TY - JOUR
T1 - Pegylated-liposomal doxorubicin versus doxorubicin, bleomycin, and vincristine in the treatment of AIDS-related Kaposi's sarcoma
T2 - Results of a randomized phase III clinical trial
AU - Northfelt, Donald W.
AU - Dezube, Bruce J.
AU - Thommes, James A.
AU - Miller, Becky J.
AU - Fischl, Margaret A.
AU - Friedman-Kien, Alvin
AU - Kaplan, Lawrence D.
AU - Du Mond, Charles
AU - Mamelok, Richard D.
AU - Henry, David H.
PY - 1998/7
Y1 - 1998/7
N2 - Purpose: Kaposi's sarcoma (KS), the most common neoplasm in patients with AIDS, is a significant clinical problem for which current therapies are frequently unsatisfactory. We conducted a randomized phase III clinical trial to compare the efficacy and toxicities of a new farm of therapy, pegylated- liposomal doxorubicin, with standard combination chemotherapy in patients with advanced AIDS-related KS (AIDS-KS). Patients and Methods: Two hundred fifty-eight patients with advanced AIDS-KS were randomly assigned to receive either pegylated-liposomal doxorubicin (20 mg/m2) or the combination of doxorubicin (20 mg/m2), bleomycin (10 mg/m2) and vincristine (1 mg) (ABV) every 14 days for six cycles. Standard response criteria, toxicity criteria, and predefined indicators of clinical benefit were examined to evaluate outcomes. Results: Among 133 patients randomized to receive pegylated- liposomal doxorubicin, one achieved a complete clinical response and 60 achieved a partial response far an overall response rate of 45.9% (95% confidence interval [CI], 37% to 54%). Among 125 patients randomized to receive ABV, 31 achieved a partial response (24.8%; 95% confidence interval [CI], 17% to 32%). This difference was statistically significant (P < .001). In addition to objective responses, prospectively defined clinical benefits and toxicity outcomes also favored pegylated-liposomal doxorubicin. Conclusion: Pegylated-liposomal doxorubicin is more effective and less toxic than the standard combination chemotherapy regimen ABV far treatment of AIDS- KS.
AB - Purpose: Kaposi's sarcoma (KS), the most common neoplasm in patients with AIDS, is a significant clinical problem for which current therapies are frequently unsatisfactory. We conducted a randomized phase III clinical trial to compare the efficacy and toxicities of a new farm of therapy, pegylated- liposomal doxorubicin, with standard combination chemotherapy in patients with advanced AIDS-related KS (AIDS-KS). Patients and Methods: Two hundred fifty-eight patients with advanced AIDS-KS were randomly assigned to receive either pegylated-liposomal doxorubicin (20 mg/m2) or the combination of doxorubicin (20 mg/m2), bleomycin (10 mg/m2) and vincristine (1 mg) (ABV) every 14 days for six cycles. Standard response criteria, toxicity criteria, and predefined indicators of clinical benefit were examined to evaluate outcomes. Results: Among 133 patients randomized to receive pegylated- liposomal doxorubicin, one achieved a complete clinical response and 60 achieved a partial response far an overall response rate of 45.9% (95% confidence interval [CI], 37% to 54%). Among 125 patients randomized to receive ABV, 31 achieved a partial response (24.8%; 95% confidence interval [CI], 17% to 32%). This difference was statistically significant (P < .001). In addition to objective responses, prospectively defined clinical benefits and toxicity outcomes also favored pegylated-liposomal doxorubicin. Conclusion: Pegylated-liposomal doxorubicin is more effective and less toxic than the standard combination chemotherapy regimen ABV far treatment of AIDS- KS.
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U2 - 10.1200/JCO.1998.16.7.2445
DO - 10.1200/JCO.1998.16.7.2445
M3 - Article
C2 - 9667262
AN - SCOPUS:0031861021
SN - 0732-183X
VL - 16
SP - 2445
EP - 2451
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 7
ER -