Table 3.
Treatment characteristics and adverse events.
| GY1508.01 | GY1508.04 | GY1508.06 | GY1508.08 | GY1508.10 | GY1508.11 | All patients | |
|---|---|---|---|---|---|---|---|
| Treatment characteristics | Median (range) | ||||||
| Days in hospital | 28 | 20 | 20 | 21 | 18 | 20 | 20 (18–28) |
| Units RBC transfusiona | 4 | 8 | 6 | 3 | 4 | 3 | 4 (3–8) |
| Units PLT transfusionb | 7 | 10 | 4 | 7 | 2 | 4 | 6 (2–10) |
| Days with neutrophils < 0,5x10^9/L | 10 | 10 | 8 | 8 | 8 | 9 | 9 (8–10) |
| Dose IL-2 administered, MIU | 78 | 126 | 109.8 | 113 | 121.5 | 135 | 117 (78–135) |
| % IL-2 administered | 61 | 100 | 100 | 94 | 90 | 100 | 97 (61–100) |
| Treatment related AEs (grade 3–4)c | Total | ||||||
| Surgery | |||||||
| Fever without infection | 3 | 1 | |||||
| Leukapheresis | |||||||
| Fewer with infection | 3* | 1 | |||||
| TIL therapyd | |||||||
| Performance status | 3 | 3 | 3 | 3 | 3 | 3 | 6 |
| Dyspnea | 4* | 1 | |||||
| Fever without infection | 3 | 1 | |||||
| Febrile neutropenia | 3 | 3 | 3 | 3 | 3 | 3 | 6 |
| Confusion | 3 | 1 | |||||
| Fatigue | 3 | 1 | |||||
| Maculopapular rash | 3 | 1 | |||||
| Hallucinations | 3 | 1 | |||||
| Hyponatremia | 3 | 3 | 3 | 3 | 3 | 3 | 6 |
| Hypophosphatemia | 3 | 3 | 3 | 3 | 3 | 5 | |
| Hypokalemia | 3 | 3 | 3 | 3 | 3 | 5 | |
| Anemia | 3 | 3 | 3 | 3 | 3 | 3 | 6 |
| Lymphocytopenia | 4 | 4 | 4 | 4 | 4 | 4 | 6 |
| Thrombocytopenia | 4 | 4 | 4 | 4 | 4 | 4 | 6 |
| All | 10 | 8 | 11 | 8 | 9 | 8 | 54 |
| SAEs | Total | ||||||
| Deep venous thrombosis | Xe | 1 | |||||
| Dyspnea | X | 1 | |||||
| Fever with infection | X | 1 | |||||
| All | 2 | 1 | 3 |
a Transfusion when hemoglobin < 6.0 mmol/L, b Transfusion when platelets < 20x10^9/L or < 30x10^9/L if the patient was in risk of bleeding, c According to the CTCAE v. 4.0, d Includes lymphodepleting chemotherapy, TIL infusion and IL-2 stimulation, e Found on baseline scan after leukapheresis and before TIL therapy, * SAE.