title: Combination of bevacizumab and 2-weekly pegylated liposomal doxorubicin as first-line therapy for locally recurrent or metastatic breast cancer. A multicenter, single-arm phase II trial (SAKK 24/06).
abstract: BACKGROUND
  pegylated liposomal doxorubicin (PLD) and bevacizumab are active agents in the treatment of metastatic breast cancer (MBC). We carried out a multicenter, single-arm phase II trial to evaluate the toxicity and efficacy of PLD and bevacizumab as first-line treatment in MBC patients.
  
  
  METHODS
  bevacizumab (10 mg/kg) and PLD (20 mg/m(2)) were infused on days 1 and 15 of a 4-week cycle for a maximum of six cycles. Thereafter, bevacizumab monotherapy was continued at the same dose until progression or toxicity. The primary objective was safety and tolerability, and the secondary objective was to evaluate efficacy of the combination.
  
  
  RESULTS
  thirty-nine of 43 patients were assessable for the primary end point. Eighteen of 39 patients (46%, 95% confidence interval 30% to 63%) had a grade 3 toxicity. Sixteen (41%) had grade 3 palmar-plantar erythrodysesthesia, one had grade 3 mucositis, and one severe cardiotoxicity. Secondary end point of overall response rate among 43 assessable patients was 21%.
  
  
  CONCLUSIONS
  in this nonrandomized single-arm trial, the combination of bimonthly PLD and bevacizumab in locally recurrent and MBC patients demonstrated higher than anticipated toxicity while exhibiting only modest activity. Based on these results, we would not consider this combination for further investigation in this setting.
authors.affiliation: Department of Oncology, University Hospital Basel, Basel. Electronic address: crochlitz@uhbs.ch.
authors.forename: C
authors.initials: C
authors.lastname: Rochlitz
authors.affiliation: Breast Center, Kantonsspital St Gallen, St Gallen.
authors.forename: T
authors.initials: T
authors.lastname: Ruhstaller
authors.affiliation: SAKK Coordinating Center, Bern.
authors.forename: S
authors.initials: S
authors.lastname: Lerch
authors.affiliation: Breast Center, Kantonsspital St Gallen, St Gallen.
authors.forename: C
authors.initials: C
authors.lastname: Spirig
authors.affiliation: Breast Center, Kantonsspital St Gallen, St Gallen.
authors.forename: J
authors.initials: J
authors.lastname: Huober
authors.affiliation: Department of Cardiology and Oncology, Inselspital Bern, Bern.
authors.forename: T
authors.initials: T
authors.lastname: Suter
authors.affiliation: Department of Cardiology and Oncology, Inselspital Bern, Bern.
authors.forename: M
authors.initials: M
authors.lastname: Bühlmann
authors.affiliation: Department of Gynecology, University Hospital Zurich, Zurich.
authors.forename: M
authors.initials: M
authors.lastname: Fehr
authors.affiliation: Department of Oncology, Kantonsspital Aarau, Aarau.
authors.forename: A
authors.initials: A
authors.lastname: Schönenberger
authors.affiliation: Department of Oncology, Kantonsspital Graubünden, Graubünden.
authors.forename: R
authors.initials: R
authors.lastname: von Moos
authors.affiliation: Department of Oncology, Kantonsspital Luzern, Luzern.
authors.forename: R
authors.initials: R
authors.lastname: Winterhalder
authors.affiliation: Department of Oncology, Regionalspital Thun, Thun.
authors.forename: D
authors.initials: D
authors.lastname: Rauch
authors.affiliation: Department of Oncology, Kantonsspital Winterthur, Winterthur.
authors.forename: A
authors.initials: A
authors.lastname: Müller
authors.affiliation: Department of Internal Medicine, Andreas Klinik Cham, Cham.
authors.forename: M
authors.initials: M
authors.lastname: Mannhart-Harms
authors.affiliation: Department of Oncology, University Hospital Basel, Basel.
authors.forename: R
authors.initials: R
authors.lastname: Herrmann
authors.affiliation: SAKK Coordinating Center, Bern.
authors.forename: B
authors.initials: B
authors.lastname: Cliffe
authors.affiliation: SAKK Coordinating Center, Bern.
authors.forename: M
authors.initials: M
authors.lastname: Mayer
authors.affiliation: Department of Oncology, University Hospital Lausanne, Lausanne, Switzerland.
authors.forename: K
authors.initials: K
authors.lastname: Zaman
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D000068258:Bevacizumab; D001943:Breast Neoplasms / Q000188:drug therapy*; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C506643:liposomal doxorubicin; D000068258:Bevacizumab; D011092:Polyethylene Glycols; D004317:Doxorubicin