Dr Dreyling on Investigating ASCT Plus Ibrutinib and R-CHOP in Younger, Fit Patients With MCL

“It’s…important to realize [that] in all studies focusing on young patients, long-term outcomes are more favorable [than it would be in older patients] because these [younger] patients normally [have] low-risk clinical features.”

Martin Dreyling, MD, a full professor in the Department of Medicine in the University Hospital and head of the Medical Clinic III at Ludwig-Maximilian University Munich, discussed the patient population enrolled in the phase 3 TRIANGLE trial (NCT02858258), which evaluated the role of autologous stem cell transplant (ASCT) in younger patients with mantle cell lymphoma (MCL) receiving ibrutinib (Imbruvica)-containing frontline therapy.

The TRIANGLE trial enrolled patients with previously untreated stage II to IV MCL who were younger than 66 years of age, eligible to receive ASCT, and had an ECOG performance status of 0 to 2. Patients were randomly assigned 1:1:1 to receive rituximab (Rituxan) plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) alternated with rituximab plus dexamethasone cytarabine, and cisplatin (R-DHAP) for 6 cycles followed by ASCT and observation; R-CHOP plus ibrutinib alternated with R-DHAP for 6 cycles followed by ASCT, 2 years of maintenance ibrutinib, and observation thereafter (arm A + I); or R-CHOP plus ibrutinib alternated with R-DHAP for 6 cycles followed by 2 years of maintenance ibrutinib, and observation thereafter (arm I).

Since the control arm of this trial used ASCT, which is reserved for certain younger, fitter patients with MCL, the entire patient population in TRIANGLE needed to align with those criteria, Dreyling began. The trial enrolled fit patients with a maximum age of 65 years. Typically, the characteristics of clinical trial populations do not exactly mirror real-world patient characteristics, Dreyling emphasized. TRIANGLE was no exception, as the median age of real-world patients with MCL is approximately 65 to 70 years old, he explained. Additionally, Dreyling explained that the TRIANGLE results must be understood within the context of the younger, fitter patient population, as long-term clinical trial outcomes tend to be more favorable in populations of patients with low-risk clinical features.