91 | 93±1 | 94±1 | 0.40 | 93±1 | 95±1 | 0.18 |
Arm restriction | 71±3 | 71±3 | 0.84 | 83±2 | 81±3 | 0.49 | 85±2 | 82±3 | 0.44 | 83±2 | 81±3 | 0.49 | 80±3 | 82±3 | 0.51 | 84±2 | 83±3 | 0.67 |
Subjective health | 75±2 | 73±3 | 0.65 | 65±3 | 61±4 | 0.30 | 67±3 | 79±3 | <0.01 | 75±3 | 83±2 | 0.01 | 79±2 | 84±2 | 0.06 | 80±2 | 86±2 | 0.01 |
(b) | ||||||||||||||||||
Hair loss | 94±2 | 96±1 | 0.24 | 36±5 | 34±6 | 0.79 | 83±3 | 85±3 | 0.63 | 94±2 | 93±2 | 0.63 | ||||||
Numbness | 92±2 | 93±1 | 0.63 | 88±2 | 90±2 | 0.43 | 89±2 | 88±2 | 0.81 | 91±2 | 87±2 | 0.16 | ||||||
Thoughts | 60±3 | 58±4 | 0.66 | 63±3 | 53±4 | 0.05 | 70±3 | 84±3 | <0.01 | 89±2 | 89±2 | 0.83 | ||||||
Sexual interest | 81±3 | 77±3 | 0.38 | 64±4 | 62±4 | 0.76 | 63±4 | 80±3 | <0.01 | 79±3 | 83±3 | 0.28 | ||||||
Sore mouth | 98±1 | 98±1 | 0.70 | 85±2 | 65±4 | <0.01 | 90±2 | 96±1 | 0.01 | 97±1 | 98±1 | 0.58 | ||||||
Pain | 90±2 | 91±2 | 0.74 | 88±2 | 84±2 | 0.11 | 88±2 | 91±2 | 0.34 | 90±2 | 92±2 | 0.44 | ||||||
Treatment burden | 78±2 | 76±3 | 0.59 | 64±3 | 50±4 | <0.01 | 68±3 | 81±3 | <0.01 | 86±2 | 82±3 | 0.24 | ||||||
Daily activity | 74±2 | 74±3 | 0.99 | 68±3 | 52±4 | <0.01 | 73±3 | 79±3 | 0.06 | 82±2 | 84±2 | 0.49 |
Abbreviations: QL=quality of life; DI-EC=dose-intensive epirubicin cyclophosphamide; SD-CT=standard dose chemotherapy (ACx4-CMFx3). Higher scores indicate a better condition for all indicators.
Estimates were obtained from a linear mixed-effects model adjusted for patients’ age, culture, and baseline score.