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  • Panitumumab and Pegylated Liposomal Doxorubicin in Platinum-Resistant Epithelial Ovarian Cancer With KRAS Wild-Type: The PaLiDo Study, a Phase II Nonrandomized Multicenter Study

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Ovarian Cancer
Panitumumab and Pegylated Liposomal Doxorubicin in Platinum-Resistant Epithelial Ovarian Cancer With KRAS Wild-Type: The PaLiDo Study, a Phase II Nonrandomized Multicenter Study
  1. Karina Dahl Steffensen, MD, PhD*,†,
  2. Marianne Waldstrøm, MD‡,
  3. Niels Pallisgård, MSc§,
  4. Bente Lund, MD∥,
  5. Kjell Bergfeldt, MD, PhD,
  6. Jessica Wihl, MD#,
  7. Nina Keldsen, MD**,
  8. Christian Marth, MD, PhD†,‡,
  9. Ignace Vergote, MD, PhD†,‡ and
  10. Anders Jakobsen, MD, DMSc*,†
  1. *Department of Oncology, Vejle Hospital, Vejle;
  2. †Institute of Regional Health Services Research, University of Southern Denmark, Odense; Departments of
  3. ‡Pathology and
  4. §Clinical Biochemistry, Vejle Hospital, Vejle;
  5. ∥Department of Oncology, Aalborg Hospital, Aalborg, Denmark;
  6. Department of Oncology, Karolinska University Hospital, Stockholm;
  7. #Department of Oncology, Skåne University Hospital, Lund, Sweden;
  8. **Department of Oncology, Regions hospital Herning, Herning, Denmark;
  9. ‡†Department of Obstetrics and Gynecology, Medical University of Innsbruck, Innsbruck, Austria; and
  10. †‡Department of Obstetrics and Gynaecology and Leuven Cancer Institute, Division of Gynaecological Oncology, Leuven, Belgium.
  1. Address correspondence and reprint requests to Karina Dahl Steffensen, MD, PhD, Department of Oncology, Vejle Hospital, Kabbeltoft 25, DK-7100 Vejle, Denmark. E-mail: Karina.Dahl.Steffensen{at}slb.regionsyddanmark.dk.

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.

Patients and 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.

  • Ovarian cancer
  • KRAS
  • EGFR inhibition
  • Liposomal doxorubicin
  • Platinum resistance

https://doi.org/10.1097/IGC.0b013e3182775fae

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    Footnotes

    • Supported by grants from Vejle Hospital (Dr Steffensen and Dr Jakobsen) and The Cancer Foundation (Dr Jakobsen). Panitumumab was supplied free of cost by the pharmaceutical company Amgen. The expenses incurred in the analysis for KRAS were also reimbursed by Amgen.

    • The authors declare no conflicts of interest.