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  • 2022-RA-1263-ESGO Phase II randomized BGOG-CX3 trial comparing atezolizumab in combination with doxorubicin versus doxorubicin alone in second-line or later recurrent cervical cancer

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Cervical cancer
2022-RA-1263-ESGO Phase II randomized BGOG-CX3 trial comparing atezolizumab in combination with doxorubicin versus doxorubicin alone in second-line or later recurrent cervical cancer
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  1. Liselore Loverix1,
  2. Rawand Salihi1,
  3. Anne-Sophie van Rompuy2,
  4. Adriaan Vanderstichele1,3,
  5. Els van Nieuwenhuysen1,
  6. Thaïs Baert1,
  7. Philip Debruyne4,
  8. Nathalie Cornez5,
  9. Stéphanie Henry6,
  10. Patrick Neven1,
  11. Sileny Han1,
  12. Patrick Berteloot1,
  13. Siel Olbrecht1,
  14. Tina Laga1,
  15. Pieter Busschaert1,
  16. Toon van Gorp1 and
  17. Ignace Vergote1
  1. 1Division of Gynaecological Oncology, Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgium
  2. 2Department of pathology, University Hospitals Leuven, Leuven, Belgium
  3. 3Department of Gynaecology, AZ Delta, Roeselare, Belgium
  4. 4Medical Oncology, AZ Groeninge Kortrijk, Kortrijk, Belgium
  5. 5Medical Oncology, CHU Ambroise Paré, Mons, Belgium
  6. 6Medical Oncology, CHU UCL Namur, Namur, Belgium

Abstract

Introduction/Background Single-agent chemotherapies, like doxorubicin, have very modest activity in recurrent cervical cancer (rCC). Recently, anti-programmed-death protein 1 (anti-PD-1) treatment has shown activity in randomized phase III studies in rCC. In the current study we investigated the combination of doxorubicin with an anti-PD-L1 inhibitor atezolizumab (DA), based on the possible synergistic effect, versus doxorubicin (D) alone.

Methodology Prospective open-label, randomized phase II BGOG-cx3 trial (EudraCT2016–000547–14) randomizing 2:1 to doxorubicin (60 mg/m2 q3 wks) with or without atezolizumab (1200 mg q3wks), respectively. The primary endpoint was progression-free survival (PFS) rate at 9 months. Secondary endpoints included objective response rate (ORR), duration of response (DOR), disease control rate (DCR), overall survival (OS), PFS and safety analysis.

Abstract 2022-RA-1263-ESGO Figure 1
Abstract 2022-RA-1263-ESGO Figure 1

Results 40 patients were randomized between November 2017 and October 2020: 23 vs 17 patients for DA and D, respectively. Baseline characteristics were similar in both arms (total population: squamous cell carcinoma 84%, prior radiochemotherapy 69%, prior anti-VEGF 61%, median prior lines of chemotherapy in advanced/recurrent setting was 1 with range 0–2). There was a tendency towards a longer median PFS of 4.8 and 3.9 months (figure 1) for DA and D, respectively with HR 0.501 (95%CI 0.246–1.017) (p= 0.0558). Similarly, the primary endpoint, PFS rate at 9 months, was numerically higher but failed to reach significance (26% vs 13% for DA and D, respectively (p=0.054)). Median OS was 10.3 and 7.8 months (p= 0.21) for DA and D, respectively. DCR at 24 weeks was 16% (DA)vs 0% (D) (p=0.279). Results according to PD-L1 staining will be presented. Discontinuation and dose reductions of D were similar in both groups. No new safety signals were noted for the combination of DA.

Conclusion Notwithstanding the limited samples size, this study showed a tendency towards a prolonged PFS and OS when doxorubicin was combined with atezolizumab compared with doxorubicin alone in rCC.

https://doi.org/10.1136/ijgc-2022-ESGO.111

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