First line therapy with paclitaxel (Taxol®) and pegylated liposomal doxorubicin (Caelyx®) in patients with metastatic breast cancer: a multicentre phase II study Journal Articles uri icon

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  • 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.


  • Vorobiof, DA
  • Rapoport, BL
  • Chasen, Martin
  • Slabber, C
  • McMichael, G
  • Eek, R
  • Mohammed, C

publication date

  • June 2004

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