Journal of Clinical Oncology, Vol 9, 770-776, Copyright © 1991 by American Society of Clinical Oncology
Comparison of chlorambucil and prednisone versus cyclophosphamide, vincristine, and prednisone as initial treatment for chronic lymphocytic leukemia: long-term follow-up of an Eastern Cooperative Oncology Group randomized clinical trial
B Raphael, JW Andersen, R Silber, M Oken, D Moore, J Bennett, H Bonner, R Hahn, WH Knospe and J Mazza
New York University Medical Center, NY 10016.
The Eastern Cooperative Oncology Group (ECOG) conducted a study in which
patients with advanced chronic lymphocytic leukemia (CLL) were randomized
between a regimen consisting of chlorambucil (30 mg/m2 orally day 1) and
prednisone (80 mg orally days 1 to 5) (C + P) administered every 2 weeks
and a more intensive regimen of cyclosphosphamide (300 mg/m2 orally days 1
to 5), vincristine (1.4 mg/m2 intravenously [IV] day 1), and prednisone
(100 mg/m2 orally days 1 to 5) (CVP) given every 3 weeks. Treatment was
continued for up to 18 months to maximal response. Of the 122 eligible
patients, 60 received C + P, while 62 received CVP. With a median follow-up
of 7 years, there were no significant differences in survival (4.8 v 3.9
years, P = .12), complete remission (CR) rate (25% v 23%; P = .83), or
duration of response (2.0 v 1.9 years; P = .78) between C + P and CVP.
Toxicity was modest despite the prolonged treatment. The long median
survival of 4.1 years for stage III and IV patients is superior to that
usually reported. This could stem from continuing treatment to maximal
response rather than an increase in intensity of therapy. These results are
comparable to those reported with cyclophosphamide, doxorubicin,
vincristine, and prednisone (CHOP) therapy by other investigators. The data
suggest that intermittent C + P administered to maximal response continues
to be the standard treatment approach for advanced CLL.
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