The Pharmaceutical Journal Vol 265 No 7128p909. December 23/30, 2000 Clinical
An interim analysis from a phase III study showed that of 328 patients treated with either CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone, 159 patients) or
R-CHOP (the rituximab combination, 169 patients), 69 per cent of the R-CHOP arm were disease-free at one year compared with 49 per cent in the CHOP arm. Complete remission was seen in 76 per cent of those treated with R-CHOP compared with 60 per cent treated with CHOP alone.
Adding rituximab 375mg/m2 to CHOP therapy on day one of each cycle did not appear to cause an increase in adverse events, say lead investigator Professor Bertrand Coiffier (haematology department, Hospices Seviles de Lyon, France) and colleagues. A total of 77 adverse events were observed in the CHOP arm and 49 events were observed in the R-CHOP arm.
The study was conducted by the adult lymphoma study group (GELA), a cancer co-operative group of more than 130 institutions in France, Belgium and Switzerland. The trial results were presented at the 42nd annual meeting of the American Society of Haematology in San Francisco on December 4.
Rituximab is not currently licensed for the treatment of aggressive NHL. However, a spokeswoman for Roche (manufacturer of Mabthera in the United Kingdom) told The Journal on December 5, that an application to extend Mabthera?s licensed indications would be submitted to the EU regulatory authority next year.