Long Term Follow Up of a Phase II study of Rituximab in Combination with CHOP Chemotherapy in Patients with Previously Untreated Aggressive Non-Hodgkins Lymphoma (NHL)

Reviewer: Julie Draznin Maltzman, MD
OncoLink
Last Modified: December 7, 2002

Presenter: J.M. Vose
Presenter's Affiliation: University of Nebraska Medical Center
Type of Session: Poster

Background

Standard therapy for NHL is combination chemotherapy with CHOP (cyclophosphamide/doxorubicin/vincristine/prednisone)
Rituxan, a mouse/human anti CD 20 antibody has a distinct mechanism of action and is synergistic with CHOP chemotherapy.
This rational is what led to the phase II study that evaluated CHOP/rituxan in previously untreated pts with aggressive NHL. 94% of the pts in that trial had a response. 61% achieved a complete response. At the time the median follow up time was 26 months.
This abstract gives long term follow up -- median of 62 months -- of this original phase II trial.

Materials and Methods

All pts were treated with 6 cycles of Rituxan 375mg/m2 day 1 and CHOP chemotherapy.
33 pts were enrolled in the trial.
Median age =52. 73% of the pts had stage III/IV disease.
Disease types included follicular large cell, diffuse large cell, and immunoblastic.

Results

At median 62 month follow up , 88% of the pts remained alive and 82% remained free of disease progression.
Overall survival curve by Kaplan Meier analysis at 60 months is 87%, with a progression free survival of 80%.
Since the first analysis at 26 months, one pt progressed and one pt died of second malignancy (NSCLCa) without progression of NHL.
During the entire follow up period 2/23 patients >60 years of age have failed with one death. Similarly, 4/10 pts >60 years of age have failed with 3 deaths.
No additional long term complications of CHOP/Rituxan have been reported.

Author's Conclusions

Long term results of this phase II trial show that this regimen is safe and active as front line therapy for aggressive NHL. This therapy produces durable response rates for many patients.

Clinical/Scientific Implications

This trial certainly expands our armementarium for fighting aggressive lymphomas.
Higher response rates, with no additional toxicities, can be achieved by combination chemotherapy and Rituxan in NHL.

Oncolink's ASH Coverage made possible by an unrestricted Educational Grant from Ortho Biotech.