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Randomized CLIO/BGOG-ov10 trial of olaparib monotherapy versus physician's choice chemotherapy in relapsed ovarian cancer

  • Author Footnotes
    1 Both authors contributed equally
    Adriaan Vanderstichele
    Footnotes
    1 Both authors contributed equally
    Affiliations
    Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Department of Gynaecology and Obstetrics, University Hospitals Leuven, Leuven, Belgium

    Laboratory of Gynaecological Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium
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  • Author Footnotes
    1 Both authors contributed equally
    Liselore Loverix
    Footnotes
    1 Both authors contributed equally
    Affiliations
    Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Department of Gynaecology and Obstetrics, University Hospitals Leuven, Leuven, Belgium

    Laboratory of Gynaecological Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium
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  • Pieter Busschaert
    Affiliations
    Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Department of Gynaecology and Obstetrics, University Hospitals Leuven, Leuven, Belgium

    Laboratory of Gynaecological Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium

    Laboratory for Translational Genetics, Department of Oncology, KU Leuven, Leuven, Belgium

    Center for Cancer Biology, VIB, Leuven, Belgium
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  • Els Van Nieuwenhuysen
    Affiliations
    Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Department of Gynaecology and Obstetrics, University Hospitals Leuven, Leuven, Belgium

    Laboratory of Gynaecological Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium
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  • Sileny N. Han
    Affiliations
    Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Department of Gynaecology and Obstetrics, University Hospitals Leuven, Leuven, Belgium

    Laboratory of Gynaecological Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium
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  • Nicole Concin
    Affiliations
    Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Department of Gynaecology and Obstetrics, University Hospitals Leuven, Leuven, Belgium

    Laboratory of Gynaecological Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium
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  • Tiene Callewaert
    Affiliations
    Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Department of Gynaecology and Obstetrics, University Hospitals Leuven, Leuven, Belgium

    Laboratory of Gynaecological Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium
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  • Siel Olbrecht
    Affiliations
    Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Department of Gynaecology and Obstetrics, University Hospitals Leuven, Leuven, Belgium

    Laboratory of Gynaecological Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium
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  • Rawand Salihi
    Affiliations
    Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Department of Gynaecology and Obstetrics, University Hospitals Leuven, Leuven, Belgium

    Laboratory of Gynaecological Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium
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  • Patrick Berteloot
    Affiliations
    Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Department of Gynaecology and Obstetrics, University Hospitals Leuven, Leuven, Belgium

    Laboratory of Gynaecological Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium
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  • Patrick Neven
    Affiliations
    Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Department of Gynaecology and Obstetrics, University Hospitals Leuven, Leuven, Belgium

    Laboratory of Gynaecological Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium
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  • Diether Lambrechts
    Affiliations
    Laboratory for Translational Genetics, Department of Oncology, KU Leuven, Leuven, Belgium

    Center for Cancer Biology, VIB, Leuven, Belgium
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  • Toon Van Gorp
    Affiliations
    Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Department of Gynaecology and Obstetrics, University Hospitals Leuven, Leuven, Belgium

    Laboratory of Gynaecological Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium
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  • Ignace Vergote
    Correspondence
    Corresponding author at: Herestraat 49, 3000 Leuven, Belgium.
    Affiliations
    Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Department of Gynaecology and Obstetrics, University Hospitals Leuven, Leuven, Belgium

    Laboratory of Gynaecological Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium
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  • Author Footnotes
    1 Both authors contributed equally
Published:February 14, 2022DOI:https://doi.org/10.1016/j.ygyno.2022.01.034

      Highlights

      • Phase II randomized study of olaparib monotherapy versus chemotherapy in recurrent ovarian cancer
      • Objective response rate was overall similar in the total study (n = 160) for olaparib and chemotherapy
      • In platinum-sensitive disease the response rate was numerically higher with chemotherapy
      • Progression free survival, clinical benefit rate and overall survival were overall not significantly different.
      • In platinum-resistant ovarian cancer with ≥4 prior lines, olaparib seemed to be more effective than chemotherapy.

      Abstract

      Objective

      Comparison of olaparib (OLA) monotherapy versus chemotherapy in patients with platinum-sensitive (PSOC) or platinum-resistant ovarian cancer (PROC).

      Methods

      Patients with measurable disease and ≥ 1 prior line of chemotherapy (CT) were randomized 2:1 to OLA (300 mg tablets, BID) or physician's choice CT.: for PSOC: Carboplatin-Pegylated-Liposomal-Doxorubicin (PLD) or Carboplatin-Gemcitabine; for PROC: PLD, Topotecan, Paclitaxel or Gemcitabine.

      Results

      160 patients (60 with PSOC and 100 with PROC) were randomized 2:1 to OLA (n = 107) or CT (n = 53). Baseline characteristics were similar between both arms. Overall objective response rate (ORR) for OLA and CT were similar (24.3% (26/107) and 28.3% (15/53), respectively). Clinical benefit rate (≥ 12 weeks) was similar with 54.2% (58/107) and 56.6% (30/53), respectively. In PSOC, ORR was 35.0% (14/40) and 65.0% (13/20) for OLA and CT (p = 0.053); in PROC, ORR was 17.9% (12/67) and 6.1% (2/33) for OLA and CT (p = 0.134). ORR in heavily pretreated PROC (>4 prior lines) was 22.9% (8/35) with OLA versus 0% (0/14) for CT. ORR of 35.7% (5/14) and 13.2% (7/53) was observed in BRCA-mutated and -wildtype PROC cases, respectively. Median PFS in PROC was not significantly different with 2.9 months (95% CI 2.8–5.1 in the OLA group versus 3.8 months (95% CI 3.0–6.4) in the CT group (hazard ratio [HR] 1.11 [95% CI 0.72–1.78]; log-rank p = 0.600).

      Conclusion

      OLA monotherapy showed overall an equal response rate in relapsed ovarian cancer compared with CT. In PROC, ORR and TFST tended to be higher with OLA than with CT. In heavily pretreated patients (four lines or more) with PROC disease, OLA treatment seemed to be more effective than CT.

      Keywords

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