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. 2024 Jun 24;116(10):1654–1663. doi: 10.1093/jnci/djae129

Table 2.

LS mean score changes from baseline for each PRO in the neoadjuvant and adjuvant treatment phases

Neoadjuvant phase
 Adjuvant phase
PRO instrument Pembrolizumab + Chemotherapy Placebo + Chemotherapy Pembrolizumab Placebo
QLQ-C30 GHS/QoL
Mean (SD) at baselinea

  • 77.08 (18.49)

  • n = 701

  • 78.96 (17.12)

  • n = 366

  • 73.82 (15.68)

  • n = 489

  • 73.14 (18.15)

  • n = 283
Mean (SD) at week 21 or 24b

  • 66.79 (19.39)

  • n = 615

  • 68.26 (17.82)

  • n = 309

  • 76.26 (16.67)

  • n = 444

  • 76.24 (16.56)

  • n = 249
LS mean (95% CI) change from baseline to week 21 or 24a, b

  • –11.24 (–12.82 to –9.66)

  • n = 762

  • –10.20 (–12.30 to –8.10)

  • n = 383

  • 2.47 (1.05 to 3.88)

  • n = 539

  • 2.88 (1.05 to 4.71)

  • n = 308
Difference in LS means (95% CI) –1.04 (–3.46 to 1.38) –0.41 (–2.60 to 1.77)
QLQ-C30 Physical Functioning
Mean (SD) at baselinea

  • 91.89 (12.80)

  •  n = 701

  • 91.51 (13.13)

  • n = 366

  • 83.30 (15.32)

  • n = 489

  • 81.63 (16.61)

  • n = 283
Mean (SD) at week 21 or 24b

  • 77.01 (18.99)

  •  n = 615

  • 79.18 (17.13)

  • n = 309

  • 84.82 (15.68)

  • n = 444

  • 85.38 (15.03)

  • n = 249
LS mean (95% CI) change from baseline to week 21 or 24a, b

  • –15.37 (–16.71 to –14.03)

  •  n = 762

  • –12.52 (–14.38 to –10.65)

  • n = 383

  • 1.60 (0.46 to 2.75)

  • n = 539

  • 3.18 (1.70 to 4.66)

  • n = 308
Difference in LS means (95% CI) –2.85 (–5.11 to –0.60) –1.57 (–3.36 to 0.21)
QLQ-C30 Emotional Functioning
Mean (SD) at baselinea

  • 76.14 (19.50)

  •  n = 701

  • 75.20 (20.69)

  • n = 366

  • 81.75 (17.72)

  • n = 489

  • 78.98 (20.81)

  • n = 283
Mean (SD) at week 21 or 24b

  • 74.61 (20.79)

  • n = 615

  • 74.95 (21.64)

  • n = 309

  • 79.62 (19.64)

  • n = 444

  • 78.41 (20.44)

  • n = 249
LS mean (95% CI) change from baseline to week 21 or 24a, b

  • –1.31 (–2.82 to 0.21)

  • n = 762

  • –0.62 (–2.67 to 1.44)

  • n = 383

  • –1.53 (–3.03 to –0.03)

  • n = 539

  • –0.92 (–2.88 to 1.04)

  • n = 308
Difference in LS means (95% CI) –0.69 (–3.13 to 1.75) –0.60 (–2.99 to 1.79)
QLQ-BR23 Breast Symptoms
Mean (SD) at baselinea

  • 18.67 (20.36)

  • n = 695

  • 18.47 (19.32)

  • n = 361

  • 22.23 (18.71)

  • n = 487

  • 23.02 (20.24)

  • n = 282
Mean (SD) at week 21 or 24b

  • 8.82 (12.92)

  • n = 611

  • 8.50 (14.03)

  • n = 307

  • 16.84 (17.19)

  • n = 442

  • 16.70 (18.14)

  • n = 247
LS mean (95% CI) change from baseline to week 21 or 24a, b

  • –9.92 (–11.34 to –8.49)

  • n = 759

  • –9.78 (–11.53 to –8.03)

  • n = 382

  • –5.73 (–7.32 to –4.15)

  • n = 538

  • –6.02 (–8.04 to –4.01)

  • n = 306
Difference in LS means (95% CI) –0.13 (–1.92 to 1.65) 0.29 (–2.05 to 2.63)
EQ-5D VAS
Mean (SD) at baselinea

  • 81.10 (18.07)

  • n = 707

  • 82.60 (16.98)

  • n = 369

  • 78.43 (14.58)

  • n = 495

  • 78.79 (14.54)

  • n = 285
Mean (SD) at week 21 or 24b

  • 72.76 (18.14)

  • n = 616

  • 74.99 (16.37)

  • n = 311

  • 80.58 (14.86)

  • n = 444

  • 81.20 (13.35)

  • n = 249
LS mean (95% CI) change from baseline to week 21 or 24a, b

  • –8.98 (–10.48 to –7.47)

  • n = 762

  • –7.36 (–9.34 to –5.38)

  • n = 384

  • 1.83 (0.66 to 3.00)

  • n = 540

  • 2.42 (0.91 to 3.93)

  • n = 310
Difference in LS means (95% CI) –1.61 (–3.87 to 0.64) –0.59 (–2.40 to 1.23)

CI = confidence interval; EQ-5D VAS = EuroQol 5-Dimension Questionnaire visual analog scale; GHS/QoL = global health status/quality of life; LS = least squares; PRO = patient-reported outcome; QLQ-BR23 = European Organisation for Research and Treatment of Cancer Breast Cancer–Specific Quality of Life Questionnaire; QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30; SD = standard deviation.

a

Baseline refers to the baseline time point for the respective phase (neoadjuvant or adjuvant).

b

The analysis time point was week 21 in the neoadjuvant phase and week 24 in the adjuvant phase.