Browsing by Author "Busakhala, Naftali"
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Item Beyond T Staging in the “Treat All” Era: Severity and Heterogeneity of Kaposi’s Sarcoma in East Africa(Wolters Kluwer, 2021) Freeman, Esther E.; Semeere, Aggrey; McMahon, Devon E.; Byakwaga, Helen; Laker-Oketta, Miriam; Regan, Susan; Wenger, Megan; Kasozi, Charles; Semakadde, Matthew; Bwana, Mwebesa; Kanyesigye, Michael; Kadama-Makanga, Philippa; Rotich, Elyne; Kisuya, Job; Wools-Kaloustian, Kara; Bassett, Ingrid V.; Busakhala, Naftali; Martin, Jeffrey; Medicine, School of MedicineBackground: Although many patients with Kaposi sarcoma (KS) in sub-Saharan Africa are diagnosed with AIDS Clinical Trials Group (ACTG) T1 disease, T1 staging insufficiently captures clinical heterogeneity of advanced KS. Using a representative community-based sample, we detailed disease severity at diagnosis to inform KS staging and treatment in sub-Saharan Africa. Methods: We performed rapid case ascertainment on people living with HIV, aged 18 years or older, newly diagnosed with KS from 2016 to 2019 at 3 clinic sites in Kenya and Uganda to ascertain disease stage as close as possible to diagnosis. We reported KS severity using ACTG and WHO staging criteria and detailed measurements that are not captured in the current staging systems. Results: We performed rapid case ascertainment within 1 month for 241 adults newly diagnosed with KS out of 389 adult patients with suspected KS. The study was 68% men with median age 35 years and median CD4 count 239. Most of the patients had advanced disease, with 82% qualifying as ACTG T1 and 64% as WHO severe/symptomatic KS. The most common ACTG T1 qualifiers were edema (79%), tumor-associated ulceration (24%), extensive oral KS (9%), pulmonary KS (7%), and gastrointestinal KS (4%). There was marked heterogeneity within T1 KS, with 25% of patients having 2 T1 qualifying symptoms and 3% having 3 or more. Conclusion: Most of the patients newly diagnosed with KS had advanced stage disease, even in the current antiretroviral therapy "treat-all" era. We observed great clinical heterogeneity among advanced stage patients, leading to questions about whether all patients with advanced KS require the same treatment strategy.Item Compression Therapy for HIV-Associated Kaposi Sarcoma Leg Lymphedema: Results of the Kenyan Improvised Compression for Kaposi Sarcoma Randomized Controlled Trial(American Society of Clinical Oncology, 2022) Chang, Aileen Y.; Karwa, Rakhi; Odhiambo, Haji; Were, Phelix; Fletcher, Sara L.; Tonui, Edith C.; Kohn, Michael A.; Lee, Jeannette; Chang, Di; Lensing, Shelly; Namaemba, Diana Flora; Busakhala, Naftali; Kiprono, Samson K.; Maurer, Toby; Goodrich, Suzanne; Pastakia, Sonak D.; Dermatology, School of MedicinePurpose: Evaluate the effectiveness of compression while receiving chemotherapy compared with chemotherapy alone in the treatment of HIV-associated Kaposi sarcoma (KS) lymphedema. Methods: A randomized controlled trial was conducted in a single oncology clinic in western Kenya (NCT03404297). A computer-generated randomization schedule was used to allocate treatment arms. Randomized block design was used for stratification by lymphedema stage. Participants were HIV positive adults age ≥ 18 years on antiretroviral therapy with biopsy-proven KS associated with leg lymphedema and being initiated on chemotherapy. The intervention was 10 weeks of weekly clinic-based application of two-component paste compression bandages. The primary outcome was change in the Lower Extremity Lymphedema Index (LELI) score from week 0 to week 14. The secondary outcomes were change in the Lymphedema Quality of Life measure (LYMQOL) and change in the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 score from week 0 to week 14. Blinded outcome assessments were conducted. Results: Of 30 participants randomly assigned, 25 eligible patients (chemotherapy [control], n = 13; compression plus chemotherapy [intervention], n = 12) returned at week 14. Change in LELI, LYMQOL, and EORTC QLQ-C30 scores between week 14 and week 0 did not significantly differ by arm. The mean (standard deviation) change in LELI score was -25.9 (34.6) for the control arm compared with -13.3 (29.5) for the intervention arm, P = .340. The difference (95% CI) in the change in LELI score was -12.6 (-39.3 to 14.1). Conclusion: Future studies evaluating a 14-week change in LELI for KS lymphedema should assume a standard deviation of approximately 30. Lessons learned from this pilot trial should inform the development of a larger, multicenter trial to evaluate