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ACTG A5263 tested whether two cheaper, easier chemotherapies could replace paclitaxel for people with HIV and advanced Kaposi sarcoma in Africa; both were clearly worse, so paclitaxel with antiretroviral therapy is the treatment to aim for wherever it can be supplied.
ACTG A5263/AMC 066 was a three-arm open-label randomised non-inferiority trial at sites in Kenya, Malawi, South Africa, Uganda, Zimbabwe and Brazil in 334 adults with advanced AIDS-associated Kaposi sarcoma starting antiretroviral therapy (efavirenz, emtricitabine and tenofovir). Patients were randomised to paclitaxel, oral etoposide, or bleomycin with vincristine. The primary endpoint was progression-free survival at week 48.
The etoposide arm was closed for inferiority in 2016 and the bleomycin-vincristine arm in 2018, ending the trial early. Week-48 progression-free survival was 50 percent with paclitaxel against 20 percent with etoposide, and 64 percent with paclitaxel against 44 percent with bleomycin-vincristine; the confidence intervals excluded non-inferiority for both. Adverse events were similar across arms. The corpus's Kaposi sarcoma page cites the trial for antiretroviral therapy plus paclitaxel where available, with bleomycin-vincristine otherwise.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
334 enrolled.
95% CI 32 to 67 · 95% CI 6 to 33; arm closed for inferiority in March 2016
Source95% CI 55 to 73 · 95% CI 35 to 53; arm closed for inferiority in March 2018
Source95% CI -52 to -8
Source95% CI -33 to -7
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival at week 48, paclitaxel against etoposide (non-inferiority)primary | Paclitaxel + antiretroviral therapy | 59 | 50% | - | - | link |
| Oral etoposide + antiretroviral therapy | 59 | 20% | ||||
| Progression-free survival at week 48, paclitaxel against bleomycin plus vincristine (non-inferiority)primary | Paclitaxel + antiretroviral therapy | 138 | 64% | - | - | link |
| Bleomycin + vincristine + antiretroviral therapy | 132 | 44% | ||||
| Absolute difference in week-48 progression-free survival, etoposide minus paclitaxel | Oral etoposide against paclitaxel | - | -30 percentage points | - | - | link |
| Absolute difference in week-48 progression-free survival, bleomycin-vincristine minus paclitaxel | Bleomycin + vincristine against paclitaxel | - | -20 percentage points | - | - | link |
Shares Bleomycin, Vincristine, Etoposide, Cytotoxic chemotherapy and the tag soc-trials.
Shares Bleomycin, Etoposide, Paclitaxel / nab-paclitaxel, Cytotoxic chemotherapy and the tag soc-trials.
Shares Vincristine, Etoposide, Sarcomas (soft tissue, bone, GIST), Cytotoxic chemotherapy and the tag soc-trials.
Shares Bleomycin, Etoposide, Cytotoxic chemotherapy and the tag soc-trials.
Shares Vincristine, Etoposide, Cytotoxic chemotherapy and the tag soc-trials.
Shares Vincristine, Etoposide, Cytotoxic chemotherapy and the tag soc-trials.
Shares Vincristine, Etoposide, Cytotoxic chemotherapy and the tag soc-trials.
Shares Vincristine, Etoposide, Cytotoxic chemotherapy and the tag soc-trials.