Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
Long-term follow-up of patients (pts) with chronic lymphocytic leukemia (CLL) receiving fludarabine (Fludara) regimens as initial therapy (Meeting abstract).
Proc Annu Meet Am Soc Clin Oncol; 14:A1012 1995. Unique Identifier : AIDSLINE ICDB/95614163 Keating M; Lerner S; O'Brien S; Robertson L; Kantarjian H; UT M.D. Anderson Cancer Center, Houston, TX 77030
Abstract:
Fludara has demonstrated striking cytotoxic activity in the management of previously treated and untreated pts with CLL. 174 pts with progressive Rai stage I-II disease or Rai III-IV disease have received Fludara alone (71 pts) or with prednisone (103 pts). Using NCI criteria for response, the complete remission (CR) rate was 61% and partial response rate 17%. The median survival time is 67 mo. The overall response rate for Rai stage I-II was 83% and Rai III-IV 73%. The only clinical features associated with CR were beta 2-microglobulin (beta 2M) level, age, and immunoglobulin levels. Survival was significantly associated with stage, white cell count, renal function, beta 2M, age, and marrow infiltrate. The major toxicity was infection with pneumonia occurring in 3% of courses, septicemia 1%, minor infections in 10%, and herpes virus infections in 3%. Myelosuppression was most marked in pts with advanced age and stage. Pts who relapsed and were retreated with Fludara had a 22/36 (61%) response rate compared with 3/12 (25%) with other Rx. Median time-to-progression was 32 mo being significantly longer for CR pts (48 mo). Significant suppression of T-lymphocyte subsets occurred during treatment and persisted during remission. However, only 1 febrile episode occurred for every 3.5 pt years-at-risk in pts in remission. The addition of prednisone had no beneficial effect on response rate, survival, or time-to-progression but was associated with an increase in opportunistic infections. No survival advantage has been demonstrated compared with other historical treatments. Fludara alone or in combination with prednisone is a very effective initial therapy for CLL associated with a long time-to-progression.
Keywords: Antineoplastic Agents, Combined/ADVERSE EFFECTS/*THERAPEUTIC USE Comparative Study Follow-Up Studies Human Leukemia, Lymphocytic, Chronic/*DRUG THERAPY/MORTALITY Prednisone/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS Remission Induction Survival Rate Vidarabine/*ANALOGS & DERIVATIVES/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS ABSTRACT 951230
M95C3214
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