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NICE guidance 2003

  • Used in combination with CHOP for 1st line treatment of people with CD20 positive DLBCL at clinical stage II, III or IV
    • Not recommended when CHOP contraindicated
  • Clinical and cost effectiveness in patients with satge I disease has not been established. In these circumstances should only be used as part of a clinical study


  • Background
    • 80-85% of NHL are derived form B lymphocytes
    • DLBCL is usually fatal within months if left untreated, however they are potentially curable with intensive chemotherapy
    • Incidence is 15 in 100, 000
    • 7th most common cancer in UK
    • 3-10% of AIDS patients develop aggressive NHL, usually large cell
    • 8 CHOP  40-50% achieve CR, 3 year survival of 30%
    • 3 CHOP in stage 1  90% achieve CR, 5 year disease free survival of 80-85%
    • Standard treatment for stage I disease is 3 chop and involved field radiotherapy


  • Rituximab
    • Chimeric genetically engineered monoclonal antibody that targets CD20
    • CD20 expressed on almost all B cell lymphomas and testing for its presence is part of normal diagnostic procedures
      • Suitable target because it doesnt circulate freely in the plasma, isnt shed from the cell surface or internalised
      • Occurs on normal and malignat B cells, but not B cell precursors
      • Induces death via
        • Antibody directed cytotxicity
        • Induction of apoptosis
        • Sensitises cells to action of conventional cytotoxics
  • Dose
    • 375mg/m2 iv on day 1 of each chemo cycle after administration of the steroid component
  • Side effects
    • Infusion related reactions
      • 50%, usually during the 1st infusion (1st 1-2hours)
      • Fever, chills, rigors
      • Flushing, angioedema, nausea, urticaria, fatigue, headache, tumour pain
      • 10% associated with bronchospasm and hypotension
      • Severe reactions are more common in patients with a high tumour burden
    • Women of child bearing age need to avoid pregnacy for at least 1 year (crosses placenta and can be teratogenic)
  • Cost
    • £9,800/ course (8 cycles)
  • Evidence
    • CHOP v R-CHOP for 8 cycles in stage I, III, IV
      • 399 untreated patients aged 60-80
      • Primary end points event free survival
      • Median follow-up 24 months
      • 43% v 61% event free survival
      • Death 29% v 41%
      • Adverse events 74% CHOP v 79% R-CHOP
    • No comparative data in younger people
      • Small uncontrolled phase II study , response rate with R-CHOP was at least as good in those people aged over 60
  • Cost effectivenes
    • Cost per QALY £6100

Original paper in NEJM 2002 (Coiffier et al.)