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Pegylated Liposomal Doxorubicin (Caelyx)-Based Regimen Carries Less Cardiac Toxicity: Presented at ESMO

By Charlene Laino

BUDAPEST, HUNGARY -- June 9, 2005 -- For patients with non-Hodgkin's lymphoma, a chemotherapy cocktail that uses pegylated liposomal doxorubicin may be just as effective at controlling disease as standard hyroxy doxorubicin, but with less cardiac toxicity, according to a prospective, randomised, phase 2 study.

Tarek Hashem, MD, Department of Clinical Oncology, Menofyia University, Gizia, Egypt, presented the findings during a poster session here on June 4^th at the European Society of Medical Oncology Scientific & Educational Conference (ESMO).

The gold standard for the treatment of intermediate and high-grade non-Hodgkin's lymphoma is cyclophosphamide, hyroxy doxorubicin, vincristine, and prednisone (CHOP). However, its main active component -- doxorubicin -- carries a significant risk of cardiotoxicity that is both cumulative and irreversible, Dr. Hashem said.

The current study was designed to explore whether using a pegylated liposomal form of doxorubicin could reduce anthracycline-associated toxicity while maintaining efficacy compared to standard CHOP therapy.

The study enrolled 60 patients with intermediate and high-grade non-Hodgkin's lymphoma and a median age of 46.8 years. They were randomised in a 1:1 fashion to CHOP or pegylated liposomal doxorubicin (Caelyx), cyclophosphamide, vincristine, and prednisone (CCOP).

At 2 years of follow-up, the compete response rate was 70% in the CHOP arm versus 65% in the CCOP arm. The partial response rates were 25% and 20% in the CHOP and CCOP groups, respectively. The values were not significantly different (P >.05).

Also, 2-year disease-free survival was 50% in both arms, the study showed.

Overall, toxicity was comparable in both arms. However, alopecia affected 100% of patients on CHOP and 55% on CCOP (P <.05).

Dr. Hashem noted that cardiac toxicity with impairment of left ventricular ejection fraction occurred in 4 patients, all from the CHOP arm.

Erythrodysesthesia occurred in 7 patients; all of them were in the CCOP arm.

Dr. Hashem called for more research to help pinpoint the subgroups of patients that are at higher risk of developing cardiac toxicity, and to compare the cost-benefits of the two regimens.


[Presentation title: Evaluation of Pegylated Liposomal Doxorubicin (Caelyx) as a Front Line Therapy in the Management of Intermediate and High Grade NHL. Abstract 120P]

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