the effectiveness of compression for KS lymphedema.Item Equitable Access to Gene Therapy: A Call to Action for the American Society of Gene and Cell Therapy(Elsevier, 2018-12-05) Cornetta, Kenneth; Patel, Kirtika; Wanjiku, Christopher Mwaniki; Busakhala, Naftali; Medical and Molecular Genetics, School of MedicineItem Evaluation of four chemotherapy regimens for treatment of advanced AIDS-associated Kaposi sarcoma in Kenya: a cost-effectiveness analysis(Elsevier, 2022) Freeman, Esther E.; McCann, Nicole C.; Semeere, Aggrey; Reddy, Krishna P.; Laker-Oketta, Miriam; Byakwaga, Helen; Pei, Pamela P.; Hajny Fernandez, Maya E.; Kiprono, Samson; Busakhala, Naftali; Martin, Jeffery N.; Maurer, Toby; Bassett, Ingrid V.; Freedberg, Kenneth A.; Hyle, Emily P.; Dermatology, School of MedicineBackground: The most effective treatment for advanced AIDS-associated Kaposi sarcoma is paclitaxel or pegylated liposomal doxorubicin (PLD); neither is routinely used in sub-Saharan Africa due to limited availability and high cost. We examined the clinical impact, costs, and cost-effectiveness of paclitaxel or PLD in Kenya, compared with etoposide or bleomycin-vincristine. Methods: In this study, we use the Cost-Effectiveness of Preventing AIDS Complications (CEPAC)-International Model to project clinical outcomes and costs among people living with HIV and advanced Kaposi sarcoma on antiretroviral therapy. We compared four different treatment strategies: etoposide, bleomycin-vincristine, paclitaxel, or PLD. We derived cohort characteristics and costs from the Kenyan Academic Model for Providing Access to Healthcare network, and adverse events, efficacy, and mortality from clinical trials. We projected model outcomes over a lifetime and included life expectancy, per-person lifetime costs, and incremental cost-effectiveness ratios (ICERs). We conducted budget impact analysis for 5-year total costs and did deterministic and probabilistic sensitivity analyses to evaluate the effect of uncertainty in input parameters. Findings: We found that paclitaxel would be more effective than bleomycin-vincristine and would increase life expectancy by 4·2 years per person. PLD would further increase life expectancy by 0·6 years per person. Paclitaxel would be the most cost-effective strategy (ICER US$380 per year-of-life-saved compared with bleomycin-vincristine) and would remain cost-effective across a range of scenarios. PLD would be cost-effective compared with paclitaxel if its price were reduced to $100 per cycle (base case $180 per cycle). Implementing paclitaxel instead of bleomycin-vincristine would save approximately 6400 life-years and would increase the overall 5-year Kenyan health-care costs by $3·7 million; increased costs would be primarily related to ongoing HIV care given improved survival. Interpretation: Paclitaxel would substantially increase life expectancy and be cost-effective compared with bleomycin-vincristine for advanced AIDS-associated Kaposi sarcoma in Kenya and should be the standard of care. PLD would further improve survival and be cost-effective with a 44% price reduction.Item Feasibility of Rapid Case Ascertainment for Cancer in East Africa: An Investigation of Community-Representative Kaposi Sarcoma in the Era of Antiretroviral Therapy(Elsevier, 2021) Semeere, Aggrey; Byakwaga, Helen; Laker-Oketta, Miriam; Freeman, Esther; Busakhala, Naftali; Wenger, Megan; Kasozi, Charles; Ssemakadde, Matthew; Bwana, Mwebesa; Kanyesigye, Michael; Kadama-Makanga, Philippa; Rotich, Elyne; Kisuya, Job; Sang, Edwin; Maurer, Toby; Wools-Kaloustian, Kara; Kambugu, Andrew; Martin, Jeffrey; Medicine, School of MedicineBackground: Rapid case ascertainment (RCA) refers to the expeditious and detailed examination of patients with a potentially rapidly fatal disease shortly after diagnosis. RCA is frequently performed in resource-rich settings to facilitate cancer research. Despite its utility, RCA is rarely implemented in resource-limited settings and has not been performed for malignancies. One cancer and context that would benefit from RCA in a resource-limited setting is HIV-related Kaposi sarcoma (KS) in sub-Saharan Africa. Methods: To determine the feasibility of RCA for KS, we searched for all potential newly diagnosed KS among HIV-infected adults attending three community-based facilities in Uganda and Kenya. Searching involved querying of electronic medical records, pathology record review, and notification by clinicians. Upon identification, a team verified eligibility and attempted to locate patients to perform RCA, which included epidemiologic, clinical and