Rituximab, Cyclophosphamide and Dexamethasone in CLL

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ASCO Abstract # 1098

Long-term results from a monthly regimen of rituximab

®, cyclophosphamide © and dexamethasone (D) in

advanced chronic lymphocytic leukemia (CLL)

Niraj K Gupta, Sudha Kavuru, Dillip V Patel,

Driscoll, Dale Janson, Bharati Prasad, Kanti R Rai,

Long Island Jewish Medical Center, New Hyde Park, NY;

Private Practice, Corbin, KY.

Background: The conventional use of R in indolent

lymphoma is as a single agent administered once a week

for 4 weeks. Our experience in CLL pts. has shown that

the use of R on a monthly schedule and administered in

combination with C and D is highly effective.

We presented the initial results of this combination

(RCD) at ASCO meeting in May 2001. In this report, we

now provide observations from a long-term follow-up on

the same series of pts.

Patients: Between 3/1999 and 5/2001, 22 pre-treated

high-risk CLL pts. received a median of 4 cycles (2-8)

of RCD. Median no. of prior treatments was 3 (2-5),

including, alkylators, fludarabine (F),

anthracyclines, vincristine, R and Campath-1H . The

cut-off date for evaluations for this report was

10/31/2001.

Treatment Regimen: R-375 mg/m2 i.v on day-1, C-750 to

1000 mg/m2 i.v. on d-2, D-12mg/d for 7 days. Cycles

were repeated every 4 weeks till a maximum response.

Results: 8/22 pts., who achieved CR (NCI 1996

criteria), are still alive with a follow-up of upto

27+ mths. 4 pts. relapsed after a median relapse free

survival (RFS) of 16 mths (8-16) and 4 remain in

remission after13+,15+, 21+ and 24+ mths. Among 9 PR

pts., five have died after median survival of 20 mths

(5-30), 3 pts. relapsed after median RFS of 6 mths

(4-7) and 1 pt. is in remission for 10+ mths. 5

F-naive pts. had higher response rates (100%) and RFS

10 mths (8-15+) compared to 17 F-treated pts. who had

a RR of 66% and RFS of 7 mths (4-21+). Median survival

was also longer (not reached after 25+ mths vs 17

mths) in F-naive pts. than F-treated pts..

Retreatment: 7 pts. relapsed after initial response

and were re-treated with RCD. Median time from last

RCD and re-treatment was 9 mths (4-18). 3 pts.

achieved CR, 3 PR, 1 had no response (NR) and died.

Re-treatment with RCD was also well-tolerated.

Conclusion: RCD, a monthly regimen of R followed a day

later by C and D results in durable high responses in

advanced heavily pre-treated CLL. RCD was also equally

effective in pts. who relapsed after an initial

response.

Survival according to response to RCD

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