Table 1:
Patient demographics by squamous cell carcinoma type (N=75 treated with immunotherapy; UCSD cohort)
| Variable | All patients (N = 75) | Cutaneous SCC (n = 15) | Other SCC (n = 60) | P-value1 |
|---|---|---|---|---|
| Median age (range) in years2 | 67 (33–90) | 67 (45–79) | 69 (33–90) | 0.4663 |
| Sex | ||||
| Male | 54 (72%) | 14 (93%) | 40 (67%) | 0.0534 |
| Female | 21 (28%) | 1 (7%) | 20 (33%) | |
| Ethnicity | ||||
| White | 61 (81%) | 14 (93%) | 47 (78%) | 0.2763 |
| Hispanic | 7 (9%) | 1 (4%) | 6 (10%) | 1.0000 |
| Black | 3 (4%) | 0 (0%) | 3 (5%) | 1.0000 |
| Asian | 3 (4%) | 0 (0%) | 3 (5%) | 1.0000 |
| Other | 1 (2%) | 0 (0%) | 1 (2%) | 1.0000 |
| Disease status2 | ||||
| Locally advanced | 23 (31%) | 5 (33%) | 18 (30%) | 0.7654 |
| Metastatic | 52 (69%) | 10 (67%) | 42 (70%) | |
| Genomics | ||||
| Median time (range) in months from biopsy used for genomic analysis to treatment with checkpoint blockade | 7.9 (−16.1–43.2) | 8.5 (−3.3–31.9) | 6.5 (−16.1–43.2) | 0.3535 |
| Median number (range) of genomic alterations3 | 7 | 10 (5–22) | 5 (0–12) | <0.0001 |
| Median TMB (range) mutations/mb3 | 10 (1–347) | 63 (12–347) | 6 (1–25) | <0.0001 |
| TMB low | 11 (27%) | 0 (0%) | 11 (38%) | 0.0175 |
| TMB intermediate | 18 (44%) | 2 (17%) | 16 (55%) | 0.0378 |
| TMB high | 12 (29%) | 10 (83%) | 2 (7%) | 0.0001 |
| MSI status4 | ||||
| MS-stable | 33 (97%) | 7 (88%) | 26 (100%) | 0.2353 |
| MS-high | 1 (3%) | 1 (12%) | 0 (%) | |
| Treatment | ||||
| Median number (range) of prior systemic therapies | 1 (0–5) | 1 (0–3) | 1 (0–5) | 0.1993 |
| PD-1/PD-L1 blockade monotherapy | 68 (91%) | 15 (100%) | 53 (88%) | 0.3327 |
| PD-1/PD-L1 blockade + chemotherapy | 1 (2%) | 0 (0%) | 1 (2%) | 1.0000 |
| PD-1/PD-L1 blockade + targeted therapy | 1 (2%) | 0 (0%) | 1 (2%) | 1.0000 |
| PD-1/PD-L1 blockade + investigational agent | 5 (6%) | 0 (0%) | 5 (8%) | 1.0000 |
| Median TTF (range) in months1,2 | 4.8 (0–32.1+) | Not reached (0–27.3+) (median follow up of 10.1 mos) | 4.2 (0.1–32.1+) |
0.0015 HR = 0.3 [95% CI, 0.2–0.5] |
| Median OS in months1,2 | 17.4 (0.1–32.1+) | Not reached (0.3–27.3+) (median follow up of 11.2 mos) | 12.5 (0.1–32.1+) | 0.0593 HR = 0.5 [95% CI, 0.2–1.0] |
| Overall benefit rate (SD for ≥ 6 months plus PR/CR) | 31/75 (41%) | 11/15 (73%) | 20/60 (33%) |
0.008 OR = 5.5 [95% CI 1.6–16.9] |
1
Calculated using Student’s T-test, Fisher’s exact test, and log-rank (Mantel-Cox) where applicable
2
At the time of initiation of checkpoint blockade
3
Not available (N = 3 patient with cutaneous SCC and N = 31 for other SCC)
4
Not available (N = 7 patients with cutaneous SCC and N = 34 for other SCC)
Abbreviations: HR = hazard ratio; mb = megabase; MSI = microsatellite instability; OR = odds ratio; OS = overall survival; SCC = squamous cell cancer; TMB = tumor mutational burden; Time to treatment failure