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my personal edition > lymphomas > news
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DGDispatch
New Regimen After Chemotherapy Improves Survival in Elderly Patients With Diffuse Large-Cell Lymphoma: Presented at ICML
By Chris Berrie
LUGANO, SWITZERLAND -- June 10, 2005 -- The addition of a cisplatin, idarubicin, and prednisone (CIP) regimen as a consolidation therapy for the P-VABEC regimen remains safe and improves survival for elderly patients with diffuse large-cell lymphoma (DLCL), according to the long-term follow-up of a multicentre phase 2 trial.
The 8-cycle P-VABEC, delivered on an outpatient basis, consisted of weeks 1, 3, 5, and 7 administration of doxorubicin 30 mg/m2, cyclophosphamide 350 mg/m2, etoposide 100 mg/m2; weeks 2, 4, 6, and 8 administration of vincristine 1.2 mg/m2, bleomycin 15 mg/td, with prednisone 50 mg/td.
Maurizio Martelli, MD, haematology researcher and principal investigator, haematology, University of Rome "La Sapienza," Rome, Italy, reported the findings here June 8th on behalf of the Italian Cooperative Study Group at the 9th International Conference on Malignant Lymphoma (ICML).
"In our previous study [Martelli et al. Ann. Oncol. 1999] we showed that P-VABEC is active for elderly patients, but with time, many of the patients relapsed," Dr. Martelli said. This new study was thus designed to improve on the progression-free survival (PFS) following the P-VABEC regimen in elderly patients through a reduction in relapse.
Of the 214 previously untreated elderly patients with DLCL who were registered from 1995 to 2000 (mean age, 70 years; range, 60-85 years), 107 were randomised at diagnosis to receive P-VABEC (male, 54%) and 95 to P-VABEC-CIP (male, 57%).
The subsequent CIP regimen consisted of cisplatin 40 mg/td on day 1, idarubicin 15 mg/m2 on day 8, and prednisone 50 mg/td on days 1 to 4 and 8 to 11. This 3-week cycle was repeated for 3 courses.
With no significant differences in the full range of patients' clinical characteristics between the 2 treatment arms, according to their age-adjusted International Prognostic Index (IPI) scores, 89 of the patients were considered as low risk (IPI, 0-1) and 113 as high risk (IPPI, 2-3).
Based on this intention-to-treat analysis, the 5-year overall survival (OS) and PFS were significantly greater in the CIS arm than in the with P-VABEC alone arm (OS, 59% vs 40%, P =.016; PFS, 51% vs 38%, P =.053).
When divided according to the IPI risk, the low-risk patients showed no significant differences in OS and PFS over the 5 years with or without CIP (OS, 69% vs 62%, P =.66; PFS, 62% vs 54%, P =.42). However, the high-risk patients showed significant 5-year improvement with the addition of CIP (OS, 49% vs 26%, P =.01; PFS, 40% vs 26%, P =.09).
In the intention-to-treat analysis between the P-VABEC and P-VABEC-CIP arms, respectively, the responses to the therapy showed no significant differences in the complete (58% vs 64%), partial (24% vs 24%), and nonresponders (14% vs 7%), and in the early deaths (4% vs 5%) and treatment-related mortality (6% vs 6%). All cases of treatment-related mortality occurred during the P-VABEC phase of treatment.
There were no significant differences in toxicities between the 2 treatment groups.
Dr. Martelli also indicated that a direct comparison between the 8-week P-VABEC and P-VABEC-CIP treatment and the use of the 24-week CHOP regimen of the GELA study demonstrated very favourable 5-year OS for the use of CIP (40% vs 59% vs 45%, respectively) and PFS (38% vs 51% vs 30%).
On the basis that the combination of rituximab with cyclophosphamide, adriamycin, vincristine, and prednisone (R-CHOP) has now become the standard therapy for these patients, Dr. Martelli concluded, "A brief chemotherapy regimen that can be devised for elderly patients would use P-VABEC plus rituximab in the low risk patients and P-VABEC plus rituximab followed by CIP for those with high risk, which should be employed for elderly patients who are not eligible for R-CHOP and needs to be compared with R-CHOP in a prospective study."
[Study title: Cisplatinum, Idarubicin, Prednisone (CIP) After P-VABEC Chemotherapy Improves Survival in Elderly Patients With Diffuse Large-Cell Lymphoma: Long-Term Follow-Up. Abstract 229]
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