Abstract
Currently utilized Kaposi's Sarcoma (KS) response criteria evaluate cutaneous disease on the basis of lesion number, lesion characteristics (flat vs raised) and bidimensional measurements of marker lesions. Pulmonary KS is evaluated by standard solid tumor response criteria while KS response in other visceral sites (e.g., gastrointestinal tract) is frequently not well documented. The evaluation of KS response has been criticized because of difficulties in reproducibility and documentation of lesion counts and measurements, the lack of a standard assessment of visceral disease and the failure of these criteria to capture the clinical benefits(e.g., resolution of KS-associated pain, edema, disfigurement) of KS treatment. Investigators from the National Cancer Institute (NCI), the Food and Drug Administration (FDA) and the AIDS Malignancy Consortium (AMC) are in the process of revising KS response criteria and are seeking to identify clinically meaningful, reproducible, and practical endpoints to monitor the response to therapy of KS. These criteria may affect the design and conduct of clinical trials, as well as facilitate drug development. Evaluation of clinical benefit is complex in KS. The new criteria will focus on tumor specific symptoms, and include evaluation both from the physician and patient perspectives. Categories considered significant include: pain; edema, particularly extremity, scrotal, and facial; facial and oral lesions; visceral related symptoms, and lesion necrosis/ulceration. Subjective evidence of clinical benefit should be supported by objective measurements relevant to the symptom and is essential in uncontrolled and/or unblinded trials. For example, a reduction in pain or improvement in mobility due to improvement in edema should be supported by photographs or measurements. After systematic consideration of the typical symptoms and findings in KS, new response criteria will be proposed. The usefulness of these new criteria will be determined in prospective clinical trials.
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