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Poster display session

4542 - OlympiAD: Health-related quality of life (HRQoL) in patients with HER2-negative metastatic breast cancer (mBC) and a germline BRCA mutation (gBRCAm) receiving olaparib monotherapy vs standard single-agent chemotherapy treatment of physician’s choice (TPC)

Date

11 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Breast Cancer

Presenters

Mark Robson

Citation

Annals of Oncology (2017) 28 (suppl_5): v74-v108. 10.1093/annonc/mdx365

Authors

M. Robson1, K.J. Ruddy2, S. Im3, E. Senkus-Konefka4, B. Xu5, S.M. Domchek6, N. Masuda7, S. Delaloge8, W. Li9, N. Tung10, A. Armstrong11, W. Wu12, C. Goessl12, A. Degboe12, P.F. Conte13

Author affiliations

  • 1 ,, Memorial Sloan-Kettering Cancer Center, , - New York/US
  • 2 ,, Mayo Clinic, Rochester/US
  • 3 Seoul National University College Of Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul/KR
  • 4 ,, Medical University of Gdańsk, Gdańsk/PL
  • 5 Chinese Academy Of Medical Sciences And Peking Union Medical College, National Cancer Centre/Cancer Hospital, Beijing/CN
  • 6 ,, Basser Center, University of Pennsylvania, Philadelphia/US
  • 7 ,, National Hospital Organization, Osaka National Hospital, Osaka/JP
  • 8 ,, Institut Gustave Roussy, Villejuif/FR
  • 9 ,, The First Hospital of Jilin University, Changchun/CN
  • 10 Dana-farber Harvard Cancer Center, Beth Israel Deaconess Medical Center, Boston/US
  • 11 ,, Christie Hospital NHS Foundation Trust and Faculty of Biology, Medicine and Health, Manchester/GB
  • 12 ,, AstraZeneca, Gaithersburg/US
  • 13 ,, University of Padova and Istituto Oncologico Veneto IRCCS, Padova/IT
More

Resources

Abstract 4542

Background

The Phase III OlympiAD study showed a statistically significant and clinically meaningful PFS survival benefit with olaparib monotherapy, compared with standard of care chemotherapy (median 7.0 vs 4.2 months, respectively, hazard ratio 0.58; 95% CI 0.43, 0.80; P = 0.0009) in patients (pts) with HER2-negative mBC and a gBRCAm. A key predefined secondary objective was to assess the effect of olaparib on HRQoL.

Methods

The randomized, open-label, Phase III OlympiAD study (NCT02000622) enrolled pts with HER2-negative mBC and a gBRCAm, after ≤2 chemotherapy lines for mBC. Pts were randomized 2:1 to olaparib tablets (300 mg bid) or single-agent treatment of physician’s choice (TPC; capecitabine, vinorelbine or eribulin). Pts were asked to complete an EORTC QLQ-C30 questionnaire (analysis focused on the Global HRQoL scale with range 0–100, and higher scores indicating a better QoL), at baseline and every 6 weeks until disease progression. Changes in Global HRQoL scores were analyzed descriptively, and mean change from baseline (cfb) by a mixed model for repeated measures.

Results

302 pts (ITT) were randomized to olaparib (n = 205) or TPC (n = 97). Overall QLQ-C30 compliance rate was 93% for olaparib vs 77% for TPC. HRQoL was better preserved with olaparib than TPC (mean cfb in Global HRQoL score across all visits was 3.9 [n = 191] vs -3.6 [n = 73], respectively, difference 7.5; 95% CI 2.48, 12.44; P=0.0035). The proportion of pts (ITT) who were free of Global HRQoL deterioration (cfb decrease in ≥ 10 points) was 81.5% in the olaparib arm vs 61.2% in the TPC arm at 6 months, and 64.0% vs 53.5% at 12 months, respectively. The median time to Global HRQoL deterioration was not reached in olaparib pts, and was 15.3 months for TPC pts. A best HRQoL response of ‘improved’ (cfb increase in ≥ 10 points over two visits ≥21 days apart) was observed in 34% olaparib pts vs 13% TPC.

Conclusions

Pts receiving olaparib experienced significantly less and later deterioration in Global HRQoL vs TPC. HRQoL was modestly and consistently greater in patients receiving olaparib compared with TPC.

Clinical trial identification

Clinical trials no: NCT02000622

Release date: 18 November 2013

AstraZeneca name: OlympiAD

AstraZeneca number: D0819C00003.

Legal entity responsible for the study

AstraZeneca

Funding

AstraZeneca

Disclosure

M. Robson: Consultancy: AstraZeneca and McKesson. Travel, accommodation and expenses and honoraria: AstraZeneca. Research funding: AstraZeneca, AbbVie, Myriad Genetics and Medivation. S-A. Im: Research grant from AstraZeneca. E. Senkus-Konefka: Honoraria, Consulting/Advisory: Amgen, AstraZeneca, Pfizer, Pierre Fabre, Roche. Travel, accommodation, expenses: Amgen, AstraZeneca, Pfizer, Novartis, Roche. S.M. Domchek: Honorarium from EMD Serrano.The University of Pennsylvania has received research funding from AbbVie and Clovis. N. Masuda: Personal honoraria from: Chugai Pharma and AstraZeneca. Institution research funding from: Chugai Pharma, AstraZeneca, Kyowa Hakka Kirin, MSD, Novartis, Pfizer and Lilly. S. Delaloge: AstraZeneca advisory board member, and institution funded for sponsored research from AstraZeneca. N. Tung: Research funding from Myriad and Ambry. A. Armstrong: Consulting/advisory: Roche, Syndax. W. Wu, C. Goessl, A. Degboe: AstraZeneca employee with stocks. P.F. Conte: Speakers\' bureau and advisory board: AstraZeneca. All other authors have declared no conflicts of interest.

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