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Широкие метастазы грудной клетки и стенки грудной клетки в качестве первоначального представления о раке молочной железы: доклад по делу и обзор литературы.

Метастатическое участие костей остается наиболее распространенной формой дальнего метастаза в раке груди, главным образом из-за анатомических и функциональных характеристик грудного позвоночника, ребер и грудины. Эти структуры примечательны высоким содержанием красного костного мозга, богатой сосудистой системы и их связью с венозным сплексом Бэтсона, что способствует их раннему участию в онкологическом распространении. В некоторых случаях многочисленные метастазы в грудном скелете могут представлять собой первое и единственное клиническое проявление недиагностированного злокачественного проце

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… Combinations such as fulvestrant plus palbociclib have demonstrated an increase in median overall survival from 28 to 34.9 months ( 1 , 42 ). In parallel, bone-modifying agents - bisphosphonates and denosumab - are essential for reducing the risk of skeletal-related events. …

Is De-escalated Bisphosphonates Therapy a Suitable Alternative to Standard Dosing in Malignant Tumor Patients With Bone Metastases: A Systematic Review and Meta-Analysis.

Background: Previous studies have preliminarily identified the non-inferior efficacy for reducing skeletal-related event (SRE) rates between de-escalated (Q12w) and standard (Q3-4w) bone-targeting agents therapy in malignant tumor patients with bone metastases. In this study, we aim to make further efforts to analyze whether the de-escalated bisphosphonates (BPs) strategy is a suitable option by comprehensively retrieving and synthesizing state-of-the-art evidence. Methods: An extensive electronic search for randomized controlled trials (RCTs) comparing a BPs standard strategy with the de-esca

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… Randomised, phase II, placebocontrolled, trial of fulvestrant plus vandetanib in postmenopausal women with bone only or bone predominant, hormone-receptor-positive metastatic breast cancer (MBC): the OCOG ZAMBONEY study. Breast Cancer Res Treat. (2014) 146:153–62. 10.1007/s10549-014-3015-6 30. …

Recent advances in precision oncology research.

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… Subsequently, abemaciclib (Verzenio) was approved for use in combination with fulvestrant, a selective estrogen receptor degrader (SERD), in similar patients but whose cancer had progressed after prior treatment. …

Small molecules in targeted cancer therapy: advances, challenges, and future perspectives.

Due to the advantages in efficacy and safety compared with traditional chemotherapy drugs, targeted therapeutic drugs have become mainstream cancer treatments. Since the first tyrosine kinase inhibitor imatinib was approved to enter the market by the US Food and Drug Administration (FDA) in 2001, an increasing number of small-molecule targeted drugs have been developed for the treatment of malignancies. By December 2020, 89 small-molecule targeted antitumor drugs have been approved by the US FDA and the National Medical Products Administration (NMPA) of China. Despite great progress, small-mol

SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocols.

Transparent and accurate reporting in early phase dose-finding (EPDF) clinical trials is crucial for informing subsequent larger trials. The SPIRIT statement, designed for trial protocol content, does not adequately cover the distinctive features of EPDF trials. Recent findings indicate that the protocol contents in past EPDF trials frequently lacked completeness and clarity. To address this gap, the international consensus-driven SPIRIT-DEFINE checklist was developed through a robust methodological framework for guideline development, with the aim to improve completeness and clarity in EPDF t

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… The projected DL of fulvestrant is the approved dose regimen of 500 mg intramuscularly (IM) on Days 1, 15, and 29 of cycle 1, and monthly thereafter. Additional doses and schedules may be explored based on emerging safety, pharmacokinetics (PK), and pharmacodynamics (PD) data. … No doses will be explored beyond 100 mg GSK525762 or 500 mg (IM) fulvestrant, these doses that are considered to be the Maximum Feasible Dose (MFD), unless emerging PK data demonstrate reduced exposure of either drug in combination compared to single agent.” 59 Example 2 “Rationale for Dose and Schedule …

Three-dimensional bone evaluation after surgical treatment with plasma rich in growth factors of Medication Related Osteonecrosis of the Jaw (MRONJ): A report of 3 cases.

