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Poster display session

230P - Olaparib maintenance therapy in patients (pts) with a BRCA1 and/or BRCA2 mutation (BRCAm) and newly diagnosed advanced ovarian cancer (OC): SOLO1 China cohort

Date

23 Nov 2019

Session

Poster display session

Topics

Tumour Site

Ovarian Cancer

Presenters

Lingying Wu

Citation

Annals of Oncology (2019) 30 (suppl_9): ix77-ix90. 10.1093/annonc/mdz426

Authors

L. Wu1, J. Zhu2, R. Yin3, X. Wu4, G. Lou5, J. Wang6, Y. Gao7, B. Kong8, X. Lu9, Q. Zhou10, Y. Wang11, Y. Chen12, W. Lu13, W. Li14, Y. Cheng15, J. Liu16, X. Ma17, J. Zhang17

Author affiliations

  • 1 Gynecologic Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, 100021 - Beijing/CN
  • 2 Department Of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou/CN
  • 3 Department Of Gynecology And Obstetrics And Key Laboratory Of Obstetrics And Gynecologic And Pediatric Diseases And Birth Defects Of The Ministry Of Education, West China Second University Hospital, Sichuan University, Chengdu/CN
  • 4 Department Of Gynecologic Oncology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai/CN
  • 5 Department Of Gynecology And Oncology, Harbin Medical University Cancer Hospital, Harbin/CN
  • 6 Department Of Gynecologic Oncology, Hunan Cancer Hospital, Changsha/CN
  • 7 Department Of Gynecologic Oncology, Beijing Cancer Hospital, Beijing/CN
  • 8 Department Of Obstetrics And Gynecology, Qilu Hospital of Shandong University, Jinan/CN
  • 9 Department Of Gynecologic Oncology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai/CN
  • 10 Chongqing Office For Cancer Control And Research, Chongqing Cancer Hospital, Chongqing/CN
  • 11 No. 1 Affiliated Hospital Of Medical School, Xi'an Jiatong University, Xi'an/CN
  • 12 Department Of Obstetrics And Gynecology, The First Affiliated Hospital of Soochow University, Suzhou/CN
  • 13 School Of Medicine, Women's Hospital, Zhejiang University, Hangzhou/CN
  • 14 Oncology Center, The First Hospital of Jilin University, Changchun/CN
  • 15 Division Of Thoracic Oncology, Jilin Cancer Hospital, Changchun/CN
  • 16 State Key Laboratory Of Oncology In South China And Department Of Gynecologic Oncology, Sun Yat-sen University Cancer Center, 510060 - Guangzhou/CN
  • 17 Clinical Development, AstraZeneca, Shanghai/CN

Resources

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Abstract 230P

Background

SOLO1 (NCT01844986) is a randomized, double-blind, phase III trial evaluating the efficacy and safety of the PARP inhibitor, olaparib, as maintenance monotherapy in newly diagnosed advanced OC pts with a BRCAm. A separate pt cohort evaluated the efficacy and safety of olaparib in Chinese pts in this setting.

Methods

The China cohort of SOLO1 planned to enrol ∼53 newly diagnosed OC pts who had completed first-line platinum-based chemotherapy and were in clinical complete or partial response. This sample size provided around a 90% chance to observe a hazard ratio (HR) of < 1, assuming a true HR of 0.62. Pts were randomized 2:1 to olaparib (300 mg bid; tablet) vs placebo. The primary endpoint was investigator-assessed progression-free survival (PFS; modified RECIST v1.1). Sensitivity analysis of PFS was performed by blinded independent central review (BICR).

Results

All 64 randomized pts received study treatment (olaparib, n = 44; placebo n = 20). Median follow-up was ∼30 months in both arms. Median PFS was not reached in the olaparib arm and was 9.3 months in the placebo arm (Table).

Table: 230P

PFS events, nMedian PFS, monthsHR (95% CI; P value)
Olaparib (n = 44)Placebo (n = 20)Olaparib (n = 44)Placebo (n = 20)Full analysis set (n = 64)
PFS, investigator assessed (48.4% maturity)1813NR9.30.46 (0.23, 0.97; 0.0320)
PFS, BICR (39.1% maturity)1312NR9.30.39 (0.17, 0.86; 0.0168)

CI, confidence interval; NR, not reached.

The most common AEs in the olaparib group were nausea (n = 28, 63.6%), anaemia (n = 25, 56.8%) and vomiting (n = 18, 40.9%). Grade ≥3 AEs occurred in 56.8% of olaparib pts vs 30.0% of placebo pts; the most common grade ≥3 AE was anaemia (n = 16, 36.4%). Olaparib dose interruptions, reductions and discontinuations occurred in 56.8%, 27.3% and 6.8% of pts, respectively (vs 30.0%, 10% and 0% of pts in the placebo arm).

Conclusions

In the China cohort of SOLO1, a clinically relevant improvement in investigator-assessed PFS was observed in newly diagnosed OC pts receiving olaparib maintenance therapy. Olaparib treatment led to a 54% reduction in risk of progression or death vs placebo. The safety results were consistent with the known profile of olaparib in Chinese pts.

Clinical trial identification

NCT01844986, release date 19 February 2016.

Editorial acknowledgement

Medical writing assistance was provided by Laura Smart, MChem, from Mudskipper Business Ltd, funded by AstraZeneca and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (MSD).

Legal entity responsible for the study

AstraZeneca.

Funding

AstraZeneca.

Disclosure

J. Liu: Research grant / Funding (institution): AstraZeneca. X. Ma: Full / Part-time employment: AstraZeneca. J. Zhang: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. All other authors have declared no conflicts of interest.

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