Results of a phase III clinical trial: CHOP versus CMED in peripheral T-cell lymphoma unspecified.

We performed a controlled clinical trial to define the use of a brief therapy: CMED (cyclophosphamide, etoposide, methotrexate, and dexamethasone) compared with standard CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) in the treatment of peripheral T-cell lymphoma unspecific (PTCLu). The end point to the study was to assess efficacy, measured from complete response rate (CRR), progression-free survival (PFS), and overall survival in 217 previously untreated patients with PTCLu. In an intent-to treat analysis all patients were evaluable. CRR was 76% in CMED regimen and 57% in CHOP arm (P<0.05); actuarial curves at 10 years showed that PFS was 70% and 43%, respectively (P<0.01); overall survival was 60% and 34%, respectively (P<0.01). Adjuvant radiotherapy was employed in 48 cases (54% of patients who achieve CR in CMED arm) and 30 patients (47% of patients who achieve CR in CHOP arm). Acute toxicity was mild and well tolerated. Our results showed that the CMED regimen is feasible and effective in PTCLu.