Patient-reported outcomes in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer receiving olaparib versus chemotherapy in the OlympiAD trial

Mark Robson; Kathryn J. Ruddy; Seock Ah IM; Elżbieta Senkus; Binghe Xu; Susan M. Domchek; Norikazu Masuda; Wei Li; Nadine Tung; Anne Armstrong; Suzette Delaloge; Wendy Bannister; Carsten Goessl; Arnold Degboe; Robert Hettle; Pierfranco Conte

doi:10.1016/j.ejca.2019.06.023

Patient-reported outcomes in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer receiving olaparib versus chemotherapy in the OlympiAD trial

Mark Robson, Kathryn J. Ruddy, Seock Ah IM, Elżbieta Senkus, Binghe Xu, Susan M. Domchek, Norikazu Masuda, Wei Li, Nadine Tung, Anne Armstrong, Suzette Delaloge, Wendy Bannister, Carsten Goessl, Arnold Degboe, Robert Hettle, Pierfranco Conte

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Abstract

Background: The phase III OlympiAD study (NCT02000622) showed a statistically significant progression-free survival benefit with olaparib versus chemotherapy treatment of physician's choice (TPC) in patients with a germline BRCA mutation and human epidermal growth factor receptor 2-negative metastatic breast cancer. From this study, we report the effect of olaparib on health-related quality of life (HRQoL). Methods: Patients were randomised 2:1 to olaparib monotherapy (300 mg twice daily) or single-agent TPC. The primary HRQoL end-point was mean change from baseline in the two-item global health status/QoL score determined from patient-completed European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item module (EORTC QLQ-C30) questionnaires and assessed using a mixed model for repeated measures. Symptoms and functioning domains, best overall response and time to deterioration of QoL were also evaluated. Results: Overall questionnaire compliance rates were 93.2% for olaparib and 76.3% for TPC. Between-treatment global health status/QoL comparison showed a significant improvement in the olaparib arm versus the TPC arm, with mean change of 3.9 (standard deviation 1.2) versus −3.6 (2.2), a difference of 7.5 points (95% confidence interval [CI]: 2.48, 12.44; P = 0.0035). A higher proportion of patients in the olaparib arm showed a best overall response of ‘improvement’ in global health status/QoL (33.7% vs 13.4%). Median time to global health status/QoL deterioration was not reached in olaparib patients and was 15.3 months for TPC patients (hazard ratio: 0.44 [95% CI: 0.25, 0.77]; P = 0.004). For EORTC QLQ-C30 symptoms and functioning subscales, only nausea/vomiting symptom score was worse in the olaparib arm than in the TPC arm (across all visits compared with baseline). Conclusion: HRQoL was consistently improved for patients treated with olaparib, compared with chemotherapy TPC.

Original language	English
Pages (from-to)	20-30
Number of pages	11
Journal	European Journal of Cancer
Volume	120
DOIs	https://doi.org/10.1016/j.ejca.2019.06.023
Publication status	Published - 1 Oct 2019

Keywords

BRCA
Breast cancer
EORTC QLQ-C30
Health-related quality of life
Olaparib
OlympiAD

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10.1016/j.ejca.2019.06.023

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Robson, M., Ruddy, K. J., IM, S. A., Senkus, E., Xu, B., Domchek, S. M., Masuda, N., Li, W., Tung, N., Armstrong, A., Delaloge, S., Bannister, W., Goessl, C., Degboe, A., Hettle, R., & Conte, P. (2019). Patient-reported outcomes in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer receiving olaparib versus chemotherapy in the OlympiAD trial. European Journal of Cancer, 120, 20-30. https://doi.org/10.1016/j.ejca.2019.06.023

