Table 3. Haematological and nonhaematological toxicity: NCI-CTC grades 3–4 adverse eventsa noted in ⩾5% of patients in any treatment group.
|
Randomised therapy
|
|||
|---|---|---|---|
| Toxicity NCI-CTC grade | Induction chemotherapy (n=108) | Chemoradiotherapyb (n=41)c | Radiotherapy alone (n=46) |
| Haematological, n (%) | |||
| Leucopenia | 28 (26) | — | — |
| Lymphocytopenia | 5 (5)d | 33 (80)d | 9 (20)d |
| Neutropenia | 50 (46) | — | 1 (2)d |
| Febrile neutropenia | 7 (6)e | — | — |
| Nonhaematologicalf, n (%) | |||
| Infection (without neutropenia) | — | 3 (7) | — |
| Vomiting | 5 (5)d | — | — |
| Oesophagitis/dysphagia | — | 7 (17)d | — |
| Fatigue | 3 (3)d | 5 (12)d | 2 (4) |
| Dyspnoea | 1 (1) | 2 (5) | 3 (7) |
NCI-CTC=National Cancer Institute Common Toxicity Criteria (version 2.0).
Serious adverse events are reported separately.
Local treatment period includes the 30 days after the last infusion for nonhaematological toxicities and the 7 days after the last infusion for haematological toxicities.
Two patients were excluded owing to being randomised to local treatment but not receiving their randomised therapy.
All grade 3.
Includes all grades of febrile neutropenia.
Alopecia graded in error as grade 3 was reported in 11 (10%) patients during induction chemotherapy, and in five (12%) and two (4%) patients in the chemoradiotherapy and radiotherapy groups, respectively, during randomised therapy. According to NCI-CTC classification, grades 3 and 4 cannot be applied to alopecia.