Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer

Geyer, Charles E.; Garber, Judy E.; Gelber, Richard D.; Yothers, Greg; Taboada, Manuel; Ross, L.; Rastogi, Priya; Cui, Karen; Arahmani, Amal; Aktan, Gursel; Armstrong, Anne; Arnedos, Mónica; Balmañà, Judith; Bergh, Jonas; Bliss, Judith M.; Delaloge, Suzette; Domchek, Susan M.; Eisen, Andrea; Elsafy, F.; Fein, L.E.; Fielding, Anitra; Ford, James M.; Friedman, Sue; Gelmon, Karen A.; Gianni, Luca; Gnant, Michael; Hollingsworth, Simon J.; Im, Seock‐Ah; Jager, Agnes; Jóhannsson, Óskar T.; Lakhani, Sunil R.; Janni, W; Linderholm, Barbro; Liu, T.-W.; Loman, Niklas; Korde, Larissa A.; Loibl, Sibylle; Lucas, Peter C.; Marmé, Frederik; Dueñas, Eduardo Martínez de; McConnell, Robin; Phillips, Kelly‐Anne; Piccart, Martine; Rossi, Giuseppe; Schmutzler, Rita K.; Senkus, Elżbieta; Shao, Zhi-Ming; Sharma, Priyanka; Singer, Christian F.; Španić, Tanja; Stickeler, Elmar; Toi, Masakazu; Traina, Tiffany A.; Viale, Giuseppe; Zoppoli, Gabriele; Park, Y.H.; Yerushalmi, Rinat; Yang, Huajing; Pang, Danmei; Jung, Kyung Hae; Mailliez, Audrey; Fan, Zhaoqing; Tennevet, Isabelle; Zhang, J.; Nagy, T.; Sonke, Gabe S.; Sun, Qiuhong; Parton, Marina; Colleoni, Marco; Schmidt, Marcus; Brufsky, Adam; Razaq, W.; Kaufman, Bella; Cameron, David; Campbell, Christine; Tutt, Andrew N.J.

doi:10.1016/j.annonc.2022.09.159

Cited by 196 publications

(105 citation statements)

References 31 publications

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“…Recent therapeutic advances have led to PARPi being used for first line maintenance treatment of BRCA1/2 mutated HER-2 negative BC and high-grade epithelial OC. Following initial improved disease-free survival in 2021 [ 77 ], increased overall survival was recently demonstrated on second interim analysis for HER-2 negative early BC (HR = 0.68; 98.5% CI = 0.47–0.97; p = 0.009) [ 78 ]. However, only progression-free survival has so far been demonstrated for OC (HR = 0.33; 95% CI = 0.25–0.43), with overall survival data remain unavailable [ 79 , 80 ].…”

Section: Discussionmentioning

confidence: 99%

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Cost-Effectiveness of Risk-Reducing Surgery for Breast and Ovarian Cancer Prevention: A Systematic Review

Xia

Oxley

Sideris

et al. 2022

Cancers

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Policymakers require robust cost-effectiveness evidence of risk-reducing-surgery (RRS) for decision making on resource allocation for breast cancer (BC)/ovarian cancer (OC)/endometrial cancer (EC) prevention. We aimed to summarise published data on the cost-effectiveness of risk-reducing mastectomy (RRM)/risk-reducing salpingo-oophorectomy (RRSO)/risk-reducing early salpingectomy and delayed oophorectomy (RRESDO) for BC/OC prevention in intermediate/high-risk populations; hysterectomy and bilateral salpingo-oophorectomy (BSO) in Lynch syndrome women; and opportunistic bilateral salpingectomy (OBS) for OC prevention in baseline-risk populations. Major databases were searched until December 2021 following a prospective protocol (PROSPERO-CRD42022338008). Data were qualitatively synthesised following a PICO framework. Twenty two studies were included, with a reporting quality varying from 53.6% to 82.1% of the items scored in the CHEERS checklist. The incremental cost-effectiveness ratio/incremental cost-utility ratio and cost thresholds were inflated and converted to US$2020, using the original currency consumer price index (CPI) and purchasing power parities (PPP), for comparison. Eight studies concluded that RRM and/or RRSO were cost-effective compared to surveillance/no surgery for BRCA1/2, while RRESDO was cost-effective compared to RRSO in one study. Three studies found that hysterectomy with BSO was cost-effective compared to surveillance in Lynch syndrome women. Two studies showed that RRSO was also cost-effective at ≥4%/≥5% lifetime OC risk for pre-/post-menopausal women, respectively. Seven studies demonstrated the cost-effectiveness of OBS at hysterectomy (n = 4), laparoscopic sterilisation (n = 4) or caesarean section (n = 2). This systematic review confirms that RRS is cost-effective, while the results are context-specific, given the diversity in the target populations, health systems and model assumptions, and sensitive to the disutility, age and uptake rates associated with RRS. Additionally, RRESDO/OBS were sensitive to the uncertainty concerning the effect sizes in terms of the OC-risk reduction and long-term health impact. Our findings are relevant for policymakers/service providers and the design of future research studies.

