Table 4.

Pertinent inclusion/exclusion criteria for phase II and phase III R-CHOP (rituximab + cyclophosphamide + doxorubicin + vincristine + prednisolone) therapy.

A. Phase II Trial13 

  • Histologically confirmed low-grade or follicular B-cell lymphoma and measurable disease

  • No prior chemotherapy or no more than 4 prior standard therapies (76% no prior therapy)

  • “Bulky” disease (defined as any single mass > 10 cm in its greatest diameter) was excluded

 
B. Phase III Trial14 

  • Histologically confirmed, previously untreated, advanced-stage follicular lymphoma (grades 1 and 2)

  • “Requirement for therapeutic intervention” (defined by one of the following):

    • presence of B symptoms

    • bulky disease (mediastinal lymphomas > 7.5 cm or other lymphomas > 5 cm in greatest diameter)

    • impairment of normal hematopoiesis (hemoglobin less than 10 g/dL, ANC < 1.5 × 109/L, or platelet count < 100 × 109/L)

    • rapidly progressive disease

 
A. Phase II Trial13 

  • Histologically confirmed low-grade or follicular B-cell lymphoma and measurable disease

  • No prior chemotherapy or no more than 4 prior standard therapies (76% no prior therapy)

  • “Bulky” disease (defined as any single mass > 10 cm in its greatest diameter) was excluded

 
B. Phase III Trial14 

  • Histologically confirmed, previously untreated, advanced-stage follicular lymphoma (grades 1 and 2)

  • “Requirement for therapeutic intervention” (defined by one of the following):

    • presence of B symptoms

    • bulky disease (mediastinal lymphomas > 7.5 cm or other lymphomas > 5 cm in greatest diameter)

    • impairment of normal hematopoiesis (hemoglobin less than 10 g/dL, ANC < 1.5 × 109/L, or platelet count < 100 × 109/L)

    • rapidly progressive disease

 
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