A Randomized Trail of Fludarabine and Mitoxantrone Plus Rituximab Versus CHOP Plus Rituximab as First-Line Treatment in Patients with Follicular Lymphoma

Reviewer: Mary Kara Bucci, MD
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: December 10, 2001

Presenter: Pier Luigi Zinzani
Presenter's Affiliation:
Type of Session: Scientific

Background
Fludarabine plus Mitoxantrone (FM) is an effective combination chemotherapy regimen for the treatment of follicular lymphoma. In this study, FM is directly compared to cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy with Rituximab in selected cases.

Materials and Methods

102 patients with Stage II-IV follicular lymphoma, CD20+, with a postive PCR analysis of either bone marrow (BM) or peripheral blood (PB) for Bcl-2/Ig-H were randomized to 6 cycles of FM or CHOP

Patients with a complete response (CR) or a partial response (PR) to chemotherapy who remained PCR + (BM or PB) went on receive 4 cycles of Rituximab

Clinical response was graded as CR, PR, or failure to respond.

Results

36 patients have completed 6 cycles of FM and 33 have completed 6 cycles of CHOP.

Clinical response rates in the FM group are: CR 64%, PR 31%, failure to respond 6%. In the CHOP group, clinical response rates are: CR 42%, PR 48%, failure to respond 9%. These differences are not statistically significant.

Molecular response rates after 6 cycles of chemotherapy are: Negative PCR analysis, 35% of the FM group and 10% of the CHOP group; positive PCR analysis in 65% of the FM group and 90% of the CHOP group, p=.007

14 and 16 patients have gone on to receive 4 cycles of Rituximab in the FM and CHOP groups, respectively.

71% of the patients who received FM + Rituximab converted to a complete molecular response, as did 44% of those who received CHOP + Rituximab, p=not significant.

50% of the Rituximab patients who had measurable disease demonstrated an increase in clinical response.

Toxicities included Grade 1-2 anemia in 34% of the CHOP patients and 19% of the FM patients, and neutropenia in 62% of the CHOP patients and 43% of FM patients.

Author's Conclusions

These results confirm the safety and efficacy of FM for patients with previously untreated Stage II-IV follicular lymphoma.

This study also demonstrates the role of Rituximab after first line chemotherapy for improving both clinical and molecular response.

Clinical/Scientific Implications
This small, randomized study suggests an important role for both the FM chemotherapy regimen and the addition of Rituximab to first line therapy for follicular lymphoma. These results should be tested in a large, prospective randomized trial.

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