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Section: Discussionmentioning

confidence: 99%

“…Nevertheless, future studies should incorporate these innovative therapies for cancer treatment into relevant cost-utility analysis as mature data emerge. While this is possible now for BC [ 78 ], overall survival data for OC remain unavailable and need to be made available for robust cost-effectiveness analysis.…”

Section: Discussionmentioning

confidence: 99%

Cost-Effectiveness of Risk-Reducing Surgery for Breast and Ovarian Cancer Prevention: A Systematic Review

Xia

Oxley

Sideris

et al. 2022

Cancers

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“…The clinical use of PARPi in BC was first reported in 2009 by the OlympiAD study, and olaparib was the first to receive the United States of America (USA) Food and Drug Administration (FDA) approval for treating metastatic breast cancer (MBC) [8]. Furthermore, a recent clinical trial, OlympiA, corroborated the benefits of PARPi in the adjuvant setting for high-risk HER2-negative BC patients with gBRCA PVs, calling for revisiting the criteria for the gBRCA testing [9,10]. Due to the OlympiA study, olaparib has recently been approved by the USA FDA for the adjuvant treatment of high-risk early breast cancer [11].…”

Section: Introductionmentioning

confidence: 99%

“…Due to the decreased cost of gBRCA testing and the promising efficacy of olaparib therapy to improve survival in patients with breast cancer and BRCA1/2 PVs, it is essential to examine whether gBRCA testing is appropriate for all patients with TNBC and HRpositive HER2-negative breast tumours [9,10,18]. Experts in the field have advocated for increasing access to gBRCA testing worldwide [19].…”

Section: Introductionmentioning

confidence: 99%

All HER2-negative breast cancer patients need gBRCA testing: cost-effectiveness and clinical benefits

Luo

et al. 2022

Br J Cancer

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Background The OlympiA trial demonstrated the benefits of adjuvant usage of olaparib for high-risk patients with human epidermal growth factor receptor 2 (HER2)-negative breast cancer (BC) and germline BRCA (gBRCA) mutation. This provoked thoughts on the clinical criteria of gBRCA testing. This study aims to estimate the costs and benefits of gBRCA testing and adjuvant olaparib therapy for patients with triple-negative breast cancer (TNBC) and hormone-receptor (HR)-positive and HER2-negative BC in China and the United States of America (USA). Methods We used a Markov chain decision tree analytic model to compare three gBRCA screening policies in China and the USA: (1) no gBRCA testing; (2) selected gBRCA testing and (3) universal gBRCA testing for nonmetastatic TNBC and HR-positive HER2-negative BC patients. We modelled the benefit of systemic therapy and risk-reducing surgeries among patients identified with pathogenic or likely pathogenic variants (PVs) in BRCA1 and BRCA2. Results Changing from the selected gBRCA testing to the universal gBRCA testing in TNBC patients is cost-effective, with the incremental cost-effectiveness ratios (ICERs) being 10991.1 and 56518.2 USD/QALY in China and the USA, respectively. Expanding universal gBRCA testing to HR-positive HER2-negative BC and TNBC patients has ICERs of 2023.3 and 16611.1 USD/QALY in China and the USA, respectively. Discussion By performing gBRCA testing on all HER2-negative BC patients, adjuvant olaparib can be offered to high-risk patients with a PV in BRCA1 or BRCA2. These patients are also candidates for risk-reducing surgeries, an important aspect of their survivorship care, and these interventions can improve survival outcomes. With the willingness-to-pay thresholds being 31,500.0 and 100,000.0 USD per QALY gained in China and the USA, respectively, universal gBRCA testing is likely cost-effective for all HER2-negative BC patients. This simplified criterion of gBRCA testing for BC is recommended for adoption by current guidelines in China and the USA.

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“…A final aspect deserving to be pointed out is the evolving scenario of PARP-inhibitor landscape based on the OlympiA trial results [ 49 , 50 ], demonstrating the value in terms of invasive disease free survival, distant-disease free survival and overall survival benefit from the incorporation of adjuvant olaparib in HER2- BRCA mutated patients at high risk of relapse. In this context, unavoidably, we will be dealing in a near future with a subgroup of HER2-negative BRCA-mutated patients relapsing while on or after adjuvant olaparib.…”

Section: Discussionmentioning

confidence: 99%

PARP-inhibitors for BRCA1/2-related advanced HER2-negative breast cancer: A meta-analysis and GRADE recommendations by the Italian Association of Medical Oncology

Cinquini¹,

Dieci²,

Cortesi³

et al. 2022

The Breast

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Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer

Cited by 196 publications

References 31 publications

Cost-Effectiveness of Risk-Reducing Surgery for Breast and Ovarian Cancer Prevention: A Systematic Review

Cost-Effectiveness of Risk-Reducing Surgery for Breast and Ovarian Cancer Prevention: A Systematic Review

All HER2-negative breast cancer patients need gBRCA testing: cost-effectiveness and clinical benefits

PARP-inhibitors for BRCA1/2-related advanced HER2-negative breast cancer: A meta-analysis and GRADE recommendations by the Italian Association of Medical Oncology

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