Table 1.
Characteristics of study patients
| Experimental cohort (AB, n = 672) | PD-L1 inhibitor monotherapy (A, n = 460) | Chemo-immunotherapy (B, n = 212) | Control cohort (C, n = 444) | P value across A/B/C | |
|---|---|---|---|---|---|
| Age at diagnosis, years, median (SD) | 65 (13) | 67 (10) | 64 (10) | 63 (9) | 0.001 |
| Sex, % male (n) | 69 (461) | 70 (324) | 65 (137) | 67 (298) | 0.283 |
| ECOG PS, % (n) | |||||
| 0 | 37 (246) | 34 (159) | 41 (87) | 51 (224) | 0.001 |
| 1 | 50 (333) | 51 (233) | 47 (100) | 46 (205) | 0.381 |
| ≥2 | 14 (93) | 15 (68) | 12 (25) | 3 (15) | 0.001 |
| Histology, % (n) | |||||
| Adenocarcinoma | 74 (494) | 69 (317) | 84 (177) | 72 (322) | 0.001 |
| Squamous carcinoma | 22 (147) | 26 (118) | 14 (29) | 19 (84) | 0.001 |
| Other | 4 (31) | 5 (25) | 3 (6) | 9 (38) | 0.012 |
| PD-L1 expression, % (n) | |||||
| Negative (TPS <1%) | 19 (129) | 18 (82) | 22 (47) | — | 0.184 |
| TPS 1-49% | 42 (279) | 37 (169) | 52 (110) | — | 0.001 |
| TPS ≥50% | 39 (264) | 45 (209) | 26 (55) | — | 0.001 |
| Type of treatment, % (n) | |||||
| PD-L1 inhibitor alone | 68 (460) | — | |||
| Chemoimmunotherapy | 32 (212) | — | |||
| Chemotherapy | — | 100 (444) | |||
| Line of treatment, % (n) | |||||
| First line | 55 (372) | 35 (160) | 100 (212)a | 100 (444) | 0.001 |
| Second and beyond | 45 (300) | 65 (300) | — | ||
| Baseline characteristics | |||||
| NLR, median (SD) | 4.8 (8.1) | 4.4 (8.9) | 5.8 (6.3) | 5.4 (6.3) | 0.001 |
| Height m, median (SD) | 1.70 (0.09) | 1.70 (0.09) | 1.71 (0.10) | 1.71 (0.09) | 0.653 |
| Weight kg, median (SD) | 72 (16) | 72 (16.5) | 74 (16.1) | 76 (16) | 0.127 |
| BMI, median (SD) | 25 (4.8) | 25 (5.0) | 25 (4.5) | 26 (5.1) | 0.182 |
| Albumin, median (SD) | 3.9 (0.5) | 3.8 (0.6) | 4.1 (0.5) | 3.9 (0.5) | 0.001 |
| ALI, median (SD) | 19.5 (25) | 20.6 (25) | 17.6 (24) | 18.3 (16.6) | 0.051 |
| Clinical outcome: | |||||
| ORR, % (95% CI) | 35 (31-38) | 31 (27-35) | 43 (36-50) | na | 0.003 |
| DCR, % (95%CI) | 61 (57-64) | 56 (52-61) | 75 (69-81) | na | 0.001 |
| TOT, median (95% CI), months | 5.8 (4.6-7.0) | 5.4 (4.3-6.5) | 8.7 (5.0-12.4) | na | 0.001 |
| PFS, median (95% CI), months | 5.3 (4.0-6.7) | 3.3 (2.1-4.4) | 8.0 (6.4-.9.7) | na | 0.001 |
| OS, median (95% CI), months | 18.6 (14.5-22.6) | 17.2 (13.3-21.1) | 25.6 (9.3-41.9) | 7.2 (6.5-7.9) | 0.001 |
Statistical comparisons across cohorts (A, B, C) were performed with a chi-square for categorical, Kruskal-Wallis for numerical data, and logrank test for survival data.
ALI, advanced lung cancer inflammation index; BMI, body-mass index; CI, confidence interval; DCR, disease control rate; ECOG PS, Eastern Cooperative Oncology Group performance status; na, not available; NLR, blood neutrophil-to-lymphocyte ratio; ORR, overall response rate; OS, overall survival; PD-L1, programmed death-ligand 1; PFS, progression-free survival; TOT, time on treatment; TPS, tumor proportion score.
a
Previous stage 3 disease in 31% (n = 67).