Table 2.
Grading of Adverse Events per Common Terminology Criteria for Adverse Events Version 4.0 (Regardless of Attribution) During Treatmenta
| Adverse Eventb | Patients, No. (%) | |
|---|---|---|
| Grade 3 | Grade 4 | |
| Preoperative mFOLFIRINOX (n = 22) | ||
| Overall | 11 (50) | 1 (5) |
| Diarrhea | 3 (14) | 0 (0) |
| Neutropenia | 2 (9) | 1 (5) |
| Lymphopenia | 0 (0) | 1 (5) |
| Dehydration | 4 (18) | 0 (0) |
| Hypokalemia | 3 (14) | 0 (0) |
| Thromboembolism | 3 (14) | 0 (0) |
| Preoperative chemoradiation (n = 21) | ||
| Overall | 9 (43) | 0 (0) |
| Lymphopenia | 3 (14) | 0 (0) |
| Pancreatectomyc (n = 15) | ||
| Overall | 8 (53) | 5 (33) |
| Anemia | 5 (33) | 0 (0) |
| Infection | 3 (20) | 1 (7) |
| Hemorrhage | 2 (13) | 0 (0) |
| ALT increased | 0 (0) | 1 (7) |
| AST increased | 0 (0) | 1 (7) |
| Thrombocytopenia | 0 (0) | 1 (7) |
| Hypoalbuminemia | 0 (0) | 1 (7) |
| Anorexia | 2 (13) | 0 (0) |
| Acute kidney injury | 0 (0) | 1 (7) |
| Atelectasis | 0 (0) | 1 (7) |
| Pleural effusion | 0 (0) | 1 (7) |
| Pulmonary edema | 0 (0) | 1 (7) |
| Respiratory failure | 0 (0) | 1 (7) |
| Postoperative gemcitabine (n = 10) | ||
| Overall | 5 (50) | 1 (10) |
| Anemia | 0 (0) | 1 (10) |
Abbreviations: ALT, alanine transaminase; AST, aspartate transaminase; mFOLFIRINOX, modified treatment with 85 mg/m2 of oxaliplatin, 180 mg/m2 of irinotecan hydrochloride, 400 mg/m2 of leucovorin calcium, and then 2400 mg/m2 of 5-fluorouracil for 4 cycles, concurrent with capecitabine and radiation therapy.
Overall rates of grade 3 and grade 4 adverse events during each phase of treatment, all individual grade 4 events, and individual grade 3 events observed in more than 10% of treated patients.
Calculated as the maximum severity during induction of mFOLFIRINOX, preoperative chemoradiation, pancreatectomy (within 30 postoperative days), and postoperative gemcitabine treatments, separately.
One patient died within 90 days of pancreatectomy.