Important note: Information in this article was accurate in 1993. The state of the art may have changed since the publication date.
Quantitative ultrasound volume measurement serves as noninvasive method to follow response of cutaneous Kaposi's sarcoma lesions to Doxil therapy (Meeting abstract).
Proc Annu Meet Am Soc Clin Oncol; 12:A7 1993. Unique Identifier : AIDSLINE ICDB/93694407 Goebel FD; Bogner JR; Spathling S; Held M; Sandor P; Trubenbach K; Rauch C; Kronawitter U; Medizinische Poliklink, Univ. of Munich, Germany
Abstract:
Objective: Within the context of a Phase II study of Doxil (Stealth liposomal doxorubicin), we sought to develop and validate an ultrasound method to quantify the response of cutaneous KS lesions to therapy, and to confirm complete response (CR) without the need for biopsy. Methods: 38 patients (pts) with advanced KS (median CD4 27/ul) were followed for safety and efficacy. Doxil was given biweekly by iv infusion at doses of 10, 20 and 40 mg/m2 (10, 25 and 3 pts, respectively). All pts had skin lesions, 8 pts presented with pulmonary KS, 9/13 endoscoped pts had GI lesions, 20 had visible oral lesions and 15 patients had facial or peripheral edema. Response was assessed in all pts using ACTG criteria and volumes of 15 selected indicator lesions in 6/38 pts were prospectively followed using ultrasound. Results: Following ACTG response guidelines, 36/38 (95%) achieved partial response (PR) within 6-8 wk as evidenced by greater than 50% decrease in indicator lesion nodularity and thickness. No progression was seen on continuous therapy. 5/20 pts with oral KS showed CR. 8/8 pts with pulmonary KS experienced PR proven by x-ray and pulmonary function. 12 pts died during the study due to intercurrent opportunistic infections (OI). Dose was reduced by half in the 3 pts receiving 40 mg/m2 due to toxicity. 15% of scheduled infusions were postponed due to reversible leukopenia or OI. Five pts complained of partial alopecia, 5 pts experienced mild stomatitis and 5 pts reported malaise and fever for 24 hr following dosing. Derivation of lesion surface area by bidirectional measurements is confounded by persistent residual pigmentation. 5/6 pts selected to be followed by ultrasound showed complete flattening of indicator lesions. Lesion vol measured in these pts by ultrasound showed a corresponding decrease: median lesion vol dropped from 451 mm3 to 66 mm3. Three of these 5 pts with essentially zero vol by ultrasound agreed to biopsy: all 3 were histologically negative for KS. Conclusion: Doxil at 10 and 20 mg/m2 appears to be an effective single-agent therapy for advanced AIDS-KS. High response rates are seen, including pts with visceral disease. Responses are durable. Ultrasound vol assessment appears to be a superior approach to area measurements to differentiate between tumor mass and residual pigmentation, and may serve as a noninvasive technique to confirm CR.
Keywords: Dose-Response Relationship, Drug Doxorubicin/*ADMINISTRATION & DOSAGE Drug Administration Schedule Drug Carriers Follow-Up Studies Human Infusions, Intravenous Liposomes Sarcoma, Kaposi's/*DRUG THERAPY/MORTALITY/ULTRASONOGRAPHY Skin Neoplasms/*DRUG THERAPY/MORTALITY/ULTRASONOGRAPHY Survival Rate ABSTRACT CLINICAL TRIAL, PHASE II 931230
M93C0820
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Important note: Information in this article was accurate in 1993. The state of the art may have changed since the publication date.
