By Sophie Bainbridge
ORLANDO, FL -- December 13, 2006 -- Rituximab, when added to first-line chemotherapy, improves median time to progression and disease-free survival and has a favorable effect on overall survival in patients with advanced follicular non-Hodgkins lymphoma, according to a phase 3 study.
The study of patients with follicular NHL, the most common form of indolent NHL was presented here at the American Hematology Society (ASH) 48th Annual Meeting and Exhibition.
Lead author, Robert E. Marcus, MD, consultant hematologist, department of hematology, Addenbrooke's Hospital, Cambridge, United Kingdom, showed that 8 cycles of rituximab added to cyclophosphamide, vincristine and prednisone (CVP) chemotherapy, significantly improved time to progression and disease-free survival in this patient population compared with chemotherapy alone.
Patients were followed for 4 years and the results provide assurance that addition of rituximab can prolong the lives of, said Dr. Marcus.
Last year, Dr. Marcus and colleagues reported that rituximab added to CVP improves time to progression and duration of response compared with CVP alone in previously untreated patients with stage III/IV CD20-positive follicular NHL (Blood 2005; 105:1417-23).
In a presentation at ASH on December 11th, he presented a protocol preplanned analysis of the study, now with a median follow-up of 53 months.
A total of 321 patients with a median age of 53 years were recruited into the study. The majority of patients (83%) had intermediate- to high-risk disease as determined by the Follicular Lymphoma International Prognostic Index (FLIPI) score. Median time to progression in the 162 patients who received rituximab in addition to CVP was 34 months, compared with 15 months in the 159 patients who received CVP alone (P <.001 log rank).
This increase in time to progression was observed in all FLIPI groups. Patients with good intermediate risk had a risk ratio of 0.40 (95% confidence interval [CI] 0.27 to 0.60). Poor-risk patients had a risk ratio of 0.51 (95% CI 0.34 to 0.76). Overall, the risk ratio was 0.44 (95% CI 0.32 to 0.57), Dr. Marcus reported.
In patients who achieved a complete response, disease-free survival was significantly prolonged (P =.0001 log rank). Of the patients receiving added rituximab, mortality rate was 19% compared with 29% in the chemotherapy alone group.
Patients receiving rituximab plus CVP had a significant improvement in overall survival compared with CVP alone (P =.03), Dr. Marcus reported.
"These results represent a major advance in the treatment of indolent NHL," commented co-investigator Kevin Imrie, MD, head, Hematology Site Group, Toronto Sunnybrook Regional Cancer Centre, Sunnybrook Health Sciences Centre, associate professor, department of medicine, faculty of medicine, University of Toronto, Toronto, Canada.
"This is clear evidence that the addition of rituximab to first-line chemotherapy for patients with indolent NHL not only extends the time that patients are free from the disease, but actually lengthens patients' lives," Dr. Imrie added.
The study was sponsored by Roche.
[Presentation title: MabThera (rituximab) Plus Cyclophosphamide, Vincristine and Prednisone (CVP) Chemotherapy Improves Survival in Previously Untreated Patients With Advanced Follicular Non-Hodgkin's Lymphoma (NHL). Abstract 481]
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