Annals of Oncology 14:881-893, 2003
© 2003 European Society for Medical Oncology
Original Paper |
Practicability and acute haematological toxicity of 2- and 3-weekly CHOP and CHOEP chemotherapy for aggressive non-Hodgkin’s lymphoma: results from the NHL-B trial of the German High-Grade Non-Hodgkin’s Lymphoma Study Group (DSHNHL)
1 Institute for Medical Informatics, Statistics and Epidemiology, University of Leipzig, Leipzig; 2 Clinic I for Internal Medicine, University of Cologne, Cologne; 3 Clinic for Haematology and Internal Oncology, Carl-Thiem Hospital, Cottbus; 4 Clinic for Internal Medicine, Georg-August University, Goettingen; 5 Department of Oncology and Haematology, University Hospital Hamburg–Eppendorf, Hamburg; 6 Department of Internal Medicine II, Friedrich-Schiller University, Jena; 7 Clinic I for Internal Medicine, University of Saarland, Homburg, Germany
Received 18 December 2002; accepted 17 February 2003
Background:
There is evidence that intensified variants of the classical 3-weekly CHOP-21 chemotherapy [cyclophosphamide (C), doxorubicin (H), vincristine (O), prednisone (P)] may improve treatment outcome in aggressive lymphoma. Three variants using either an addition of etoposide (CHOEP-21: 100 mg/m2 on days 1–3), the shortening to 2-week intervals using recombinant human granulocyte colony-stimulating factor (rhG-CSF; CHOP-14) or both (CHOEP-14) are currently compared with CHOP-21 in the NHL-B trial of the German High-Grade Non-Hodgkin’s Lymphoma Study Group (DSHNHL). To enable more extensive testing of these schemes we here characterise their practicability regarding schedule adherence, acute haematotoxicity and need for supportive treatment.
Patients and methods:
The trial included patients with normal lactate dehydrogenase (LDH) aged ≤60 years (NHL-B1) and patients aged 61–75 years (NHL-B2). The data are taken from an interim analysis. Data from 959 patients (CHOP-21: 232; CHOP-14: 238; CHOEP-21: 244; CHOEP-14: 245) from 162 institutions with a total of 5331 therapy cycles were evaluated.
Results:
The dose adherence in the NHL-B1 trial was excellent. The median relative dose (RD; i.e. actually given compared to planned dose) exceeds 98% for the myelosuppressive drugs in all four regimens. Only ≤5% of patients received a relative dose <80% (RD <80). The median treatment duration could be shortened as scheduled for both CHOP-14 by 36 days and CHOEP-14 by 35 days. The dose adherence in the NHL-B2 trial was excellent for CHOP-21 and CHOP-14 for the myelosuppressive drugs (median RD ≥98%, RD <80 ≤15%). Addition of etoposide, however, was accompanied by more dose erosion (median RD ≥97%, RD <80 ≤17% for CHOEP-21 and ≤27% for CHOEP-14). The median treatment duration could be shortened by 34 days with CHOP-14 compared with CHOP-21. Less treatment shortening was feasible for CHOEP-14 compared with CHOP-21 (median of 29 days). CHOP-14 and CHOP-21 were similar regarding toxicity profile, rate of infection, use of antibiotics, rate of transfusions and hospitalisation. CHOEP schemes were associated with a higher rate of infections, more transfusion requirements, more antibiotic use and longer hospitalisation than the CHOP schemes, particularly in patients aged >60 years. Haematopoietic recovery was age- and treatment-related.
Conclusions:
CHOP-14 with the addition of rhG-CSF is safe and practicable in a large multicentre setting in patients aged 18–75 years. Despite shorter treatment intervals it can be delivered at the same dose as the classical 3-weekly CHOP with a comparable toxicity profile. The addition of etoposide is feasible and safe for patients ≤60 years old in both the CHOEP-21 and CHOEP-14 schemes. For patients >60 years of age the addition of etoposide is associated with marked dose erosion due to increased toxicity. In this age group CHOEP should be used with caution.
Key words: aggressive lymphomas, CHOP regimen, clinical study, relative dose toxicity
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