Table 3.
Toxicity relevant symptom burden 30 days after CAR T-cell infusion
| Acute CRS | Acute ICANS | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade 0–1 (N=17) | Grade 2–4 (N=15) | 95% CI | Grade 0–1 (N=20) | Grade 2–4 (N=12) | 95% CI | |||||||||
| Mean | SD | Mean | SD | Effect size | Lower | Upper | Mean | SD | Mean | SD | Effect size | Lower | Upper | |
| MDASI-Core items | ||||||||||||||
| Pain | 1.59 | 2.85 | 1.6 | 2.69 | 0.00 | −0.70 | 0.69 | 1.65 | 2.96 | 1.5 | 2.43 | 0.05 | −0.66 | 0.77 |
| Fatigue | 2.94 | 2.79 | 4.07 | 2.74 | −0.41 | −1.10 | 0.30 | 2.8 | 2.86 | 4.58 | 2.35 | −0.66 | −1.38 | 0.09 |
| Nausea | 0.71 | 1.61 | 1.2 | 1.97 | −0.27 | −0.96 | 0.43 | 0.6 | 1.5 | 1.5 | 2.11 | −0.51 | −1.23 | 0.22 |
| Sleep | 2.76 | 3.03 | 2.4 | 2.8 | 0.12 | −0.57 | 0.81 | 2.9 | 3.09 | 2.08 | 2.54 | 0.28 | −0.44 | 0.99 |
| Distress | 1.82 | 2.51 | 1.27 | 1.83 | 0.25 | −0.46 | 0.94 | 1.6 | 2.41 | 1.5 | 1.88 | 0.04 | −0.67 | 0.76 |
| Short breath | 1.24 | 1.89 | 1.67 | 2.26 | −0.21 | −0.90 | 0.49 | 1.35 | 2.03 | 1.58 | 2.15 | −0.11 | −0.82 | 0.61 |
| Remember | 1.06 | 1.52 | 1.53 | 1.88 | −0.28 | −0.97 | 0.43 | 1.05 | 1.54 | 1.67 | 1.92 | −0.37 | −1.08 | 0.36 |
| Appetite | 1.41 | 2.43 | 3 | 3.34 | −0.55 | −1.24 | 0.17 | 1.4 | 2.6 | 3.42 | 3.18 | −0.71 | −1.43 | 0.04 |
| Drowsy | 2.18 | 2.83 | 3.87 | 3.36 | −0.55 | −1.24 | 0.17 | 2.35 | 3.01 | 4 | 3.25 | −0.53 | −1.25 | 0.21 |
| Dry mouth | 1.24 | 2.44 | 2.13 | 2.88 | −0.34 | −1.03 | 0.37 | 1.65 | 2.81 | 1.67 | 2.46 | −0.01 | −0.72 | 0.71 |
| Sadness | 0.71 | 1.53 | 1.53 | 2.5 | −0.40 | −1.09 | 0.31 | 1 | 1.86 | 1.25 | 2.42 | −0.12 | −0.83 | 0.60 |
| Vomiting | 0.29 | 0.77 | 0.87 | 2.13 | −0.37 | −1.06 | 0.34 | 0.25 | 0.72 | 1.08 | 2.35 | −0.54 | −1.25 | 0.20 |
| Numbness | 1.82 | 2.7 | 1 | 1.41 | 0.37 | −0.34 | 1.06 | 1.3 | 2.41 | 1.67 | 1.87 | −0.17 | −0.88 | 0.55 |
| MDASI-Interference Items | ||||||||||||||
| Activity | 1.94 | 2.93 | 2.64 | 2.62 | −0.25 | −0.95 | 0.47 | 2.2 | 2.86 | 2.36 | 2.73 | −0.06 | −0.79 | 0.68 |
| Mood | 1.71 | 3.02 | 2 | 1.8 | −0.11 | −0.82 | 0.60 | 1.9 | 2.88 | 1.73 | 1.74 | 0.07 | −0.67 | 0.80 |