INTRODUCTION: Medication Related Osteonecrosis of the Jaw (MRONJ) is an adverse effect of antiresorptive and antiangiogenic agents that consists of progressive bone destruction in the maxillofacial area. The purpose of this study is to analyze the effect on bone volume of a surgical protocol using plasma rich in growth factors (PRGF) for successfully treating MRONJ. METHODS: Three patients were treated combining surgical debridement with PRGF. Cone bean computed tomography scans were taken prior to surgery and 12 months after to measure bone volume changes. Biopsies were taken for histology a

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… Patient characteristics Case 1 A 67-year-old woman, heavy smoker, with a 20-year history of treatment of breast cancer with mastectomy surgery, radiotherapy, and chemotherapy with Tamoxifen, Paclitaxel and Carboplatin; and treated with Exemestane (25 mg/day), Fulvestrant (250 mg/day) Everolimus (2.5 …

Mechanisms, Diagnosis and Treatment of Bone Metastases.

Bone and bone marrow are among the most frequent metastatic sites of cancer. The occurrence of bone metastasis is frequently associated with a dismal disease outcome. The prevention and therapy of bone metastases is a priority in the treatment of cancer patients. However, current therapeutic options for patients with bone metastatic disease are limited in efficacy and associated with increased morbidity. Therefore, most current therapies are mainly palliative in nature. A better understanding of the underlying molecular pathways of the bone metastatic process is warranted to develop novel, wel

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… In patients with estrogen receptor-dependent breast cancer, antiestrogens (e.g., tamoxifen, fulvestrant) [ 264 , 265 ] and aromatase inhibitors (anastrozole, letrozole, exemestane) are used [ 266 ]. …

Active Pharmacovigilance Study: A Follow-Up Model of Oral Anti-Cancer Drugs under Additional Monitoring.

Adverse drug reactions (ADRs) are responsible for almost 5% of hospital admissions, making it necessary to implement different pharmacovigilance strategies. The additional monitoring (AM) concept has been highlighted and intended to increase the number of suspected ADRs reported, namely in medicines with limited safety data. A prospective, descriptive study of active pharmacovigilance (AP) was conducted between 2019 and 2021 in the Local Health Unit of Matosinhos (LHUM) (Porto, Portugal). A model of AP for medicines under AM, namely oral antineoplastic agents, was designed. Follow-up consultat

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… Palbociclib and ribociclib are cyclin-dependent kinase (CDK) 4/6 inhibitors and are indicated as a treatment option for patients with HR+, HER2- advanced breast cancer, either as a first-line therapy combined with an aromatase inhibitor or as second-line therapy in combination with fulvestrant [ 33 ] …

Targeting mTOR and Metabolism in Cancer: Lessons and Innovations.

Cancer cells support their growth and proliferation by reprogramming their metabolism in order to gain access to nutrients. Despite the heterogeneity in genetic mutations that lead to tumorigenesis, a common alteration in tumors occurs in pathways that upregulate nutrient acquisition. A central signaling pathway that controls metabolic processes is the mTOR pathway. The elucidation of the regulation and functions of mTOR can be traced to the discovery of the natural compound, rapamycin. Studies using rapamycin have unraveled the role of mTOR in the control of cell growth and metabolism. By sen

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… 270 ] Cyclophosphamide | DNA | [ 271 ] Doxorubicin | Topoisomerase | [ 272 ] Vincristine | Microtubules | [ 273 ] Docetaxel | Microtubules | [ 274 ] Temozolomide | DNA | [ 275 ] Oxaliplatin | DNA | [ 276 ] Other Targeted Therapies | | Exemestane | Aromatase | [ 277 ] Letrozole | Aromatase | [ 278 ] Fulvestrant … In a randomized phase II trial in post-menopausal women with hormone receptor positive, EGFR2-negative metastatic breast cancer resistant to aromatase inhibitor therapy, the combination of everolimus with fulvestrant, which downregulates the estrogen receptor, enhanced efficacy compared to fulvestrant …

Dermatologic Adverse Events Associated with Selective Fibroblast Growth Factor Receptor Inhibitors: Overview, Prevention, and Management Guidelines.

Fibroblast growth factor receptor (FGFR) tyrosine kinases, which are expressed on the cell membrane, are involved in a wide range of biological functions such as cell proliferation, survival, migration, and differentiation. The identification of FGFR fusions and other alterations in a wide range of solid tumors, including cholangiocarcinoma and bladder cancer, has resulted in the development of several selective FGFR inhibitors for use in these indications, for example, infigratinib, erdafitinib, derazantinib, pemigatinib, and futibatinib. In addition to the typical adverse events associated w

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… Pemigatinib; combination therapy | 325 Derazantinib (ARQ 087) NCT03230318 | II | Cholangiocarcinoma | Derazantinib | 143 NCT04045613 | Ib/II | Urothelial cancer | Derazantinib vs. derazantinib + atezolizumab | 303 Futibatinib (TAS‐120) NCT04024436 | II | Breast cancer | Futibatinib or futibatinib + fulvestrant …

Cutaneous Skin Toxicities of Oncological Targeted Therapies: Comprehensive Overview of Mechanisms, Management, and Research Gaps-A Narrative Review.

