Table A1.
Treatment-Related Adverse Events Occurring in At Least 5% of Patients in Cohort B of RTOG-0630 (n = 79)
| Adverse Event | Grade |
|||||
|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | All (%) | 3 to 4 (%) | |
| Blood/bone marrow | ||||||
| Decreased hemoglobin | 7 | 2 | 2 | 1 | 15.2 | 3.8 |
| Constitutional symptoms | ||||||
| Fatigue | 11 | 7 | 4 | 0 | 27.8 | 5.1 |
| Weight loss | 4 | 0 | 0 | 0 | 5.1 | 0.0 |
| Dermatology/skin | ||||||
| Skin induration | 25 | 11 | 1 | 0 | 46.8 | 1.3 |
| Radiation dermatitis | 10 | 10 | 2 | 1 | 29.1 | 3.8 |
| Skin hyperpigmentation | 14 | 0 | 0 | 0 | 17.7 | 0.0 |
| Dermatologic radiation recall reaction | 4 | 4 | 1 | 0 | 11.4 | 1.3 |
| Skin disorder | 5 | 3 | 0 | 0 | 10.1 | 0.0 |
| Desquamating rash | 4 | 1 | 0 | 0 | 6.3 | 0.0 |
| Wound dehiscence | 2 | 0 | 2 | 0 | 5.1 | 2.5 |
| Gastrointestinal | ||||||
| Nausea | 6 | 1 | 0 | 0 | 8.9 | 0.0 |
| Anorexia | 4 | 0 | 0 | 0 | 5.1 | 0.0 |
| Infection with normal or grade 1 to 2 ANC | ||||||
| Wound infection | 0 | 1 | 8 | 0 | 11.4 | 10.1 |
| Skin infection | 0 | 1 | 3 | 0 | 5.1 | 3.8 |
| Lymphatics | ||||||
| Limb edema | 30 | 18 | 2 | 0 | 63.3 | 2.5 |
| Musculoskeletal/soft tissue | ||||||
| Joint disorder | 14 | 12 | 2 | 0 | 35.4 | 2.5 |
| Seroma | 7 | 0 | 3 | 0 | 12.7 | 3.8 |
| Abnormal gait | 4 | 1 | 0 | 0 | 6.3 | 0.0 |
| Neurology | ||||||
| Peripheral sensory neuropathy | 12 | 1 | 1 | 0 | 17.7 | 1.3 |
| Peripheral motor neuropathy | 1 | 2 | 3 | 0 | 7.6 | 3.8 |
| Neurologic disorder NOS | 4 | 0 | 0 | 0 | 5.1 | 0.0 |
| Pain | ||||||
| In extremity | 16 | 17 | 1 | 0 | 43.0 | 1.3 |
| Other | 5 | 3 | 1 | 0 | 11.4 | 1.3 |
| Skin | 1 | 5 | 0 | 0 | 7.6 | 0.0 |
NOTE. Treatment related adverse event could be definitely, probably, or possibly related to protocol treatment (or with unknown relationship). Adverse events were classified according to Common Terminology Criteria for Adverse Events, version 3.0.
Abbreviations: ANC, absolute neutrophil count; NOS, not otherwise specified; RTOG-0630, Radiation Therapy Oncology Group RTOG-0630 (A Phase II Trial of Image-Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity) trial.