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The purpose of this study was to determine the efficacy and toxicity of the cyclophosphamide and fludarabine (CF) regimen in patients with newly diagnosed and relapsed/refractory mantle cell lymphoma (MCL). Thirty patients with pathologically confirmed MCL were treated with the CF regimen. Ten (33%) had no prior therapy, six (20%) had one previous regimen, and 14 (47%) received two or more prior regimens. Ninety cycles of CF with a median of 3 cycles/patient (range, 1-5 cycles) were administered to patients with MCL. Nine patients (30%) had a complete response (CR) and 10 (33%) had a partial response (PR) for an overall response rate (RR) of 63%. The median failure-free survival (FFS) and overall survival (OS) was 4.8 months and 17.5 months, respectively. When patients were analyzed based upon the number of previous treatments (0, 1, or 2 or more), those with no previous treatment (n=10) had an overall response of 100%, with 70% CR. The median FFS was 28.1 months and the median OS for this group has not been reached at 42.3+ months. Hematologic and infectious toxicity were the major toxicities encountered with the CF regimen. Grade 3-4 neutropenia, thrombocytopenia and anemia were seen in 50%, 37%, and 36% of patients, respectively. There were 13 episodes of grade 3 infections. There was no treatment related mortality, In conclusion, the high response rate associated with the CF regimen merits further investigation in previously untreated patients with MCL, particularly in those who are not candidates for aggressive therapy.
Cohen et al. (Mon,) studied this question.