Circulating tumor DNA validity and potential uses in metastatic breast cancer DOI Creative Commons
Ottavia Amato,

Nefeli Giannopoulou,

Michail Ignatiadis

et al.

npj Breast Cancer, Journal Year: 2024, Volume and Issue: 10(1)

Published: March 12, 2024

Abstract Following the first characterization of circulating tumor DNA (ctDNA) in 1990s, recent advances led to its introduction clinics. At present, European Society Of Medical Oncology (ESMO) recommendations endorse ctDNA testing routine clinical practice for genotyping direct molecularly targeted therapies patients with metastatic cancer. In studies on breast cancer, has been utilized treatment tailoring, tracking mechanisms drug resistance, and predicting disease response before imaging. We review available evidence regarding applications

Language: Английский

ESMO recommendations on the use of circulating tumour DNA assays for patients with cancer: a report from the ESMO Precision Medicine Working Group DOI Creative Commons
Javier Pascual, Gerhardt Attard, François‐Clément Bidard

et al.

Annals of Oncology, Journal Year: 2022, Volume and Issue: 33(8), P. 750 - 768

Published: July 6, 2022

•Validated and sensitive ctDNA assays can be used to genotype advanced cancers select patients for targeted therapies.•Initial genotyping with should considered when rapid results are needed, tissue is unavailable.•ctDNA assay limited by false-negative results, lower sensitivity fusion events copy number changes.•Use of detect molecular residual disease not recommended, due lack evidence its clinical utility. Circulating tumour DNA (ctDNA) conducted on plasma rapidly developing a strong base use in cancer. The European Society Medical Oncology convened an expert working group review the analytical validity utility assays. For cancer, validated adequately have identifying actionable mutations direct therapy, may routine practice, provided limitations taken into account. Tissue-based testing remains preferred test many cancer patients, detecting changes, although routinely faster will clinically important, or biopsies possible inappropriate. Reflex following non-informative result, testing. In treated early-stage cancers, detection relapse, has high anticipating future relapse cancers. Molecular disease/molecular cannot recommended as currently there no directing treatment. Additional potential applications assays, under research development include responding therapy early dynamic changes levels, monitoring resistance before progression, screening asymptomatic people Recommendations reporting made.

Language: Английский

Citations

387
Capivasertib in Hormone Receptor–Positive Advanced Breast Cancer DOI
Nicholas C. Turner, Mafalda Oliveira, Sacha J. Howell

et al.

New England Journal of Medicine, Journal Year: 2023, Volume and Issue: 388(22), P. 2058 - 2070

Published: May 31, 2023

AKT pathway activation is implicated in endocrine-therapy resistance. Data on the efficacy and safety of inhibitor capivasertib, as an addition to fulvestrant therapy, patients with hormone receptor-positive advanced breast cancer are limited.

Language: Английский

Citations

326
Switch to fulvestrant and palbociclib versus no switch in advanced breast cancer with rising ESR1 mutation during aromatase inhibitor and palbociclib therapy (PADA-1): a randomised, open-label, multicentre, phase 3 trial DOI Creative Commons
François‐Clément Bidard, Anne‐Claire Hardy‐Bessard, Florence Dalenc

et al.

The Lancet Oncology, Journal Year: 2022, Volume and Issue: 23(11), P. 1367 - 1377

Published: Sept. 29, 2022

Language: Английский

Citations

182
The CDK4/6 inhibitor revolution — a game-changing era for breast cancer treatment DOI
Laura Morrison, Sibylle Loibl, Nicholas C. Turner

et al.

Nature Reviews Clinical Oncology, Journal Year: 2023, Volume and Issue: 21(2), P. 89 - 105

Published: Dec. 11, 2023

Language: Английский

Citations

108
Randomized Phase II Trial of Endocrine Therapy With or Without Ribociclib After Progression on Cyclin-Dependent Kinase 4/6 Inhibition in Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer: MAINTAIN Trial DOI
Kevin Kalinsky, Melissa Accordino, Codruța Chiuzan

et al.

Journal of Clinical Oncology, Journal Year: 2023, Volume and Issue: 41(24), P. 4004 - 4013

Published: May 19, 2023

PURPOSE Cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) with endocrine therapy (ET) improves progression-free survival (PFS) and overall (OS) in hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–) metastatic breast cancer (MBC). Although preclinical clinical data demonstrate a benefit changing ET continuing CDK4/6i at progression, no randomized prospective trials have evaluated this approach. METHODS In investigator-initiated, phase II, double-blind placebo-controlled trial patients HR+/HER2– MBC whose progressed during CDK4/6i, participants switched (fulvestrant or exemestane) from used pre-random assignment randomly assigned 1:1 to the ribociclib versus placebo. PFS was primary end point, defined as time random disease progression death. Assuming median of 3.8 months placebo, we had 80% power detect hazard ratio (HR) 0.58 (corresponding least 6.5 ribociclib) 120 using one-sided log-rank test significance level set 2.5%. RESULTS Of 119 participants, 103 (86.5%) previously received palbociclib 14 (11.7%). There statistically significant improvement for plus (median, 5.29 months; 95% CI, 3.02 8.12 months) placebo 2.76 2.66 3.25 HR, 0.57 (95% 0.39 0.85); P = .006. At 6 12 months, rate 41.2% 24.6% ribociclib, respectively, compared 23.9% 7.4% CONCLUSION trial, there who after previous different ET.

