SAN FRANCISCO—Autologous hematopoietic stem cell transplantation (AHCT) should be considered standard of care for patients with chemotherapy-sensitive relapsed/refractory human immunodeficiency virus (HIV)-associated lymphoma (HAL) who meet standard transplant criteria, a prospective phase 2 trial (Abstract 674) concluded at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition.
Risk of non-Hodgkin lymphoma and Hodgkin lymphoma (HL) is 11 to 17 times higher in patients with HIV, said Joseph Alvarnas, MD, of the City of Hope National Medical Center in Duarte, CA, on behalf of the Blood and Marrow Transplant Clinical Trials Network (BMT CTN 0803)/AIDS Malignancy Consortium (AMC-071) phase 2 trial, which was sponsored by the National Heart, Lung, and Blood Institute and the National Cancer Institute.
Although patients with HAL have received therapies comparable to those offered to patients with lymphoma over the past decade, they have been considered ineligible for stem cell transplantation due to their immunocompromised status, placing them at a significant treatment disadvantage.
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The study enrolled 43 patients with treatable HIV-1 infection between July 2010 and May 2013. Patients received the modified, dose-reduced cytarabine BEAM regimen—carmustine 300 mg/m2 day -6; etoposide 100 mg/m2 twice daily days -5 to -2; cytarabine 100 mg/m2 days -5 to -2; and melphalan 140 mg/m2 day -1—then AHCT on day 0 and standard supportive care through discharge.
Combination antiretroviral treatment (cART) was withheld during the preparative regimen and resumed following resolution of GI toxicities. All patients received blood stem cell grafts.
Three patients had disease progression prior to AHCT and were excluded from the analysis. Of the 40 patients who underwent AHCT, 35 were male and median age was 46.9 years (range 22.5-62.2).
Prior to transplant, 30 patients (75%) were in complete remission (CR), 8 (20%) were in partial remission (PR), and 2 (5%) had relapsed or progressive disease.
At day 100 following AHCT, 36 of 39 patients (92.3%) were in CR, 1 (2.6%) was in PR and 2 (5.1%) had relapsed or progressive disease. One patient was not evaluable due to early death. By 1-year post-AHCT, 5 patients had died, 3 from recurrent/persistent disease, 1 from cardiac arrest, and 1 from invasive fungal infection.
At a median follow-up of 24 months post-AHCT, 1-year overall survival was 86.6% (95% confidence interval [CI] 70.8%-94.2%, and 1-year progression-free survival, 82.3% (95% CI 66.3%-91.1%). The cumulative incidence of relapse/progression at 1-year post-HCT was 12.5% (95% CI 4.5%-24.8%).
Within 1 year of HCT, 13 patients had grade 3 adverse events (AEs) and 2 patients had grade 4 AEs (mucositis and dyspnea/hypoxia/ cardiac arrhythmia/hypotension). Seventeen patients (42.5%) developed 42 episodes of infection, 9 of which were severe. A total of 14 patients required readmission following post-AHCT discharge.
Cumulative incidence of transplant-related mortality was 5.2% (95% CI 0.9%-15.7%).
“These impressive survival data demonstrate that autologous stem cell transplants can be highly effective, tolerable, and not overly toxic for patients with HIV-associated lymphoma,” said Dr. Alvarnas in a press release. “Ultimately, our results provide a persuasive argument that HIV or AIDS status should not be a barrier to autologous stem cell transplant for patients who meet standard eligibility criteria.”
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