Randomized trial of paclitaxel versus pegylated liposomal doxorubicin for advanced human immunodeficiency virus-associated Kaposi sarcoma: Evidence of symptom palliation from chemotherapy Journal Article
| Authors: | Cianfrocca, M.; Lee, S.; Von Roenn, J.; Tulpule, A.; Dezube, B. J.; Aboulafia, D. M.; Ambinder, R. F.; Lee, J. Y.; Krown, S. E.; Sparano, J. A. |
| Article Title: | Randomized trial of paclitaxel versus pegylated liposomal doxorubicin for advanced human immunodeficiency virus-associated Kaposi sarcoma: Evidence of symptom palliation from chemotherapy |
| 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. © 2010 American Cancer Society. |
| Keywords: | adult; cancer chemotherapy; controlled study; aged; disease-free survival; middle aged; functional assessment; major clinical study; overall survival; clinical trial; constipation; fatigue; neutropenia; doxorubicin; advanced cancer; diarrhea; drug efficacy; drug safety; drug withdrawal; hypertension; side effect; treatment duration; paclitaxel; human immunodeficiency virus infection; anorexia; evidence based medicine; cancer palliative therapy; disease association; progression free survival; quality of life; controlled clinical trial; infection; multiple cycle treatment; pain; sensory neuropathy; anemia; blood toxicity; heart disease; leukopenia; nausea; randomized controlled trial; thrombocytopenia; antineoplastic combined chemotherapy protocols; myalgia; dexamethasone; bone pain; alanine aminotransferase blood level; arthralgia; aspartate aminotransferase blood level; febrile neutropenia; fever; lymphocytopenia; pneumonia; lung embolism; chemotherapy induced emesis; depression; symptom; thrombosis; daily life activity; antiretrovirus agent; highly active antiretroviral therapy; kaposi sarcoma; virus load; antiretroviral therapy, highly active; sarcoma, kaposi; recombinant granulocyte colony stimulating factor; alopecia; bilirubin blood level; recombinant erythropoietin; lung infiltrate; polyethylene glycols; hiv infections; sinus tachycardia; motor neuropathy; zidovudine; diphenhydramine; cimetidine; pegylated liposomal doxorubicin; acquired immunodeficiency syndrome (aids); human immunodeficiency virus (hiv) infection; histamine h2 receptor antagonist; indinavir; hemoglobinopathy; human immunodeficiency virus infected patient; swelling; work; early termination of clinical trials |
| Journal Title: | Cancer |
| Volume: | 116 |
| Issue: | 16 |
| ISSN: | 0008-543X |
| Publisher: | Wiley Blackwell |
| Date Published: | 2010-08-15 |
| Start Page: | 3969 |
| End Page: | 3977 |
| Language: | English |
| DOI: | 10.1002/cncr.25362 |
| PUBMED: | 20564162 |
| PROVIDER: | scopus |
| PMCID: | PMC3157242 |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 1" - "Export Date: 20 April 2011" - "CODEN: CANCA" - "Source: Scopus" |
