title: Rituximab plus HyperCVAD alternating with high dose cytarabine and methotrexate for the initial treatment of patients with mantle cell lymphoma, a multicentre trial from Gruppo Italiano Studio Linfomi.
abstract: This study investigated the clinical activity and toxicity of R-HCVAD-AM [rituximab plus HyperCVAD (R-HCVAD) alternating with high-dose cytarabine and methotrexate (AM)] in patients with newly diagnosed Mantle Cell Lymphoma (MCL). Patients aged ≤70years with confirmed MCL received four alternating cycles each of R-HCVAD and AM. Patients who obtained a partial response proceeded to autologous stem cell transplant. Sixty-three patients were enrolled and 60 were fully eligible. Median age was 57years (22-66); 60%, 33% and 7% were classified at low (L)-, intermediate (I)- or high (H)-risk, respectively, according to the MCL International Prognostic Index (MIPI). Only 22 patients (37%) completed the four cycles and three patients died during therapy. Overall response and complete response rates were 83% and 72% respectively. After a median follow-up of 46months (range 1-72) the estimated 5-year overall survival (OS) and progression-free survival rates were 73% [95% confidence interval (CI) 59-83%], and 61% (95%CI 45-73%) respectively. MIPI maintained the prognostic value with an estimated 5-year OS of 89%, 80% and 24% for L, I, and H groups respectively (P<0·001). This multicentre study confirms that R-HCVAD-AM is an active regimen for the initial treatment of patients with MCL, but is associated with significant toxicity.
authors.affiliation: Ematologia, Dipartimento Oncologico, Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia, Italy. merli.francesco@asmn.re.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Merli
authors.forename: Stefano
authors.initials: S
authors.lastname: Luminari
authors.forename: Fiorella
authors.initials: F
authors.lastname: Ilariucci
authors.forename: Mario
authors.initials: M
authors.lastname: Petrini
authors.forename: Carlo
authors.initials: C
authors.lastname: Visco
authors.forename: Achille
authors.initials: A
authors.lastname: Ambrosetti
authors.forename: Caterina
authors.initials: C
authors.lastname: Stelitano
authors.forename: Francesco
authors.initials: F
authors.lastname: Caracciolo
authors.forename: Nicola
authors.initials: N
authors.lastname: Di Renzo
authors.forename: Francesco
authors.initials: F
authors.lastname: Angrilli
authors.forename: Angelo M
authors.initials: AM
authors.lastname: Carella
authors.forename: Isabella
authors.initials: I
authors.lastname: Capodanno
authors.forename: Elisa
authors.initials: E
authors.lastname: Barbolini
authors.forename: Sara
authors.initials: S
authors.lastname: Galimberti
authors.forename: Massimo
authors.initials: M
authors.lastname: Federico
mesh_terms: D000328:Adult; D000368:Aged; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D003561:Cytarabine / Q000008:administration & dosage / Q000009:adverse effects; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D005819:Genetic Markers; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D007239:Infections / Q000209:etiology; D053208:Kaplan-Meier Estimate; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy* / Q000235:genetics; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D011446:Prospective Studies; D000069283:Rituximab; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage / Q000009:adverse effects; D055815:Young Adult
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D005819:Genetic Markers; D003561:Cytarabine; D000069283:Rituximab; D014750:Vincristine; D003907:Dexamethasone; D004317:Doxorubicin; D003520:Cyclophosphamide; D008727:Methotrexate