Targeted therapies in oncology have become a mainstay in therapy of numerous types of cancers. They work by targeting and utilizing (activating, inhibiting, or modulating) molecular pathways that are crucial in pathogenesis of certain cancers and can be divided into numerous classes according to their mechanism. However, since the antigens and molecules they target can take part in homeostasis of the skin and the integument, cutaneous toxicities are a common occurrence. The frequency of certain cutaneous adverse events (CAEs) depends on the causal drug and varies even between drugs of the same

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… Sledge GW Toi M Neven P MONARCH 2: abemaciclib in combination with fulvestrant in women with HR+/HER2− advanced breast cancer who had progressed while receiving endocrine therapy J Clin Oncol 2017 35 25 2875 2884 10.1200/JCO.2017.73.7585 28580882 Sledge GW, Toi M, Neven P, et al. … MONARCH 2: abemaciclib in combination with fulvestrant in women with HR+/HER2− advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017;35(25):2875–84. 10.1200/JCO.2017.73.7585. 28580882 10.1200/JCO.2017.73.7585 31. …

New genomic and proteomic biomarker discovery in cancer: revolutionizing diagnosis and prognostication.

Cancer remains a major global health challenge, with substantial morbidity and mortality worldwide. Advances in genomic and proteomic biomarker discovery have transformed cancer diagnosis, prognosis, and treatment selection. The evolution from early serological markers such as carcinoembryonic antigen (CEA) and prostate-specific antigen (PSA) to modern multi-omics approaches enabled by next-generation sequencing (NGS), mass spectrometry (MS), and advanced bioinformatics has revolutionized personalized medicine and targeted therapy, leading to improved outcomes. This review highlights the histo

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… That Are Advanced or Have Spread COMPLETED DRUG: BMS-986,178|DRUG: Nivolumab|DRUG: Ipilimumab|BIOLOGICAL: Tetanus vaccine|BIOLOGICAL: DPV-001 vaccine|DRUG: Cyclophosphamide NCT02206984 Endocrine Response in Women With Invasive Lobular Breast Cancer COMPLETED DRUG: Tamoxifen|DRUG: Anastrozole|DRUG: Fulvestrant … Advanced or Have Spread | COMPLETED | DRUG: BMS-986,178|DRUG: Nivolumab|DRUG: Ipilimumab|BIOLOGICAL: Tetanus vaccine|BIOLOGICAL: DPV-001 vaccine|DRUG: Cyclophosphamide NCT02206984 | Endocrine Response in Women With Invasive Lobular Breast Cancer | COMPLETED | DRUG: Tamoxifen|DRUG: Anastrozole|DRUG: Fulvestrant …

A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2023.

With 54 new drugs and seven cellular and gene therapy products, the approvals by the US Food and Drug Administration (FDA) recovered 2023 from the 2022 dent back to the levels of 2020-2021. As in previous years of this annual review, we assign these new drugs to one of three levels of innovation: first drug against a condition ("first-in-indication"), first drug using a novel molecular mechanism ("first-in-class"), and "next-in-class," i.e., a drug using an already exploited molecular mechanism. We identify four (7%) "first-in-indication," 22 (36%) "first-in-class," and 35 (57%) "next-in-class

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… Capivasertib has been approved for treating hormone receptor-positive (estrogen or progesterone receptors, or both), HER2-negative, locally advanced or metastatic breast cancer in combination with the estrogen receptor antagonist fulvestrant in with the presence of one or more biomarker alterations ( … The most frequent AE of the combination of capivasertib and fulvestrant are skin rash and diarrhea (Mullard 2023 ). Merkel cell carcinoma is a rare, aggressive form of skin cancer. …

Deregulation of the EGFR/PI3K/PTEN/Akt/mTORC1 pathway in breast cancer: possibilities for therapeutic intervention.