laboratory measurements. Results: We identified 593 patients with suspected new KS. Of the 593, 171 were ineligible, mainly because biopsy failed to confirm KS (65%) or KS was not new (30%). Among the 422 remaining, RCA was performed within 1 month for 56% of patients and within 3 months for 65% (95% confidence interval: 59 to 70%). Reasons for not performing RCA included intervening death (47%), inability to contact (44%), refusal/unsuitable to consent (8.3%), and patient re-location (0.7%). Conclusions: We found that RCA - an important tool for cancer research in resource-rich settings - is feasible for the investigation of community-representative KS in East Africa. Feasibility of RCA for KS suggests feasibility for other cancers in Africa.Item Lay perceptions of breast cancer in Western Kenya(Baishideng Publishing Group, 2015-10-10) Naanyu, Violet; Asirwa, Chite Fredrick; Wachira, Juddy; Busakhala, Naftali; Kisuya, Job; Otieno, Grieven; Keter, Alfred; Mwangi, Anne; Omenge, Orango Elkanah; Inui, Thomas; Department of Medicine, IU School of MedicineAIM: To explore lay perceptions of causes, severity, presenting symptoms and treatment of breast cancer. METHODS: In October-November 2012, we recruited men and women (18 years and older) from households and health facilities in three different parts of Western Kenya, chosen for variations in their documented burdens of breast cancer. A standardized and validated tool, the breast cancer awareness measure (BCAM), was administered in face-to-face interviews. Survey domains covered included socio-demographics, opinions about causes, symptoms, severity, and treatment of breast cancer. Descriptive analyses were done on quantitative data while open-ended answers were coded, and emerging themes were integrated into larger categories in a qualitative analysis. The open-ended questions had been added to the standard BCAM for the purposes of learning as much as the investigators could about underlying lay beliefs and perceptions. RESULTS: Most respondents were female, middle-aged (mean age 36.9 years), married, and poorly educated. Misconceptions and lack of knowledge about causes of breast cancer were reported. The following (in order of higher to lower prevalence) were cited as potential causes of the condition: Genetic factors or heredity (n = 193, 12.3%); types of food consumed (n = 187, 11.9%); witchcraft and curses (n = 108, 6.9%); some family planning methods (n = 56, 3.6%); and use of alcohol and tobacco (n = 46, 2.9%). When asked what they thought of breast cancer’s severity, the most popular response was “it is a killer disease” (n = 266, 19.7%) a lethal condition about which little or nothing can be done. While opinions about presenting symptoms and signs of breast cancer were able to be elicited, such as an increase in breast size and painful breasts, early-stage symptoms and signs were not widely recognized. Some respondents (14%) were ignorant of available treatment altogether while others felt breast cancer treatment is both dangerous and expensive. A minority reported alternative medicine as providing relief to patients. CONCLUSION: The impoverished knowledge in these surveys suggests that lay education as well as better screening and treatment should be part of breast cancer control in Kenya.Item Pitfalls of practicing cancer epidemiology in resource-limited settings: the case of survival and loss to follow-up after a diagnosis of Kaposi’s sarcoma in five countries across sub-Saharan Africa.(BMC, 2016) Freeman, Esther; Semeere, Aggrey; Wenger, Megan; Bwana, Mwebesa; Asirwa, F. Chite; Busakhala, Naftali; Oga, Emmanuel; Jedy-Agba, Elima; Kwaghe, Vivian; Iregbu, Kenneth; Jaquet, Antoine; Dabis, Francois; Yumo, Habakkuk Azinyui; Dusingize, Jean Claude; Bangsberg, David; Anastos, Kathryn; Phiri, Sam; Bohlius, Julia; Egger, Matthias; Yiannoutsos, Constantin; Wools-Kaloustian, Kara; Martin, Jeffrey; Department of Biostatistics, Fairbanks School of Public HealthSurvival after diagnosis is a fundamental concern in cancer epidemiology. In resource-rich settings, ambient clinical databases, municipal data and cancer registries make survival estimation in real-world populations relatively straightforward. In resource-poor settings, given the deficiencies in a variety of health-related data systems, it is less clear how well we can determine cancer survival from ambient data.Item The role of dermatology in Kaposi sarcoma diagnosis across three regions in sub-Saharan Africa(Elsevier, 2020) Seth, Divya; Williams, Victoria L.; McMahon, Devon E.; Regan, Susan; Busakhala, Naftali; Wools-Kaloustian, Kara; Mosoajane, Karen; Ralefala, Tlotlo