Journal Article > ResearchFull Text
Infect Agent Cancer. 2021 January 7; Volume 16 (Issue 1); DOI:10.1186/s13027-020-00341-4
Coldiron ME, Gutierrez Zamudio AG, Manuel R, Luciano G, Rusch B, et al.
Infect Agent Cancer. 2021 January 7; Volume 16 (Issue 1); DOI:10.1186/s13027-020-00341-4
BACKGROUND
Kaposi’s sarcoma (KS) is a common HIV-associated malignancy frequently associated with poor outcomes. It is the most frequently diagnosed cancer in major cities of Mozambique. Antiretroviral therapy is the cornerstone of KS treatment, but many patients require cytotoxic chemotherapy. The traditional regimen in Mozambique includes conventional doxorubicin, bleomycin and vincristine, which is poorly tolerated. In 2016, pegylated liposomal doxorubicin was introduced at a specialized outpatient center in Maputo, Mozambique.
METHODS
We performed a prospective, single-arm, open-label observational study to demonstrate the feasibility, safety, and outcomes of treatment with pegylated liposomal doxorubicin (PLD) in patients with AIDS-associated Kaposi sarcoma (KS) in a low-resource setting. Chemotherapy-naïve adults with AIDS-associated KS (T1 or T0 not responding to 6 months of antiretroviral therapy) were eligible if they were willing to follow up for 2 years. Patients with Karnofsky scores < 50 or contraindications to PLD were excluded. One hundred eighty-three patients were screened and 116 participants were enrolled. Patients received PLD on three-week cycles until meeting clinical stopping criteria. Follow-up visits monitored HIV status, KS disease, side effects of chemotherapy, mental health (PHQ-9) and quality of life (SF-12). Primary outcome measures included vital status and disease status at 6, 12, and 24 months after enrollment.
RESULTS
At 24 months, 23 participants (20%) had died and 15 (13%) were lost to follow-up. Baseline CD4 < 100 was associated with death (HR 2.7, 95%CI [1.2–6.2], p = 0.016), as was T1S1 disease compared to T1S0 disease (HR 2.7, 95%CI [1.1–6.4], p = 0.023). Ninety-two participants achieved complete or partial remission at any point (overall response rate 80%), including 15 (13%) who achieved complete remission. PLD was well-tolerated, and the most common AEs were neutropenia and anemia. Quality of life improved rapidly after beginning PLD.
DISCUSSION
PLD was safe, well-tolerated and effective as first-line treatment of KS in Mozambique. High mortality was likely due to advanced immunosuppression at presentation, underscoring the importance of earlier screening and referral for KS.
Kaposi’s sarcoma (KS) is a common HIV-associated malignancy frequently associated with poor outcomes. It is the most frequently diagnosed cancer in major cities of Mozambique. Antiretroviral therapy is the cornerstone of KS treatment, but many patients require cytotoxic chemotherapy. The traditional regimen in Mozambique includes conventional doxorubicin, bleomycin and vincristine, which is poorly tolerated. In 2016, pegylated liposomal doxorubicin was introduced at a specialized outpatient center in Maputo, Mozambique.
METHODS
We performed a prospective, single-arm, open-label observational study to demonstrate the feasibility, safety, and outcomes of treatment with pegylated liposomal doxorubicin (PLD) in patients with AIDS-associated Kaposi sarcoma (KS) in a low-resource setting. Chemotherapy-naïve adults with AIDS-associated KS (T1 or T0 not responding to 6 months of antiretroviral therapy) were eligible if they were willing to follow up for 2 years. Patients with Karnofsky scores < 50 or contraindications to PLD were excluded. One hundred eighty-three patients were screened and 116 participants were enrolled. Patients received PLD on three-week cycles until meeting clinical stopping criteria. Follow-up visits monitored HIV status, KS disease, side effects of chemotherapy, mental health (PHQ-9) and quality of life (SF-12). Primary outcome measures included vital status and disease status at 6, 12, and 24 months after enrollment.
RESULTS
At 24 months, 23 participants (20%) had died and 15 (13%) were lost to follow-up. Baseline CD4 < 100 was associated with death (HR 2.7, 95%CI [1.2–6.2], p = 0.016), as was T1S1 disease compared to T1S0 disease (HR 2.7, 95%CI [1.1–6.4], p = 0.023). Ninety-two participants achieved complete or partial remission at any point (overall response rate 80%), including 15 (13%) who achieved complete remission. PLD was well-tolerated, and the most common AEs were neutropenia and anemia. Quality of life improved rapidly after beginning PLD.