@article{f4d4802cdb49444bb2d592d7e29ec90e,

title = "Patient-reported outcomes in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer receiving olaparib versus chemotherapy in the OlympiAD trial",

abstract = "Background: The phase III OlympiAD study (NCT02000622) showed a statistically significant progression-free survival benefit with olaparib versus chemotherapy treatment of physician's choice (TPC) in patients with a germline BRCA mutation and human epidermal growth factor receptor 2-negative metastatic breast cancer. From this study, we report the effect of olaparib on health-related quality of life (HRQoL). Methods: Patients were randomised 2:1 to olaparib monotherapy (300 mg twice daily) or single-agent TPC. The primary HRQoL end-point was mean change from baseline in the two-item global health status/QoL score determined from patient-completed European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item module (EORTC QLQ-C30) questionnaires and assessed using a mixed model for repeated measures. Symptoms and functioning domains, best overall response and time to deterioration of QoL were also evaluated. Results: Overall questionnaire compliance rates were 93.2% for olaparib and 76.3% for TPC. Between-treatment global health status/QoL comparison showed a significant improvement in the olaparib arm versus the TPC arm, with mean change of 3.9 (standard deviation 1.2) versus −3.6 (2.2), a difference of 7.5 points (95% confidence interval [CI]: 2.48, 12.44; P = 0.0035). A higher proportion of patients in the olaparib arm showed a best overall response of {\textquoteleft}improvement{\textquoteright} in global health status/QoL (33.7% vs 13.4%). Median time to global health status/QoL deterioration was not reached in olaparib patients and was 15.3 months for TPC patients (hazard ratio: 0.44 [95% CI: 0.25, 0.77]; P = 0.004). For EORTC QLQ-C30 symptoms and functioning subscales, only nausea/vomiting symptom score was worse in the olaparib arm than in the TPC arm (across all visits compared with baseline). Conclusion: HRQoL was consistently improved for patients treated with olaparib, compared with chemotherapy TPC.",

keywords = "BRCA, Breast cancer, EORTC QLQ-C30, Health-related quality of life, Olaparib, OlympiAD",

author = "Mark Robson and Ruddy, {Kathryn J.} and IM, {Seock Ah} and El{\.z}bieta Senkus and Binghe Xu and Domchek, {Susan M.} and Norikazu Masuda and Wei Li and Nadine Tung and Anne Armstrong and Suzette Delaloge and Wendy Bannister and Carsten Goessl and Arnold Degboe and Robert Hettle and Pierfranco Conte",

note = "Publisher Copyright: {\textcopyright} 2019 Elsevier Ltd",

year = "2019",

month = oct,

day = "1",

doi = "10.1016/j.ejca.2019.06.023",

language = "English",

volume = "120",

pages = "20--30",

journal = "European Journal of Cancer",

issn = "0959-8049",

}

Robson, M, Ruddy, KJ, IM, SA, Senkus, E, Xu, B, Domchek, SM, Masuda, N, Li, W, Tung, N, Armstrong, A, Delaloge, S, Bannister, W, Goessl, C, Degboe, A, Hettle, R & Conte, P 2019, 'Patient-reported outcomes in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer receiving olaparib versus chemotherapy in the OlympiAD trial', European Journal of Cancer, vol. 120, pp. 20-30. https://doi.org/10.1016/j.ejca.2019.06.023

TY - JOUR

T1 - Patient-reported outcomes in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer receiving olaparib versus chemotherapy in the OlympiAD trial

AU - Robson, Mark

AU - Ruddy, Kathryn J.

AU - IM, Seock Ah

AU - Senkus, Elżbieta

AU - Xu, Binghe

AU - Domchek, Susan M.

