Table 1.

Baseline characteristics of 118 patients with advanced NSCLC receiving anti–PD-1/PD-L1 blockade.

Probiotic CBT N = 39No probiotic CBT N = 79P
Median age (range)68.0 (62.0–71.0)67.0 (60.0–72.0)0.83
Sex, N (%)
 Male33 (85%)66 (84%)1.00
 Female6 (15%)13 (16%)
ECOG performance status, N (%)
 010 (26%)23 (29%)0.07
 115 (38%)45 (57%)
 211 (28%)11 (14%)
 32 (5%)0 (0%)
 41 (3%)0 (0%)
Body weight, median (range)61.9 (55.6–68.7)59.4 (51.4–68.5)0.24
Smoking history, N (%)
 Current5 (13%)9 (11%)0.77
 Former30 (77%)57 (72%)
 Never4 (10%)13 (17%)
Stage at initial diagnosis, N (%)
 I–III16 (41%)32 (41%)1.00
 IV23 (59%)47 (59%)
Histology, N (%)
 Adenocarcinoma25 (64%)56 (71%)0.53
 Squamous/NOS14 (36%)23 (29%)
EGFR mutation status, N (%)
 Wild-type25 (64%)64 (81%)0.10
 Mutant3 (8%)3 (4%)
 Unknown11 (28%)12 (15%)
PD-L1 status, N (%)
 TPS ≥50%16 (41%)24 (30%)0.019
 TPS 1%–49%5 (13%)14 (18%)
 TPS <1%14 (36%)15 (19%)
 Unknown/undeterminable4 (10.5%)26 (33%)
ICB therapy line, N (%)
 1st line14 (36%)23 (29%)0.33
 2nd line16 (41%)27 (34%)
 ≥3rd line9 (23%)29 (37%)
ICB, N (%)
 Nivolumab12 (31%)39 (49%)0.038
 Pembrolizumab20 (51%)36 (46%)
 Atezolizumab7 (18%)4 (5%)
ICB monotherapy/combination therapy, N (%)
 Monotherapy33 (85%)74 (94%)0.18
 Combination therapy6 (15%)5 (6%)
Antibiotic use within 60 days before the start of ICB therapy, N (%)22 (56%)24 (30%)0.009
Time point of administration of probiotic MIYA-BM, N (%)
 Before ICI initiation9 (23%)
 During ICI therapy12 (31%)
 Before and during ICI therapy18 (46%)
Response to ICB, N (%)N = 37N = 69
 CR3 (8%)1 (1%)0.08
 PR15 (40%)17 (25%)
 SD11 (30%)31 (45%)
 PD8 (22%)20 (29%)
 ORR49%26%
 DCR78%71%
  • Note: Pembrolizumab/pemetrexed/platinum (n = 6), pembrolizumab/nab-paclitaxel/carboplatin (n = 4), and atezolizumab/bevacizumab/carboplatin/paclitaxel (n = 1) were used as combination therapies with ICB and chemotherapies. Tumor response to therapy was objectively assessed by pulmonary physicians according to RECIST, version 1.1.

  • Abbreviations: CR, complete response; DCR, disease control rate; NOS, not otherwise specified; ORR, objective response rate; PD, progression disease; PR, partial response; SD, stable disease; TPS, tumor proportion score.