| Methods |
RCT, 1991‐95, central allocation* |
| Participants |
85 patients randomised, 74 pts evaluated, age: 19‐72*, median age 52, gender m/f: 43/31, country: Austria, high grade NHL, untreated, stage I‐IV |
| Interventions |
1. CT
Cyclophosphamide 750 mg/m², iv, d1
Epirubicin 70 mg/m², iv, d1
Vincristine 1.4 mg/m², iv, d1 and 8
Prednisolone 100 mg po, d1‐5
Ifosfamide 2000 mg/m2, iv, d15‐17
Uromitexane 400 mg/m², iv, d15‐17
VP16 100 mg/m², iv, d15‐17
Dexamethasone 40 mg/m², po, d15‐19
Methotrexate 800 mg/m², iv, d22
Ca‐folinate 15 mg/m², po, d23‐25
2. G‐CSF (E.coli derived, Amgen) was given in a dose of 5 µg/kg on d2‐7, d9‐14, d18‐21 and d23‐27. After 10 G‐CSF receiving patients entered the study, the dose was modulated, and instead of d9‐14 G‐CSF was given 2 days less, thus d9‐12
3. no placebo used
4. no AB prophylaxis given* |
| Outcomes |
incidence of febrile neutropenia, febrile episodes, number of documented infections, use of iv antibiotics, number of days in hospital due to febrile neutropenia, dose intensity, tumour response, time to first febrile neutropenia, time to relapse, time to treatment failure, survival, adverse effects |
| Notes |
funding: Roche Austria, later AMGEN* |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
