title: Panitumumab and pegylated liposomal doxorubicin in platinum-resistant epithelial ovarian cancer with KRAS wild-type: the PaLiDo study, a phase II nonrandomized multicenter study.
abstract: OBJECTIVE
  The increasing number of negative trials for ovarian cancer treatment has prompted an evaluation of new biologic agents, which in combination with chemotherapy may improve survival. The aim of this study was to investigate the response rate in platinum-resistant, KRAS wild-type ovarian cancer patients treated with pegylated liposomal doxorubicin (PLD) supplemented with panitumumab.
  
  
  METHODS
  Major eligibility criteria were relapsed ovarian/fallopian/peritoneal cancer patients with platinum-resistant disease, measurable disease by GCIG CA125 criteria and KRAS wild-type. Patients were treated with panitumumab 6 mg/kg day 1 and day 15 and with PLD 40 mg/m2 day 1, every 4 weeks.
  
  
  RESULTS
  Forty-six patients were enrolled by 6 study sites in this multi-institutional phase II trial. The response rate in the intention-to-treat population (n = 43) was 18.6%. Progression-free and overall survival in the intention-to-treat population was 2.7 months (2.5-3.2 months, 95% confidence interval) and 8.1 months (5.6-11.7 months, 95% confidence interval), respectively. The most common treatment-related grade 3 toxicities included skin toxicity (42%), fatigue (19%), and vomiting (12%).
  
  
  CONCLUSIONS
  The combination of PLD and panitumumab demonstrates efficacy in platinum refractory/resistant patients but the skin toxicity was considerable.
authors.affiliation: Department of Oncology, Vejle Hospital, Vejle, Denmark. Karina.Dahl.Steffensen@slb.regionsyddanmark.dk
authors.forename: Karina Dahl
authors.initials: KD
authors.lastname: Steffensen
authors.forename: Marianne
authors.initials: M
authors.lastname: Waldstrøm
authors.forename: Niels
authors.initials: N
authors.lastname: Pallisgård
authors.forename: Bente
authors.initials: B
authors.lastname: Lund
authors.forename: Kjell
authors.initials: K
authors.lastname: Bergfeldt
authors.forename: Jessica
authors.initials: J
authors.lastname: Wihl
authors.forename: Nina
authors.initials: N
authors.lastname: Keldsen
authors.forename: Christian
authors.initials: C
authors.lastname: Marth
authors.forename: Ignace
authors.initials: I
authors.lastname: Vergote
authors.forename: Anders
authors.initials: A
authors.lastname: Jakobsen
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000077216:Carcinoma, Ovarian Epithelial; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D019008:Drug Resistance, Neoplasm / Q000187:drug effects / Q000235:genetics; D005260:Female; D006801:Humans; D008875:Middle Aged; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality; D000077544:Panitumumab; D017671:Platinum Compounds / Q000627:therapeutic use; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011518:Proto-Oncogene Proteins / Q000235:genetics / Q000378:metabolism; D016283:Proto-Oncogene Proteins p21(ras); D016019:Survival Analysis; D016896:Treatment Outcome; D018631:ras Proteins / Q000235:genetics / Q000378:metabolism
chemical_list: D000911:Antibodies, Monoclonal; C117307:KRAS protein, human; D017671:Platinum Compounds; D011518:Proto-Oncogene Proteins; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D000077544:Panitumumab; D004317:Doxorubicin; D016283:Proto-Oncogene Proteins p21(ras); D018631:ras Proteins