title: Biweekly rituximab, cyclophosphamide, vincristine, non-pegylated liposome-encapsulated doxorubicin and prednisone (R-COMP-14) in elderly patients with poor-risk diffuse large B-cell lymphoma and moderate to high 'life threat' impact cardiopathy.
abstract: This Phase II study assessed feasibility and efficacy of a biweekly R-COMP-14 regimen (rituximab, cyclophosphamide, non-pegylated liposome-encapsulated doxorubicin, vincristine and prednisone) in untreated elderly patients with poor-risk diffuse large B-cell lymphoma (DLBCL) and moderate to high 'life threat' impact NIA/NCI cardiac comorbidity. A total of 208 courses were delivered, with close cardiac monitoring, to 41 patients (median age: 73years, range: 62-82; 37% >75years) at a median interval of 15·6 (range, 13-29) days; 67% completed all six scheduled courses. Response rate was 73%, with 68% complete responses (CR); 4-year disease-free survival (DFS) and time to treatment failure (TTF) were 72% and 49%, respectively. Failures were due to early death (n=3), therapy discontinuations (no-response n=2; toxicity n=6), relapse (n=6) and death in CR (n=3). Incidence of cardiac grade 3-5 adverse events was 7/41 (17%; 95% confidence interval: 8-31%). Time to progression and overall survival at 4-years were 77% and 67%, respectively. The Age-adjusted Charlson Comorbidity Index (aaCCI) correlated with failures (P=0·007) with patients scoring ≤7 having a longer TTF (66% vs. 29%; P=0·009). R-COMP-14 is feasible and ensures a substantial DFS to poor-risk DLBCL patients who would have been denied anthracycline-based treatment due to cardiac morbidity. The aaCCI predicted both treatment discontinuation rate and TTF.
authors.affiliation: Haematology-Oncology and Stem Cell Transplantation Unit, National Cancer Institute, Fondazione G. Pascale, IRCCS, Naples, Italy. g.corazzelli@istitutotumori.na.it
authors.forename: Gaetano
authors.initials: G
authors.lastname: Corazzelli
authors.forename: Ferdinando
authors.initials: F
authors.lastname: Frigeri
authors.forename: Manuela
authors.initials: M
authors.lastname: Arcamone
authors.forename: Anna
authors.initials: A
authors.lastname: Lucania
authors.forename: Maria
authors.initials: M
authors.lastname: Rosariavilla
authors.forename: Emanuela
authors.initials: E
authors.lastname: Morelli
authors.forename: Alfonso
authors.initials: A
authors.lastname: Amore
authors.forename: Gaetana
authors.initials: G
authors.lastname: Capobianco
authors.forename: Antonietta
authors.initials: A
authors.lastname: Caronna
authors.forename: Cristina
authors.initials: C
authors.lastname: Becchimanzi
authors.forename: Francesco
authors.initials: F
authors.lastname: Volzone
authors.forename: Gianpaolo
authors.initials: G
authors.lastname: Marcacci
authors.forename: Filippo
authors.initials: F
authors.lastname: Russo
authors.forename: Rosaria
authors.initials: R
authors.lastname: De Filippi
authors.forename: Lucia
authors.initials: L
authors.lastname: Mastrullo
authors.forename: Antonio
authors.initials: A
authors.lastname: Pinto
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D015897:Comorbidity; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006331:Heart Diseases / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D016403:Lymphoma, Large B-Cell, Diffuse / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage; D011241:Prednisone / Q000008:administration & dosage; D011379:Prognosis; D012306:Risk; D000069283:Rituximab; D016019:Survival Analysis; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D000069283:Rituximab; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone