title: Excellent clinical outcomes and retention in care for adults with HIV-associated Kaposi sarcoma treated with systemic chemotherapy and integrated antiretroviral therapy in rural Malawi.
abstract: BACKGROUND
  HIV-associated Kaposi sarcoma (HIV-KS) is the most common cancer in Malawi. In 2008, the non-governmental organization, Partners In Health, and the Ministry of Health established the Neno Kaposi Sarcoma Clinic (NKSC) to treat HIV-KS in rural Neno district. We aimed to evaluate 12-month clinical outcomes and retention in care for HIV-KS patients in the NKSC, and to describe our implementation model, which featured protocol-guided chemotherapy, integrated antiretroviral therapy (ART) and psychosocial support delivered by community health workers.
  
  
  METHODS
  We conducted a retrospective cohort study using routine clinical data from 114 adult HIV-KS patients who received ART and ≥1 chemotherapy cycle in the NKSC between March 2008 and February 2012.
  
  
  RESULTS
  At enrolment 97% of patients (n/N=103/106) had advanced HIV-KS (stage T1). Most patients were male (n/N=85/114, 75%) with median age 36 years (interquartile range, IQR: 29-42). Patients started ART a median of 77 days prior to chemotherapy (IQR: 36-252), with 97% (n/N=105/108) receiving nevirapine/lamivudine/stavudine. Following standardized protocols, we treated 20 patients (18%) with first-line paclitaxel and 94 patients (82%) with bleomycin plus vincristine (BV). Of the 94 BV patients, 24 (26%) failed to respond to BV requiring change to second-line paclitaxel. A Division of AIDS grade 3/4 adverse event occurred in 29% of patients (n/N=30/102). Neutropenia was the most common grade 3/4 event (n/N=17/102, 17%). Twelve months after chemotherapy initiation, 83% of patients (95% CI: 74-89%) were alive, including 88 (77%) retained in care. Overall survival (OS) at 12 months did not differ by initial chemotherapy regimen (p=0.6). Among patients with T1 disease, low body mass index (BMI) (adjusted hazard ratio, aHR=4.10, 95% CI: 1.06-15.89) and 1 g/dL decrease in baseline haemoglobin (aHR=1.52, 95% CI: 1.03-2.25) were associated with increased death or loss to follow-up at 12 months.
  
  
  CONCLUSIONS
  The NKSC model resulted in infrequent adverse events, low loss to follow-up and excellent OS. Our results suggest it is safe, effective and feasible to provide standard-of-care chemotherapy regimens from the developed world, integrated with ART, to treat HIV-KS in rural Malawi. Baseline BMI and haemoglobin may represent important patient characteristics associated with HIV-KS survival in rural sub-Saharan Africa.
authors.affiliation: Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.|Abwenzi Pa Za Umoyo, Neno, Malawi.|Partners In Health, Boston, MA, USA; michael_herce@med.unc.edu.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Herce
authors.affiliation: Abwenzi Pa Za Umoyo, Neno, Malawi.|Partners In Health, Boston, MA, USA.
authors.forename: Noel
authors.initials: N
authors.lastname: Kalanga
authors.affiliation: Abwenzi Pa Za Umoyo, Neno, Malawi.|Partners In Health, Boston, MA, USA.|Department of Medicine, Brigham & Women's Hospital, Boston, MA, USA.
authors.forename: Emily B
authors.initials: EB
authors.lastname: Wroe
authors.affiliation: Abwenzi Pa Za Umoyo, Neno, Malawi.|Partners In Health, Boston, MA, USA.|Department of Family Medicine, Tufts University School of Medicine, Boston, MA, USA.
authors.forename: James W
authors.initials: JW
authors.lastname: Keck
authors.affiliation: Neno District Health Office, Malawi Ministry of Health, Neno, Malawi.
authors.forename: Felix
authors.initials: F
authors.lastname: Chingoli
authors.affiliation: Neno District Health Office, Malawi Ministry of Health, Neno, Malawi.
authors.forename: Listern
authors.initials: L
authors.lastname: Tengatenga
authors.affiliation: Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
authors.forename: Satish
authors.initials: S
authors.lastname: Gopal
authors.affiliation: Abwenzi Pa Za Umoyo, Neno, Malawi.|Partners In Health, Boston, MA, USA.
authors.forename: Atupere
authors.initials: A
authors.lastname: Phiri
authors.affiliation: Abwenzi Pa Za Umoyo, Neno, Malawi.|Partners In Health, Boston, MA, USA.
authors.forename: Bright
authors.initials: B
authors.lastname: Mailosi
authors.affiliation: Abwenzi Pa Za Umoyo, Neno, Malawi.|Partners In Health, Boston, MA, USA.
authors.forename: Junior
authors.initials: J
authors.lastname: Bazile
authors.affiliation: Abwenzi Pa Za Umoyo, Neno, Malawi.|Partners In Health, Boston, MA, USA.|Division of Allergy & Infectious Diseases, Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.
authors.forename: Jason A
authors.initials: JA
authors.lastname: Beste
authors.affiliation: Harvard Medical School, Boston, MA, USA.
authors.forename: Shekinah N
authors.initials: SN
authors.lastname: Elmore
authors.affiliation: Abwenzi Pa Za Umoyo, Neno, Malawi.|Department of Medicine, Beth Israel Deaconess Hospital, Boston, MA, USA.
authors.forename: Jonathan T
authors.initials: JT
authors.lastname: Crocker
authors.affiliation: Abwenzi Pa Za Umoyo, Neno, Malawi.|Partners In Health, Boston, MA, USA.|Haiti Assistance Program, American Red Cross, Washington, DC, USA.
authors.forename: Jonas
authors.initials: J
authors.lastname: Rigodon
mesh_terms: D000328:Adult; D015331:Cohort Studies; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008295:Malawi; D008297:Male; D019829:Nevirapine / Q000627:therapeutic use*; D012189:Retrospective Studies; D012424:Rural Population; D012514:Sarcoma, Kaposi / Q000188:drug therapy*; D018119:Stavudine / Q000627:therapeutic use*
chemical_list: C516355:stavudine, lamivudine, nevirapine drug combination; D019259:Lamivudine; D019829:Nevirapine; D018119:Stavudine
keywords: Kaposi sarcoma; Malawi; antiretroviral therapy; bleomycin; community health worker; paclitaxel; psychosocial support; vincristine