Table 1.
Type of study and clinical outcomes.
| Study | Type of Study | Response Assessment Criteria | Number of Patients Who Discontinued Treatment | BOR, N. Pts (%) | Reason for Discontinuation (N. Pts) | Median Time of Treatment (Months) | Relapse % | Median PFS (Months) | Estimated 24-Month DFS |
|---|---|---|---|---|---|---|---|---|---|
| Keynote 001 [9,20] | phase 1b | RECIST 1.1 | 91 | Not reached | 85.8% | ||||
| CR, 91 (100) | Joint decision (67) Other 1 (24) |
23 | 6% | - | 89.9% | ||||
| 12 | - | - | |||||||
| Keynote 006 [1] | phase 3 | RECIST 1.1 | 103 | 26% | Not reached | 78.4% | |||
| CR, 21 (20.4) | End of protocol | 24 | 24% | Not reached | 85.4% | ||||
| PR, 69 (67) | 23% | Not reached | 82.3% | ||||||
| SD, 13 (12.6) | 46% | Not reached | 39.9% | ||||||
| Jansen [22] | Retrospective/prospective | irRC | 185 | 12 | 22% | ||||
| CR, 117 (63) | Joint decision | 11 | 14% | Not reached | - | ||||
| PR, 44 (24) | 15 | 32% | Not reached | - | |||||
| SD, 16 (9) 2 | 14 | 50% | 16 | - | |||||
| Betof Warner [25] | Retrospective | RECIST 1.1 | 102 | CR, 102 (100) | PD after CR (3) | 9.4 | 22.5% | Not reached | 83.3% |
| TLT (24) | |||||||||
| CR (72) | |||||||||
| Other (3) | |||||||||
| Dimitriou [21] | Retrospective | RECIST 1.1 | 125 | CR, 125 (100) | CR (86) | 22 | 8% | Not reached | - |
| Other 3 (39) | 3 | 7.7% | Not reached | - | |||||
| van Zeijl [23] | Retrospective | Physician’s judgment | 324 | CR 4,90 (27.8) | Joint decision (63) | 12 | 17.8% | Not reached | 64% |
| Other 5 (27) | |||||||||
| PR 4,190 (58.6) | Joint decision (98) | 13 | 27.4% | Not reached | 53% | ||||
| Other 6 (92) | |||||||||
| SD 4,44 (13.6) | Joint decision (15) | 15 | 43.2% | 10 | 31% | ||||
| Other 7 (29) | |||||||||
| Pokorny [24] | Retrospective | RECIST 1.1 | 52 | 25% | - | ||||
| CR,13 (25) | Joint decision | 11.1 | 15.3% | not reached | |||||
| PR, 28 (53.8) | 25% | ||||||||
| SD, 11 (21.2) | 63.3% | ||||||||
| Asher N [26] | Retrospective | Not specified | 106 | 15.2 | 32% | - | |||
| CR, 80 (75.5) | TLT (60) CR (32) Long-term PR (14) |
15.5 | 23.7% | Not reached | |||||
| PR, 22 (20.7) | 12.9 | 50% | 36.5 | ||||||
| SD, 4 (3.8) | 12.4 | 100% | 12.8 | ||||||
| Valentin [27] | Retrospective | RECIST 1.1 | 65 | 14.1 | 18.5% | - | - | ||
| CR (25) | 16.8 | 12% | |||||||
| PR/SD (12) | 21.2 | 16.7% | |||||||
| TLT (28) | 7.2 | 25% | |||||||
| Perez [28] | Retrospective | RECIST 1.1 | 46 | CR, 46 (100) | CR (46) | 9.6 | 8% | - | - |
CR: complete response; PR: partial response; SD: stable disease; PD: progressive disease; TLT: treatment-limiting toxicity; BOR: best overall response. 1 Twelve pts due to AEs, two pts for subsequent PD, seven pts for physician’s decision, three for withdrawal of consent. 2 Eight (4%) patients were non-evaluable for BOR. 3 Thirty-three patients due to TLT and six due to physician’s decision. 4 Response at the time of anti-PD-1 discontinuation. 5 Five pts due to patient’s choice, seven due to TLT, other reasons in thirteen pts, unknown in two. 6 Seven pts due to patient’s choice, sixty-one due to TLT, other reasons in twenty-two pts, unknown in two. 7 Two pts due to patient’s choice, twenty-one due to TLT, other reasons in six pts.