title: Maintenance treatment with pegylated liposomal doxorubicin versus observation following induction chemotherapy for metastatic breast cancer: GEICAM 2001-01 study.
abstract: This randomized multicenter phase III trial evaluated the role of maintenance therapy with pegylated liposomal doxorubicin (PLD) after induction chemotherapy in patients with metastatic breast cancer (MBC). Patients without disease progression following first-line induction chemotherapy consisting of three cycles of doxorubicin (75 mg/m(2)) followed by three cycles of docetaxel (100 mg/m(2)) both every 21 days, were randomized to PLD (40 mg/m(2)) every 28 days for six cycles or to observation. Time to progression (TTP) was the primary endpoint. 288 patients were enrolled and received induction first-line chemotherapy. One hundred and fifty-five achieved response or stable disease and were randomized to maintenance PLD (n = 78) or observation (n = 77). With a median follow-up of 20 months from randomization (range 1-56), disease progression occurred in 94% of patients. PLD significantly improved TTP by 3.3 months (8.4 vs. 5.1 months; hazard ratio [HR] = 0.54, 95% CI: 0.39 to 0.76, P = 0.0002) compared with observation. Overall survival was not significantly prolonged with PLD (24.8 vs. 22.0 months, respectively; HR = 0.86, 95% CI: 0.58-1.27, P = 0.44). PLD-induced toxicity was mild and manageable with up to 5% of patients experiencing grade 3/4 non-hematologic events (fatigue, mucositis, palmar-plantar erythrodysesthesia). Grade 3/4 neutropenia occurred in 12% of patients; two patients developed febrile neutropenia. This phase III trial demonstrated that maintenance chemotherapy with PLD is well tolerated and offers improved TTP in patients with MBC following first-line chemotherapy.
authors.affiliation: Department of Medical Oncology, Hospital Clínico Universitario Virgen de la Victoria, 29010 Malaga, Spain. ealbac@uma.es
authors.forename: Emilio
authors.initials: E
authors.lastname: Alba
authors.forename: Manuel
authors.initials: M
authors.lastname: Ruiz-Borrego
authors.forename: Mireia
authors.initials: M
authors.lastname: Margelí
authors.forename: Alvaro
authors.initials: A
authors.lastname: Rodríguez-Lescure
authors.forename: Pedro
authors.initials: P
authors.lastname: Sánchez-Rovira
authors.forename: Amparo
authors.initials: A
authors.lastname: Ruiz
authors.forename: Jose Ramón
authors.initials: JR
authors.lastname: Mel-Lorenzo
authors.forename: Manuel
authors.initials: M
authors.lastname: Ramos-Vázquez
authors.forename: Nuria
authors.initials: N
authors.lastname: Ribelles
authors.forename: Elisa
authors.initials: E
authors.lastname: Calvo
authors.forename: Antonio
authors.initials: A
authors.lastname: Casado
authors.forename: Antonia
authors.initials: A
authors.lastname: Márquez
authors.forename: David
authors.initials: D
authors.lastname: Vicente
authors.forename: José Angel
authors.initials: JA
authors.lastname: García-Sáenz
authors.forename: Miguel
authors.initials: M
authors.lastname: Martín
mesh_terms: D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000628:therapy; D009202:Cardiomyopathies / Q000139:chemically induced; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008081:Liposomes; D008875:Middle Aged; D052016:Mucositis / Q000139:chemically induced; D009362:Neoplasm Metastasis; D009503:Neutropenia / Q000139:chemically induced; D010292:Paresthesia / Q000139:chemically induced; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000903:Antibiotics, Antineoplastic; D008081:Liposomes; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin