Table 1.
Baseline characteristics and tumor responses.
| Variables | Total patients receiving NPS, n=182 | Patients without progression within 4 months during NPS treatment | |
|---|---|---|---|
| Baseline characteristics | Overall, n=123 | With S-1 maintenance, n=74 | |
| Age (years) | |||
| Median (range) | 58 (34-78) | 58 (34-76) | 59 (34-76) |
| Sex (%) | |||
| Male | 108 (59.3) | 66 (53.7) | 37 (50.0) |
| Female | 74 (40.7) | 57 (46.3) | 37 (50.0) |
| ECOG PS score at baseline (%) | |||
| 0 | 142 (78.0) | 96 (78.0) | 55 (74.3) |
| 1 | 40 (22.0) | 27 (22.0) | 19 (25.7) |
| Stage (%) | |||
| Locally advanced | 15 (8.2) | 14 (11.4) | 9 (12.2) |
| Metastatic | 167 (91.8) | 109 (88.6) | 65 (87.8) |
| Location of primary tumor (%) | |||
| Head/neck | 62 (34.1) | 40 (32.5) | 26 (35.1) |
| Body/tail | 120 (65.9) | 83 (67.5) | 48 (64.9) |
| Tumor differentiation (%) | |||
| Well/well-moderately/moderately differentiated | 67 (36.8) | 51 (41.5) | 35 (47.3) |
| Moderately-poorly/poorly differentiated | 115 (63.2) | 72 (58.5) | 39 (52.7) |
| Metastasis site (%) & | |||
| Liver only | 66 (39.5) | 35 (32.1) | 20 (30.8) |
| Liver and others | 66 (39.5) | 45 (41.3) | 25 (38.5) |
| Others except liver | 35 (21.0) | 29 (26.6) | 20 (30.8) |
| Number of metastases | |||
| 0-1 | 92 (50.5) | 59 (48.0) | 35 (47.3) |
| 2 | 53 (29.1) | 42 (34.1) | 27 (36.5) |
| ≥3 | 37 (20.3) | 22 (17.9) | 12 (16.2) |
| Elevated levels of tumor biomarkers at baseline (%) # | |||
| Elevated level of CA19-9 only | 22 (12.1) | 20 (16.7) | 16 (22.2) |
| Elevated levels of CA19-9 and others | 134 (73.6) | 81 (65.9) | 43 (59.7) |
| Elevated levels of others except CA19-9 | 23 (12.6) | 19 (15.4) | 13 (18.1) |
| Baseline CA19-9 level | |||
| Normal | 26 (14.3) | 22 (17.9) | 15 (20.3) |
| Elevated | 156 (85.7) | 101 (82.1) | 59 (79.3) |
| Baseline CA19-9 level | |||
| <2000 U/mL | 94 (51.6) | 77 (62.6) | 52 (70.3) |
| ≥2000 U/mL | 88 (48.4) | 46 (37.4) | 22 (29.7) |
| Cycles of first-line NPS chemotherapy | |||
| Median (range) | 5 (2 - 12) | 6 (4 - 12) | 6 (4 - 12) |
| Tumor responses | |||
| >50% decline from baseline CA19-9 level in 4 cycles (%) $ | |||
| Yes | 94 (59.1) | 79 (77.5) | 53 (89.8) |
| No | 65 (40.9) | 23 (22.5) | 6 (10.2) |
| Best response to NPS chemotherapy (%) ** | |||
| CR or PR | 98 (53.8) | 84 (68.3) | 57 (77.0) |
| SD | 67 (36.8) | 39 (31.7) | 17 (23.0) |
| PD | 17 (9.3) | NA | NA |
| ORR | 53.8% | 68.3% | 77.0% |
| PFS (months), median (95% CI) | 6.0 (5.0, 7.0) | 8.0 (7.2, 8.8) | 9.6 (8.4,10.8) |
| OS (months), median (95% CI) | 11.2 (9.5, 13.0) | 14.3 (12.4, 16.2) | 16.7 (13.9, 19.5) |
&Metastasis site was evaluated only in metastatic diseases, the number of which were 167 in the total NPS-treated patients and 109 in the NPS-treated patients without progression within 4 cycles of treatment.
#Three patients had normal levels of tumor biomarkers at baseline.
$The change of CA19-9 level after treatment was evaluated only in the patients with elevated baseline CA19-9 levels, the number of whom were 159 in the total NPS-treated patients and 102 in the NPS-treated patients without progression within 4 cycles of treatment.
**The best response to NPS chemotherapy was CR, PR, or SD in the NPS-treated patients.
CA19-9, Carbohydrate Antigen 199; CI, confidence interval; CR, complete response; ECOG PS, Eastern Cooperative Oncology Group Performance Status; HR, hazard ratio; NA, not applicable; NPS, nab-paclitaxel plus S-1; ORR, objective response rate; OS, overall survival; PFS, progression free survival; PR, partial response; SD, stable disease.