Table 3.
Comparison of PRO End Points Between Tamoxifen Alone and Tamoxifen Plus OFS in Analyzable Participants
| End Points | Tamoxifen Alone |
Tamoxifen + OFS |
Difference in Mean | P (t test) | ||||
|---|---|---|---|---|---|---|---|---|
| No. | Mean | SD | No. | Mean | SD | |||
| FACT-B* | ||||||||
| Baseline | 103† | 113.30 | 16.87 | 102 | 110.26 | 19.48 | 3.04 | .23 |
| Month 6 | 134 | 112.28 | 19.72 | 128 | 112.35 | 18.12 | −0.07 | .98 |
| Year 1 | 130 | 114.47 | 17.74 | 132 | 110.96 | 18.52 | 3.51 | .12 |
| Year 2 | 109 | 114.02 | 19.70 | 113 | 109.39 | 19.35 | 4.63 | .08 |
| Year 3 | 99 | 118.18 | 15.92 | 104 | 110.46 | 20.49 | 7.72 | .003 |
| Year 4 | 98 | 114.65 | 17.52 | 96 | 113.14 | 19.24 | 1.52 | .57 |
| Year 5 | 93 | 117.04 | 17.51 | 84 | 116.24 | 15.49 | 0.80 | .75 |
| FACT-G‡ | ||||||||
| Baseline | 158 | 86.24 | 13.18 | 164 | 85.79 | 13.91 | 0.45 | .76 |
| Month 6 | 149 | 86.98 | 14.61 | 137 | 86.26 | 14.57 | 0.72 | .68 |
| Year 1 | 136 | 88.52 | 13.24 | 137 | 86.18 | 14.61 | 2.34 | .17 |
| Year 2 | 116 | 89.19 | 14.93 | 123 | 85.50 | 15.06 | 3.69 | .06 |
| Year 3 | 102 | 92.47 | 12.15 | 113 | 86.54 | 16.08 | 5.39 | .003 |
| Year 4 | 106 | 90.10 | 13.37 | 104 | 88.57 | 14.85 | 1.54 | .43 |
| Year 5 | 97 | 91.30 | 12.87 | 91 | 89.88 | 12.62 | 1.42 | .45 |
| Breast subscale§ | ||||||||
| Baseline | 104† | 25.98 | 5.12 | 102 | 25.13 | 5.68 | 0.85 | .26 |
| Month 6 | 134 | 25.68 | 6.10 | 129 | 25.56 | 5.47 | 0.12 | .88 |
| Year 1 | 130 | 25.88 | 5.82 | 132 | 24.72 | 5.60 | 1.16 | .10 |
| Year 2 | 109 | 25.22 | 6.03 | 113 | 23.75 | 5.85 | 1.47 | .07 |
| Year 3 | 99 | 25.87 | 5.07 | 104 | 24.38 | 5.89 | 1.49 | .06 |
| Year 4 | 98 | 25.18 | 5.57 | 97 | 24.84 | 5.75 | 0.34 | .67 |
| Year 5 | 94 | 25.85 | 6.21 | 85 | 25.78 | 5.62 | 0.07 | .94 |
| Menopausal symptoms‖ | ||||||||
| Baseline | 148 | 47.61 | 7.99 | 157 | 48.71 | 7.99 | −1.10 | .23 |
| Month 6 | 139 | 42.13 | 9.16 | 128 | 40.21 | 8.59 | 1.92 | .08 |
| Year 1 | 131 | 42.85 | 9.04 | 136 | 39.40 | 8.71 | 3.45 | .002 |
| Year 2 | 114 | 42.59 | 9.13 | 118 | 38.74 | 8.06 | 3.85 | .001 |
| Year 3 | 97 | 43.37 | 8.41 | 113 | 39.78 | 8.59 | 3.59 | .003 |
| Year 4 | 105 | 41.98 | 8.98 | 103 | 40.86 | 8.11 | 1.12 | .35 |
| Year 5 | 97 | 43.22 | 9.46 | 90 | 41.83 | 8.08 | 1.39 | .28 |
| Sexual function¶ | ||||||||
| Baseline | 128 | 15.83 | 3.40 | 145 | 15.97 | 3.77 | −0.14 | .75 |
| Month 6 | 118 | 14.45 | 4.58 | 115 | 13.08 | 4.38 | 1.37 | .020 |
| Year 1 | 110 | 14.00 | 4.59 | 123 | 12.50 | 4.79 | 1.50 | .016 |
| Year 2 | 98 | 13.83 | 5.25 | 106 | 11.87 | 4.68 | 1.96 | .005 |
| Year 3 | 81 | 13.84 | 4.77 | 103 | 11.20 | 4.73 | 2.64 | < .001 |
| Year 4 | 85 | 13.26 | 4.76 | 85 | 11.38 | 4.73 | 1.87 | .011 |
| Year 5 | 80 | 13.18 | 4.85 | 78 | 11.45 | 4.49 | 1.73 | .022 |
Abbreviation: FACT-B, Functional Assessment of Cancer Therapy-Breast; FACT-G, FACT-General; OFS, ovarian function suppression; PRO, patient-reported outcome; SD, standard deviation.
Out of possible score 144, higher score indicates better HRQL.
On the original version of the baseline survey, the last page containing the breast subscale was missing. Thus, the FACT-B and breast subscales are unavailable for some patients. This was corrected in early 1995.
Out of possible score of 108, higher scores indicate better HRQL.
Out of possible score of 36, higher scores indicate fewer breast cancer-specific symptoms.
Out of possible score of 60, higher scores indicate fewer complaints or difficulty.
Out of possible score of 20, higher scores indicate better sexual activity.