Fludarabine phosphate-CVP in patients over 60 years of age with advanced, low-grade and follicular lymphoma: a dose-finding study.
The aim of this study was to establish a safe and effective regimen of fludarabine phosphate, cyclophosphamide, vincristine and prednisone (F-CVP) as first-line treatment for elderly patients with advanced, low-grade non-Hodgkin's lymphoma. Twenty-three patients >60 years were assigned successively to eight treatment cycles (Dose level 1: low F, low CV [n=4]; 2A: high F, low CV [n=8]; 2B: low F, high CV [n=4]; 3: high F, high CV [n=7]). High and low levels were: F, 25 and 20mg/m(2), respectively (Days 1-5); C, 750 and 500 mg/m(2), respectively (Day 1); and V, 1.4 and 1mg/m(2), respectively (Day 1). Patients received P at 40 mg/m(2) on Days 1-5. Response was assessed after Cycles 2, 4, 6 and 8. At level 3, dose-limiting toxicity (opportunistic infections and neutropenia) became evident, particularly after Cycle 6. Further patients were recruited at Dose level 2A. All regimens proved effective, with an OR rate of 78% (65% CR), and 3-year survival of 65% (+/-10%). Among 18 responders, 51% were still in response at 3 and 5 years. The study shows that this combination therapy is highly effective. The addition of F to CVP at Dose level 2A was feasible and increased the CR rate, with good tolerability in elderly patients.
Soubeyran
Pierre
P
The Institute Bergonié, Regional Cancer Center, 229 cours de l'Argonne, 33076 Bordeaux Cedex, France and Schering AG, Lys Lez Lannoy, France. soubeyran_p@bergonie.org
Monnereau
Alain
A
Eghbali
Houchingue
H
Soubeyran
Isabelle
I
Kind
Michèle
M
Cany
Laurent
L
Buy
Elizabeth
E
Guibon
Odile
O
Hoerni
Bernard
B
D000284:Administration, Oral; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008224:Lymphoma, Follicular / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage; D016019:Survival Analysis; D016896:Treatment Outcome; D001084:Vidarabine Phosphate / Q000008:administration & dosage / Q000031:analogs & derivatives; D014750:Vincristine / Q000008:administration & dosage
D001084:Vidarabine Phosphate; C042382:fludarabine phosphate; D014750:Vincristine; D003520:Cyclophosphamide; D011241:Prednisone