Phase II study of infusional chemotherapy with doxorubicin, vincristine and etoposide plus cyclophosphamide and prednisone (I-CHOPE) in resistant diffuse aggressive non-Hodgkin's lymphoma: CALGB 9255 |
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| Authors: | S. M. Lichtman D. Niedzwiecki M. Barcos T. L. Carlisle M. R. Cooper J. L. Johnson B. A. Peterson |
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| Affiliation: | (1) Don Monti Division of Oncology, North Shore University Hospital-NYU School of Medicine, Manhasset, New York, USA;(2) Department of Biostatistics, Duke University Medical Center, Durham, North Carolina, USA;(3) Roswell Park Memorial Institute, Buffalo, New York, U, SA;(4) Division of Hematology Oncology, University of Iowa Hospitals, Iowa City, Iowa, USA;(5) Bowman Gray School of Medicine, Winston-Salem, North Carolina, USA;(6) Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA |
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| Abstract: | ![]()
Background:Patients with resistant diffuse aggressivenon-Hodgkin's lymphoma (DA-NHL) have a poor prognosis. Studies have suggestedinfusional therapy may be beneficial.Patients and methods:This trial used an infusional regimen calledI-CHOPE in resistant patients who had previously received only bolus CHOPE orCHOP regimen. Resistance was defined as: a) primary refractory disease, b)progression on therapy, c) partial response, d) complete remission lastingless than one year. Eligibility criteria included a diagnosis of DA-NHL (IWFE-H), no prior irradiation and adequate organ function.Results:Thirty-seven patients were entered and twenty-nine wereeligible. Reasons for ineligibility were incorrect histology (5) and other(3). The median age was 57 years (range 29–81) with 21 males. Theperformance status scores were: 0 (12 patients); 1 (9 patients); 2 (8patients). Prior therapy consisted of standard CHOP (26 patients), bolus CHOPE(2 patients), high dose CHOP (1 patient). Therapy consisted of a 120 hourcontinuous intravenous infusion of doxorubicin 10 mg/m2/day,vincristine 0.28 mg/m2/day (maximum 0.4 mg/day), and etoposide 48mg/m2/day. Cyclophosphamide 750 mg/m2 was given as aniv bolus day 6 and prednisone was given at 100 mg/day p.o. on days 1–5.G-CSF was allowed for myelosuppression. The overall response rate was48% (CR 17%; PR 31%). Freedom from progression was24% at six months and 8% at one year. Survival was 69%at six months and 40% at one year. In an exploratory analysis a priorCR or PR predicted response to I-CHOPE. Twelve of sixteen patients who had aCR/PR on previous therapy responded while two of thirteen who had no priorresponse, responded to I-CHOPE (P= 0.003). The toxicity wastolerable with grade 3–4 hematologic toxicity being leucopenia94% and thrombocytopenia 41%. The grade 3–4non-hematologic toxicities were infection in 28%, phlebitis in11%, and stomatitis in 15%.Conclusions:I-CHOPE can induce responses in this group ofpatients with a poor prognosis, but most were seen in those who had previouslyhad a response to bolus chemotherapy. |
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| Keywords: | CHOPE infusional therapy non-Hodgkin's lymphoma refractory lymphoma relapsed lymphoma |
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