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Sunitinib, non-ritonavir-based HAART well-tolerated in patients with HIV
CHICAGO — The rate of non-AIDS-defining cancers in those with HIV taking highly active antiretroviral therapy now exceeds that of AIDS-defining cancers in this patient population. Based on this, researchers from the AIDS Malignancy Consortium set out to determine the potential drug-drug interactions between highly active antiretroviral therapy and chemotherapy.
John F. Deeken, MD, of the Georgetown Lombardi Comprehensive Cancer Center, and colleagues conducted the first of several studies that will examine the interaction between new targeted therapies and HAART in patients with HIV. The first study, presented here during a poster presentation at the 2011 American Society of Clinical Oncology (ASCO) Annual Meeting, enrolled 19 patients and was designed to determine the maximum tolerated dose of sunitinib (Sutent, Pfizer).
“Up to this point, oncologists have not had much information about treating cancer in people taking HAART,” Deeken said in a press release. “We’re basically at square one because people with HIV usually are not included in cancer clinical trials. They’re excluded because physicians are worried about causing further immune suppression in HIV patients and because HAART drugs are notorious for causing drug-drug interactions and serious side effects.”
Patients were assigned to one of two arms: non-ritonavir-based HAART or ritonavir-based HAART. Those in the first arm were administered the standard dose of sunitinib (50 mg) and those in the second arm underwent a phase 1 three-plus-three dose escalation design of sunitinib (25 mg, 37.5 mg and 50 mg). Both arms received sunitinib daily on a 4-week on/2-week off cycle.
The standard dose of sunitinib was well-tolerated in patients taking non-ritonavir-based HAART regimens. Patients treated with sunitinib who were taking the ritonavir-based therapy experienced more adverse effects, including higher rates of neutropenia, compared with those reported on phase 3 studies of sunitinib, according to the release.
“Already, we have important information that can impact treatment,” Deeken said in the release. “When the trial is complete, we may have data to recommend that patients take different dosages of sunitinib based on what HAART cocktail they are taking. We also found that patients could keep taking their HIV medications safely, and that sunitinib did not affect the HIV disease status of patients in either group.”
For more information:
- Deeken JF. #2591. Presented at: 2011 ASCO Annual Meeting; June 3-7, 2011; Chicago.
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