A phase III randomized trial of high-dose CEOP + filgrastim versus standard-dose CEOP in patients with non-Hodgkin lymphoma: 10-year follow-up data: Australasian Leukaemia and Lymphoma Group (ALLG) NHL07 trial

Mark Hertzberg, Jane Matthews, Janey Stone, Ming-Celine Dubosq, Andrew Grigg, David Ellis, Warwick Benson, Peter Browett, Noemi Horvath, Henry Januszewicz, Ehtesham Abdi, Michael Green, Tony Bonaventura, Paula Marlton, Paul Cannell, Max Wolf

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    Abstract

    Increasing dose intensity (DI) of chemotherapy for patients with aggressive non-Hodgkin lymphoma (NHL) may improve outcomes at the cost of increased toxicity. This issue was addressed in a randomized trial aiming to double the DI of myelosuppressive drugs. Between 1994 and 1999, 250 patients with previously untreated aggressive NHL were randomized to treatment with six cycles of 3-weekly standard (s) or intensive (i) chemotherapy: s-CEOP-cyclophosphamide 750, epirubicin 75, vincristine 1.4 mg/m 2 all on day 1, and prednisolone 100 mg days 1-5; i-CEOP-cyclophosphamide 1,500, epirubicin 150, vincristine 1.4 mg/m 2 all on day 1, and prednisolone 100 mg days 1-5. Primary endpoint was 5-year overall survival (OS). Relative to s-CEOP patients, i-CEOP patients achieved a 78% increase in the DI of cyclophosphamide and epirubicin. Despite this, there was no significant difference in any outcome: 5-year OS (56.7% i-CEOP; 55.1% s-CEOP; P=0.80), 5-year progression free survival (PFS; 41% i-CEOP; 43% s-CEOP; P=0.73), 5-year time to progression (TTP; 44% i-CEOP; 47% s-CEOP; P=0.72), or complete remission (CR)+unconfirmed CR (CRu) rates (53% i-CEOP; 59% s-CEOP; P=0.64). Long-term follow up at 10 years also showed no significant differences in OS, PFS, or TTP. The i-CEOP arm had higher rates of febrile neutropenia (70 vs. 26%), hospitalisations, blood product utilisation, haematological and gastrointestinal toxicities, and lower quality of life scores during treatment, although without significant differences 6-month later. In the treatment of aggressive NHL in the prerituximab era, increasing DI did not result in improved outcomes, while at the same time lead to increased toxicity.

    Original languageEnglish
    Pages (from-to)536-541
    Number of pages6
    JournalAMERICAN JOURNAL OF HEMATOLOGY
    Volume89
    Issue number5
    DOIs
    Publication statusPublished - May 2014

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    Hertzberg, M., Matthews, J., Stone, J., Dubosq, M-C., Grigg, A., Ellis, D., Benson, W., Browett, P., Horvath, N., Januszewicz, H., Abdi, E., Green, M., Bonaventura, T., Marlton, P., Cannell, P., & Wolf, M. (2014). A phase III randomized trial of high-dose CEOP + filgrastim versus standard-dose CEOP in patients with non-Hodgkin lymphoma: 10-year follow-up data: Australasian Leukaemia and Lymphoma Group (ALLG) NHL07 trial. AMERICAN JOURNAL OF HEMATOLOGY, 89(5), 536-541. https://doi.org/10.1002/ajh.23684