Journal of Clinical Oncology, Vol 15, 1110-1117, Copyright © 1997 by American Society of Clinical Oncology
Comparison in low-tumor-burden follicular lymphomas between an initial no-treatment policy, prednimustine, or interferon alfa: a randomized study from the Groupe d'Etude des Lymphomes Folliculaires. Groupe d'Etude des Lymphomes de l'Adulte
P Brice, Y Bastion, E Lepage, N Brousse, C Haioun, P Moreau, N Straetmans, H Tilly, I Tabah and P Solal-Celigny
Hopital Saint-Louis, Paris, France.
PURPOSE: To evaluate prospectively in patients with follicular lymphoma and
a low tumor burden three therapeutic options: delay of any treatment until
clinically meaningful progression, immediate treatment with an oral
alkylating agent, or treatment with a biologic response modifier,
interferon alfa-2b. PATIENTS AND METHODS: Newly diagnosed follicular
lymphoma patients with a low tumor burden (n = 193) were randomly assigned
to one of three arms: arm 1, no initial treatment (n = 66); arm 2,
prednimustine 200 mg/m2/d for 5 days per month for 18 months (n = 64); or
arm 3, interferon alfa 5 MU/d for 3 months then 5 MU three times per week
for 15 months (n = 63). Clinical characteristics were similar in the three
arms. RESULTS: Overall response rates with prednimustine and interferon
alfa were 78% and 70%, respectively. The overall response to therapy, when
deferred, was similar at 70%. With a median follow-up duration of 45 months
after randomization, the median freedom-from-treatment (FFT) interval was
24 months in arm 1 and the interval of freedom from treatment failure
(FFTF) was 40 months in arm 2 and 35 months in arm 3. The median overall
survival time was not reached and the overall survival rate at 5 years was
78% in arm 1, 70% in arm 2, and 84% in arm 3. Therefore, deferred treatment
does not adversely influence survival at 5 years. Patients who progressed
within 1 year had a significantly shorter survival duration (median, 48
months). CONCLUSION: Delayed treatment is feasible in patients with
follicular lymphoma and a low tumor burden. For patients with early
progression, more intensive therapy should be considered. For others,
because delay of treatment until significant clinical progression does not
seem to hamper the prognosis or subsequent response to treatment, the
long-term toxicity of alkylating agents can be reduced.
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