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
| Autor: | Dirk P. Dittmer, Thomas B. Campbell, Otoniel Martinez-Maza, Jeffrey N. Martin, Mina C. Hosseinipour, Amc React-Ks Team, Aggrey Bukuru, Minhee Kang, Agnes Moses, Margaret Borok, Susan E. Krown, Catherine Godfrey, Brenda Hoagland, Mostafa Nokta, Mulinda Nyirenda, Richard F. Ambinder, Rosie Mngqbisa, Deborah Langat, Triin Umbleja, Wadzanai Samaneka, Noluthando Mwelase, Naftali Busakhala, John MacRae, Jackson Orem |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Male Pediatric AIDS Biopsy Administration Oral HIV Infections chemotherapy etoposide Medical and Health Sciences law.invention chemistry.chemical_compound 0302 clinical medicine Randomized controlled trial law Immune Reconstitution Inflammatory Syndrome Phytogenic Antiretroviral Therapy Highly Active 030212 general & internal medicine Articles and Commentaries Etoposide Cancer Skin Pediatric Sarcoma Biological Sciences Chemotherapy regimen Infectious Diseases 6.1 Pharmaceuticals Administration HIV/AIDS Health Resources Female Patient Safety Infection medicine.drug Microbiology (medical) Oral Adult medicine.medical_specialty Efavirenz A5264/AMC-067 REACT-KS Team Clinical Trials and Supportive Activities antiretroviral therapy Antineoplastic Agents Kaposi Emtricitabine Microbiology 03 medical and health sciences Immune reconstitution inflammatory syndrome Acquired immunodeficiency syndrome (AIDS) Clinical Research Internal medicine medicine Humans Highly Active Sarcoma Kaposi Africa South of the Sahara AIDS-Related Opportunistic Infections business.industry Evaluation of treatments and therapeutic interventions Kaposi sarcoma HIV South America medicine.disease 030112 virology Antineoplastic Agents Phytogenic Clinical trial Good Health and Well Being chemistry business |
| Zdroj: | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, vol 67, iss 2 |
| Popis: | 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. Clinical trials registration NCT01352117. |
| Databáze: | OpenAIRE |
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