CEOP-21 versus CEOP-14 chemotherapy with or without rituximab for the first-line treatment of patients with aggressive lymphomas: results of the HE22A99 trial of the Hellenic Cooperative Oncology Group.
BACKGROUND
In this study we investigated whether administering CEOP (cyclophosphamide, epirubicin, vincristine [Oncovin], and prednisone) every 2 weeks (CEOP-14) instead of every 3 weeks (the standard CEOP-21 regimen) improves outcomes in patients with previously untreated aggressive lymphomas. In a secondary analysis we evaluated the impact of adding rituximab to CEOP-14/CEOP-21 chemotherapy.


METHODS
The trial opened in March 1999, and patients were randomly assigned to either CEOP-14 or CEOP-21. All patients enrolled from May 2002 onward received rituximab with each chemotherapy cycle, and those attaining a complete response received rituximab consolidation.


RESULTS
Complete and overall response rates in the CEOP-21 +/- rituximab (N = 114) and CEOP-14 +/- rituximab (N = 103) arms were similar, as were the overall survival (P = 0.769) and time to progression distributions (P = 0.969). Rituximab was shown to have a beneficial effect both on the overall survival and on the time to progression.


CONCLUSIONS
Thus far, no significant improvement in outcome has been demonstrated with CEOP-14 +/- rituximab versus CEOP-21 +/- rituximab. However, with addition of rituximab to CEOP-21/CEOP-14, significant improvements in time to progression and overall survival were achieved.
Economopoulos
T
T
Department of Medicine, Yale University, New Haven, CT, USA.
Psyrri
A
A
Dimopoulos
M A
MA
Kalogera-Fountzila
A
A
Pavlidis
N
N
Tsatalas
C
C
Nikolaides
C
C
Mellou
S
S
Xiros
N
N
Fountzilas
G
G
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D058846:Antibodies, Monoclonal, Murine-Derived; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000009:adverse effects / Q000627:therapeutic use; D015251:Epirubicin / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D016393:Lymphoma, B-Cell / Q000188:drug therapy / Q000473:pathology; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy / Q000473:pathology; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy* / Q000473:pathology; D016399:Lymphoma, T-Cell / Q000188:drug therapy / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000009:adverse effects / Q000627:therapeutic use; D000069283:Rituximab; D014750:Vincristine / Q000009:adverse effects / Q000627:therapeutic use
D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D015251:Epirubicin; D000069283:Rituximab; D014750:Vincristine; D003520:Cyclophosphamide; D011241:Prednisone