In a French study (CUTALLO) reported in The Lancet, de Masson et al found that patients with advanced-stage cutaneous T-cell lymphomas who were able to undergo allogeneic hematopoietic stem cell transplantation (HSCT) had prolonged progression-free survival vs matched patients receiving investigator-selected non-HSCT therapy.
Study Details
Ninety-nine patients in complete (19%) or partial remission with advanced-stage mycosis fungoides or Sézary syndrome and at least one poor prognostic feature were enrolled in the multicenter trial between June 2016 and March 2022. Patients with an available compatible related donor were assigned to undergo allogeneic HSCT (n = 55); those without a suitable donor received investigator-selected non-HSCT therapy (n = 44). Propensity score 1:1 matching was performed between the HSCT and non-HSCT groups: each patient in the HSCT group was matched to the patient with the closest propensity score in the non-HSCT therapy group, even if the patient had already been matched. The primary endpoint was progression-free survival in the matched intention-to-treat population.
Key Findings
In the HSCT group, 51 patients were 1:1 matched to patients in the non-HSCT group. Median progression-free survival was 9.0 months (95% confidence interval [CI] = 6.6–30.5 months) in the matched HSCT group vs 3.0 months (95% CI = 2.0–6.3 months) in the matched non-HSCT group (hazard ratio [HR] = 0.38, 95% CI = 0.21–0.69, P < .0001).
The cumulative incidence of relapse at 1 year was 45.4% (95% CI = 29.6%–60.0%) in the matched HSCT group vs 86.0% (95% CI = 70.9%–93.6%) in the matched non-HSCT group (HR = 0.29, 95% CI = 0.17–0.58).
Median overall survival was not reached in the matched HSCT group compared with 26.9 months (95% CI = 16.1 months to not reached) in the matched non-HSCT group (HR = 0.54, 95% CI = 0.23–1.29).
Serious adverse events occurred in 78% of patients in the HSCT group vs 67% of the non-HSCT group. The cumulative 3-month incidence of acute graft-vs-host disease (GVHD) in the HSCT group was 55.9%, and the 1-year cumulative incidence of chronic GVHD was 31.4%. Apart from GVHD, the most common adverse event in both groups was infection, occurring in 59% of patients in the HSCT group vs 44% in the non-HSCT group.
The investigators concluded, “Allogeneic HSCT was associated with significantly longer progression-free survival in participants with advanced-stage cutaneous T-cell lymphomas. These results indicate that allogeneic HSCT treatment should be made available to individuals with high-risk, advanced-stage mycosis fungoides or Sézary syndrome who achieve pretransplant disease remission.”
Adèle de Masson, MD, of the Department of Dermatology, Saint-Louis Hospital, Assistance Publique–Hôpitaux de Paris, is the corresponding author for The Lancet article.
Disclosure: The study was funded by the French Ministry of Health, Programme Hospitalier de Recherche Clinique en Cancérologie, and others. For full disclosures of the study authors, visit thelancet.com.
