Table 1:
Cohort Data and Univariate Survival Analysis
| Overall Survival (OS) | Disease Free Survival (DFS) | ||||
|---|---|---|---|---|---|
| Variable | (mean ± SD) or n (%) | HR | p-value | HR | p-value |
| Demographics | |||||
| Age (years) | 61.7 ± 8.9 | 1.01 | 0.73 | 1.00 | 0.98 |
| Gender | |||||
| Female | 49 (51%) | 1.16 | 0.50 | 1.03 | 0.90 |
| Male | 47 (49%) | ||||
| Race | |||||
| Caucasian | 88 (94%) | 1.50 | 0.045 | 1.53 | 0.041 |
| Black | 3 (3%) | ||||
| Asian | 3 (3%) | ||||
| Hispanic | 0 (0%) | ||||
| BMI | 25.8 ± 5.6 | 0.97 | 0.32 | 1.01 | 0.55 |
| ASA Category | 0.87 | 0.64 | 0.78 | 0.35 | |
| 1 | 0 (0%) | ||||
| 2 | 54 (56%) | ||||
| 3 | 42 (44%) | ||||
| Charlson Comorbidity Index Score | 2.3 ± 2.5 | 1.07 | 0.52 | 1.23 | 0.048 |
| ECOG Score | 1.27 | 0.30 | 1.18 | 0.47 | |
| 0 | 65 (70%) | ||||
| 1 | 27 (29%) | ||||
| 2 | 0 (0%) | ||||
| 3 | 1 (1%) | ||||
| Radiographic and Serum Biomarkers | |||||
| Tumor Diameter at Diagnosis (cm) | 3.4 ± 1.1 | 1.47 | 0.003 | 1.33 | 0.013 |
| RECIST | 1.08 | 0.62 | 0.97 | 0.88 | |
| Complete Response (CR) | 8 (8%) | ||||
| Partial Response (PR) | 66 (69%) | ||||
| Stable Disease (SD) | 16 (17%) | ||||
| Progressive Disease (PD) | 1 (1%) | ||||
| Inevaluable | 5 (5%) | ||||
| Cycles of Chemotherapy | 8 ± 2.5 | 1.02 | 0.64 | 1.02 | 0.58 |
| CA-19–9 at Diagnosis (U/mL; normal < 35) | 1.21 | 0.008 | 1.28 | 0.001 | |
| < 35 | 30 (34%) | ||||
| 35 – 100 | 11 (12%) | ||||
| 101 – 500 | 23 (26%) | ||||
| 501 – 1000 | 10 (11%) | ||||
| > 1000 | 15 (17%) | ||||
| Operative and Pathologic Data | |||||
| Pathologic Regression Score | 1.53 | 0.005 | 1.37 | 0.032 | |
| Complete Response | 7 (7%) | ||||
| Moderate Response | 42 (44%) | ||||
| Minimal Response | 29 (30%) | ||||
| Poor Response | 18 (19%) | ||||
| Collagen Proportional Area (CPA, %) | 69.4 ± 8.0 | 0.94 | 0.001 | 0.95 | 0.009 |
| Pathologic Tumor Diameter (cm) | 2.3 ± 1.5 | 1.45 | < 0.0001 | 1.22 | 0.018 |
| T stage | 1.49 | 0.017 | 1.26 | 0.10 | |
| 0 | 8 (8%) | ||||
| 1 | 10 (10%) | ||||
| 2 | 9 (9%) | ||||
| 3 | 68 (71%) | ||||
| 4 | 1 (1%) | ||||
| N stage | 1.96 | 0.018 | 2.18 | 0.003 | |
| 0 | 65 (68%) | ||||
| 1 | 30 (31%) | ||||
| 2 | 1 (1%) | ||||
| LVI | 21 (22%) | 1.56 | 0.17 | 1.27 | 0.45 |
| PNI | 59 (63%) | 2.28 | 0.013 | 1.31 | 0.33 |
| Margin Status | 1.35 | 0.46 | 1.47 | 0.31 | |
| R0 | 86 (90%) | ||||
| R1 | 10 (10%) | ||||
| EBL (mL) | 728 ± 474 | 1.00 | 0.91 | 0.99 | 0.89 |
| Operative Time | 389 ± 121 | 1.20 | 0.005 | 1.11 | 0.092 |
| Vascular Reconstruction | 24 (25%) | 0.89 | 0.72 | 1.12 | 0.69 |
| IORT | 31 (32%) | 0.87 | 0.65 | 0.81 | 0.46 |
| Postoperative Clinical Data | |||||
| Adjuvant Chemotherapy | 38 (40%) | 1.88 | 0.027 | 3.76 | < 0.0001 |
| Adjuvant Radiotherapy | 17 (18%) | 1.54 | 0.21 | 1.97 | 0.033 |
ASA PS, American Society of Anesthesiologists Physical Status; BMI, body mass index; College of American Pathologists (CAP) Regression Grades: 0 = complete response, no viable tumor cells; 1 = moderate response, single small cells or groups of cells; 2 = minimal response, residual cancer outgrown by fibrosis; 3 = poor response, minimal or no tumor kill, extensive residual cancer; EBL, estimated blood loss; ECOG, Eastern Cooperative Oncology Group; IORT, intraoperative radiation therapy; LVI, lymphovascular invasion; PNI, perineural invasion; RECIST, response evaluation cirteria in solid tumors; SD, standard deviation.