Randomized Comparison of COPP/ABVD vsDose- and Time-Escalated COPP/ABVD With GM-CSF Support for Advanced Hodgkin’s Disease

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OncologyONCOLOGY Vol 13 No 3
Volume 13
Issue 3

Patients with advanced Hodgkin’s disease-Ann Arbor stage IIB to IV-were randomized to treatment with either four

Patients with advanced Hodgkin’s disease—Ann Arbor stage IIB to IV—were randomized to treatment with either four double cycles of standard COPP/ABVD (cyclophosphamide, Oncovin, procarbazine, and prednisone/Adriamycin, bleomycin, vinblastine, and dacarbazine) chemotherapy (control arm) or a dose- and time-intensified COPP/ABVD regimen supported by 7 days of granulocyte-macrophage colony-stimulating factor (GM-CSF, sargramostim [Leukine, Prokine]) following each chemotherapy (intensified arm).Between April 1992 and June 1996, 264 patients from 28 institutions were randomized and 238 cases were eligible and evaluable (119 in the standard regimen and 119 in the time- and dose-intensified regimen). Age ranged from 17 to 71 years (mean, 37 years) with a proportion of 64% male; 21% of the patients had stage IIB disease; 51%, stage III; and 28%, stage IV. A total of 182 patients (75%) completed all cycles, while 62 (25%) stopped or switched treatment earlier.

If dose intensity was calculated according to the Hryniuk method from the drugs actually given, considering all eight drugs, the ratios of dose intensity were as follows: cycle 1, 0.96 vs. 1.35; cycle 2, 0.91 vs 1.22; cycle 3, 0.90 vs 1.13; cycle 4, 0.92 vs 1.22. The dose intensity for the whole treatment was 0.93 (control) vs 1.24 (intensified arm; P < .0001).

Infectious complications occurred in 53% of the control group and 62% of the intensified group, with grade 3-4 infection in five vs nine patients, respectively. Other adverse events were equally distributed, with the exception of musculoskeletal pain, rash and skin disorders, and headache, which occurred more often in the intensified arm (9.4% vs 14.6%, 5.6% vs 8.4%, and 9.5% vs 24.4%, respectively).

Complete remissions were achieved in 65% vs 81% in the control vs intensified groups (P < .003 by chi-square test), partial responses in 25% vs 16%, and disease progression in 7.6% vs 1.7%. Survival data are still incomplete but so far are in line with the response rates.

CONCLUSION: These preliminary data show that an intensified GM-CSF–supported COPP/ABVD regimen can be administered with acceptable toxicity and improved response rate, which is a prerequisite for improved survival in Hodgkin’s disease.

Click here for Dr. Bruce Cheson’s commentary on this abstract.

Articles in this issue

WHO Declares Lymphatic Mapping to Be the Standard of Care for Melanoma
Rituximab: Phase II Retreatment Study in Patients With Low-Grade or Follicular Non-Hodgkin’s Lymphoma
Response Criteria for NHL: Importance of “Normal” Lymph Node Size and Correlations With Response
Chemotherapy Plus Radiation Improves Survival in Patients With Cervical Cancer
A Randomized Trial of Fludarabine, Mitoxantrone (FM) Versus Doxorubicin, Cyclophosphamide, Vindesine, Prednisone (CHEP) as First Line Treatment in Patients With Advanced Low-Grade Non-Hodgkin's Lymphoma: A Multicenter Study by GOELAMS Group
Navelbine Increased Elderly Lung Cancer Patients’ Survival
Fludarabine Versus Conventional CVP Chemotherapy in Newly C Diagnosed Patients With Stages III and IV Low-Grade Malignant Non-Hodgkin’s Lymphoma: Preliminary Results From a Prospective, Randomized Phase III Clinical Trial in 381 Patients
Multicenter, Phase III Study of Iodine-131 Tositumomab (Anti-B1 Antibody) for Chemotherapy-Refractory Low-Grade or Transformed Low-Grade Non-Hodgkin’s Lymphoma
T-Cell–Depleted Allogeneic Bone Marrow Transplant From HLA-Matched Sibling Donors for Non-Hodgkin’s Lymphoma
Consensus Statement on Prevention and Early Diagnosis of Lung Cancer
In Vivo Purging and Adjuvant Immunotherapy With Rituximab During PBSC Transplant For NHL
Fludarabine and Cyclophosphamide: A Highly Active and Well-Tolerated Regimen for Patients With Previously Untreated Indolent Lymphomas
Campath-1H Monoclonal Antibody in Therapy for Advanced Low-Grade Non-Hodgkin’s Lymphomas: A Phase II Study
AIDS Drugs Effective Against Most Common HIV Strain
Rituximab Therapy in Previously Treated Waldenström’s Macroglobulinemia: Preliminary Evidence of Activity
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