Dr Moustafa on the Influence of the SHINE Trial in MCL

Muhamad Alhaj Moustafa, MD, MS, hematologist/medical oncologist, Mayo Clinic, assistant professor, Mayo Clinic School of Medicine, discusses the phase 3 SHINE trial (NCT01776840), which evaluated ibrutinib (Imbruvica) given with bendamustine (Treanda) and rituximab (Rituxan; BR) in patients with mantle cell lymphoma (MCL).

The SHINE trial aimed to address the needs of patients with MCL 65 years of age and older who are ineligible for autologous stem cell transplantation, Moustafa begins. Investigators compared the efficacy and safety of ibrutinib given in combination with BRvs BR alone in in this population, he states. The findings from the SHINE trial have illuminated a substantial progression-free survival (PFS) benefit with ibrutinib plus BR vs BR alone, Moustafa says, adding that the investigational treatment approach extended the median PFS by 27.7 months. These results underscore the potential of incorporating ibrutinib as a therapeutic strategy for patients with MCL, particularly in the first-line setting, he notes.

However, this favorable outcome with ibrutinib plus BR was associated with an increase in the incidence of grade 3/4 adverse effects (AEs), and oncologists should evaluate the nuances of the risk-benefit profile of the SHINE regimen when contemplating this treatment approach, Moustafa expands.

Questions remain regarding the sequencing of BR with rituximab maintenance therapyand ibrutinib, he notes. For instance, it is unknown whether administering these therapies sequentially could lead to a PFS similar to that achieved with concurrent administration while mitigating the elevated toxicity that might result from concurrent administration.

A dearth of comprehensive data in this area persists, leaving room for further investigation and consideration. However, there is still promise with the use of these therapies, Moustafa continues. Furthermore, the SHINE trial contributes significantly to the growing body of evidence that informs treatment decisions for patients with MCL, highlighting potential pathways for more tailored and effective treatment strategies in the future, Moustafa concludes.