DISCUSSION
PLD was safe, well-tolerated and effective as first-line treatment of KS in Mozambique. High mortality was likely due to advanced immunosuppression at presentation, underscoring the importance of earlier screening and referral for KS.
Journal Article > ResearchFull Text
BMC Cancer. 2017 December 2; Volume 17 (Issue 1); 806.; DOI:10.1186/s12885-017-3771-x
Bekolo CE, Soumah MM, Tiemtore OW, Diallo AK, Yuma JD, et al.
BMC Cancer. 2017 December 2; Volume 17 (Issue 1); 806.; DOI:10.1186/s12885-017-3771-x
BACKGROUND
Médecins Sans Frontières is supporting comprehensive HIV care and treatment for Kaposi Sarcoma (KS) in Guinea, where antiretroviral coverage is low and access to KS treatment is very limited. We aimed to evaluate treatment response and survival outcomes of epidemic KS in this setting.
METHODS
Retrospective survival analysis of routinely collected clinical data of HIV-infected patients with clinically diagnosed KS, receiving ART and chemotherapy consisting of a combination of bleomycin and vincristine at the Donka National Hospital in Conakry between 2012 and 2015.
RESULTS
A total of 225 patients were enrolled for KS treatment within the three-year period. Late presentation with stage T1 disease was common (82.7%). At the end of a median of 8 cycles of chemotherapy (IQR: 2-12), complete remission was observed in 65 (28.9%), partial remission in 53 (23.6%), stable disease in 15 (6.7%) and unknown response for all 92 (40.9%) patients who dropped out of care. The chances of achieving complete remission doubled after each additional cycle of chemotherapy (aOR = 2.09 95% CI: 1.44-3.01) but were reduced by about two-thirds for each additional month delay between treatment and onset of KS (aOR = 0.31, 95% CI: 0.11-0.86). Treatment response was seriously compromised in patients with woody skin oedema (aOR = 0.05, 95% CI: 0.01-0.38) and those with prior chemotherapy (aOR = 0.21, 95% CI: 0.05-0.80). The median survival time was 7.6 months (95% CI: 5.9-9.8). Attrition from care was reduced by 22% for every additional cycle of chemotherapy administered (aH0R = 0.78, 95% CI: 0.71-0.84) and was lower in those with complete remission compared with those with partial or no response (aHR = 0.05, 95% CI: 0.007-0.43).
CONCLUSION
There has been an increased access to KS treatment. The overall response rate is 52.4%, which is considered a satisfactory result. Poor outcomes were common and were largely due to late presentation and defaulting on treatment. Efforts towards early HIV/KS diagnosis and adherence to a full round of chemotherapy are needed for optimising outcomes. Newer drugs may be required for patients previously exposed to chemotherapy.
Médecins Sans Frontières is supporting comprehensive HIV care and treatment for Kaposi Sarcoma (KS) in Guinea, where antiretroviral coverage is low and access to KS treatment is very limited. We aimed to evaluate treatment response and survival outcomes of epidemic KS in this setting.
METHODS
Retrospective survival analysis of routinely collected clinical data of HIV-infected patients with clinically diagnosed KS, receiving ART and chemotherapy consisting of a combination of bleomycin and vincristine at the Donka National Hospital in Conakry between 2012 and 2015.
RESULTS
A total of 225 patients were enrolled for KS treatment within the three-year period. Late presentation with stage T1 disease was common (82.7%). At the end of a median of 8 cycles of chemotherapy (IQR: 2-12), complete remission was observed in 65 (28.9%), partial remission in 53 (23.6%), stable disease in 15 (6.7%) and unknown response for all 92 (40.9%) patients who dropped out of care. The chances of achieving complete remission doubled after each additional cycle of chemotherapy (aOR = 2.09 95% CI: 1.44-3.01) but were reduced by about two-thirds for each additional month delay between treatment and onset of KS (aOR = 0.31, 95% CI: 0.11-0.86). Treatment response was seriously compromised in patients with woody skin oedema (aOR = 0.05, 95% CI: 0.01-0.38) and those with prior chemotherapy (aOR = 0.21, 95% CI: 0.05-0.80). The median survival time was 7.6 months (95% CI: 5.9-9.8). Attrition from care was reduced by 22% for every additional cycle of chemotherapy administered (aH0R = 0.78, 95% CI: 0.71-0.84) and was lower in those with complete remission compared with those with partial or no response (aHR = 0.05, 95% CI: 0.007-0.43).
CONCLUSION
There has been an increased access to KS treatment. The overall response rate is 52.4%, which is considered a satisfactory result. Poor outcomes were common and were largely due to late presentation and defaulting on treatment. Efforts towards early HIV/KS diagnosis and adherence to a full round of chemotherapy are needed for optimising outcomes. Newer drugs may be required for patients previously exposed to chemotherapy.
