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CLL

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Chronic Lymphocytic Leukemia

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FLUDARABINE + Rituxan (phase I/II)
Fludarabine 30 mg/m2, IV QD days 1-4
Rituxan 125-375 mg/m2 Day 5
Q28 days
REF:
Savage et al. Blood 98: 248b, 2001
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FLUDARABINE
25 mg/m2, IV QD X 5 days Q28 days
REF:
NEJM 343:1750, 2000
Conclusions As the initial treatment for CLL, fludarabine yields higher RR & a longer duration of remission & PFS than chlorambucil; OS is not enhanced.
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Chlorambucil & Prednisone ECOG


Chlorambucil 30 mg/m2 PO day 1
Prednisone 80 mg PO days 1-5

Ref: Raphael B, Anderson JW, Silber R, et al: JCO 9:70-776, 1991.

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CVP


Cyclophosphamide 300-400 mg/m2 PO days 1-5
Vincristine 1.4 mg/m2 IVB* day 1
Prednisone 100 mg PO days 1-5**

Repeat cycle every 21 days.


*Maximum vincristine dose is 2 mg.
**Prednisone dose should be tapered.

Ref: Bagley CM, et al: Ann Int Med 76:227 (1972).
Skeel RT: In RT Skeel (ed): Handbook of Chemotherapy,
Boston, Little Brown, p 217 (1987).

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FAMP


Fludarabine 25-30 mg/m2 IV/30 min days 1-5

Repeat cycle every 4 weeks.

Ref:
Chun HG, et al: J Clin Oncol 9:175 (1991).
Keating MJ, et al: Blood 74:19 (1989).
Keating MJ, et al: J Clin Oncol 9:44 (1991).
Rai et al: NEJM 343:1750 (2000)- this article compared fludarabine to chlorambucil to fludarabine + chlorambucil. The combo group was stopped secondary to excessive toxicities. In the fludarabine arm 20%CR,43%PR,N=170. In the chlorambucil arm, 4%CR,33%PR,N=181. Median duration of response & PFS 25 & 20 months in the fludarabine arm vs 14 & 14 months in the chlorambucil arm. Median survival the same for all three arms (55-60 months). Severe infections & neutropenia more frequent in fludarabine compared to chlorambucil arm (p=.08). Overall toxic effects were tolerable in both arms. Median age:64 (33-88) & 30% above age 70 in the fludarabine arm. ECOG 0-1:95%, study initiated in 1990 & closed in 1994. Interemediate or high risk patients who had not previously received cytotoxic therapy.

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Pulse Chlorambucil & Prednisone


Chlorambucil 0.4 - 1 mg/kg PO day 1 every other week
Prednisone 100 mg PO days 1-7 every other week

Ref: Nigro ND, et al: Cancer 51:1826 (1983).
Knospe WH, et al: Cancer 33:555 (1974).
Han T, et al: Cancer 31:502 (1973).
Gale RP, Foon KA: Ann Int Med 103:101 (1985).

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CAMPATH-1H (humanized monoclonal antibody against CD52)
Campath-1H Test dose 3mg then 30 mg IV t.i.w. for 6 weeks
Notes-1. premedicate with Tylenol & H1/H2 antagonists. 7. prophylaxis with Bactrim & Acyclovir recommended.
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CHLORAMBUCIL
Chlorambucil 6-14 mg/d until signs & symptoms diminish
then:0.7 mg/kg PO over 2-4 days. Repeat Q3wesks until disease stabilizes.
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CYCLOPHOSPHAMIDE
Cyclophosphamide 2-3 mg/kg Po days 1-10 Q21-28 days
OR:
Cyclophosphamide 20 mg/kg IV Q2-3 weeks.
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PREDNISONE
Prednisone 20-40 mg/m2/d PO for 1-3 weeks. Use for symptomatic pt with autoimmune thrombocytopenia or hemolytic anemia.
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FCR regimen
Fludarabine 25 mg/m2 QD x 3 days
Cyclophosphamide 250 mg/m2 QD x 3 days
above to be given Q4 weeks x 6
Rituximab 375 mg/m2 day-1 of course-1 and at 500 mg/m2 on day-1 of courses 2-6
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Rituximab 3x weekly
Rituximab 100 mg



CLL NOTES:

RAI STAGING:
STAGE 0 (LOW RISK);Manifestation:lymphocytosis; Median Survival:>10years
STAGE I (INTERMEDIATE RISK); Manifestation: Lympahdenopathy; Median Survival:9 years
STAGE II (INTERMEDIATE RISK);Manifestation: Splenomegaly, lymphadenopathy, or both; Median survival:7 years
STAGE III (HIGH RISK); Manifestation: anemia,organomegaly, or both; Median survival:5 years
STAGE IV (HIGH RISK); Manifestation: anemia or thrombocytopenia, + organomegaly; median survival: 5 years
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BINET STAGING
STAGE A (LOW RISK); Manifestations: lymphocytosis or >3 lymphoid areas enlarged. Median Survival: >10 years
STAGE B (INTERMEDIATE RISK); Manifestations: >3 lymphoid areas enlarged; Median Survival:7 years
STAGE C (HIGH RISK); Manifestations: anemia, thrombocytopenia, or both; Median Survival: 5 years
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Genomic Aberrations & Survival in CLL:
Chromosomal aberrations were detected in 268 of 325 cases (82%). The most frequent changes were a deletion in 13q (55%), a deletion in 11q (18%), trisomy of 12q (16%), a deletion in 17p (7%), and a deletion in 6q (6%). Five categories were defined with a statistical model: 17p deletion, 11q deletion, 12q trisomy, normal karyotype, & 13q deletion as the sole abnormality; the median survival times for patients in these groups were 32, 79, 114, 111, & 133 months, respectively. Patients in the 17p- and 11q-deletion groups had more advanced disease than those in the other three groups. Patients with 17p deletions had the shortest median treatment-free interval (9 months), and those with 13q deletions had the longest (92 months). In multivariate analysis, the presence or absence of a 17p deletion, the presence or absence of an 11q deletion, age, Binet stage, the serum LDH level, and the WBC count gave significant prognostic information.

REF:NEJM 343:1910, 2000

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