| Author | Hosseinipour, Mina C. | |
| Author | Kang, Minhee | |
| Author | Krown, Susan E. | |
| Author | Bukuru, Aggrey | |
| Author | Umbleja, Triin | |
| Author | Martin, Jeffrey N. | |
| Author | Orem, Jackson | |
| Author | Godfrey, Catherine | |
| Author | Hoagland, Brenda | |
| Author | Mwelase, Noluthando | |
| Author | Langat, Deborah | |
| Author | Nyirenda, Mulinda | |
| Author | MacRae, John | |
| Author | Borok, Margaret | |
| Author | Samaneka, Wadzanai | |
| Author | Moses, Agnes | |
| Author | Mngqbisa, Rosie | |
| Author | Busakhala, Naftali | |
| Author | Martínez-Maza, Otoniel | |
| Author | Ambinder, Richard | |
| Author | Dittmer, Dirk P. | |
| Author | Nokta, Mostafa | |
| Author | Campbell, Thomas B. | |
| Access date | 2019-02-04T13:27:57Z | |
| Available date | 2019-02-04T13:27:57Z | |
| Document date | 2018 | |
| Citation | HOSSEINIPOUR, Mina C. et al. As-Needed Vs Immediate Etoposide Chemotherapy in Combination With Antiretroviral Therapy for Mild-to-Moderate AIDS-Associated Kaposi Sarcoma in Resource-Limited Settings: A5264/AMC-067 Randomized Clinical Trial. Clinical Infectious Diseases, v. 67, n. 2, p. 251-260, July 2018. | pt_BR |
| ISSN | 1058-4838 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/31396 | |
| Description | For the A5264/AMC-067 REACT-KS Team. | |
| Sponsorship | Research reported in this article was supported by the National Institute of Allergy and Infectious Diseases of the NIH (UM1 AI068634, UM1 AI068636, and UM1 AI106701) and by the National Cancer Institute (UM1CA121947). Further support was provided to M. H., A. M., and D. P. D. (CA190152) and to D. P. D. (CA019014). | |
| Language | eng | pt_BR |
| Publisher | Oxford | pt_BR |
| Rights | open access | pt_BR |
| Title | As-Needed Vs Immediate Etoposide Chemotherapy in Combination With Antiretroviral Therapy for Mild-to-Moderate AIDS-Associated Kaposi Sarcoma in Resource-Limited Settings: A5264/AMC-067 Randomized Clinical Trial | pt_BR |
| Type | Article | pt_BR |
| DOI | 10.1093/cid/ciy044 | |
| Abstract | Background: Mild-to-moderate AIDS-associated Kaposi sarcoma (KS) often responds to antiretroviral therapy (ART) alone; the role of chemotherapy is unclear. We assessed the impact of immediate vs as-needed oral etoposide (ET) among human immunodeficiency virus (HIV)-infected individuals with mild-to-moderate KS initiating ART. Methods: Chemotherapy-naive, HIV type 1-infected adults with mild-to-moderate KS initiating ART in Africa and South America were randomized to ART (tenofovir/emtricitabine/efavirenz) alone (chemotherapy "as-needed" arm) vs ART plus up to 8 cycles of oral ET (immediate arm). Participants with KS progression on ART alone received ET as part of the as-needed strategy. Primary outcome was ordinal as follows: failure, stable, and response at 48 weeks. Secondary outcomes included time to initial KS progression, KS-associated immune reconstitution inflammatory syndrome (KS-IRIS), and KS response. Results: Of 190 randomized participants (as-needed = 94, immediate = 96), the majority were men (71%) and African (93%). Failure (53.8% vs 56.6%), stable (16.3% vs 10.8%), and response (30% vs 32.5%) did not differ between arms (as-needed vs immediate) among those with week 48 data potential (N = 163, P = .91). Time to KS progression (P = .021), KS-IRIS (P = .003), and KS response (P = .003) favored the immediate arm. Twenty-five participants died (13%). Mortality, adverse events, CD4+ T-cell changes, and HIV RNA suppression were similar at 48 weeks. Conclusions: Among HIV-infected adults with mild-to-moderate KS, immediate ET provided early, nondurable clinical benefits. By 48 weeks, no clinical benefit was observed compared to use of ET as needed. Mortality was high and tumor response was low. | pt_BR |
| Affilliation | UNC Project. Lilongwe, Malawi / University of North Carolina. School of Medicine. Chapel Hill, USA. | pt_BR |
| Affilliation | Harvard T.H. Chan School of Public Health. Center for Biostatistics in AIDS Research. Boston, Massachusetts, USA. | pt_BR |
| Affilliation | AIDS Malignancy Consortium. New York, USA. | pt_BR |
| Affilliation | Joint Clinical Research Center. Kampala, Uganda. | pt_BR |
| Affilliation | Harvard T.H. Chan School of Public Health. Center for Biostatistics in AIDS Research. Boston, Massachusetts, USA. | pt_BR |
| Affilliation | University of California. San Francisco, USA. | pt_BR |
| Affilliation | Uganda Cancer Institute. Kampala, Uganda. | pt_BR |
| Affilliation | National Institutes of Health. HIV Research Branch. Rockville, Maryland, USA. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | University of Witwatersrand. Johannesburg, South Africa. | pt_BR |
| Affilliation | Kenya Medical Research Institute. Walter Reed Project. Kericho, Kenya. | pt_BR |
| Affilliation | Johns Hopkins Project. University of Malawi. College of Medicine. Blantyre, Malawi. | pt_BR |
| Affilliation | IMPACTA Peru. Lima, Peru. | pt_BR |
| Affilliation | AIDS Malignancy Consortium. New York, USA / University of Zimbabwe. Harare, Zimbabwe. | pt_BR |
| Affilliation | UNC Project. Lilongwe, Malawi / University of North Carolina. School of Medicine. Chapel Hill, USA / AIDS Malignancy Consortium. New York, USA. | pt_BR |
| Affilliation | DICRS. Enhancing Care Foundation. Durban, South Africa. | pt_BR |
| Affilliation | Moi University. Eldoret, Kenya. | pt_BR |
| Affilliation | AIDS Malignancy Consortium. New York, USA / University of California. Los Angeles, USA. | pt_BR |
| Affilliation | AIDS Malignancy Consortium. New York, USA / Johns Hopkins University. Baltimore, USA. | pt_BR |
| Affilliation | University of North Carolina. School of Medicine. Chapel Hill, USA / AIDS Malignancy Consortium. New York, USA. | pt_BR |
| Affilliation | National Cancer Institute. Bethesda, Maryland, USA. | pt_BR |
| Affilliation | University of Colorado. School of Medicine. Aurora, USA. | pt_BR |
| Subject | Kaposi sarcoma | pt_BR |
| Subject | HIV | pt_BR |
| Subject | Etoposide | pt_BR |
| Subject | Chemotherapy | pt_BR |
| Subject | Antiretroviral therapy | pt_BR |
| e-ISSN | 1537-6591 | |
