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A phase II trial of 200% ProMACE-CytaBOM in patients with previously untreated aggressive lymphomas: analysis of response, toxicity, and dose intensity.

Abstract
We showed in a phase I trial that the maximum tolerated dose of the ProMACE-CytaBOM regimen in patients with aggressive lymphoma was 200% (Gordon et al, J Clin Oncol 14:1275, 1996). Based on these observations, we initiated a phase II trial designed to determine response, toxicity, and dose intensity using this regimen. We analyzed 74 patients with advanced-stage (III or IV) or bulky stage II aggressive lymphoma. The overall complete response rate was 69% (72% in evaluable patients). With a median follow-up of 4.5 years, the median survival has not yet been reached. The 4-year survival rate is 73% (95% confidence interval [CI] 62, 83%) and no difference was observed among International Prognostic Index (IPI) groups. The 4-year disease-free survival was 71% (95% CI 58, 84%) with no statistical difference between patients with IPI 0 to 1 versus 2 to 4. The toxicity was acceptable, though the grade 4 hematologic toxicity rate for this regimen was 100%. Grade 4 nonhematologic toxicity was 36%. Three cases of either myelodysplastic syndrome or acute leukemia occurred at 7 months, 3.4 years, and 4.2 years after registration. Cytogenic analysis was available in two cases, showing inv(16) without French American British classification (FAB) M4 EO histology in one patient and a 5q-syndrome in the other. These data suggest that 200% ProMACE-CytaBOM with either granulocyte-macrophage colony-stimulating factor (GM-CSF) or G-CSF results in a high complete remission rate and a disease-free survival comparable to any prior risk-based analysis in aggressive lymphoma. Before using this regimen in general practice, phase III clinical trials should be conducted.
AuthorsL I Gordon, M Young, E Weller, T M Habermann, J N Winter, J Glick, C Ghosh, P Flynn, P A Cassileth
JournalBlood (Blood) Vol. 94 Issue 10 Pg. 3307-14 (Nov 15 1999) ISSN: 0006-4971 [Print] United States
PMID10552939 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, U.S. Gov't, P.H.S.)
Chemical References
  • Cytarabine
  • Bleomycin
  • Vincristine
  • Etoposide
  • Doxorubicin
  • Cyclophosphamide
  • Prednisone
  • Methotrexate
Topics
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
  • Bleomycin (administration & dosage, adverse effects, therapeutic use)
  • Cohort Studies
  • Cyclophosphamide (administration & dosage, adverse effects, therapeutic use)
  • Cytarabine (administration & dosage, adverse effects, therapeutic use)
  • Disease-Free Survival
  • Doxorubicin (administration & dosage, adverse effects, therapeutic use)
  • Etoposide (administration & dosage, adverse effects, therapeutic use)
  • Female
  • Humans
  • Lymphoma, Non-Hodgkin (drug therapy, mortality)
  • Male
  • Methotrexate (administration & dosage, adverse effects, therapeutic use)
  • Middle Aged
  • Prednisone (administration & dosage, adverse effects, therapeutic use)
  • Treatment Failure
  • Treatment Outcome
  • Vincristine (administration & dosage, adverse effects, therapeutic use)

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