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Poster Discussion – Gynaecological cancers

2325 - Patient-centred outcomes with maintenance olaparib in newly diagnosed patients with advanced ovarian cancer (OC) and a BRCA mutation (BRCAm) in the Phase III SOLO1 trial to support the clinical benefit of prolongation of progression-free survival (PFS)

Date

29 Sep 2019

Session

Poster Discussion – Gynaecological cancers

Presenters

Michael Friedlander

Citation

Annals of Oncology (2019) 30 (suppl_5): v403-v434. 10.1093/annonc/mdz250

Authors

M.L. Friedlander1, K. Moore2, N. Colombo3, G. Scambia4, B. Kim5, A. Oaknin6, A. Lisyanskaya7, A. Floquet8, A. Leary9, G.S. Sonke10, C. Gourley11, S. Banerjee12, A. Oza13, A. González-Martín14, C. Aghajanian15, W. Bradley16, E. Lowe17, R. Hettle18, E. Flood17, P. DiSilvestro19

Author affiliations

  • 1 -, University of New South Wales Clinical School, Prince of Wales Hospital, - - Randwick/AU
  • 2 -, Stephenson Cancer Center at the University of Oklahoma, - - Oklahoma City/US
  • 3 -, University of Milan-Bicocca and Istituto Europeo di Oncologia, 20141 - Milan/IT
  • 4 -, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, Rome/IT
  • 5 -, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul/KR
  • 6 -, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), 08035 - Barcelona/ES
  • 7 -, St Petersburg City Oncology Dispensary, St Petersburg/RU
  • 8 -, Institut Bergonié, Comprehensive Cancer Centre, Bordeaux, and Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens, 33076 - -/FR
  • 9 -, Gustave-Roussy Cancer Campus, Villejuif, and Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens, -/FR
  • 10 -, The Netherlands Cancer Institute, 1066 CX - Amsterdam/NL
  • 11 -, Cancer Research UK Edinburgh Centre, Institute of Genetics and Molecular Medicine, University of Edinburgh, EH4 2XR - Edinburgh/GB
  • 12 -, The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London/GB
  • 13 -, Princess Margaret Cancer Centre, Toronto/CA
  • 14 -, Clínica Universidad de Navarra, Madrid/ES
  • 15 -, Memorial Sloan Kettering Cancer Center, New York/US
  • 16 -, Froedtert and the Medical College of Wisconsin, Milwaukee/US
  • 17 -, AstraZeneca, Gaithersburg/US
  • 18 -, AstraZeneca, Cambridge/GB
  • 19 -, Women & Infants Hospital, Providence/US

Resources

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Abstract 2325

Background

In SOLO1 (NCT01844986; GOG-3004), maintenance olaparib significantly improved PFS vs placebo (HR 0.30; 95% CI 0.23–0.41; Moore et al. NEJM 2018) in patients with newly diagnosed advanced OC, a BRCAm and clinical complete or partial response after platinum-based chemotherapy. Most patients in the maintenance setting are well following first-line treatment; thus, it is important to show that extending PFS is not at the expense of decreased health-related quality of life because of toxicity. We assessed the duration of ‘good quality of life’ while on maintenance therapy based on time without significant symptoms of toxicity (TWiST) and quality-adjusted PFS (QAPFS) which both incorporate the adverse effects experienced by patients on maintenance therapy.

Methods

Patients were randomized 2:1 to olaparib tablets 300 mg bid or placebo. Patient-centred outcomes were assessed by QAPFS (product of adjusted mean estimate of the EuroQol 5D-5L single-index utility score from randomization to disease progression and mean PFS time) and TWiST (period without significant symptoms post-randomization and before disease progression or censoring for progression) in a post hoc analysis in the full analysis set.

