Best response and survival outcomes to anti-PD-1 treatment
| Variables | PMME (n=28) | NEMM (n=64) | |
| Response, No. (%) | |||
| CR | 0 (0) | 1 (1.6) | |
| PR | 9 (32.1) | 3 (4.7) | |
| SD | 11 (39.3) | 19 (29.7) | |
| PD | 7 (25.0) | 38 (59.4) | |
| NE* | 1 (3.6) | 3 (4.7) | |
| ORR† | |||
| No. (%) | 9 (33.3) | 4 (6.6) | |
| 95% CI, % | 14.3 to 52.3 | 0.2 to 12.9 | |
| Univariate P value | 0.002 | ||
| Multivariate‡ | P value | 0.010 | |
| OR (95% CI) | 6.660 (1.568 to 28.284) | ||
| DCR§ | |||
| No. (%) | 20 (74.1) | 23 (37.7) | |
| 95% CI, % | 56.4 to 91.7 | 25.2 to 50.2 | |
| Univariate p value | 0.002 | ||
| Multivariate‡ | P value | 0.001 | |
| OR (95% CI) | 8.478 (2.421 to 29.691) | ||
| PFS | |||
| Median (95% CI), weeks | 32.0 (17.8 to 46.2) | 13.0 (7.8 to 18.2) | |
| Univariate | P value | 0.311 | |
| HR (95% CI) | 0.787 (0.495 to 1.251) | ||
| Multivariate¶ | P value | 0.234 | |
| HR (95% CI) | 0.589 (0.246 to 1.409) | ||
| OS | |||
| Median (95% CI), weeks | 40.0 (27.1 to 52.9) | 42.0 (23.3 to 60.7) | |
| Univariate | P value | 0.512 | |
| HR (95% CI) | 1.178 (0.708 to 1.960) | ||
| Multivariate¶ | P value | 0.584 | |
| HR (95% CI) | 0.781 (0.323 to 1.892) | ||
*Patients not evaluable for response: two patients died before the evaluation of the disease and two patients were lost to follow-up.
†ORR = (CR + PR)/(CR + PR + SD + PD) × 100%.
‡Multivariate logistic regression analysis adjusted for age (>55 vs ≤55), sex (male vs female), baseline LDH level (elevated vs normal), baseline ECOG (1 vs 0), distant metastasis (with vs without), and prior systemic treatment (yes vs no).
§DCR = (CR + PR + SD)/(CR + PR + SD + PD) × 100%.
¶Other covariates included in the multivariate Cox proportional hazard regression model of PFS and OS were age, sex, baseline LDH level, baseline ECOG, distant metastasis, and previous systemic treatment.
CR, complete response; DCR, disease control rate; ECOG, Eastern Cooperative Oncology Group; LDH, lactate dehydrogenase; NE, not evaluable; NEMM, non-esophageal mucosal melanomas; ORR, overall response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PMME, primary malignant melanoma of the esophagus; PR, partial response; SD, stable disease.