Panitumumab in platinum-sensitive epithelial ovarian cancer patients with KRAS wild-type: The PROVE-study, a phase II randomized multicenter study of the North-Eastern German Society of Gynaecologic Oncology.

Authors

null

Radoslav Chekerov

NOGGO and Department of Gynecology, Campus Virchow-Klinikum, Charité Universitätsmedizin Berlin, Berlin, Germany

Radoslav Chekerov , Peter Klare , Petra Krabisch , Jochem Potenberg , Georg Heinrich , Lothar Mueller , Christian M. Kurbacher , Eva-Maria Grischke , Elena Ioana Braicu , Pauline Wimberger , Jalid Sehouli

Organizations

NOGGO and Department of Gynecology, Campus Virchow-Klinikum, Charité Universitätsmedizin Berlin, Berlin, Germany, Praxisklinik Krebsheilkunde, Berlin, Germany, Klinikum Chemnitz, Chemnitz, Germany, Department of Hematology, Waldkrankenhaus Spandau, Berlin, Germany, Gynäkologisch-Onkologische Schwerpunktpraxis, Fürstenwalde, Germany, Oncology Leer, Leer, Germany, Gynecologic Center Bonn-Friedensplatz, Bonn, Germany, Universitӓts-Frauenklinik Tubingen, Eberhard Karls University, Tubingen, Germany, Charité Universitätsmedizin Berlin, Department of Gynaecology, European Competence Center for Ovarian Cancer, Charité Campus Virchow-Klinikum, Berlin, Germany, Department of Gynecology and Obstetrics, University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany

Research Funding

Other

Background: For ovarian cancer (OC) patients with platinum-sensitive recurrence the addition of new biologic agents to chemotherapy may improve survival. Panitumumab is a fully human monoclonal antibody specific to the epidermal growth factor receptor (EGFR). The purpose of this trial was to investigate the therapeutic efficacy of panitumumab in the combination with carboplatin-based chemotherapy in relation to the respective standard combination in patients with a KRAS wildtype with platinum-sensitive recurrent ovarian cancer (NCT01388621). Methods: Major eligibility criteria were pretreated platinum-sensitive epithelial ovarian/ fallopian/ peritoneal cancer and no more than 2 prior treatments for this disease. Only patients with measurable disease or elevated CA125 and with KRAS wild type were eligible. Patients were treated with Carboplatin AUC4/Gemcitabine 1000 mg/m² or Carboplatin AUC5/PLD 40 mg/m² and randomized to panitumumab 6 mg/kg day 1 and day 15, every 3 or 4 weeks. Tumor assessment was performed at baseline and at every third cycle according to CT-scan and CA-125 criteria. Results: In this multi-institutional phase II trial 102 patients were randomized and 96 enrolled for the final analysis. Progression-free survival in the intention-to-treat population (N=96) was 9.5 vs. 10.7 months (HR 0.829, 95%CI of 8.5-11.6 months vs 8.5-13.1 months) for the experimental vs. standard arm, p=0.45. Data of overall survival are not jet evaluable. The most common treatment related grade 3+ toxicities included hematologic toxicity (54%), skin reactions (18%) and gastrointestinal events (16%). Conclusions: The addition of panitumumab to platinum-based chemotherapy for recurrent ovarian cancer does not influence efficacy and progression-free survival in platinum sensitive patients, while no new additional toxicity aspects for panitumumab were evaluated. Clinical trial information: NCT01388621

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Abstract Details

Meeting

2017 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Ovarian Cancer

Clinical Trial Registration Number

NCT01388621

Citation

J Clin Oncol 35, 2017 (suppl; abstr 5558)

DOI

10.1200/JCO.2017.35.15_suppl.5558

Abstract #

5558

Poster Bd #

380

Abstract Disclosures