Results

Of 391 randomized patients, 260 received olaparib and 130 placebo (one patient did not receive placebo). Mean QAPFS and TWiST improved to a clinically meaningful extent with olaparib vs placebo, with highly significant between-group improvements of at least 12 months (Table).Table: 996PD

OlaparibPlacebo
QAPFSn = 260n = 131
Mean duration (95% CI), months29.75 (28.20–31.63)17.58 (15.05–20.18)
Between-group difference (95% CI), months12.17 (9.07–15.11)
P valueP < 0.001
TWiST*n = 260n = 131
Mean duration (95% CI), months33.15 (30.82–35.49)20.24 (17.36–23.11)
Between-group difference (95% CI), months12.92 (9.30–16.54)
P valueP < 0.001
*

TWiST is the time without significant symptoms of toxicity, defined as grade ≥2 nausea, vomiting or fatigue

Conclusions

There were clinically meaningful patient-centred benefits with maintenance olaparib in both QAPFS and TWiST supporting the substantial benefit of PFS improvement seen with olaparib in newly diagnosed advanced OC.

Clinical trial identification

NCT01844986 (SOLO1; GOG-3004).

Editorial acknowledgement

Gillian Keating, MBChB, 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 and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (MSD).

Funding

AstraZeneca and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (MSD).

Disclosure

M.L. Friedlander: Honoraria (self), Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: MSD; Advisory / Consultancy: Lilly; Advisory / Consultancy: Takeda; Non-remunerated activity/ies: AbbVie. K. Moore: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Advaxis; Advisory / Consultancy: Clovis Oncology; Advisory / Consultancy: Tesaro; Advisory / Consultancy: Genentech/Roche; Advisory / Consultancy: Immunogen; Advisory / Consultancy: VBL Therapeutics; Advisory / Consultancy: Merck; Advisory / Consultancy: Janssen; Advisory / Consultancy: Aravive; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Eisai; Advisory / Consultancy: Samumed; Advisory / Consultancy: Oncomed. N. Colombo: Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Tesaro; Honoraria (self), Advisory / Consultancy: PharmaMar; Advisory / Consultancy: Clovis Oncology; Advisory / Consultancy: Pfizer. A. Oaknin: Advisory / Consultancy: Roche; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: PharmaMar; Advisory / Consultancy: Clovis Oncology; Advisory / Consultancy: Tesaro; Advisory / Consultancy: Immunogen; Advisory / Consultancy: Genmab. A. Floquet: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Clovis Oncology; Advisory / Consultancy: Roche; Advisory / Consultancy: PharmaMar; Advisory / Consultancy: Tesaro. A. Leary: Honoraria (self), Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Clovis Oncology; Advisory / Consultancy: Biocad; Advisory / Consultancy: Seattle Genetics. G.S. Sonke: Research grant / Funding (self): AstraZeneca; Research grant / Funding (self): Merck; Research grant / Funding (self): Novartis; Research grant / Funding (self): Roche. C. Gourley: Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): AstraZeneca; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Tesaro; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Nucana; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Clovis Oncology; Honoraria (self), Advisory / Consultancy: Foundation One; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Sierra Oncology; Research grant / Funding (self): Novartis; Research grant / Funding (self): Aprea. S. Banerjee: Honoraria (self), Research grant / Funding (institution): AstraZeneca; Honoraria (self): Tesaro; Honoraria (self): Clovis Oncology; Honoraria (self): Merck; Honoraria (self): PharmaMar; Honoraria (self): Roche; Honoraria (self): Seattle Genetics; Honoraria (self): Nucana. A. Oza: Non-remunerated activity/ies: AstraZeneca; Non-remunerated activity/ies: Clovis Oncology; Non-remunerated activity/ies: Tesaro. A. González-Martín: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Tesaro; Advisory / Consultancy: PharmaMar; Advisory / Consultancy: Roche; Advisory / Consultancy: Clovis Oncology; Advisory / Consultancy: Immunogen; Advisory / Consultancy: Genmab; Advisory / Consultancy: Pfizer; Advisory / Consultancy: MSD. C. Aghajanian: Honoraria (self): Tesaro; Honoraria (self): ImmunoGen; Honoraria (self): Clovis Oncology. E. Lowe: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. R. Hettle: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. E. Flood: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. P. DiSilvestro: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Tesaro. All other authors have declared no conflicts of interest.

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