Pegylated-liposomal doxorubicin versus doxorubicin, bleomycin, and vincristine in the treatment of AIDS-related Kaposi's sarcoma: Results of a randomized phase III clinical trial

Donald W. Northfelt, Bruce J. Dezube, James A. Thommes, Becky J. Miller, Margaret A Fischl, Alvin Friedman-Kien, Lawrence D. Kaplan, Charles Du Mond, Richard D. Mamelok, David H. Henry

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Abstract

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.

Original languageEnglish
Pages (from-to)2445-2451
Number of pages7
JournalJournal of Clinical Oncology
Volume16
Issue number7
StatePublished - Jul 1 1998
Externally publishedYes

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Phase III Clinical Trials
Vincristine
Doxorubicin
Randomized Controlled Trials
Acquired Immunodeficiency Syndrome
Kaposi's Sarcoma
Combination Drug Therapy
Therapeutics
Confidence Intervals
Poisons
Bleomycin
indium-bleomycin
AIDS-related Kaposi sarcoma
liposomal doxorubicin
Neoplasms

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Pegylated-liposomal doxorubicin versus doxorubicin, bleomycin, and vincristine in the treatment of AIDS-related Kaposi's sarcoma : Results of a randomized phase III clinical trial. / Northfelt, Donald W.; Dezube, Bruce J.; Thommes, James A.; Miller, Becky J.; Fischl, Margaret A; Friedman-Kien, Alvin; Kaplan, Lawrence D.; Du Mond, Charles; Mamelok, Richard D.; Henry, David H.

In: Journal of Clinical Oncology, Vol. 16, No. 7, 01.07.1998, p. 2445-2451.

Research output: Contribution to journalArticle

Northfelt, DW, Dezube, BJ, Thommes, JA, Miller, BJ, Fischl, MA, Friedman-Kien, A, Kaplan, LD, Du Mond, C, Mamelok, RD & Henry, DH 1998, 'Pegylated-liposomal doxorubicin versus doxorubicin, bleomycin, and vincristine in the treatment of AIDS-related Kaposi's sarcoma: Results of a randomized phase III clinical trial', Journal of Clinical Oncology, vol. 16, no. 7, pp. 2445-2451.
Northfelt, Donald W. ; Dezube, Bruce J. ; Thommes, James A. ; Miller, Becky J. ; Fischl, Margaret A ; Friedman-Kien, Alvin ; Kaplan, Lawrence D. ; Du Mond, Charles ; Mamelok, Richard D. ; Henry, David H. / Pegylated-liposomal doxorubicin versus doxorubicin, bleomycin, and vincristine in the treatment of AIDS-related Kaposi's sarcoma : Results of a randomized phase III clinical trial. In: Journal of Clinical Oncology. 1998 ; Vol. 16, No. 7. pp. 2445-2451.
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abstract = "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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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.

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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.

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