San Francisco, CA—Patients with HIV-related lymphoma should not be excluded from clinical trials of autologous hematopoietic-cell transplant (AHCT). Moreover, they should be offered AHCT as a standard treatment option, according to the results of a phase 2 trial reported at the 2014 American Society of Hematology meeting.
The concern has been that immunocompromised patients, such as those with HIV infection, are at greater risk for serious infections. Thus, they are typically not considered candidates for AHCT, which is a curative therapy for lymphoma. Despite effective antiretroviral therapy, HIV infection (AIDS) persists as a risk factor for lymphoma.
“Chemotherapy-sensitive patients with relapsed/refractory HIV-related lymphoma may successfully undergo AHCT with favorable outcomes. Our study shows that exclusion from clinical trials on the basis of HIV infection alone is no longer justified. In fact, in clinical practice, patients with controlled HIV infection—with emphasis on the word ‘controlled’—should be receiving transplants as standard of care,” said lead study investigator Joseph Alvarnas, MD, Director of Medical Quality at City of Hope, Duarte, CA.
“These results are an important advancement for patients and their physicians seeking access to effective treatments. Payers should also recognize that this treatment should now be the standard of care for these patients,” Dr Alvarnas stated.
Single-Arm Clinical Trial
The single-arm, multi-institutional trial was conducted jointly by the Blood and Marrow Transplant Clinical Trials Network and the AIDS Malignancy Clinical Trials Consortium. The results should be generalizable to a broader spectrum of centers, because the 16 transplant centers included in the study do not specialize in the treatment of HIV and AIDS.
The single-arm study showed that AHCT achieved an estimated 1-year overall survival rate of 86.6% and a progression-free survival rate of 82.3% in patients with HIV-related lymphoma. The estimated rate of disease progression at 1 year was 12.5% and the estimated mortality rate was 5%.
The study included 40 HIV-infected patients with lymphoma who had at least 1 risk factor for disease progression; approximately 50% had ≥3 risk factors for disease progression. Patients underwent AHCT with a modified BEAM (carmustine, etoposide [Toposar], cytarabine [Depocyt], melphalan [Alkeran]) regimen.
Patients did not receive antiretroviral therapy during the preparative regimen; that therapy was resumed after the resolution of gastrointestinal toxicities. All patients received standard institutional supportive care after transplant.
At a press conference, Dr Alvarnas noted that a case-control study of 151 matched patients with lymphoma who did not have HIV infection showed similar mortality outcomes to the patients in the present study.