Randomized trial of paclitaxel versus pegylated liposomal doxorubicin for advanced human immunodeficiency virus-associated Kaposi sarcoma: Evidence of symptom palliation from chemotherapy

Mary Cianfrocca, Sandra Lee, Jamie Von Roenn, Anil Tulpule, Bruce J. Dezube, David M. Aboulafia, Richard F. Ambinder, Jeannette Y. Lee, Susan E. Krown, Joseph A. Sparano

Research output: Contribution to journalArticle

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Abstract

BACKGROUND: Paclitaxel and pegylated liposomal doxorubicin (PLD) are active cytotoxic agents for the treatment of human immunodeficiency virus (HIV)-associated Kaposi sarcoma (KS). A randomized trial comparing the efficacy and toxicity of paclitaxel and PLD was performed, and the effects of therapy on symptom palliation and quality of life were determined. METHODS: Patients with advanced HIV-associated KS were randomly assigned to receive paclitaxel at a dose of 100 mg/m2 intravenously (iv) every 2 weeks or PLD at a dose of 20 mg/m2 iv every 3 weeks. The KS Functional Assessment of HIV (FAHI) quality of life instrument was used before and after every other treatment cycle. RESULTS: The study included 73 analyzable patients enrolled between 1998 and 2002, including 36 in the paclitaxel arm and 37 in the PLD arm; 73% of patients received highly active antiretroviral therapy (HAART) and 32% had an undetectable viral load (<400 copies/mL). Treatment was associated with significant improvements in pain (P=.024) and swelling (P < .001). Of the 36 patients who reported that pain interfered with their normal work or activities at baseline, 25 (69%) improved. Of the 41 patients who reported swelling at baseline, 38 (93%) improved. Comparing the paclitaxel and PLD arms revealed comparable response rates (56% vs 46%; P = .49), median progression-free survival (17.5 months vs 12.2 months; P = .66), and 2-year survival rates (79% vs 78%; P = .75), but somewhat more grade 3 to 5 toxicity for paclitaxel (84% vs 66%; P = .077). CONCLUSIONS: Treatment with either paclitaxel or PLD appears to produce significant improvements in pain and swelling in patients with advanced, symptomatic, HIV-associated KS treated in the HAART era.

Original languageEnglish (US)
Pages (from-to)3969-3977
Number of pages9
JournalCancer
Volume116
Issue number16
DOIs
StatePublished - Aug 15 2010

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Kaposi's Sarcoma
Paclitaxel
HIV
Drug Therapy
Highly Active Antiretroviral Therapy
Pain
Quality of Life
Therapeutics
Cytotoxins
liposomal doxorubicin
Viral Load
Disease-Free Survival
Survival Rate

Keywords

  • Acquired immunodeficiency syndrome (AIDS)
  • Human immunodeficiency virus (HIV) infection
  • Kaposi sarcoma
  • Paclitaxel
  • Pegylated liposomal doxorubicin

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

Cite this

Randomized trial of paclitaxel versus pegylated liposomal doxorubicin for advanced human immunodeficiency virus-associated Kaposi sarcoma : Evidence of symptom palliation from chemotherapy. / Cianfrocca, Mary; Lee, Sandra; Von Roenn, Jamie; Tulpule, Anil; Dezube, Bruce J.; Aboulafia, David M.; Ambinder, Richard F.; Lee, Jeannette Y.; Krown, Susan E.; Sparano, Joseph A.

In: Cancer, Vol. 116, No. 16, 15.08.2010, p. 3969-3977.

Research output: Contribution to journalArticle

Cianfrocca, Mary ; Lee, Sandra ; Von Roenn, Jamie ; Tulpule, Anil ; Dezube, Bruce J. ; Aboulafia, David M. ; Ambinder, Richard F. ; Lee, Jeannette Y. ; Krown, Susan E. ; Sparano, Joseph A. / Randomized trial of paclitaxel versus pegylated liposomal doxorubicin for advanced human immunodeficiency virus-associated Kaposi sarcoma : Evidence of symptom palliation from chemotherapy. In: Cancer. 2010 ; Vol. 116, No. 16. pp. 3969-3977.
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abstract = "BACKGROUND: Paclitaxel and pegylated liposomal doxorubicin (PLD) are active cytotoxic agents for the treatment of human immunodeficiency virus (HIV)-associated Kaposi sarcoma (KS). A randomized trial comparing the efficacy and toxicity of paclitaxel and PLD was performed, and the effects of therapy on symptom palliation and quality of life were determined. METHODS: Patients with advanced HIV-associated KS were randomly assigned to receive paclitaxel at a dose of 100 mg/m2 intravenously (iv) every 2 weeks or PLD at a dose of 20 mg/m2 iv every 3 weeks. The KS Functional Assessment of HIV (FAHI) quality of life instrument was used before and after every other treatment cycle. RESULTS: The study included 73 analyzable patients enrolled between 1998 and 2002, including 36 in the paclitaxel arm and 37 in the PLD arm; 73{\%} of patients received highly active antiretroviral therapy (HAART) and 32{\%} had an undetectable viral load (<400 copies/mL). Treatment was associated with significant improvements in pain (P=.024) and swelling (P < .001). Of the 36 patients who reported that pain interfered with their normal work or activities at baseline, 25 (69{\%}) improved. Of the 41 patients who reported swelling at baseline, 38 (93{\%}) improved. Comparing the paclitaxel and PLD arms revealed comparable response rates (56{\%} vs 46{\%}; P = .49), median progression-free survival (17.5 months vs 12.2 months; P = .66), and 2-year survival rates (79{\%} vs 78{\%}; P = .75), but somewhat more grade 3 to 5 toxicity for paclitaxel (84{\%} vs 66{\%}; P = .077). CONCLUSIONS: Treatment with either paclitaxel or PLD appears to produce significant improvements in pain and swelling in patients with advanced, symptomatic, HIV-associated KS treated in the HAART era.",
keywords = "Acquired immunodeficiency syndrome (AIDS), Human immunodeficiency virus (HIV) infection, Kaposi sarcoma, Paclitaxel, Pegylated liposomal doxorubicin",
author = "Mary Cianfrocca and Sandra Lee and {Von Roenn}, Jamie and Anil Tulpule and Dezube, {Bruce J.} and Aboulafia, {David M.} and Ambinder, {Richard F.} and Lee, {Jeannette Y.} and Krown, {Susan E.} and Sparano, {Joseph A.}",
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T1 - Randomized trial of paclitaxel versus pegylated liposomal doxorubicin for advanced human immunodeficiency virus-associated Kaposi sarcoma

