Table 3. Recurrence and management in the observation cohort.
| Characteristics | All (N=580) | Observation (N=358) | Treatment (N=222) | P value |
|---|---|---|---|---|
| First recurrence type | ||||
| Distant | 121/360 (33.6%) | 75/247 (30.4%) | 46/113 (40.7%) | 0.094 |
| Regional | 205/360 (56.9%) | 145/247 (58.7%) | 60/113 (53.1%) | |
| Both | 34/360 (9.4%) | 27/247 (10.9%) | 7/113 (6.2%) | |
| Initial management of first recurrence (n=247)* | ||||
| Systemic therapy alone | 87 (35%) | |||
| Surgery alone | 72 (29%) | |||
| Surgery+systemic | 20 (8%) | |||
| BSC | 26 (11%) | |||
| Radiotherapy alone | 9 (4%) | |||
| Surgery+RT | 8 (3%) | |||
| RT+systemic | 7 (3%) | |||
| Surgery+RT+systemic | 2 (1%) | |||
| Local therapy (TVEC/diphencyprone) | 2 (1%) | |||
| Systemic+TVEC | 1 (<1%) | |||
| Not recorded | 13 (5%) | |||
| Systemic therapy for recurrence (n=247) | ||||
| As first-line management | 117 (47%) | |||
| Only later, after locoregional treatment | 26 (11%) | |||
| Never | 104 (42%) | |||
| First-line systemic regimen (n=117)† | ||||
| Anti-PD-1 monotherapy | 74 (63%) | |||
| BRAF/MEK inhibitors | 21 (18%) | |||
| Ipilimumab+anti-PD-1 | 7 (6%) | |||
| Ipilimumab monotherapy | 7 (6%) | |||
| Nivolumab+relatlimab | 5 (4%) | |||
| Anti-PD-1+experimental agent | 3 (3%) | |||
*
Treatment modality, or combination of modalities, used first to manage the first recurrence. Categories are mutually exclusive; percentages are calculated among the 247 observation patients with recurrence. Post-recurrence management was not collected for the adjuvant cohort.
†
Percentages are calculated among the 117 patients who received systemic therapy as first-line management of recurrence
BRAF/MEK, serine/threonine-protein kinase B-Raf/mitogen-activated protein kinase; BSC, best supportive care; PD-1, programmed cell death protein 1; RT, radiotherapy; TVEC, talimogene laherparepvec.