Patients with advanced-stage cutaneous T-cell lymphomas (CTCL) who underwent allogeneic hematopoietic stem cell transplantation (HSCT) demonstrated longer progression-free survival (PFS) than matched controls, according to the results of a prospective propensity-matched study.
Patient-reported, health-related quality of life was also improved with allogeneic HSCT, despite nearly one-third of patients developing chronic graft-versus-host disease GVHD. The results of the CUTALLO trial (ClinicalTrials.gov identifier: NCT02520908) was published in the Lancet.
The propensity score trial assigned 55 patients with a sibling or matched unrelated donor to allogeneic HSCT and 44 patients without a donor to receive non-HSCT treatment. All patients had advanced-stage mycosis fungoides or Sézary syndrome that was refractory or had relapsed after at least 1 prior systemic therapy, had early histological large-cell transformation, or nodal or visceral involvement. The primary endpoint was PFS.
The median age at diagnosis was 50.0 and age 56.0 at enrollment; 64% of patients were male. The median number of prior lines of systemic therapy was 3. Complete or partial skin remission at enrollment was 17% and 80.5%, respectively. The median follow-up was 12.6 months.
In the allogeneic HSCT group, 44% of patients had a sibling donor, 40% has a 10/10 human leukocyte antigen (HLA)-matched unrelated donor, and 13% had a haploidentical donor. The graft source for all patients was peripheral blood.
There was a significant improvement in the PFS in the allogeneic HSCT group, with a median of 9.0 months compared with 3.0 months in the matched control group (hazard ratio [HR], 0.38; 95% CI, 0.21-0.69; P <.0001).
The rate of disease relapse was also lower in the HSCT group, with a rate of 65% compared with 86% in the matched control group. The cumulative incidence of relapse at 1 year was 45.4% and 86.0% in the HSCT and control groups, respectively (HR, 0.29; 95% CI, 0.17-0.58).
The median OS was not yet reached in the HSCT group compared with 26.9 months in the control group (HR, 0.54; 95% CI, 0.23-1.29). Nonrelapse mortality was significantly higher in the HSCT group, with a rate of 8.5% compared with 0% in the control group (P =.017).
Health-related quality of life as measured by the EORTC Quality of Life Questionnaire C30 improved significantly in the HSCT group compared with the control group (P =.0050).
The rate of serious adverse events (AEs) was 78% in the HSCT group and 67% in the control group. Among patients in the HSCT group, the most common serious AEs was GVHD, with 55.9% experiencing acute disease by 3 months and 31.4% chronic disease by 1 year, and infections, which occurred among 59% of patients compared with 44% in the control group.
“These results indicate that allogeneic HSCT treatment should be made available t individuals with high-risk, advanced-stage mycosis fungoides or Sézary syndrome who achieve pre-transplant disease remission,” the authors concluded in their report.
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
de Masson A, Beylot-Barry M, Ram-Wolff C, et al. Allogeneic transplantation in advanced cutaneous T-cell lymphomas (CUTALLO): a propensity score matched controlled prospective study. Lancet. Published online April 24, 2023. doi: 10.1016/S0140-6736(23)00329-X