Appendix 1—table 1. Clinicopathological characteristics of study-eligible patients with localized pancreatic ductal adenocarcinoma who received neoadjuvant chemotherapy (NAC) and underwent curative-intent pancreatectomy (BMI: body mass index; HRD: Homologous Recombination Deficiency; ECOG: Easter Cooperative Oncology Group; CAP: College of American Pathology; G-CSF: Granulocyte-colony stimulating factor).
| Variable | All patients (n=94) | Complete/ partial response to NAC (n=66) | Absent/poor response to NAC(n=28) | P-value |
|---|---|---|---|---|
| Age (mean ± SD) | 67.3±10.3 | 67.5±10.9 | 66.9±8.9 | 0.78 |
| Female gender, n (%) | 58 (61.7 %) | 41 (62.1%) | 17 (60.7%) | 0.89 |
| Diagnosis BMI, (mean ± SD) | 26.7±4.9 | 26.8±5 | 26.4±4.6 | 0.68 |
| Hispanic Ethnicity, n (%) | 43 (45.8%) | 30 (45.5%) | 13 (46.4%) | 0.64 |
|
Germline HRD mutation, n (%) Germline HRD mutation No germline HRD mutation |
6 (6.3%) 88 (93.7%) |
6 (9.1%) 60 (91.9%) |
0 (0%) 28 (100%) |
0.17 |
|
Pre-chemotherapy Absolute Blood Counts Total Leukocyte count (103 /μl) Neutrophil count (%) Lymphocyte count (%) Platelet count (103 /μl) |
7.2±1.6 65.3±7.3 22.3±7.0 243±71.5 |
7.2±1.8 63.7±6.9 24.8±6.7 246±69.5 |
7.25±1.5 69.7±4.1 17.6±3.5 234±77.3 |
0.92 <0.001 <0.001 0.59 |
| Pre-chemotherapy Neutrophil/Lymphocyte Ratio (median ± SD) | 3.0±1.3 | 2.5±1.0 | 3.9±1.2 | <0.001 |
|
Diagnosis CA 19–9 levels (median ± SD) |
181±1,823 | 147±923 | 202±2,944 | 0.50 |
|
Pre-Surgery Absolute Blood Counts Total Leukocyte count (103 /ul) Neutrophil count (%) Lymphocyte count (%) Platelet count (* 103 /ul) |
7±1.92 63.2±9.5 23.6±7.7 198±74.1 |
6.1±1.72 60±7.8 26.5±6.4 203±57.8 |
8.5±1.95 71±6.25 16.7±4.7 181±104 |
0.01
<0.001 <0.001 0.03 |
|
Pre-Surgery Neutrophil/ Lymphocyte Ratio (median ± SD) |
2.6±1.57 | 2.3±0.78 | 4.2±1.68 | <0.001 |
| ΔNLR (=Pre-Surgery-Pre-Chemo NLR) (median ± SD) | - 0.1±1.25 | - 0.38±1.1 | 0.21±1.5 | 0.01 |
|
ECOG Status, n (%) 0 1 2 |
36 (38.3%) 49 (52.1%) 9 (9.6%) |
27 (40.9%) 34 (51.5%) 5 (7.6%) |
9 (32.1%) 15 (53.6%) 4 (14.3%) |
0.51 |
|
Tumor location Head Body Tail |
76 (80.8%) 9 (9.6%) 9 (9.6%) |
53 (80.3%) 6 (9.1%) 7 (10.6%) |
23 (82.1%) 3 (10.7%) 2 (7.2%) |
0.96 |
|
Resectability status Resectable Borderline resectable Locally advanced |
21 (22.3%) 50 (53.2%) 23 (24.5%) |
15 (22.7%) 36 (54.6%) 15 (22.7%) |
6 (21.4%) 14 (50.0%) 8 (28.6%) |
0.83 |
|
Radiographic tumor size (median ± SD) |
30±14.2 | 30±10.7 | 28.5±20.2 | 0.19 |
|
Neoadjuvant Chemotherapy Gemcitabine/Abraxane FOLFIRINOX Both |
35 (37.2%) 49 (52.2%) 10 (10.6%) |
26 (39.4%) 33 (50.0%) 7 (10.6%) |
9 (32.1%) 16 (57.1%) 3 (10.8%) |
0.79 |
| Duration of NAC (months) * | 4±2.3 | 4±2.2 | 4±2.6 | 0.22 |
| Use of G-CSF during NAC | 91 (96.8%) | 64 (97.0%) | 27 (96.4%) | 1.00 |
| Neoadjuvant radiation | 6 (6.4%) | 4 (6.1%) | 2 (7.1%) | 1.00 |
|
Histology grade† Well Differentiated Moderately differentiated Poorly differentiated |
2 (2.1%) 59 (62.8%) 27 (28.7%) |
2 (3%) 49 (74.2%) 11 (16.7%) |
0 (0%) 10 (35.7%) 16 (57.1%) |
0.002 |
|
pT classification T1 T2 T3 T4 |
27 (28.7%) 33 (35.1%) 28 (29.8%) 6 (6.4%) |
27 (40.9%) 22 (33.3%) 14 (21.3%) 3 (4.5%) |
0 (0%) 11 (39.3%) 14 (50.0%) 3 (10.7%) |
<0.001 |
|
pN classification Positive Negative |
52 (55.3%) 42 (44.7%) |
32 (48.5%) 34 (51.5%) |
20 (71.4%) 8 (28.6%) |
0.04 |
|
Pathological Stage IA IB IIA IIB III IV |
17 (18.1%) 12 (12.8%) 10 (10.6%) 47 (50%) 7 (7.4%) 1 (1.1%) |
17 (25.7%) 9 (13.6%) 6 (9.1%) 30 (45.5%) 4 (6.1%) 0 (0%) |
0 (0%) 3 (10.7%) 4 (14.3%) 17 (60.7%) 3 (10.7%) 1 (3.6%) |
0.04 |
|
Neoadjuvant therapy response (CAP grading)‡ Grade 0 Grade 1 Grade 2 Grade 3 |
0 (0%) 12 (12.8%) 54 (57.4%) 28 (29.8%) |
- 12 (18.2%) 54 (81.8%) - |
28 (100%) | N/A |
|
R0 resection margin Yes No (R1 resection) |
78 (83%) 16 (17%) |
61 (92.4%) 5 (7.6%) |
17 (60.7%) 11 (39.3%) |
<0.001 |
| Adjuvant therapy, n (%) | 58 (61.7%) | 43 (65.2%) | 15 (53.6%) | 0.29 |
|
Local Recurrence Yes No |
19 (20.2%) 75 (79.8 %) |
10 (15.2%) 56 (84.8%) |
9 (32.1%) 19 (67.8%) |
0.06 |
|
Distant Recurrence Yes No |
55 (58.5%) 39 (41.5%) |
34 (51.5%) 32 (48.5%) |
21 (75%) 7 (25%) |
0.03 |
*
Due to variation in dose scheduling between FOLFIRINOX and gemcitabine/abraxane, duration of NAC is reported in months (vs. number of cycles).
†
Grade information missing in 6 patients.
‡
College of American Pathologist (CAP) grading: Grade 0, no viable residual tumor (pathologic complete response); Grade 1, marked response (minimal residual cancer with single cells or small groups of cancer cells); Grade 2, partial response (residual cancer with evident tumor regression, but more than single cells or rare small groups of cancer cells); and Grade 3, poor or no response (extensive residual cancer with no evident tumor regression).