Results from a multi-institutional trial presented at ASH 2014 debunk the common myth that HIV-positive patients with lymphoma might not be suitable for autologous hematopoietic stem cell transplants (HSCT).
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. But, according to the study’s lead author, Joseph Alvarnas, MD, “This trial confirms that HIV-associated lymphoma patients may successfully undergo autologous transplants with favorable outcomes.”
Dr. Alvarnas, associate clinical professor at the City of Hope National Medical Center in Duarte, California, presented results from the single-arm, multi-institutional clinical trial, which included 40 patients with treatable HIV-1 infection who underwent HSCT 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%). All patients underwent a pre-transplant regimen of carmustine, etoposide, cytarabine, and melphalan (or a modified BEAM regimen) followed by autologous HSCT.
Investigators measured response rates before transplant and at 100 days after transplant (TABLE). At 100 days, one patient had died after undergoing HSCT. Response to transplant in the remaining 39 patients was overwhelmingly positive – 36 achieved complete remission and one achieved partial remission, while two patients experienced relapse or progressive disease.
|TABLE. Response Rates Before and After HSCT Transplant|
Prior to transplant
|100 days post-HCT|
|(n = 40)||
(n = 39)
After a median follow-up of 24 months, the estimated probability of one-year overall survival was 86.6 percent (95% CI 70.8-94.2%), and the estimated probability of one-year progression-free survival was 82.3 percent (95% CI 66.3–91.1%).
Five patients had relapsed by one year post-HSCT (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%).
Notably, 11 of 38 evaluable patients (28.9%) were able to recover full hematologic function at 100 days post-transplant; this number increased to 24 of 32 evaluable patients (75%) at one year post-HSCT.
In terms of safety, 17 patients (42.5%) developed a total of 42 episodes of infection within one year of
receiving HCT, 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.”
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.
- Alvarnas J, Rademacher JL, Wang Y, 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.