Language: Английский

Citations

103
Recommendations for the use of next-generation sequencing (NGS) for patients with advanced cancer in 2024: a report from the ESMO Precision Medicine Working Group DOI Creative Commons
M.F. Mosele, C. Benedikt Westphalen,

A Stenzinger

et al.

Annals of Oncology, Journal Year: 2024, Volume and Issue: 35(7), P. 588 - 606

Published: May 27, 2024

Advancements in the field of precision medicine have prompted European Society for Medical Oncology (ESMO) Precision Medicine Working Group to update recommendations use tumour next-generation sequencing (NGS) patients with advanced cancers routine practice.

Language: Английский

Citations

89
Abemaciclib plus a nonsteroidal aromatase inhibitor as initial therapy for HR+, HER2− advanced breast cancer: final overall survival results of MONARCH 3 DOI Creative Commons

M.P. Goetz,

M. Toi,

Jens Huober

et al.

Annals of Oncology, Journal Year: 2024, Volume and Issue: 35(8), P. 718 - 727

Published: May 8, 2024

Highlights•This phase III trial evaluated abemaciclib + NSAI versus placebo as initial therapy for HR+, HER2− ABC.•Addition of to an resulted in numerically longer OS; however, statistical significance was not reached.•Absolute improvement median OS clinically meaningful (ITT: 13.1 months; sVD: 14.9 months).•The previously demonstrated PFS benefit with the addition sustained (median 14.3 delayed subsequent receipt chemotherapy 16.1 months).AbstractBackgroundIn MONARCH 2, fulvestrant significantly improved both progression-free survival (PFS) and overall (OS) patients hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (ABC) disease progression on prior endocrine therapy. In 3, a nonsteroidal aromatase inhibitor (NSAI) ABC PFS. Here, we present prespecified final results 3.Patients methodsMONARCH 3 is randomized, double-blind, study plus (anastrozole or letrozole) postmenopausal women without systemic setting. The primary objective investigator-assessed PFS; gated secondary endpoint, chemotherapy-free exploratory endpoint.ResultsA total 493 were randomized 2 : 1 receive (n = 328) 165). After follow-up 8.1 years, there 198 events (60.4%) arm 116 (70.3%) (hazard ratio, 0.804; 95% confidence interval 0.637-1.015; P 0.0664, non-significant). Median 66.8 53.7 months placebo. subgroup visceral disease, 113 (65.3%) 65 (72.2%) 0.758; 0.558-1.030; 0.0757, 63.7 48.8 sustained, abemaciclib. No new safety signals observed.ConclusionsAbemaciclib combined (intent-to-treat population: disease: months) HR+ ABC; reached.

Language: Английский

Citations

76
An emerging generation of endocrine therapies in breast cancer: a clinical perspective DOI Creative Commons
Rima Patel,

Paula Klein,

Amy Tiersten

et al.

npj Breast Cancer, Journal Year: 2023, Volume and Issue: 9(1)

Published: April 5, 2023

Abstract Anti-estrogen therapy is a key component of the treatment both early and advanced-stage hormone receptor (HR)-positive breast cancer. This review discusses recent emergence several anti-estrogen therapies, some which were designed to overcome common mechanisms endocrine resistance. The new generation drugs includes selective estrogen modulators (SERMs), orally administered degraders (SERDs), as well more unique agents such complete antagonists (CERANs), proteolysis targeting chimeric (PROTACs), covalent (SERCAs). These are at various stages development being evaluated in metastatic settings. We discuss efficacy, toxicity profile, completed ongoing clinical trials for each drug highlight differences their activity study population that have ultimately influenced advancement.

Language: Английский

Citations

68
Trastuzumab Deruxtecan after Endocrine Therapy in Metastatic Breast Cancer DOI
Aditya Bardia, Xichun Hu, Rebecca Dent

et al.

New England Journal of Medicine, Journal Year: 2024, Volume and Issue: unknown

Published: Sept. 14, 2024

Outcomes in patients with hormone receptor-positive metastatic breast cancer worsen after one or more lines of endocrine-based therapy. Trastuzumab deruxtecan has shown efficacy low expression human epidermal growth factor receptor 2 (HER2) previous chemotherapy.

Language: Английский

Citations

63
Testing for ESR1 Mutations to Guide Therapy for Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer: ASCO Guideline Rapid Recommendation Update DOI Open Access
Harold J. Burstein, Angela DeMichele, Mark R. Somerfield

et al.

Journal of Clinical Oncology, Journal Year: 2023, Volume and Issue: 41(18), P. 3423 - 3425

Published: May 17, 2023

ASCO Rapid Recommendations Updates highlight revisions to select guideline recommendations as a response the emergence of new and practice-changing data. The rapid updates are supported by an evidence review follow development processes outlined in Guideline Methodology Manual. goal these articles is disseminate updated recommendations, timely manner, better inform health practitioners public on best available cancer care options. See Appendix for disclaimers other important information (Appendix 1andAppendix 2, online only).

Language: Английский

Citations

60