Background: Gemcitabine is a novel nucleoside analogue which has shown prom
ising results in most solid tumors; like the arabinosylcytosine analogue, g
emcitabine may be an active drug in lymphoproliferative malignancies. We te
sted it in pre treated peripheral T-cell lymphoma patients with isolated sk
in involvement.
Patients and methods: We performed a phase II study with the drug in 13 pre
treated patients with peripheral T-cell lymphoma, five of whom had advanced
-stage mycosis fungoides (MF), and eight peripheral T-cell lymphoma unspeci
fied (PTCLU). Patients were treated on days 1, 8, and 15 of a 28-day schedu
le at the dosage of 1200 mg/m(2) for a total of three courses.
Results: Of the 13 patients, one achieved complete response (CR) and eight
achieved partial responses (PR); the remaining four showed no benefit from
the treatment. Among the responders, one CR and four PR were documented in
the PTCLU patients and four PR in MF patients. Treatment was well tolerated
; hematologic toxicity was mild and no nausea/vomiting or organ toxicity wa
s recorded.
Conclusions: In view of its significant activity and its modest toxicity pr
ofile, the role of gemcitabine deserves further evaluation in the managemen
t of pretreated patients with peripheral T-cell lymphoma.