B.; Kayembe, Mukendi; Iregbu, Kenneth; Kwaghe, Vivian; Jedy-Agba, Elima; Oyesiku, Linda; Maurer, Toby; Jaquet, Antoine; Bassett, Ingrid V.; Martin, Jeff; Grover, Surbhi; Freeman, Esther E.; Medicine, School of MedicineItem Survival Following Diagnosis of HIV-Associated Kaposi Sarcoma Among Adults in East Africa in the "Treat-All" Era(medRxiv, 2024-08-28) Byakwaga, Helen; Semeere, Aggrey; Laker-Oketta, Miriam; Busakhala, Naftali; Freeman, Esther; Rotich, Elyne; Wenger, Megan; Kadama-Makanga, Philippa; Kisuya, Job; Semakadde, Matthew; Mwine, Bronia; Kasozi, Charles; Mwebesa, Bwana; Maurer, Toby; Glidden, David V.; Wools-Kaloustian, Kara; Kambugu, Andrew; Martin, Jeffrey; Dermatology, School of MedicineBackground: Despite widespread access to antiretroviral therapy (ART) in the "Treat All" era, HIV-associated Kaposi sarcoma (KS) remains among the most common malignancies in sub-Saharan Africa. Survival after KS diagnosis has historically been poor in Africa, but knowledge whether survival has changed at the population level in the contemporary era has been limited by lack of community-representative surveillance and monitoring systems. Methods: We identified all adult persons living with HIV (PLWH) with a new diagnosis of KS made between 2016 and 2019 during outpatient or inpatient care at prototypical primary care-providing medical facilities in Kenya and Uganda using rapid case ascertainment. Participants were subsequently followed for vital status, including community tracking for those who became lost to follow-up. Findings: Among 411 participants with newly diagnosed KS, 71% were men, median age was 34 (IQR: 30 to 41) years, and 91% had ACTG T1 tumor extent. Over a median follow-up of 7.8 (IQR: 2.4 to 17.9) months, cumulative incidence of death (95% CI) at months 6, 12 and 18 were 34% (30% to 39%), 41% (36% to 46%) and 45% (40% to 51%), respectively. Having the highest number of anatomic sites (11 to 16) harboring KS lesions (hazard ratio 2.2 (95% CI: 1.3-3.8) compared to 1 to 3 sites) and presence of oral KS lesions (hazard ratio 2.2 (95% CI: 1.4-3.3)) were independently associated with higher mortality. Lower hemoglobin and CD4 count as well as higher plasma HIV RNA were also associated with higher mortality. Interpretation: Among PLWH with newly diagnosed KS in East Africa in the "Treat All" era, survival was poor and related to mucocutaneous extent of KS. The findings emphasize the need for better control of KS in Africa, including novel approaches for earlier detection, better linkage to oncologic care, and more potent therapy.Item Telehospice for Cancer Patients Discharged from a Tertiary Care Hospital in Western Kenya(Elsevier, 2023) Cornetta, Kenneth; Nyariki, Sarah; Manji, Imran; Kiplimo, Ivan; Korir, Millicent; Muinga, Esther; Busakhala, Naftali; Elias, Hussein; Medical and Molecular Genetics, School of MedicineContext: Worldwide, most patients lack access to hospice services. Objectives: Assess the feasibility of telephone monitoring (Telehospice) in providing symptom management for patients discharged from a tertiary care hospital in Western Kenya. Methods: Inclusion criteria included adults with cancer no longer eligible for chemo-radiation and receiving opioid therapy. Thirty patients were enrolled in a weekly monitoring program assessing physical symptoms and patient and caregiver distress. The participants also had access to a 24-hour hotline. Symptom assessment included 18 questions with 8 from the African Palliative Outcome Scale. Participants were followed for eight weeks or until death or admission to an inpatient hospital or hospice. Results: The primary objective was participation in weekly calls, and we obtained 100% participation. A secondary objective was the use of "comfort kits" which contained 30 doses of six medications. Most patients utilized one or more of the provided medications, with high usage of bisacodyl, paracetamol, and omeprazole. While 12% of weekly calls and 24% of hotline calls led to medication changes, participants continued to express worry and there was only a modest decrease in pain scores despite having morphine available throughout the follow-up period. Family confidence in providing care and access to information remained high. At the end of the eight-weeks of observation, eight participants were alive, 10 died at home, and 12 were admitted to an in-patient facility. Conclusion: Patient and family participation in Telehospice is feasible and may provide an interim solution to managing end-of-life patients who lack access to home hospice.