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Addition of Rituximab to Combination Chemotherapy Improves Outcomes in Advanced Stage Lymphoplasmocytoid/ic Immunocytoma: Presented at ICML

By Chris Berrie

LUGANO, SWITZERLAND -- June 15, 2005 -- Immunotherapy that combines cyclophosphamide, adriamycin, vincristine, and prednisolone (CHOP) with rituximab (R-CHOP) appears to have a sustained beneficial effect over standard CHOP treatment for first-line treatment of lymphoplasmocytoid/ic immunocytoma (LP-IC).

According to the Kiel classification, advanced stage LP-IC, which includes Waldenstrom's disease, is an indolent lymphoma that cannot be cured by conventional treatment.

Reporting on behalf of the German Low-Grade Lymphoma Study Group (GLSG) here June 10^th at the 9^th International Conference on Malignant Lymphoma (ICML), Christian Buske, MD, coordinator and assistant professor, department of medicine III, University Hospital Grosshadern/LMU, Munich, Germany, presented the findings of a multicentre, prospective, randomised phase 3 trial.

"The purpose of the whole study was to compare the efficacy of the standard CHOP polychemotherapy regimen with the combination of rituximab plus CHOP, and we were specifically interested to see whether R-CHOP is more efficient with regards to initial cytoreduction response rates as well as time to treatment failure in this lymphoma subtype," Dr. Buske said.

Patients were treated with 6 to 8 cycles of standard CHOP therapy alone or in combination with 375 mg/m² rituximab. For inclusion in the study, patients had to have histological diagnosis of LP-IC stage III/IV with a requirement for therapeutic intervention and no previous treatment.

The initial 75 patients were classified as lymphoplasmacytic lymphoma ("cytic"; 72%) and lymphoplasmocytoid subtype ("cytoid"; 28%). The researchers randomised 38 patients to CHOP combination therapy (median age, 62 years; range 37-77 years: cytic, 71%), and 37 to R-CHOP (median age, 60 years; range, 40-78 years; cytic, 73%).

There were no significant differences between treatment groups in baseline clinical characteristics, including bone marrow involvement, elevated lactate dehydrogenase levels, B-symptoms, median immunoglobulin M, and International Prognostic Index (IPI) risk grading (low-intermediate risk [0-2], 76% on CHOP, 78% on R-CHOP).

Of the 37 evaluable LP-IC patients in each arm, those on CHOP alone achieved a 5% rate of complete remission (CR) and a 70% overall response rate (ORR). This ORR was significantly improved upon by the inclusion of rituximab (92%; P =.035).

Median estimated time to treatment failure for the CHOP arm of the LP-IC patients was 1.8 years, while that for the R-CHOP arm was not reached after a maximum follow-up of 4 years (P =.0001).

Among the 26 CHOP and 27 R-CHOP cytic patients, although the CR was the same (8%, 7%, respectively), the ORR was again significantly better for the R-CHOP arm (CHOP, 65%; R-CHOP, 93%; P =.019), with a similar significant improvement in the time to treatment failure for the R-CHOP arm versus CHOP (P =.0032).

Finally, for the responses of the 25 CHOP and 21 R-CHOP Waldenstrom's disease patients, the ORR was significantly better for the R-CHOP arm (CHOP, 64%; R-CHOP, 95%; P =.013), with an increase in the CR (4%, 14%, respectively), along with a significant improvement in the time to treatment failure for the R-CHOP arm versus CHOP (P =.0061).

There were no significant differences seen in toxicity rates in the 2 treatment arms.

Dr Buske said, "So this phase 3 randomised trial clearly tells us that the combination of rituximab plus CHOP is more efficient with regard to overall response rate, with the recurrence of the disease being definitely postponed."

He added that R-CHOP should be the standard treatment for these patients when they do not have medical contradictions for other reasons.


[Presentation title: The Addition of Rituximab to Combination Chemotherapy With CHOP Results in a Significantly Superior Response Rate and Time to Treatment Failure in the First Line Treatment of Advanced Stage Lymphoplasmocytoid/ic Immunocytoma (LP-IC) -- Results of a Prospective Randomised Trial of the German Low Grade Lymphoma Study Group (GLSG). Abstract 250]

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