| Work | 2 | 3.02 | 2.46 | 2.33 | −0.17 | −0.89 | 0.56 | 2 | 2.89 | 2.55 | 2.46 | −0.20 | −0.93 | 0.54 |
| Relations | 1.53 | 2.65 | 0.86 | 1.61 | 0.30 | −0.42 | 1.00 | 1.4 | 2.5 | 0.91 | 1.7 | 0.22 | −0.53 | 0.95 |
| Walking | 1.94 | 2.7 | 2.92 | 2.72 | −0.36 | −1.08 | 0.38 | 1.85 | 2.6 | 3.4 | 2.76 | −0.58 | −1.34 | 0.20 |
| Enjoyment of life | 1.76 | 2.95 | 3.07 | 2.76 | −0.46 | −1.16 | 0.27 | 1.75 | 2.77 | 3.45 | 2.91 | −0.60 | −1.34 | 0.16 |
| CAR-T related Symptoms | ||||||||||||||
| Diarrhea | 0.82 | 2.01 | 1.6 | 3.46 | −0.28 | −0.97 | 0.42 | 0.7 | 1.87 | 2 | 3.79 | −0.48 | −1.19 | 0.26 |
| Inability to eat | 0.76 | 2.05 | 1.2 | 2.14 | −0.21 | −0.90 | 0.49 | 0.6 | 1.85 | 1.58 | 2.35 | −0.48 | −1.19 | 0.26 |
| Rash | 0.41 | 1.18 | 0 | 0 | 0.48 | −0.24 | 1.17 | 0.35 | 1.09 | 0 | 0 | 0.40 | −0.33 | 1.12 |
| Malaise | 5 | 4.6 | 2.13 | 2.67 | 0.95 | −0.33 | 2.15 | 1.4 | 2.19 | 2.67 | 2.74 | −0.53 | −1.24 | 0.21 |
| Lack of energy | 2.18 | 2.38 | 3.8 | 3.17 | −0.58 | −1.28 | 0.14 | 2 | 2.18 | 4.5 | 3.23 | −0.96 | −1.68 | −0.18 |
| Tremors | 0.59 | 1.58 | 0.4 | 1.3 | 0.13 | −0.57 | 0.82 | 0.5 | 1.47 | 0.5 | 1.45 | 0.00 | −0.72 | 0.72 |
| Muscle weakness | 2.06 | 2.38 | 1.67 | 2.64 | 0.16 | −0.54 | 0.85 | 1.7 | 2.27 | 2.17 | 2.86 | −0.19 | −0.90 | 0.53 |
| Weakness | 1.12 | 1.93 | 3.67 | 3.29 | −0.96 | −1.67 | −0.21 | 1.5 | 2.69 | 3.67 | 2.87 | −0.79 | −1.51 | −0.03 |
| Fever | 0.53 | 1.01 | 0.87 | 1.51 | −0.27 | −0.96 | 0.44 | 0.7 | 1.13 | 0.67 | 1.5 | 0.02 | −0.69 | 0.74 |
| Headache | 1 | 2 | 1.07 | 2.43 | −0.03 | −0.73 | 0.66 | 0.8 | 1.85 | 1.42 | 2.68 | −0.28 | −0.99 | 0.44 |
| Irritability | 1.18 | 1.81 | 2 | 2.73 | −0.36 | −1.05 | 0.35 | 1.2 | 1.7 | 2.17 | 3.01 | −0.43 | −1.14 | 0.31 |
| Balance | 0.35 | 1 | 1.8 | 2.76 | −0.72 | −1.41 | 0.02 | 0.8 | 2.35 | 1.42 | 1.68 | −0.29 | −1.00 | 0.44 |
| Mouth sore | 0.35 | 1.22 | 0 | 0 | 0.39 | −0.32 | 1.08 | 0.3 | 1.13 | 0 | 0 | 0.33 | −0.39 | 1.05 |
| Dizziness | 0.59 | 1.7 | 1.8 | 2.81 | −0.53 | −1.22 | 0.19 | 0.45 | 1.57 | 2.33 | 2.93 | −0.87 | −1.59 | −0.10 |
| Difficulty Swallowing | 0.06 | 0.24 | 0.73 | 2.34 | −0.42 | −1.11 | 0.30 | 0.05 | 0.22 | 0.92 | 2.61 | −0.55 | −1.26 | 0.19 |
