Article Text

Download PDFPDF

#66 Survival of PARP inhibitor (PARPi) naïve ovarian cancer patients with a BRCA-mutation receiving maintenance olaparib after chemotherapy for first recurrence. An exploratory analysis of the solo2/engot-ov21 trial
  1. Jonathan A Ledermann1,
  2. Isabelle Ray-Coquard2,
  3. Richard Penson3,
  4. Chee Lee4,
  5. Amit Oza5,
  6. Jacob Korach6,
  7. Nuria Lainez7,
  8. Giovanni Scambia8,
  9. Val Gebski4,
  10. Nicoletta Colombo9,
  11. Julia Welz10,
  12. Keiichi Fujiwara11,
  13. Elizabeth S Lowe12 and
  14. Eric Pujade-Lauraine13
  1. 1UCL Cancer Institute and UCL Hospitals, London, UK
  2. 2Centre Léon Berard, Lyon, France
  3. 3Harvard Medical School, Massachusetts General Hospital, Boston, USA
  4. 4University of Sydney, Sydney, Australia
  5. 5Princess Margaret Cancer Centre, Toronto, Canada
  6. 6Sheba Medical Center, Tel Aviv University, Tel Hashomer and ISGO, Tel Hashomer, Israel
  7. 7Oncoligia Médica, Complejo Hospitalario de Navarra, Pampelona and GEICO, Pampelona, Spain
  8. 8University of Eastern Piedmont, Novara and Fondazione Policlinico Universitario A Gemelli IRCCS, Rome and MITO, Rome, Italy
  9. 9University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan, and MaNGO, Milan, Italy
  10. 10Evangelische Kliniken Essen-Mitte, Essen and AGO, Essen, Germany
  11. 11Saitama Medical University, Saitama, Japan
  12. 12AstraZeneca, Global Medicines Development, Oncology,, Gaithersburg, USA
  13. 13ARCAGY-GINECO, 8 rue Lamennais, 75008, Paris, France


Introduction/Background BACKGROUND: While an increasing number of patients with BRCA-mutated ovarian cancer receive first-line maintenance PARP inhibitors, there is still a group of patients who are PARPi naïve for various reasons, and who relapse. A subgroup analysis of the SOLO2 trial of maintenance olaparib provides information about the outcome of patients receiving maintenance olaparib after a response to platinum-based therapy for first recurrence.

Methodology In SOLO2/ENGOT-Ov21 patients with high grade ovarian cancer and a BRCA-mutation were randomised 2:1 to receive olaparib or placebo after a response to platinum-based therapy. Out of the 295 patients enrolled in the trial, 172 had one prior line of chemotherapy (110 olaparib; 62 placebo) prior to recurrence. Treatment with olaparib or placebo continued until progression, toxicity, or lack of further clinical benefit. An exploratory analysis of progression-free survival (PFS) and overall survival (OS) was performed as well as the long-term toxicity.

Results In the 172 second-line patients, a complete response to chemotherapy was seen in 52%, and 70% had a platinum-free interval of more than 12 months before randomisation. The median PFS was 24.2 (16.4–33.2) versus 5.7 (95%CI 5.3–8.2) months in the olaparib and placebo arms respectively (HR 0.46, 95%CI 0.32–0.66). With 58% data maturity, OS favoured olaparib (median 56.3 months, 95%CI 43.9–67.4) over placebo (37.4 months, 95%CI 27.1–60.3) (HR 0.79, 95%CI 0.53–1.19).

Conclusion For patients with a BRCA mutation who did not have the opportunity to receive a PARPi in first-line, this exploratory analysis of SOLO2 in patients with first recurrence showed that maintenance olaparib following a response to chemotherapy leads to a clinically meaningful survival benefit. These results support the recommended use of olaparib in this patient subgroup.

Disclosures Sponsored by AstraZeneca. Led by GINECO Group

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.