One uncontrolled phase II study of 20 patients with cutaneous AIDS-related KS, treated with

Table 29.2 AIDS Clinical Trials Group (ACTG) response criteria

Complete response (CR) Clinical complete response (CCR)

Partial response (PR)

Stable disease (SD) Progressive disease (PD)

The absence of any detectable residual disease, including tumour-associated oedema, persisting for at least 4 weeks. In patients in whom pigmented (brown or tan) macular skin lesions persist after apparent CR, biopsy of at least one representative lesion is required to document the absence of malignant cells. In patients known to have had visceral disease, an attempt at restaging with appropriate endoscopic or radiographic procedures should be made. If such procedures are medically contraindicated, the patient may be classified as having CCR.

The absence of new cutaneous or oral lesions, new visceral sites of involvement, or the appearance or worsening of tumour-associated oedema or effusions in addition to at least one of the following:

• A 50% or greater decrease in the number of all previously existing skin lesions (skin, oral, measurable or evaluable visceral disease)

• A 50% decrease in the size of lesions (includes a 50% decrease in the sum of the products of the largest perpendicular diameters of bi-dimensionally measurable marker lesions and/or complete flattening of at least 50% of the lesions (i.e. 50% of previously nodular or plaque-like lesions become macules).

• In those patients with predominantly nodular lesions, flattening to an indurated plaque of 75% or more of the nodules.

• Patients with residual tumour-associated oedema or effusion who otherwise meet the criteria for CR.

Any response not meeting the criteria for progression or PR.

An increase of 25% or more in the size of previously existing lesions and/or the appearance of new lesions or new sites of disease and/or a change in the character of 25% or more of the skin or oral lesions from macular to plaque-like or nodular. The development of new or increasing tumour-associated oedema or effusion is also considered to represent disease progression.

liquid-nitrogen cryotherapy, reported a complete response rate of 80% lasting a minimum of 6 weeks.11 On average, each lesion required three treatments at three-weekly intervals and the main side-effects were blistering and local discomfort. Another uncontrolled study of patients with AIDS-related facial KS found cryosurgery to be effective for small lesions measuring less than 1 cm.12

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