title: First line therapy with paclitaxel (Taxol) and pegylated liposomal doxorubicin (Caelyx) in patients with metastatic breast cancer: a multicentre phase II study.
abstract: The aim of this multicentric phase II study was to investigate the efficacy and toxicity of a combination of chemotherapy containing paclitaxel (Taxol) and a novel compound, a liposomal encapsulated doxorubicin (Caelyx), as first line therapy for patients with metastatic breast cancer. Thirty-four patients with advanced breast cancer were treated with a combination of paclitaxel 175 mg/m2 and liposomal doxorubicin 30 mg/m2, every 3 weeks. The combination chemotherapy was effective in 73% of the patients (ITT) (95% CI 55-86%) (7 complete and 18 partial responses). Grade 3/4 toxicities were documented in a small number of patients. Two toxic deaths (6%) were documented, one a hepatorenal failure and another a febrile neutropenia. One patient experienced pulmonary embolism but continued on treatment after appropriate therapy. The combination of paclitaxel and liposomal encapsulated doxorubicin induces a high and durable response rate with a moderate toxicity profile.
authors.affiliation: Sandton Oncology Centre, P.O. Box 2059, Parklands 2121, Johannesburg, South Africa. voro@global.co.za
authors.forename: D A
authors.initials: DA
authors.lastname: Vorobiof
authors.forename: B L
authors.initials: BL
authors.lastname: Rapoport
authors.forename: M R
authors.initials: MR
authors.lastname: Chasen
authors.forename: C
authors.initials: C
authors.lastname: Slabber
authors.forename: G
authors.initials: G
authors.lastname: McMichael
authors.forename: R
authors.initials: R
authors.lastname: Eek
authors.forename: C
authors.initials: C
authors.lastname: Mohammed
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000556:secondary; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008081:Liposomes / Q000008:administration & dosage; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy / Q000556:secondary; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage; D012983:Soft Tissue Neoplasms / Q000188:drug therapy / Q000556:secondary; D013019:South Africa; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D008081:Liposomes; D004317:Doxorubicin; D017239:Paclitaxel