HOMEPRODUCTSCOMPANYCONTACTFAQResearchDictionaryPharmaSign Up FREE or Login

Treatment of older patients with mantle-cell lymphoma.

AbstractBACKGROUND:
The long-term prognosis for older patients with mantle-cell lymphoma is poor. Chemoimmunotherapy results in low rates of complete remission, and most patients have a relapse. We investigated whether a fludarabine-containing induction regimen improved the complete-remission rate and whether maintenance therapy with rituximab prolonged remission.
METHODS:
We randomly assigned patients 60 years of age or older with mantle-cell lymphoma, stage II to IV, who were not eligible for high-dose therapy to six cycles of rituximab, fludarabine, and cyclophosphamide (R-FC) every 28 days or to eight cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) every 21 days. Patients who had a response underwent a second randomization to maintenance therapy with rituximab or interferon alfa, each given until progression.
RESULTS:
Of the 560 patients enrolled, 532 were included in the intention-to-treat analysis for response, and 485 in the primary analysis for response. The median age was 70 years. Although complete-remission rates were similar with R-FC and R-CHOP (40% and 34%, respectively; P=0.10), progressive disease was more frequent with R-FC (14%, vs. 5% with R-CHOP). Overall survival was significantly shorter with R-FC than with R-CHOP (4-year survival rate, 47% vs. 62%; P=0.005), and more patients in the R-FC group died during the first remission (10% vs. 4%). Hematologic toxic effects occurred more frequently in the R-FC group than in the R-CHOP group, but the frequency of grade 3 or 4 infections was balanced (17% and 14%, respectively). In 274 of the 316 patients who were randomly assigned to maintenance therapy, rituximab reduced the risk of progression or death by 45% (in remission after 4 years, 58%, vs. 29% with interferon alfa; hazard ratio for progression or death, 0.55; 95% confidence interval, 0.36 to 0.87; P=0.01). Among patients who had a response to R-CHOP, maintenance therapy with rituximab significantly improved overall survival (4-year survival rate, 87%, vs. 63% with interferon alfa; P=0.005).
CONCLUSIONS:
R-CHOP induction followed by maintenance therapy with rituximab is effective for older patients with mantle-cell lymphoma. (Funded by the European Commission and others; ClinicalTrials.gov number, NCT00209209.).
AuthorsH C Kluin-Nelemans, E Hoster, O Hermine, J Walewski, M Trneny, C H Geisler, S Stilgenbauer, C Thieblemont, U Vehling-Kaiser, J K Doorduijn, B Coiffier, R Forstpointner, H Tilly, L Kanz, P Feugier, M Szymczyk, M Hallek, S Kremers, G Lepeu, L Sanhes, J M Zijlstra, R Bouabdallah, P J Lugtenburg, M Macro, M Pfreundschuh, V Procházka, F Di Raimondo, V Ribrag, M Uppenkamp, M André, W Klapper, W Hiddemann, M Unterhalt, M H Dreyling
JournalThe New England journal of medicine (N Engl J Med) Vol. 367 Issue 6 Pg. 520-31 (Aug 09 2012) ISSN: 1533-4406 [Electronic] United States
PMID22873532 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Antibodies, Monoclonal, Murine-Derived
  • R-CHOP protocol
  • Rituximab
  • Vincristine
  • Doxorubicin
  • Cyclophosphamide
  • Vidarabine
  • fludarabine
  • Prednisone
Topics
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal, Murine-Derived (administration & dosage, adverse effects, therapeutic use)
  • Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
  • Cyclophosphamide (administration & dosage, adverse effects, therapeutic use)
  • Doxorubicin (adverse effects, therapeutic use)
  • Female
  • Humans
  • Induction Chemotherapy
  • Intention to Treat Analysis
  • Lymphoma, Mantle-Cell (drug therapy, mortality)
  • Maintenance Chemotherapy
  • Male
  • Middle Aged
  • Prednisone (adverse effects, therapeutic use)
  • Prospective Studies
  • Remission Induction
  • Rituximab
  • Survival Rate
  • Vidarabine (administration & dosage, analogs & derivatives)
  • Vincristine (adverse effects, therapeutic use)

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!


Choose Username:
Email:
Password:
Verify Password:
Enter Code Shown: