A randomized trial comparing chlorambucil plus prednisone vs cyclophosphamide, melphalan, and prednisone in the treatment of chronic lymphocytic leukemia stages B and C.
Ninety-six previously untreated patients (67 males/29 females; mean age: 63 years; range: 46-84) with CLL in stage B (62 cases) or C (34 cases) were randomized to be treated with either chlorambucil (0.4 mg/kg orally days 5 and 6) plus prednisone (60 mg/m2 orally days 1 to 4) (CL + PDN) every 2 weeks or cyclophosphamide (160 mg/m2 orally days 1 to 4), melphalan (6 mg/m2 orally days 1 to 4), and prednisone (60 mg/m2 orally days 1 to 4) (CMP) every 3 weeks for 10 months. Forty-eight patients were treated with CLR + PDN, and the remaining 48 with CMP. The following types of response were considered: complete response (CR): total disappearance of symptoms and signs related to the disease. Partial response (PR): shift of the disease to a less advanced stage. Stable disease (SD) no change in the stage after treatment. Progressive disease (PD): progression of the disease to a more advanced stage. Thirty-six (75%) responses (27% CR) with CLR + PDN and 26 (54.5%, 12.5% CR) with CMP were observed (p = 0.054). Although more responses were achieved in stage B (69%, 24% CR) than in stage C (54%, 12% CR) this difference did not achieve statistical significance. Survival was statistically not different for those patients treated with LCR + PDN as compared to those receiving CMP.(ABSTRACT TRUNCATED AT 250 WORDS)
Montserrat
E
E
Postgraduate School of Hematology Farreras Valentí, University of Barcelona, Hospital Clinic, Spain.
Alcalá
A
A
Alonso
C
C
Besalduch
J
J
Moraleda
J M
JM
García-Conde
J
J
Gutierrez
M
M
Gomis
F
F
Garijo
J
J
Guzmán
M C
MC
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002699:Chlorambucil / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D003520:Cyclophosphamide / Q000627:therapeutic use; D005260:Female; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008558:Melphalan / Q000627:therapeutic use; D008875:Middle Aged; D009367:Neoplasm Staging; D011241:Prednisone / Q000627:therapeutic use; D011897:Random Allocation; D013030:Spain
D002699:Chlorambucil; D003520:Cyclophosphamide; D008558:Melphalan; D011241:Prednisone