Table 4.
Adverse events and treatment delays
| TPF + CCRT (n = 138) |
PF + CCRT (n = 138) |
P-Value* | |
|---|---|---|---|
| Adverse events during induction chemotherapy, n (%) | |||
| Hematologic | |||
| Anemia (grade 3 or 4) | 3 (2.2) | 3 (2.2) | - |
| Thrombocytopenia (grade 3 or 4) | 3 (2.2) | 2 (1.4) | - |
| Neutropenia (grade 3 or 4) | 88 (63.8) | 39 (28.3) | <.001 |
| Febrile neutropenia | 14 (10.1) | 4 (2.9) | .015 |
| Non-hematologic (grade 3 or 4) | |||
| Stomatitis (mucositis) | 3 (2.2) | 6 (4.3) | .501† |
| Nausea | 12 (8.7) | 18 (13.0) | .246 |
| Vomiting | 6 (4.3) | 14 (10.1) | .063 |
| Diarrhea | 10 (7.2) | 4 (2.9) | .100 |
| Fatigue | 15 (10.9) | 10 (7.2) | .294 |
| Anorexia | 10 (7.2) | 10 (7.2) | - |
| Liver dysfunction (grade 1 or 2) | 70 (50.7) | 60 (43.5) | .228 |
| Kidney dysfunction (grade 1 or 2) | 3 (2.2) | 11 (8.0) | .028 |
| Adverse events during chemoradiotherapy | |||
| Hematologic | |||
| Anemia (grade 3 or 4) | 34 (24.6) | 17 (12.3) | .008 |
| Thrombocytopenia (grade 3 or 4) | 32 (23.2) | 17 (12.3) | .018 |
| Neutropenia (grade 3 or 4) | 49 (35.5) | 20 (7.2) | <.001 |
| Febrile neutropenia | 5 (3.6) | 2 (1.4) | .447† |
| Non-hematologic (grade 3 or 4) | |||
| Stomatitis (mucositis) | 30 (21.7) | 35 (25.4) | .478 |
| Nausea | 11 (8.0) | 12 (8.7) | .828 |
| Vomiting | 9 (6.5) | 10 (7.2) | .812 |
| Diarrhea | 2 (1.4) | 1 (7.2) | - |
| Fatigue | 20 (14.5) | 18 (13.0) | .727 |
| Anorexia | 28 (20.3) | 24 (17.4) | .538 |
| Dermatitis | 14 (10.1) | 16 (11.6) | .699 |
| Esophagitis, dysphagia or odynophagia | 5 (3.6) | 7 (5.1) | .555 |
| Dry mouth | 7 (5.1) | 8 (5.8) | .791 |
| Liver dysfunction (grade 1 or 2) | 62 (44.9) | 22 (15.9) | <.001 |
| Kidney dysfunction (grade 1 or 2) | 44 (31.9) | 22 (15.9) | .002 |
| Cycles of concurrent chemotherapy | |||
| One | 26 (18.8) | 27 (19.6) | .879 |
| Two | 112 (81.2) | 111 (80.4) | .879 |
*
Calculated using the χ2 test.
†
Calculated using Fisher's exact test.