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High dose chlorambucil versus Binet's modified cyclophosphamide, doxorubicin, vincristine, and prednisone regimen in the treatment of patients with advanced B‐cell chronic lymphocytic leukemia
Author(s) -
Jaksic Branimir,
Brugiatelli Maura,
Krc Ivo,
Losonczi Hajna,
Holowiecki Jerzy,
PlanincPeraica Ana,
Kusec Rajko,
Morabito Fortunato,
Iacopino Pasquale,
Lutz Dieter
Publication year - 1997
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/(sici)1097-0142(19970601)79:11<2107::aid-cncr7>3.0.co;2-l
Subject(s) - medicine , chlorambucil , vincristine , prednisone , cyclophosphamide , regimen , chronic lymphocytic leukemia , progressive disease , gastroenterology , surgery , chop , oncology , chemotherapy , leukemia
Abstract BACKGROUND In recent years, much attention has been paid to the possible efficacy of intensive chemotherapy in the treatment of advanced, progressive B‐cell chronic lymphocytic leukemia (CLL) patients. For this reason, the International Society for Chemo‐Immunotherapy, Chronic Lymphocytic Leukemia Cooperative Group, has begun a randomized multicenter trial comparing Binet's modified cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen with continuous high dose chlorambucil (HD‐CLB). METHODS During the period January 1987 to May 1993, 228 previously untreated CLL patients from 7 cooperative institutions were randomized to this trial. Advanced and/or progressive disease was defined by high Total Tumor Mass (TTM) score (>9), and/or short doubling time (DT) (<12 months), and/or bone marrow failure. The response to therapy was defined by reduction of the initial TTM score. The end points of the trial were response rate, survival, and toxicity. RESULTS HD‐CLB resulted in a higher response rate than CHOP in evaluable cases, with 89.5% overall responses (complete response + partial response) versus 75%, respectively ( P < 0.001). At the time of an analysis performed in July 1995 (after a median follow‐up period of 37 months), overall survival was also longer in the HD‐CLB treatment arm (median survival, 68 months) than in the CHOP treatment arm (median survival, 47 months) ( P < 0.005). Toxicity was acceptable and comparable in the two treatment arms. CONCLUSIONS The current study showed that HD‐CLB is an effective and well‐tolerated therapeutic option for patients with advanced and/or progressive CLL. Therefore, the authors recommend its wider use, possibly in comparison with and/or in combination with new therapeutic agents, such as purine analogues. Cancer 1997; 79:2107‐14. © 1997 American Cancer Society.