T2 - Evidence of symptom palliation from chemotherapy

AU - Cianfrocca, Mary

AU - Lee, Sandra

AU - Von Roenn, Jamie

AU - Tulpule, Anil

AU - Dezube, Bruce J.

AU - Aboulafia, David M.

AU - Ambinder, Richard F.

AU - Lee, Jeannette Y.

AU - Krown, Susan E.

AU - Sparano, Joseph A.

PY - 2010/8/15

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N2 - BACKGROUND: Paclitaxel and pegylated liposomal doxorubicin (PLD) are active cytotoxic agents for the treatment of human immunodeficiency virus (HIV)-associated Kaposi sarcoma (KS). A randomized trial comparing the efficacy and toxicity of paclitaxel and PLD was performed, and the effects of therapy on symptom palliation and quality of life were determined. METHODS: Patients with advanced HIV-associated KS were randomly assigned to receive paclitaxel at a dose of 100 mg/m2 intravenously (iv) every 2 weeks or PLD at a dose of 20 mg/m2 iv every 3 weeks. The KS Functional Assessment of HIV (FAHI) quality of life instrument was used before and after every other treatment cycle. RESULTS: The study included 73 analyzable patients enrolled between 1998 and 2002, including 36 in the paclitaxel arm and 37 in the PLD arm; 73% of patients received highly active antiretroviral therapy (HAART) and 32% had an undetectable viral load (<400 copies/mL). Treatment was associated with significant improvements in pain (P=.024) and swelling (P < .001). Of the 36 patients who reported that pain interfered with their normal work or activities at baseline, 25 (69%) improved. Of the 41 patients who reported swelling at baseline, 38 (93%) improved. Comparing the paclitaxel and PLD arms revealed comparable response rates (56% vs 46%; P = .49), median progression-free survival (17.5 months vs 12.2 months; P = .66), and 2-year survival rates (79% vs 78%; P = .75), but somewhat more grade 3 to 5 toxicity for paclitaxel (84% vs 66%; P = .077). CONCLUSIONS: Treatment with either paclitaxel or PLD appears to produce significant improvements in pain and swelling in patients with advanced, symptomatic, HIV-associated KS treated in the HAART era.

AB - BACKGROUND: Paclitaxel and pegylated liposomal doxorubicin (PLD) are active cytotoxic agents for the treatment of human immunodeficiency virus (HIV)-associated Kaposi sarcoma (KS). A randomized trial comparing the efficacy and toxicity of paclitaxel and PLD was performed, and the effects of therapy on symptom palliation and quality of life were determined. METHODS: Patients with advanced HIV-associated KS were randomly assigned to receive paclitaxel at a dose of 100 mg/m2 intravenously (iv) every 2 weeks or PLD at a dose of 20 mg/m2 iv every 3 weeks. The KS Functional Assessment of HIV (FAHI) quality of life instrument was used before and after every other treatment cycle. RESULTS: The study included 73 analyzable patients enrolled between 1998 and 2002, including 36 in the paclitaxel arm and 37 in the PLD arm; 73% of patients received highly active antiretroviral therapy (HAART) and 32% had an undetectable viral load (<400 copies/mL). Treatment was associated with significant improvements in pain (P=.024) and swelling (P < .001). Of the 36 patients who reported that pain interfered with their normal work or activities at baseline, 25 (69%) improved. Of the 41 patients who reported swelling at baseline, 38 (93%) improved. Comparing the paclitaxel and PLD arms revealed comparable response rates (56% vs 46%; P = .49), median progression-free survival (17.5 months vs 12.2 months; P = .66), and 2-year survival rates (79% vs 78%; P = .75), but somewhat more grade 3 to 5 toxicity for paclitaxel (84% vs 66%; P = .077). CONCLUSIONS: Treatment with either paclitaxel or PLD appears to produce significant improvements in pain and swelling in patients with advanced, symptomatic, HIV-associated KS treated in the HAART era.

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