Table 2. Acute and Late Adverse Events Related to Radiotherapy and Chemotherapy.
| Eventa | Group, No. (%)b | |||
|---|---|---|---|---|
| IMRT alone (n = 165) | Concurrent chemoradiotherapy (n = 169) | |||
| Grade 1/2 | Grade 3/4 | Grade 1/2 | Grade 3/4 | |
| Acute toxicities | ||||
| Hematologic | ||||
| Leukocytes <4000/μL | 37 (22) | 2 (1) | 103 (61) | 17 (10) |
| Hemoglobin <lower limits of normal | 27 (16) | 0 | 127 (75) | 3 (2) |
| Neutropenia <2000/μL | 12 (7) | 3 (2) | 60 (36) | 11 (7) |
| Thrombocytopenia <105/μL | 2 (1) | 1 (1) | 41 (24) | 1 (1) |
| Nonhematologic | ||||
| Mucositis | 116 (70) | 16 (10) | 113 (67) | 32 (19) |
| Dry mouth | 33 (20) | 0 | 50 (30) | 0 |
| Dermatitis | 31 (19) | 0 | 54 (32) | 0 |
| Weight loss | 28 (17) | 1 (1) | 94 (56) | 8 (5) |
| Anorexia | 22 (13) | 8 (5) | 28 (17) | 49 (29) |
| Vomiting | 14 (8) | 2 (1) | 48 (28) | 25 (15) |
| Nausea | 14 (8) | 1(1) | 57 (34) | 22 (13) |
| Dysphagia | 5 (3) | 1 (1) | 22 (13) | 3 (2) |
| Fever | 0 | 0 | 0 | 1 (1) |
| Increase > upper limits of normal | ||||
| Creatinine | 16 (10) | 0 | 58 (34) | 1 (1) |
| ALT | 10 (6) | 0 | 34 (20) | 1 (1) |
| GGT | 8 (5) | 1 (1) | 28 (17) | 0 |
| AST | 3 (2) | 0 | 14 (8) | 0 |
| ALP | 1 (1) | 0 | 7 (4) | 0 |
| Late toxicities | ||||
| Dry mouth | 90 (55) | 0 | 96 (57) | 1 (1) |
| Auditory/hearing | 66 (40) | 1 (1) | 80 (47) | 1 (1) |
| Skin/neck tissue damage | 35 (21) | 1 (1) | 50 (30) | 0 |
| Hypothyroidism | 31 (19) | 4 (2) | 60 (36) | 1 (1) |
| Peripheral neuropathy | 6 (4) | 0 | 17 (10) | 0 |
| Temporal lobe injury | 6 (4) | 0 | 6 (4) | 0 |
| Trismus | 3 (2) | 0 | 3 (2) | 0 |
| Bone necrosis | 1 (1) | 0 | 0 | 0 |
Abbreviations: ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate transaminase; GGT, gammaglutamyl transferase; IMRT, intensity-modulated radiation therapy.
The National Cancer Institute Common Toxicity Criteria version 4.0 scale was used to grade acute radiation and chemotherapy toxicities. The late radiation morbidity scoring schemes of The Radiation Therapy Oncology Group and European Organisation for Research and Treatment of Cancer (EORTC) was used to grade late radiation toxic effects. (as detailed in the study protocol, see Supplement 2). The adverse event grading system rates adverse events from mild (1) to death (5) with 3 or 4 representing severe or potentially life-threatening events.
Indicates patients who received actual treatment consistent with protocol (patients treated only with IMRT in IMRT-alone group and patients who received at least 1 cycle of concurrent chemotherapy in concurrent chemoradiotherapy group). No treatment-related deaths occurred in either group.