| Attention | 1.82 | 2.38 | 1.67 | 2.35 | 0.06 | −0.63 | 0.76 | 1.5 | 2.28 | 2.17 | 2.44 | −0.29 | −1.00 | 0.44 |
| Bone aches | 1.53 | 2.24 | 1.93 | 2.79 | −0.16 | −0.85 | 0.54 | 1.65 | 2.54 | 1.83 | 2.48 | −0.07 | −0.79 | 0.65 |
| Heart bead | 0.88 | 2.18 | 0.93 | 1.83 | −0.02 | −0.72 | 0.67 | 0.85 | 2.03 | 1 | 2 | −0.07 | −0.79 | 0.64 |
| Swelling | 0.65 | 1.17 | 1.07 | 2.69 | −0.21 | −0.90 | 0.49 | 0.3 | 0.73 | 1.75 | 2.99 | −0.76 | −1.48 | 0.00 |
| Difficulty Speaking | 0.12 | 0.33 | 1.87 | 3.16 | −0.81 | −1.51 | −0.06 | 0.55 | 1.47 | 1.58 | 3.26 | −0.45 | −1.16 | 0.29 |
| Coughing | 1.65 | 2.37 | 2.93 | 3.37 | −0.44 | −1.14 | 0.27 | 1.8 | 2.33 | 3 | 3.67 | −0.41 | −1.13 | 0.32 |
| Sexual function | 1.24 | 2.56 | 2.29 | 3.83 | −0.33 | −1.03 | 0.39 | 1.2 | 2.61 | 2.64 | 4.01 | −0.46 | −1.19 | 0.30 |
| Health Status and HRQoL | ||||||||||||||
| EQ5D-5L VAS scale* | 81.6 | 18.9 | 68.1 | 23.6 | 0.63 | −0.12 | 1.35 | 81.6 | 18.8 | 64.8 | 23.6 | 0.81 | 0.03 | 1.54 |
| HRQoL* | 8.35 | 1.69 | 7.4 | 1.68 | 0.56 | −0.16 | 1.26 | 8.5 | 1.5 | 6.92 | 1.68 | 1.01 | 0.23 | 1.74 |
| PROMIS-29 Domains and Pain rating | ||||||||||||||
| Physical function* | 45.7 | 8.76 | 38.3 | 12.3 | 0.70 | −0.03 | 1.40 | 46.5 | 10 | 35.1 | 8.99 | 1.18 | 0.38 | 1.92 |
| Anxiety | 45.6 | 8.73 | 48.3 | 8.07 | −0.32 | −1.01 | 0.39 | 45.5 | 8.4 | 49.1 | 8.24 | −0.43 | −1.14 | 0.30 |
| Depression | 51.9 | 2.18 | 51.3 | 1.85 | 0.30 | −0.41 | 0.99 | 51.3 | 1.64 | 52 | 2.56 | −0.35 | −1.06 | 0.38 |
| Fatigue | 48.1 | 11.9 | 54.2 | 11 | −0.53 | −1.22 | 0.19 | 47.8 | 10.8 | 56.2 | 11.6 | −0.76 | −1.48 | 0.00 |
| Sleep disturbance | 49.5 | 8.1 | 51.8 | 7.68 | −0.29 | −0.98 | 0.41 | 50 | 8.72 | 51.4 | 6.47 | −0.18 | −0.89 | 0.55 |
| Social roles* | 53.2 | 8.46 | 46.1 | 9.08 | 0.81 | 0.07 | 1.51 | 51.3 | 10.1 | 47.5 | 7.72 | 0.41 | −0.32 | 1.12 |
| Pain interference | 50.2 | 8.97 | 49.5 | 12 | 0.07 | −0.63 | 0.76 | 49.7 | 10.4 | 50.2 | 10.7 | −0.05 | −0.76 | 0.67 |
| Pain average | 2.53 | 2.72 | 2.73 | 2.91 | −0.07 | −0.76 | 0.63 | 2.35 | 2.83 | 3.08 | 2.71 | −0.26 | −0.97 | 0.46 |
indicates ES>=0.5