Relevant outcomes

Response rate in terms of the number and size of lesions, flattening, and degree of pigmentation, is an important endpoint for systemic therapies in the treatment of cutaneous disease. One of the problems in comparing studies of systemic therapy in KS is the subjective nature of the assessment of response. Recent randomised studies of systemic therapies in AIDS-related KS have adopted the AIDS Clinical Trials Group (ACTG) criteria for assessment of response (Table 29.2).10 The overall cosmetic effect is also an important endpoint, particularly for local therapies such as radiotherapy which have long-term effects on the normal skin surrounding lesions. Consider, for example, the young homosexual man with telltale purple nodular HIV-associated KS lesions on a highly visible area such as the face. Local radiotherapy to this area, with a wide margin of normal skin, may leave him with an equally unsightly area of residual brown discoloration and a contrasting "halo" of depigmentation. Palliation of associated symptoms such as tumour-associated oedema is another endpoint for which assessment is highly subjective.

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