Nonpegylated liposomal doxorubicin (MyocetTM) combination (R-COMP) chemotherapy in elderly patients with diffuse large B-cell lymphoma (DLBCL): results from the phase II EUR018 trial.
BACKGROUND
To evaluate the activity and safety of nonpegylated liposomal doxorubicin (Myocet) when substituted for doxorubicin in the R-CHOP regimen (R-COMP).


METHODS
Seventy-five elderly patients with diffuse large B-cell lymphoma (DLBCL) were studied. Only patients with left ventricular ejection fraction (LVEF) > or =50% were allowed. R-COMP regimen was administered every 3 weeks for three cycles, followed by additional five cycles in case of complete response (CR) or partial response.


RESULTS
From November 2002 to April 2005, 75 patients were registered, of which 72 were evaluated. Median age was 72 years (range 61-83); 56% of patients had high or high-intermediate International Prognostic Index score. Median LVEF at baseline was 61%. Thirty-eight patients had history of abnormal cardiovascular conditions. The overall response rate was 71%, with a CR rate of 57%. After a median follow-up of 33 months, the 3-year overall survival, failure-free survival, and progression-free survival rates were 72%, 39%, and 69%, respectively. Neutropenia (54%) was the most frequent grade 3-4 adverse event (AE); 21% of patients experienced cardiac AEs, graded as 3-4 in 4% of the cases.


CONCLUSIONS
R-COMP is an effective regimen for the treatment of DLBCL in elderly patients, with an acceptable tolerability profile.
Luminari
S
S
Department of Oncology and Haematology, University of Modena and Reggio Emilia, Modena, Italy.
Montanini
A
A
Department of Oncology and Haematology, University of Modena and Reggio Emilia, Modena, Italy.
Caballero
D
D
Department of Haematology, University Hospital of Salamanca, Salamanca, Spain.
Bologna
S
S
Department of Hematology, Hospital of Brabois, Vandoeuvre les Nancy, Cedex, France.
Notter
M
M
Department of Medicine III (Hematology and Oncology), Campus Benjamin Franklin, Charité, University of Berlin, Berlin, Germany.
Dyer
M J S
MJS
Medical Research Council Toxicology Unit, University of Leicester, Leicester, UK.
Chiappella
A
A
Division of Hematology 2, Department of Oncology, San Giovanni Battista Hospital and University, Torino, Italy.
Briones
J
J
Department of Haematology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Petrini
M
M
Department of Oncology, Transplant and Advances in Medicine, Section of Hematology, University of Pisa, Pisa, Italy.
Barbato
A
A
Cephalon, Inc., Frazer, PA, USA.
Kayitalire
L
L
Cephalon, Inc., Frazer, PA, USA.
Federico
M
M
Department of Oncology and Haematology, University of Modena and Reggio Emilia, Modena, Italy. Electronic address: federico@unimore.it.
D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D058846:Antibodies, Monoclonal, Murine-Derived; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage; D011446:Prospective Studies; D000069283:Rituximab; D015996:Survival Rate; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage
D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone