Adoptive transfer of autologous tumour-infiltrating lymphocytes with interleukin-2 after lymphodepletion in 93 heavily pretreated patients with metastatic melanoma (three sequential clinical trials)
N = 93
- Population
- 93 patients with measurable metastatic melanoma; 95% had progressive disease after a prior systemic treatment. Median potential follow-up 62 months.
- Design
- Pooled report of three sequential clinical trials of autologous TIL given with interleukin-2 after a lymphodepleting preparative regimen: chemotherapy alone, or with 2 Gy or 12 Gy total-body irradiation.
- Arms
- All patients (three trials) (experimental, n = 93): TIL plus interleukin-2 after lymphodepletion (three preparative regimens, below)
- Chemotherapy-only preparative regimen (experimental, n = 43): Non-myeloablative lymphodepleting chemotherapy alone (cyclophosphamide 60 mg/kg/day for 2 days and fludarabine 25 mg/m2/day for 5 days), then TIL and high-dose interleukin-2
- Chemotherapy plus 2 Gy (experimental, n = 25): Lymphodepleting chemotherapy as above plus 2 Gy total-body irradiation, then TIL and high-dose interleukin-2
- Chemotherapy plus 12 Gy (experimental, n = 25): Lymphodepleting chemotherapy as above plus 12 Gy total-body irradiation (2 Gy twice daily for 3 days), then TIL and high-dose interleukin-2
- Patients with a complete tumour regression (experimental, n = 20): The 20 of 93 patients who achieved a complete tumour regression (a group defined by outcome, not an assigned arm)
- People
- Rosenberg SA, senior author Dudley ME
Show the numbers
| Endpoint | Analysis | All patients (three trials) / Chemotherapy-only preparative regimen / Chemotherapy plus 2 Gy / Chemotherapy plus 12 Gy / Patients with a complete tumour regression | Control | Effect |
|---|---|---|---|---|
| ORRPatients in each of the three sequential trials (43, 25 and 25 patients; per-trial numbers from the full text)Objective response rate by RECIST, in each of the three sequential trials | long term-updatemedian follow-up 62 monthsRosenberg 2011 | 49% | — | Follow-up is the median potential follow-up. The three trials were sequential and not randomised against each other; the percentages must not be read as a comparison of regimens. |
| OSAll 93 patients, and separately the 20 patients with a complete tumour regressionActuarial overall survival at 3 and 5 years | long term-updatemedian follow-up 62 monthsRosenberg 2011 | 36% at 3 y; 29% at 5 y | — | Follow-up is the median potential follow-up. The complete-responder group is defined by outcome, so its survival is not comparable with the whole group. |
| Endpoint | Analysis | All patients (three trials) / Chemotherapy-only preparative regimen / Chemotherapy plus 2 Gy / Chemotherapy plus 12 Gy / Patients with a complete tumour regression | Control | Effect |
|---|---|---|---|---|
| ORRPatients in each of the three sequential trials (43, 25 and 25 patients; per-trial numbers from the full text)Objective response rate by RECIST, in each of the three sequential trials | long term-updatemedian follow-up 62 monthsRosenberg 2011 | 49% | — | Follow-up is the median potential follow-up. The three trials were sequential and not randomised against each other; the percentages must not be read as a comparison of regimens. |
| OSAll 93 patients, and separately the 20 patients with a complete tumour regressionActuarial overall survival at 3 and 5 years | long term-updatemedian follow-up 62 monthsRosenberg 2011 | 36% at 3 y; 29% at 5 y | — | Follow-up is the median potential follow-up. The complete-responder group is defined by outcome, so its survival is not comparable with the whole group. |
- All patients (three trials) (experimental)
- Patients with a complete tumour regression (experimental)
Data table (modelled values)
| Months | All patients (three trials) | Patients with a complete tumour regression |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 16 | 67.9% | 100.0% |
| 32 | 40.2% | 100.0% |
| 49 | 30.5% | 97.0% |
| 65 | 29.0% | 93.0% |