AEGiS-CATIE: Doxil for severe Kaposi's sarcoma

Doxil for severe Kaposi's sarcoma

TreatmentUpdate77 - Vol. 7, No. 7; April 1997
Sean Hosein

Background

Doxorubicin is an anticancer drug that's been repackaged into tiny bubbles of fat called liposomes. The bubbles are coated with PEG (polyethylene glycol) which helps them resist being processed by the body. The drug thus remains in circulation longer than non-PEG-coated liposomes. The reason for using liposomes is that tumours seem to absorb more anticancer drugs when given in this way rather than in their regular form. In theory, this is supposed to make the treatment more effective. This new form of doxorubicin is called Doxil.

Study details

Researchers enrolled 53 male subjects, half of whom had 10 CD4+ cells. Before entering the study, over half the subjects had worsening Kaposi's sarcoma (KS) despite having received combination chemotherapy which included regular doxorubicin. Subjects received an infusion of Doxil 20 mg/square metre of skin over 30 to 60 minutes every 3 weeks. Doctors could prescribe bone marrow stimulants if subjects blood cell counts fell below normal.

Results -- benefits

* 50% with raised lesions had them turn flat

* 56% with red/purple lesions had them fade

* 45% with "moderate to severe pain" reported either mild pain or no pain

* 83% with fluid build-up had this problem clear.

On average, these benefits lasted for about 4 months.

Toxicity

The study doctors reported the following side effects:

* bone marrow toxicity - 40%

* nausea and/or vomiting - 19%

* temporary hair loss - 9%

* weakness - 9%

* fever - 8%

* diarrhea - 6%

* low levels of platelets - 6%

Two subjects had allergic reactions to Doxil. Doctors did not find any signs/symptoms of heart damage. Five subjects died because of complications due to KS and 17 others from "AIDS-related complications".

Doxil can be an option for PHAs with KS which does not respond to standard treatment. The drug is made by Sequus Pharmaceuticals, Inc, Menlo Park, California.

REFERENCES:

1. Northfelt DW, Dezube BJ, Thommes JA et al. Efficacy of pegylated-liposomal doxorubicin in the treatment of AIDS-related Kaposi's sarcoma after failure of standard chemotherapy. Journal of Clinical Oncology 1997;15(2):653-659.

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