In the Phase II PROPEL study, 29% of patients with relapsed or refractory peripheral T-cell lymphoma (a type of non-Hodgkin’s lymphoma) experienced a complete or partial disappearance of detectable cancer following treatment with Folotyn® (pralatrexate). These results—published in the Journal of Clinical Oncology—formed the basis for the approval of Folotyn for this disease.
Peripheral T-cell lymphoma (PTCL) is a relatively uncommon type of non-Hodgkin’s lymphoma. The optimal approach to the treatment of PTCL remains uncertain, and the prognosis for many patients is poor.
Folotyn is an antifolate drug. The drug is thought to accumulate in cancer cells, interfere with DNA synthesis, and trigger cell death.
To evaluate Folotyn in the treatment of PTCL, researchers conducted a Phase II clinical trial known as PROPEL (Pralatrexate in patients with Relapsed OR refractory PEripheral T-cell Lymphoma). The study enrolled 115 patients with PTCL that had returned after previous treatment or that was resistant to previous treatment.
Study participants received intravenous (IV) Folotyn in addition to vitamin B12 and folic acid supplementation.
The primary outcome of interest was response to treatment. A complete response refers to the complete disappearance of detectable cancer, and a partial response refers to a reduction in the amount of detectable cancer.
Information about 109 patients was available for analysis.
- 32 of the 109 patients (29%) experienced a complete or partial response to treatment. Twelve of these responses were complete and 20 were partial.
- The median duration of response was 10.1 months. Median overall survival was 14.5 months.
- The most common severe side effects of treatment were low blood cell counts and mucositis (inflammation of the lining of the digestive tract; often seen as mouth sores).
These results suggest that Folotyn is active against relapsed or refractory PTCL, and Folotyn has been approved for this use by the US Food and Drug Administration.
Reference: O’Connor OA, Pro B, Pinter-Brown L et al. Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: results from the pivotal PROPEL study. Journal of Clinical Oncology. Early online publication January 18, 2011.