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Blood, 1 September 2002, Vol. 100, No. 5, pp. 1634-1640
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Phase 2 trial of infusional cyclophosphamide, doxorubicin, and
etoposide in patients with poor-prognosis, intermediate-grade
non-Hodgkin lymphoma: an Eastern Cooperative Oncology Group
trial (E3493)
Joseph A. Sparano,
Edie Weller,
Tipu Nazeer,
Thomas Habermann,
Ann E. Traynor,
Jane Manalo, and
Peter Cassileth
From the Albert Einstein Comprehensive Cancer
Center/Montefiore Medical Center, Bronx, NY; Dana Farber Cancer
Institute, Boston, and Eastern Cooperative Oncology Group, Brookline,
MA; Albany Medical College, NY; Mayo Clinic, Rochester, MN;
Northwestern University Medical Center, Chicago, IL; and Sylvester
Cancer Center, University of Miami, FL.
Preclinical and clinical evidence suggest a potential advantage for
infusional therapy in lymphoma. Sixty-two analyzable patients with
predominantly intermediate-grade non-Hodgkin lymphoma received cyclophosphamide (200 mg/m2 per day), doxorubicin
(12.5 mg/m2 per day), and etoposide (60 mg/m2
per day) (CDE) by continuous intravenous infusion for 4 days (96 hours) every 3 weeks for a maximum of 8 cycles. By the age-adjusted International Prognostic Index (IPI), 42% were at high risk and 58%
were at high-intermediate risk. Complete response (CR) occurred in 30 (48%) patients (95% confidence interval [CI], 35%, 64%), and
partial response occurred in 16 (26%) patients, yielding an overall
response rate of 74% (95% CI, 62%, 84%). Failure-free survival
(FFS) rates at 1 and 2 years were 55% (95% CI, 43%, 67%) and 50%
(95% CI, 38%, 62%), respectively. When comparing the outcome for 62 patients receiving infusional CDE with historical data derived from 927 IPI-matched lymphoma patients using a Cox proportional hazards model,
there was a nonsignificant trend favoring CDE in FFS
(P = .12) and overall survival (P = .09).
Severe or life-threatening toxicity included neutropenia (68%), anemia
(57%), thrombocytopenia (44%), and infection (24%). Two patients
(3%) died of treatment-related infectious complications. The primary
end point of improving 1-year FFS from 55% to 70% was not achieved
with infusional CDE given as initial therapy in patients with poor-risk
intermediate-grade lymphoma. It is unlikely that infusional therapy as
used in this study produces a 25% or greater relative improvement in
FFS compared with standard therapy.
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