title: Non-pegylated liposome-encapsulated doxorubicin citrate plus cyclophosphamide or vinorelbine in metastatic breast cancer not previously treated with chemotherapy:a multicenter phase III study.
abstract: We conducted a phase III multicenter randomized trial to compare the efficacy of the combination of liposome encapsulated doxorubicin (Myocet(©)) plus either cyclophosphamide (MC) or vinorelbine (MV). Since July 2006, 233 patients affected with metastatic breast cancer were randomized to receive the combination of Myocet (M) 60 mg/m(2) i.v. plus cyclophosphamide (C) 600 mg/m2 on Day 1 of a 21‑day cycle (Arm A) or Myocet (M) at 50 mg/m2 plus vinorelbine (V) 25 mg/m2 i.v. on Day 1 and V 60 mg/m2 orally on Day 8 on a 21‑day cycle (Arm B). The primary endpoints of the study was time to progression (TTP); secondary endpoints were RR, toxicity and OS. Response was observed in 53/116 (45.7%) evaluable patients of Arm A vs. 51/112 (45.5%) of Arm B, respectively (P=NS). Median TTP was 41 weeks (95% CI, 32‑51) and 34 weeks (95% CI, 26‑39), for M/C and M/V, respectively (P=0.0234). The difference in median OS was not statistically significant (131 vs. 122 weeks; P=0.107). With regard to toxicity, patients treated with MV showed a slight increase of neutropenia and constipation, as compared to those treated with MC. No clinical signs of cardiotoxicity were observed. The MC combination remains as an unbeaten 'standard' in first line treatment of MBC.
authors.affiliation: National Cancer Research Center, Istituto Tumori Giovanni Paolo II, Bari, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Lorusso
authors.affiliation: National Cancer Research Center, Istituto Tumori Giovanni Paolo II, Bari, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Giotta
authors.affiliation: Catania Hospital, Catania, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Bordonaro
authors.affiliation: Casa Sollievo della Sofferenza Hospital IRCCS, San Giovanni Rotondo (FG), Italy.
authors.forename: E
authors.initials: E
authors.lastname: Maiello
authors.affiliation: Frattamaggiore Hospital, Frattamaggiore (NA), Italy.
authors.forename: S
authors.initials: S
authors.lastname: Del Prete
authors.affiliation: La Maddalena Hospital, Palermo, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Gebbia
authors.affiliation: Paola Hospital, Paola (CS), Italy.
authors.forename: G
authors.initials: G
authors.lastname: Filippelli
authors.affiliation: Taranto Hospital, Taranto, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Pisconti
authors.affiliation: Brindisi Medical Oncology Department and Breast Unit e Medical Department, European Insitute of Oncology, Milan, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Cinieri
authors.affiliation: Ospedali Riuniti Hospital, Foggia, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Romito
authors.affiliation: Cardarelli Hospital, Napoli, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Riccardi
authors.affiliation: Vito Fazzi Hospital, Lecce, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Forcignanò
authors.affiliation: Vito Fazzi Hospital, Lecce, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Ciccarese
authors.affiliation: Vito Fazzi Hospital, Lecce, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Petrucelli
authors.affiliation: Vito Fazzi Hospital, Lecce, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Saracino
authors.affiliation: Vito Fazzi Hospital, Lecce, Italy.
authors.forename: L I
authors.initials: LI
authors.lastname: Lupo
authors.affiliation: Vito Fazzi Hospital, Lecce, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Gambino
authors.affiliation: Vito Fazzi Hospital, Lecce, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Leo
authors.forename: G
authors.initials: G
authors.lastname: Colucci
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003520:Cyclophosphamide / Q000008:administration & dosage*; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004337:Drug Carriers; D064420:Drug-Related Side Effects and Adverse Reactions / Q000473:pathology; D005260:Female; D006801:Humans; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects; D016019:Survival Analysis; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D004337:Drug Carriers; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D014747:Vinblastine; D004317:Doxorubicin; D003520:Cyclophosphamide; D000077235:Vinorelbine