TABLE 2.
Adverse event and response of NACRT (n = 132)
| Adverse events | Grade 1‐2 | Grade 3 | Grade 4 | ≥Grade 3 a | ||
|---|---|---|---|---|---|---|
| White blood cell decrease | 98 (74.2) | 13 (9.8) | 0 (0) | 13 (9.8) | ||
| Neutrophil decrease | 78 (59.1) | 9 (6.8) | 0 (0) | 9 (6.8) | ||
| Anemia | 108 (81.8) | 0 (0) | 0 (0) | 0 (0) | ||
| Platelet count decrease | 101 (76.5) | 0 (0) | 1 (0.8) | 0 (0) | ||
| Febrile neutropenia | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| Blood bilirubin increased | 7 (5.3) | 1 (0.8) | 0 (0) | 1 (0.8) | ||
| AST increased | 8 (6) | 4 (3) | 1 (0.8) | 4 (3) | ||
| ALT increased | 9 (6.8) | 5 (3.8) | 0 (0) | 5 (3.8) | ||
| Creatinine increased | 2 (1.5) | 0 (0) | 0 (0) | 0 (0) | ||
| Anorexia | 19 (14.4) | 4 (3) | 0 (0) | 4 (3) | ||
| Diarrhea | 5 (3.8) | 1 (0.8) | 0 (0) | 1 (0.8) | ||
| Nausea | 22 (16.7) | 4 (3) | 0 (0) | 4 (3) | ||
| Taste alteration | 3 (2.3) | 0 (0) | 0 (0) | 0 (0) | ||
| Mucositis | 2 (1.5) | 0 (0) | 0 (0) | 0 (0) | ||
| Skin rash | 4 (3) | 1 (0.8) | 0 (0) | 1 (0.8) | ||
| Dermatitis | 5 (3.8) | 0 (0) | 0 (0) | 0 (0) | ||
| Stomatitis | 5 (3.8) | 0 (0) | 0 (0) | 0 (0) | ||
| Gastric ulcer | 1 (0.8) | 0 (0) | 0 (0) | 0 (0) | ||
| Fatigue | 7 (5.3) | 0 (0) | 0 (0) | 0 (0) | ||
| Fever/Sepsis | 12 (9.1) | 3 (2.3) | 0 (0) | 3 (2.3) | ||
| Any adverse events | 110 (83.3) | 30 (22.7) | 2 (1.5) | 30 (22.7) | ||
| Initial S1 dose, mg/m2/day | 71.9 (49‐87.9) | |||||
| Diagnosis to treatment, days | 16 (1‐60) | |||||
| Completion of treatment | 130 (98.5) | |||||
| Prolongation of treatment | 27 (20.5) | |||||
| Dose reduction | 20 (15.2) | |||||
| RDI of S1 | 100 (32‐100) | |||||
| Post NACRT tumor size, mm | 20 (0‐60) | |||||
| Tumor shrinkage rate, % | 89.1 (0‐129) | |||||
| Response (CR/PR/SD/PD) | 1//31/85/15 | |||||
| Reason of PD | ||||||
| Distant metastases | 10 (7.6) | |||||
| Local progression | 5 (3.8) | |||||
| Post NACRT CA19‐9, U/mL | 22.2 (<0.4‐7940) | |||||
| CA19‐9 decrease | 112 (84.8) | |||||
| Reduction rate of CA19‐9, % | 50.4 (2‐1009) | |||||
| Post NACRT DUPAN‐2, U/mL b | 47 (<25‐>1600) | |||||
| DUPAN‐2 decrease c | 107 (88.4) | |||||
| Reduction rate of DUPAN‐2, % c | 67.9 (4‐379) | |||||
Note: Expressed as median (range) or number (percentage).
Abbreviations: CR, complete response; NACRT, neoadjuvant chemoradiotherapy; PD, progression of disease; PR, partial response; RDI, relative dose intensity; SD, stable disease.
a
Counted as one if multiple in one patient.
b
Data of seven patients are missing.
c
Data of 11 patients are missing.