Table 2. Metrics of Response to Chemotherapy Among All 485 Included Patients.
| Characteristic | No. (%) of patients | P value | ||
|---|---|---|---|---|
| All (N = 485) | First-line chemotherapy regimen | |||
| FOLFIRINOX (n = 285) | GA (n = 200) | |||
| Radiographic measures after treatment | ||||
| Reduction in primary tumor volume | ||||
| Yes | 324 (67) | 189 (66) | 135 (67) | .80 |
| No | 161 (33) | 96 (34) | 65 (33) | |
| %Δvol, Median (range) | 20 (−297 to 92) | 21 (−297 to 90) | 15 (−227 to 92) | .50 |
| RECIST 1.1 | ||||
| CR | 0 | 0 | 0 | .40 |
| PR | 55 (11) | 37 (13) | 18 (9) | |
| SD | 382 (79) | 219 (77) | 163 (82) | |
| PDa | 48 (10) | 29 (10) | 19 (9) | |
| Local tumor downstagingb | ||||
| Yesc | 17 (6) | 10 (5) | 7 (6) | .60 |
| Noc | 287 (94) | 181 (95) | 103 (94) | |
| Serologic measures after treatment | ||||
| Posttreatment CA 19-9 level, median (range), U/mL | 63 (1-24 390) | 59 (1-24 390) | 72 (1-11 570) | .40 |
| Change in CA 19-9 | ||||
| Not expressed | 27 (6) | 18 (6) | 9 (5) | .60 |
| Normal to normal | 71 (14) | 46 (16) | 25 (12) | |
| Elevated to normal | 95 (20) | 56 (21) | 39 (20) | |
| Elevated to elevated | 283 (58) | 161 (56) | 122 (61) | |
| Normal to elevated | 9 (2) | 4 (1) | 5 (2) | |
Abbreviations: CA 19-9, cancer antigen 19-9; CR, complete response; FOLFIRINOX, fluorouracil, leucovorin, irinotecan, and oxaliplatin; GA, gemcitabine plus nanoparticle albumin-bound paclitaxel; PD, progressive disease; PR, partial response; RECIST 1.1, Response Evaluation Criteria in Solid Tumors, version 1.1; SD, stable disease; %Δvol, percentage of volume change in primary tumor.
SI conversion factor: To convert CA 19-9 levels to kU/L, multiply by 1.
Of 485 patients with PD, 24 (5%) had isolated or local disease, and 24 (5%) had distant disease with or without local disease.
Downstaging was defined as any change from locally advanced disease to either borderline resectable or resectable disease or from borderline resectable to resectable disease.
Percentage of patients with borderline resectable or locally advanced disease at baseline (n = 304).