Table 4.
Ability to detect change of the FACT-M in the MCC population by comparing change in score from baseline to week 7 across change groups defined by percentage change in tumor size (n = 105) and change in EQ VAS (n = 121), respectively
| FACT-M subscale, summary and MCC-specific scores | Percent change in tumor size; mean (effect size) | Change in EQ VAS (MID = 7); mean (effect size) | ||||||
|---|---|---|---|---|---|---|---|---|
| Reduction ≤ − 30%[a] (N = 47) | Reduction > − 30% to ≤0 (N = 14) |
Increase > 0% (N = 44) |
p-value[b] | Improved ≥7 points (n = 35) | Stable > − 7 to < 7 (n = 56) | Worsened ≤ − 7 points (n = 30) | p-value[b] | |
| FACT-G subscales | ||||||||
| Physical well-being | −0.02 (− 0.01) | −0.50 (− 0.11) | − 1.86 (− 0.36) | 0.101 | 0.46 (0.10) | −0.54 (− 0.11) | −3.17 (− 1.03) | < 0.001 |
| Social/Family well-being | 0.47 (0.09) | − 0.21 (− 0.06) | − 1.55 (− 0.24) | 0.209 | 0.72 (0.15) | − 1.19 (− 0.21) | − 0.13 (− 0.02) | 0.272 |
| Emotional well-being | 1.38 (0.35) | 0.79 (0.14) | 0.23 (0.05) | 0.292 | 2.37 (0.63) | 0.99 (0.20) | −2.03 (− 0.65) | <.0001 |
| Functional well-being | 0.06 (0.01) | − 0.43 (− 0.06) | − 2.16 (− 0.30) | 0.164 | 0.34 (0.05) | − 0.91 (− 0.12) | −2.24 (− 0.40) | 0.165 |
| Melanoma-specific subscales | ||||||||
| Melanoma subscale | 1.64 (0.21) | −2.64 (− 0.44) | − 2.32 (− 0.27) | 0.006 | 1.74 (0.24) | − 0.18 (− 0.02) | −4.63 (− 0.69) | <.0001 |
| Melanoma surgery scale | 1.50 (0.36) | −1.79 (− 0.48) | −1.16 (− 0.15) | 0.043 | 0.69 (0.12) | 0.02 (0.02) | − 0.67 (− 0.09) | 0.619 |
| Summary scales | ||||||||
| FACT-M TOI | 1.68 (0.10) | − 3.57 (− 0.23) | − 6.34 (− 0.32) | 0.012 | 2.54 (0.16) | − 1.63 (− 0.08) | −10.04 (− 0.76) | < 0.001 |
| FACT-G Total score | 1.89 (0.13) | − 0.36 (− 0.02) | − 5.34 (− 0.29) | 0.026 | 3.90 (0.26) | − 1.65 (− 0.09) | −7.56 (− 0.56) | 0.001 |
| FACT-M Total score | 3.53 (0.17) | −3.00 (− 0.14) | − 7.65 (− 0.30) | 0.009 | 5.64 (0.27) | −1.83 (− 0.07) | −12.20 (− 0.67) | <.0001 |
| MCC-Specific scores | ||||||||
| Physical function score (PF) | −0.30 (− 0.06) | −1.64 (− 0.32) | −2.18 (− 0.33) | 0.100 | −0.09 (− 0.01) | −0.95 (− 0.15) | −3.60 (− 0.79) | 0.002 |
| Psychological impact score (PI) | 1.40 (0.32) | 1.21 (0.22) | 0.30 (0.07) | 0.393 | 2.94 (0.71) | 0.98 (0.20) | −2.10 (−0.62) | <.0001 |
| MCC summary score | 1.11 (0.14) | −0.43 (− 0.04) | −1.89 (− 0.19) | 0.129 | 2.86 (0.33) | 0.04 (0.00) | −5.70 (− 0.91) | <.0001 |
MCC = Merkel cell carcinoma; MID = Minimal important difference; TOI = Trial Outcome Index
[a] reduction in tumor size ≥30% was used as one anchor for MID thresholds; [b] p-value from ANOVA comparing score change from baseline to week 7 between the three groups based on change in tumor size or change in EQ VAS respectively