SAN FRANCISCO — Results from a multi-institutional trial presented at ASH 2014 debunk common myths that HIV-positive patients with lymphoma might not be suitable for autologous hematopoietic stem cell transplantation (AHCT).
Until now, HIV-positive patients have been excluded from this therapy due to concerns about higher risks of infection and poorer graft function because of their need for HIV medications. Transplant is also limited to centers with experience in HIV treatment. But, according to the study’s lead author, Joseph Alvarnas, MD, “This trial confirms that HAL patients may successfully undergo autologous transplants with favorable outcomes.”
Dr. Alvarnas, director of Medical Quality at City of Hope National Medical Center in Duarte, California, presented results from the single-arm, multi-institutional clinical trial at the 2014 ASH Annual Meeting. The trial included 40 patients with treatable HIV-1 infection who underwent AHCT for HIV-associated lymphoma (HAL); all were aged 15 years or older and had failed prior therapy.
Lymphoma subtypes included diffuse large B-cell lymphoma (40%), plasmablastic lymphoma (5%), Burkitt/Burkitt-like lymphoma (17.5%), and Hodgkin lymphoma (37.5%). Prior to entering the trial, 31 patients (77.5%) had undetectable viral loads, while the remainder had low median loads (84 copies/mL). Median CD4 count was 250.5 μL.
|TABLE. Response Rates Before and After AHCT Transplant|
|Prior to AHCT||100 Days Post-AHCT|
|(n = 40)||(n = 39)|
|Complete remission||30 (75%)||36 (92.3%)|
|Partial remission||8 (20%)||1 (2.6%)|
|Relapsed/progressive disease||2 (5%)||2 (5.1%)|
After a median follow-up of 24 months, the overall one-year survival was 86.6 percent (95% CI 70.8-94.2%), and one-year progression-free survival was 82.3 percent (95% CI 66.3–91.1%). These results compared favorably with 151 matched control patients with lymphoma, but not HIV.
Five patients had relapsed by one year post-HCT (three of whom subsequently died), totaling a cumulative incidence of relapse/progression of 12.5 percent (95% CI 4.5-24.8%). Incidence of transplant-related mortality was 5.2 percent (95% CI 0.9-15.7%).
In terms of safety, 17 patients (42.5%) developed a total of 42 episodes of infection within one year of receiving HSCT, including nine “severe” infections.
“These results are an important advancement for patients and their physicians seeking access to effective treatments,” Dr. Alvarnas commented. “Payers should also recognize that this treatment may now be the best standard of care for these patients.”
“When I started at UCSF back in 1985, the median survival for someone with HIV diagnosed with one of these lymphomas was less than two months,” Dr. Alvarnas said during a press conference. Now, with the advent of combination antiviral therapy, the treatment options for HAL patients have expanded to include standard antilymphoma activities.
This trial, conducted by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) in collaboration with the AIDS Malignancy Clinical Trials Consortium, also has implications for clinical research, according to Richard Little, MD, head of hematologic, HIV and stem cell therapeutics at the National Cancer Institute. “NCI sees a real need for additional study of treatment options for HIV-infected patients with malignancies,” said Dr. Little. “The results of this trial make us confident that exclusion from autologous transplant studies on the basis of HIV serostatus alone is no longer justified.”
An additional BMT CTN study is currently underway to demonstrate the feasibility and safety of allogeneic blood stem cell transplants for patients with chemotherapy-sensitive hematological malignancies and HIV-infection.
Source: Alvarnas J, et al. Autologous hematopoietic stem cell transplantation (AHCT) in patients with chemotherapy-sensitive, relapsed/refractory (CSRR) human immunodeficiency virus (HIV)-associated lymphoma (HAL): results from the Blood and Marrow Transplant Clinical Trials Network (BMT CTN 0803)/AIDS Malignancy Consortium (AMC-071) trial. Abstract #674. Presented at the ASH Annual Meeting, December 8, 2014.