Conference Material > Abstract
Coldiron ME
Epicentre Scientific Day Paris 2021. 2021 June 10
BACKGROUND
Kaposi’s sarcoma (KS) is an HIV-associated malignancy associated with poor outcomes. Antiretroviral therapy (ART) is the cornerstone of KS treatment, but many patients require cytotoxic chemotherapy. Traditional regimens include conventional doxorubicin, bleomycin and vincristine, which are poorly tolerated. Pegylated liposomal doxorubicin (PLD) has been standard in high-income countries but largely unavailable in sub-Saharan Africa. In 2016, PLD was introduced at a specialized outpatient center in Maputo, Mozambique.
METHODS
We performed a prospective, single-arm, open-label observational study to demonstrate the feasibility, safety, and outcomes of treatment with PLD in patients with AIDS-associated KS in a low-resource setting. Chemotherapy-naïve adults were eligible; patients with Karnofsky scores <50 or contraindications to PLD were excluded. Patients received PLD on three-week cycles until meeting clinical stopping criteria. Follow-up visits monitored HIV status, KS disease, adverse events, mental health (PHQ-9) and quality of life (SF-12). Primary outcome measures included vital status and disease status at 6, 12, and 24 months after enrollment.
RESULTS
183 patients were screened and 116 participants were enrolled. At 24 months, 23 participants (20%) had died and 15 (13%) were lost to follow-up. Baseline CD4<100 was associated with death (HR 2.7, 95%CI [1.2-6.2], p=0.016), as was T1S1 disease compared to T1S0 disease (HR 2.7, 95%CI [1.1-6.4], p=0.023). 92 participants achieved complete or partial remission at any point (overall response rate 80%), including 15 (13%) who achieved complete remission. The most common AEs were neutropenia and anemia. Quality of life improved rapidly after beginning PLD, particularly in the physical component of the SF-12.
CONCLUSIONS
PLD was safe, well-tolerated and effective as first-line treatment of KS in Mozambique. High mortality was likely due to advanced immunosuppression at presentation, underscoring the importance of earlier screening and referral for KS. Improving supply of and access to PLD is essential for improving outcomes for KS patients.
KEY MESSAGE: The use of PLD as first-line chemotherapy for KS was successful. Advocacy efforts are needed to scale up access.
This abstract is not to be quoted for publication.
Kaposi’s sarcoma (KS) is an HIV-associated malignancy associated with poor outcomes. Antiretroviral therapy (ART) is the cornerstone of KS treatment, but many patients require cytotoxic chemotherapy. Traditional regimens include conventional doxorubicin, bleomycin and vincristine, which are poorly tolerated. Pegylated liposomal doxorubicin (PLD) has been standard in high-income countries but largely unavailable in sub-Saharan Africa. In 2016, PLD was introduced at a specialized outpatient center in Maputo, Mozambique.
METHODS
We performed a prospective, single-arm, open-label observational study to demonstrate the feasibility, safety, and outcomes of treatment with PLD in patients with AIDS-associated KS in a low-resource setting. Chemotherapy-naïve adults were eligible; patients with Karnofsky scores <50 or contraindications to PLD were excluded. Patients received PLD on three-week cycles until meeting clinical stopping criteria. Follow-up visits monitored HIV status, KS disease, adverse events, mental health (PHQ-9) and quality of life (SF-12). Primary outcome measures included vital status and disease status at 6, 12, and 24 months after enrollment.
RESULTS
183 patients were screened and 116 participants were enrolled. At 24 months, 23 participants (20%) had died and 15 (13%) were lost to follow-up. Baseline CD4<100 was associated with death (HR 2.7, 95%CI [1.2-6.2], p=0.016), as was T1S1 disease compared to T1S0 disease (HR 2.7, 95%CI [1.1-6.4], p=0.023). 92 participants achieved complete or partial remission at any point (overall response rate 80%), including 15 (13%) who achieved complete remission. The most common AEs were neutropenia and anemia. Quality of life improved rapidly after beginning PLD, particularly in the physical component of the SF-12.
CONCLUSIONS
PLD was safe, well-tolerated and effective as first-line treatment of KS in Mozambique. High mortality was likely due to advanced immunosuppression at presentation, underscoring the importance of earlier screening and referral for KS. Improving supply of and access to PLD is essential for improving outcomes for KS patients.
KEY MESSAGE: The use of PLD as first-line chemotherapy for KS was successful. Advocacy efforts are needed to scale up access.
This abstract is not to be quoted for publication.
Conference Material > Video
Coldiron ME
Epicentre Scientific Day Paris 2021. 2021 June 10