AU - Masuda, Norikazu

AU - Li, Wei

AU - Tung, Nadine

AU - Armstrong, Anne

AU - Delaloge, Suzette

AU - Bannister, Wendy

AU - Goessl, Carsten

AU - Degboe, Arnold

AU - Hettle, Robert

AU - Conte, Pierfranco

PY - 2019/10/1

Y1 - 2019/10/1

N2 - Background: The phase III OlympiAD study (NCT02000622) showed a statistically significant progression-free survival benefit with olaparib versus chemotherapy treatment of physician's choice (TPC) in patients with a germline BRCA mutation and human epidermal growth factor receptor 2-negative metastatic breast cancer. From this study, we report the effect of olaparib on health-related quality of life (HRQoL). Methods: Patients were randomised 2:1 to olaparib monotherapy (300 mg twice daily) or single-agent TPC. The primary HRQoL end-point was mean change from baseline in the two-item global health status/QoL score determined from patient-completed European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item module (EORTC QLQ-C30) questionnaires and assessed using a mixed model for repeated measures. Symptoms and functioning domains, best overall response and time to deterioration of QoL were also evaluated. Results: Overall questionnaire compliance rates were 93.2% for olaparib and 76.3% for TPC. Between-treatment global health status/QoL comparison showed a significant improvement in the olaparib arm versus the TPC arm, with mean change of 3.9 (standard deviation 1.2) versus −3.6 (2.2), a difference of 7.5 points (95% confidence interval [CI]: 2.48, 12.44; P = 0.0035). A higher proportion of patients in the olaparib arm showed a best overall response of ‘improvement’ in global health status/QoL (33.7% vs 13.4%). Median time to global health status/QoL deterioration was not reached in olaparib patients and was 15.3 months for TPC patients (hazard ratio: 0.44 [95% CI: 0.25, 0.77]; P = 0.004). For EORTC QLQ-C30 symptoms and functioning subscales, only nausea/vomiting symptom score was worse in the olaparib arm than in the TPC arm (across all visits compared with baseline). Conclusion: HRQoL was consistently improved for patients treated with olaparib, compared with chemotherapy TPC.

AB - Background: The phase III OlympiAD study (NCT02000622) showed a statistically significant progression-free survival benefit with olaparib versus chemotherapy treatment of physician's choice (TPC) in patients with a germline BRCA mutation and human epidermal growth factor receptor 2-negative metastatic breast cancer. From this study, we report the effect of olaparib on health-related quality of life (HRQoL). Methods: Patients were randomised 2:1 to olaparib monotherapy (300 mg twice daily) or single-agent TPC. The primary HRQoL end-point was mean change from baseline in the two-item global health status/QoL score determined from patient-completed European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item module (EORTC QLQ-C30) questionnaires and assessed using a mixed model for repeated measures. Symptoms and functioning domains, best overall response and time to deterioration of QoL were also evaluated. Results: Overall questionnaire compliance rates were 93.2% for olaparib and 76.3% for TPC. Between-treatment global health status/QoL comparison showed a significant improvement in the olaparib arm versus the TPC arm, with mean change of 3.9 (standard deviation 1.2) versus −3.6 (2.2), a difference of 7.5 points (95% confidence interval [CI]: 2.48, 12.44; P = 0.0035). A higher proportion of patients in the olaparib arm showed a best overall response of ‘improvement’ in global health status/QoL (33.7% vs 13.4%). Median time to global health status/QoL deterioration was not reached in olaparib patients and was 15.3 months for TPC patients (hazard ratio: 0.44 [95% CI: 0.25, 0.77]; P = 0.004). For EORTC QLQ-C30 symptoms and functioning subscales, only nausea/vomiting symptom score was worse in the olaparib arm than in the TPC arm (across all visits compared with baseline). Conclusion: HRQoL was consistently improved for patients treated with olaparib, compared with chemotherapy TPC.

KW - BRCA

KW - Breast cancer

KW - EORTC QLQ-C30

KW - Health-related quality of life

KW - Olaparib

KW - OlympiAD

UR - http://www.scopus.com/inward/record.url?scp=85070926015&partnerID=8YFLogxK

U2 - 10.1016/j.ejca.2019.06.023

DO - 10.1016/j.ejca.2019.06.023

M3 - Article

C2 - 31446213

AN - SCOPUS:85070926015

SN - 0959-8049

VL - 120

SP - 20

EP - 30

JO - European Journal of Cancer

JF - European Journal of Cancer

ER -

Patient-reported outcomes in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer receiving olaparib versus chemotherapy in the OlympiAD trial

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Keywords

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