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

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

doi:10.1016/j.ejca.2019.06.023

Cited by 75 publications

(77 citation statements)

References 16 publications

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“…About EORTC QLQ-C30 symptoms and functioning subscales,the EMBRACA phase III trial showed that compared to the PCT arm,patients who treated with TALA signi cantly delayed TTD in all symptoms [25].Meanwhile,there is similar result in the OlympiAD trial,except vomiting/nausea symptom score compared with TPC arm [36].…”

Section: Discussionmentioning

confidence: 93%

Poly(ADP-Ribose) Polymerase Inhibitors (PARPi) for Patients With Advanced Breast Cancer: a Meta-analysis of Randomized Controlled Trials

Su¹,

Zheng²

2020

Preprint

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BACKGROUND: Poly(ADP–ribose) polymerase (PARP) inhibitors are new class of drugs that are currently being studied in several malignancies. However, datas about the efficacy and safety of the PARP inhibitors are limited. Therefore, we conducted a meta-analysis of randomized controlled trials (RCT) in patients with breast cancer.METHODS: Pubmed/Medline, Embase, Cochrane Library, and abstracts presented at the annual meeting of the American Society of Clinical Oncology (ASCO) were searched for articles published from 2000 to June 2018.Summary incidences and the RR, HR with 95% confidence intervals, were calculated by using a random-effects or fixed-effects model.RESULTS: The summary HR indicated PARPi was not associated with OS (HR=0.83, 95%CI 0.66–1.06, Z=1.49, P=0.14), while it could significantly improve PFS ande time to deterioration (TTD) of global health status/quality of life(GHS/QoL) as compared with traditional standard therapy, the HR was 0.60(95%CI 0.50-0.72; Z=5.52, P＜0.00001) and 0.4 (95%CI 0.29–0.54,z=5.80 ,p=0.000),respectively.The RR of grade 3 or more anemia ,fatigue and headache was 3.02 (95% CI, 0.69–13.17;p = 0.14,,I2=90%),0.77 (95%CI, 0.34–1.73;p=0.52,I2=7%) and 1.13 (95% CI,0.30–4.18;p=0.86,I2=0%),respectively.CONCLUSION: The findings of this meta-analysis showed that PARPi has no significant effect on OS, while it could significantly improve in PFS and TTD of GHS/QoL for patients with advanced or metastatic breast cancer.Furthermore,our findings also demonstrated that the PARPi treatment is connected with an increased risk of grade 3 or more anemia adverse events.

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Section: Discussionmentioning

confidence: 93%

Poly(ADP-Ribose) Polymerase Inhibitors (PARPi) for Patients With Advanced Breast Cancer: a Meta-analysis of Randomized Controlled Trials

Su¹,

Zheng²

2020

Preprint

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“…Later, other PARPi, such as nirapararib and rucaparib were approved [ 25 , 26 , 27 , 28 ]. On January 2018, based on data from OlympiAD trial (NCT02000622), FDA granted regular approval to Olpararib for the treatment of patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer previously treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting [ 9 ]. FDA also approved the BRACAnalysis CDx ® test (Myriad Genetic Laboratories, Inc., Salt Lake City, UT, USA), whose accuracy was established based on a retrospective/prospective analysis of the OlympiAD trial population.…”

Section: Brca1/2 and Other Genes Involved In Dna Repairmentioning

confidence: 99%

“…In the last years, a great effort has been spent to identify new biomarkers and relative therapies, but only few of these have proven useful in clinical trials. Beside poly ADP-ribose polymerase (PARP) inhibitors, that have successfully been incorporated in the clinical practice in the BRCA1/2 subgroup of patients [ 9 , 10 ], and checkpoint inhibitor Atezolizumab, that was recently approved as front-line therapy in the metastatic setting [ 11 ], traditional chemotherapy without biomarker guide still remains the main therapeutic options for a large part of TNBC patients [ 12 ]. In this context, the implementation of more refined “omics” assays, along with appropriately designed clinical trials, may lead to the identification of new biomarkers to select new molecularly targeted therapies in TNBC.…”

Section: Introductionmentioning

confidence: 99%

Biomarkers in Triple-Negative Breast Cancer: State-of-the-Art and Future Perspectives

Cocco

Piezzo

Calabrese

et al. 2020

IJMS

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Triple-negative breast cancer (TNBC) is a heterogeneous group of tumors characterized by aggressive behavior, high risk of distant recurrence, and poor survival. Chemotherapy is still the main therapeutic approach for this subgroup of patients, therefore, progress in the treatment of TNBC remains an important challenge. Data derived from molecular technologies have identified TNBCs with different gene expression and mutation profiles that may help developing targeted therapies. So far, however, only a few of these have shown to improve the prognosis and outcomes of TNBC patients. Robust predictive biomarkers to accelerate clinical progress are needed. Herein, we review prognostic and predictive biomarkers in TNBC, discuss the current evidence supporting their use, and look at the future of this research field.

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“…A higher proportion of patients in the olaparib arm showed improvement in global health status/quality of life (QoL) (33.7% vs 13.4%). Median time to QoL deterioration was not reached in patients receiving olaparib and was 15.3 months for patients receiving TPC (hazard ratio: 0.44 [95% CI, 0.25‐ 0.77]; P = .004) 17 …”

Section: Parpi In Advanced or Metastatic Breast Cancermentioning

confidence: 99%

Medical Management of newly diagnosed breast cancer in a BRCA1/2 mutation carrier

Desai

Tung

2020

Breast J

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Germline BRCA1/2 mutations may be infrequent in unselected breast cancer population but are concentrated in those with triple‐negative breast cancer or high‐risk family history. Insight into the biology of BRCA mutation is now allowing a targeted therapeutic approach to these carriers with breast cancer. Functional BRCA genes play a critical role in DNA damage repair. Agents such as platinum salts and poly (ADP‐ribose) polymerase (PARP) inhibitors exploit this vulnerability of impaired DNA damage repair mechanism in BRCA mutant cancers to leverage therapeutic benefit. Research has demonstrated improved response rates to platinum salts in BRCA‐mutated compared with non‐BRCA‐mutated breast cancer, particularly in the metastatic setting. Additionally, clinical trials of single‐agent PARP inhibitors have shown encouraging response rates and progression‐free survival in patients with BRCA1/2‐mutated breast cancer. In this review, we summarize the medical management of BRCA‐associated breast cancer.

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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

Cited by 75 publications

References 16 publications

Poly(ADP-Ribose) Polymerase Inhibitors (PARPi) for Patients With Advanced Breast Cancer: a Meta-analysis of Randomized Controlled Trials

Poly(ADP-Ribose) Polymerase Inhibitors (PARPi) for Patients With Advanced Breast Cancer: a Meta-analysis of Randomized Controlled Trials

Biomarkers in Triple-Negative Breast Cancer: State-of-the-Art and Future Perspectives

Medical Management of newly diagnosed breast cancer in a BRCA1/2 mutation carrier

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