Table 4.
Patient | CRS maximum grade (ASTCT) | Site-specific toxicities | Peak peripheral blood CAR % (% of T cells) | Peak site-specific CAR+ % (% of T cells) |
---|---|---|---|---|
1 | 2 | Possibility of inflammation at site of retroperitoneal disease with transient appendiceal thickening identified on CT imaging. Etiology of CT findings could not be confirmed with imaging alone | 1.6 | − |
5 | 1 | Possibility of pain from inflammation at psoas site of disease with focal abnormality in paravertebral soft tissues potentially related to inflammatory process. Etiology of CT findings could not be confirmed with imaging alone | 60.0 | − |
6 | 2 | Increased work of breathing and oxygen requirement with onset of CRS. Worsening bilateral pleural effusions and ground-glass opacities demonstrated on CT imaging | 89.5 | Pleural fluid: 72, day +27; BAL: 74, day +33 |
7 | 3 | Oxygen requirement with onset of CRS and inflammation of orbital mass with eyelid swelling. Swelling of right upper extremity associated with inflammation in lymph nodes manipulated in prior mastectomy | 97.8 | BAL: 90, day +28 |
9 | 2 | Oxygen requirement during CRS. Bilateral pleural effusions and ground-glass opacities consistent with inflammation at site of pleural-based disease seen on CT imaging. Rising serum creatinine with onset of CRS (peak, 0.88 mg/dL, day +11; baseline, 0.50-0.66 mg/dL) and acute kidney injury | 88.0 | − |
15 | 0 | Pain and swelling associated with breast erythema during CRS and pain associated with swelling of axillary lymph node | 3.3 | − |
39* | 1 | Respiratory distress with oxygen requirement during CRS. Malignant bilateral pleural effusions with alveolar infiltrates revealed on CT imaging during CRS | 90.2 | BAL: 85.0, day +54 |
Of the patients (66.6%) without evidence of site-specific toxicity after CAR T-cell infusion, six did not show symptoms of CRS, four experienced CRS grade 1 to 2, and two experienced CRS grade 3. ASTCT, American Society of Transplantation and Cellular Therapy; BAL, bronchoalveolar lavage.
Patient 39 presented with unique pulmonary toxicities but did not have FDG-avid non-CNS EMD at the time of treatment and was not included in the serial scan study cohort.