Everolimus in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) was effective as first-line treatment for patients with peripheral T-cell lymphoma (PTCL), a study published in the Journal of Clinical Oncology has shown.1
Because everolimus, an oral mammalian target of rapamycin inhibitor, has demonstrated single-agent activity against relapsed lymphoma, researchers sought to evaluate everolimus plus CHOP for the frontline treatment of patients with PTCL. For the phase 2 study, researchers enrolled 30 patients and assigned them to receive everolimus 5 mg daily on days 1 to 14 in 3-week cycles for a total of 6 cycles plus CHOP chemotherapy.
Researchers used immunohistochemistry to assess the expression of phosphatase and tensin homology (PTEN) and phosphorylated S6 kinase (pS6K) as a response, in addition to determining the overall response rate.
Results showed that the objective response rate was 90% with 17 complete responses and 10 partial responses. When subgroup analyses were performed, researchers found that the 3 patients with angioimmunoblastic T-cell lymphoma (AITL) had a 100% complete response rate, while patients with PTCL-not-otherwise specified and ALK-negative anaplastic large-cell lymphoma (ALCL) had a 63% and 29% complete response rate, respectively.
The study also demonstrated that PTEN expression was preserved in all patients with AITL but only in 67% of patients with ALCL, suggesting that the efficacy of the regimen may be association with the preservation of PTEN.
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In terms of safety, most common toxicities were hematologic adverse events. A total of 80% of patients experienced at least 1 event of grade 3 or 4 neutropenia, and 60% of patients experienced grade 3 or 4 thrombocytopenia.
- Kim SJ, Shin D-Y, Kim JS, et al. A phase II study of everolimus (RAD001), an mTOR inhibitor plus CHOP for newly diagnosed peripheral T-cell lymphomas [published online ahead of print February 8, 2016]. Ann Oncol. doi: 10.1093/annonc/mdv624.