The purpose of this study was to determine the efficacy and toxicity of the
cyclophosphamide and fludarabine (CF) regimen in patients with newly diagn
osed and relapsed/refractory mantle cell lymphoma (MCL). Thirty patients wi
th pathologically confirmed MCL were treated with the CF regimen. Ten (33%)
had no prior therapy, six (20%) had one previous regimen, and 14 (47%) rec
eived two or more prior regimens. Ninety cycles of CF with a median of 3 cy
cles/patient (range, 1-5 cycles) were administered to patients with MCL. Ni
ne patients (30%) had a complete response (CR) and 10 (33%) had a partial r
esponse (PR) for an overall response rate (RR) of 63%. The median failure-f
ree survival (FFS) and overall survival (OS) was 4.8 months and 17.5 months
, respectively. When patients were analyzed based upon the number of previo
us 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 month
s and the median OS for this group has not been reached at 42.3+ months. He
matologic and infectious toxicity were the major toxicities encountered wit
h the CF regimen. Grade 3-4 neutropenia, thrombocytopenia and anemia were s
een in 50%, 37%, and 36% of patients, respectively. There were 13 episodes
of grade 3 infections, There was no treatment related mortality. In conclus
ion, the high response rate associated with the CIF regimen merits further
investigation in previously untreated patients with MCL, particularly in th
ose who are not candidates for aggressive therapy.