ESMO recommendations on the use of circulating tumour DNA assays for patients with cancer: a report from the ESMO Precision Medicine Working Group

Annals of Oncology, Год журнала: 2022, Номер 33(8), С. 750 - 768

Опубликована: Июль 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.

Язык: Английский

---

Capivasertib in Hormone Receptor–Positive Advanced Breast Cancer

New England Journal of Medicine, Год журнала: 2023, Номер 388(22), С. 2058 - 2070

Опубликована: Май 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.

Язык: Английский

---

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

The Lancet Oncology, Год журнала: 2022, Номер 23(11), С. 1367 - 1377

Опубликована: Сен. 29, 2022

Язык: Английский

---

The CDK4/6 inhibitor revolution — a game-changing era for breast cancer treatment

Nature Reviews Clinical Oncology, Год журнала: 2023, Номер 21(2), С. 89 - 105

Опубликована: Дек. 11, 2023

Язык: Английский

---

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

Journal of Clinical Oncology, Год журнала: 2023, Номер 41(24), С. 4004 - 4013

Опубликована: Май 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.

Язык: Английский

---

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

Annals of Oncology, Год журнала: 2024, Номер 35(7), С. 588 - 606

Опубликована: Май 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.

Язык: Английский

---

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

Annals of Oncology, Год журнала: 2024, Номер 35(8), С. 718 - 727

Опубликована: Май 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.

Язык: Английский

---

An emerging generation of endocrine therapies in breast cancer: a clinical perspective

npj Breast Cancer, Год журнала: 2023, Номер 9(1)

Опубликована: Апрель 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.

Язык: Английский

---

Trastuzumab Deruxtecan after Endocrine Therapy in Metastatic Breast Cancer

New England Journal of Medicine, Год журнала: 2024, Номер unknown

Опубликована: Сен. 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.

Язык: Английский

---

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

Journal of Clinical Oncology, Год журнала: 2023, Номер 41(18), С. 3423 - 3425

Опубликована: Май 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).

Язык: Английский

---