In this large study, patients with chronic lymphocytic leukaemia who had not yet been treated and were in good physical condition received either two chemotherapy drugs (fludarabine and cyclophosphamide) or the same two drugs together with rituximab. Adding rituximab meant patients stayed longer without their disease getting worse, and their overall survival was also better. On the other hand, more severe drops in white blood cell counts were more common, but serious infections did not increase.
Chronic lymphocytic leukaemia, fit patients without prior treatment
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Fludarabine | 25 mg/m² daily | IV | Days 1 to 3 |
| Cyclophosphamide | 250 mg/m² daily | IV | Days 1 to 3 |
| Rituximab | 375 mg/m² (day 0 of cycle 1), then 500 mg/m² (day 1 of cycles 2 to 6) | IV |
Doses from the CLL8 trial.
On the page “Cyclophosphamide (Endoxan)” · Regimens and dosing
CD20-positive chronic lymphocytic leukaemia, previously untreated or treated
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Cycle 1 | |||
| Rituximab | 375 mg/m² | IV infusion | One day before starting FC |
| Cycles 2 to 6 | |||
| Rituximab | 500 mg/m² | IV infusion | Day 1 |
| Fludarabine + cyclophosphamide | 25 mg/m²/day + 250 mg/m²/day | IV | Days 1 to 3 |
Pneumocystis and herpes prophylaxis during treatment and for up to 12 months afterwards as needed. In exploratory analyses, no benefit from adding rituximab to FC was shown in patients over 70.
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Six cycles of IV fludarabine 25 mg/m² per day and cyclophosphamide 250 mg/m² per day for the first three days of each 28-day cycle, with rituximab 375 mg/m² on day 0 of the first cycle and 500 mg/m² on day 1 of the second to sixth cycles.
Six cycles of IV fludarabine 25 mg/m² per day and cyclophosphamide 250 mg/m² per day for the first three days of each 28-day cycle, without rituximab.
Source of the regimen details: Abstract of the paper
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Treatment-naive, physically fit patients aged 30 to 81 years with CD20-expressing chronic lymphocytic leukaemia (CLL).
Primary endpoint: progression-free survival (PFS). The analysis was by intention to treat. Overall survival was also reported.
Grade 3 and 4 neutropenia was more common in the chemoimmunotherapy group (136 [34%] of 404 versus 83 [21%] of 396; P<0.0001). Grade 3 and 4 leucocytopenia was also more frequent (97 [24%] versus 48 [12%]; P<0.0001). Other adverse events, including severe infections, did not increase.
This trial showed that adding rituximab to fludarabine and cyclophosphamide in first-line treatment of fit patients with CLL improves both progression-free survival and overall survival. The authors conclude that the choice of first-line treatment can change the natural course of the disease. The current status of this regimen in clinical guidelines should be checked separately.
The study was open-label, and investigators and patients were not masked to treatment allocation. The study population was limited to treatment-naive, physically fit patients, and the findings cannot be generalised to frailer patients. The study was funded by F Hoffmann-La Roche.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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