The EGFR/PI3K/PTEN/Akt/mTORC1/GSK-3 pathway plays prominent roles in malignant transformation, prevention of apoptosis, drug resistance and metastasis. The expression of this pathway is frequently altered in breast cancer due to mutations at or aberrant expression of: HER2, ERalpha, BRCA1, BRCA2, EGFR1, PIK3CA, PTEN, TP53, RB as well as other oncogenes and tumor suppressor genes. In some breast cancer cases, mutations at certain components of this pathway (e.g., PIK3CA) are associated with a better prognosis than breast cancers lacking these mutations. The expression of this pathway and upstre

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… Silencing PTEN can also result in hormonal-independenc, 4HT and fulvestrant resistance. Silencing PTEN can in some cases also lead in some cases to IL-6 production and an IL-6 inflammatory feed back loop which results in EMT and CIC formation. … Furthermore the cells were resistant to 4HT and fulvestrant. Fulvestrant is an ER antagonist that functions by down regulating the ER. …

The impact of willingness-to-pay threshold on price reduction recommendations for oncology drugs: a review of assessments conducted by the Canadian Agency for Drugs and Technologies in Health.

Since late 2020, the Canadian Agency of Drugs and Technologies in Health (CADTH) has been using a threshold of $50,000 (CAD) per quality-adjusted life-year (QALY) for both oncology and non-oncology drugs. When used for oncology products, this threshold is hypothesized to have a higher impact on the time to access these drugs in Canada. We studied the impact of price reductions on time to engagement and negotiation with the pan-Canadian Pharmaceutical Alliance for oncology drugs reviewed by CADTH between January 2020 and December 2022. Overall, 103 assessments reported data on price reductions

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… CADTH Ribociclib (Kisqali) + Fulvestrant Advanced or Metastatic BC__ pCODR Final Economic Guidance Report . ( Accessed 25 February 2022 ). https://www.cadth.ca/sites/default/files/pcodr/Reviews2020/10195RibociclibFulvestrantMBC_fnEGR_NOREDACT-ABBREV_EC_22Apr2020_final.pdf 21. …

Chemistry and Pharmacology of Fluorinated Drugs Approved by the FDA (2016-2022).

Fluorine is characterized by high electronegativity and small atomic size, which provide this molecule with the unique property of augmenting the potency, selectivity, metabolic stability, and pharmacokinetics of drugs. Fluorine (F) substitution has been extensively explored in drug research as a means of improving biological activity and enhancing chemical or metabolic stability. Selective F substitution onto a therapeutic or diagnostic drug candidate can enhance several pharmacokinetic and physicochemical properties such as metabolic stability and membrane permeation. The increased binding a

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… Abemaciclib has been administered for the treatment of solid tumors, including glioblastoma, melanoma, and lymphoma, whether alone or in combination with fulvestrant. It continues to be beneficial for treatment of breast cancer in women who have HR-positive and HER2-negative hormone receptors. … To treat postmenopausal women and men with advanced or metastatic breast cancer, alpelisib and fulvestrant are recommended. …

A review of patient-reported outcomes used for regulatory approval of oncology medicinal products in the European Union between 2017 and 2020.

IntroductionCancer and corresponding available treatments are associated with substantial symptoms and functional limitations. In this context, collection of patient-reported outcomes (PRO) in clinical trials gained special interest and is recommended by regulatory authorities. Within clinical trials framework, PRO may provide evidence to support medicines approval, labeling and marketing claims. This study aims to analyze the existing evidence based on PRO as part of new oncology indications receiving positive opinions issued by the European Medicines Agency (EMA) between 2017 and 2020 and to

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… type | Medicine generic name | PROM | Type of claim granted | Study design ALL | Tisagenlecleucel | PedsQL EQ-5D | HRQoL | Open-label single arm trial Breast Neoplasms | Abemaciclib | BPI EORTC QLQ-C30 EORTC QLQ-BR23 EQ-5D 5L | HRQoL (no difference between groups) | Double-blind RCT Breast Neoplasms | Fulvestrant …

The added value of whole-body magnetic resonance imaging in the management of patients with advanced breast cancer.

This study investigates the impact of whole-body MRI (WB-MRI) in addition to CT of chest-abdomen-pelvis (CT-CAP) and 18F-FDG PET/CT (PET/CT) on systemic treatment decisions in standard clinical practice for patients with advanced breast cancer (ABC). WB-MRI examinations in ABC patients were extracted from our WB-MRI registry (2009-2017). Patients under systemic treatment who underwent WB-MRI and a control examination (CT-CAP or PET/CT) were included. Data regarding progressive disease (PD) reported either on WB-MRI or on the control examinations were collected. Data regarding eventual change i

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… The PD reported at WB-MRI determined a change in treatment from Letrozole to Fulvestrant. Most of the AS reported by the control examination were in lymph nodes, being found in 3 PET/CT (sub-clavicular, hilar or mediastinal lymph nodes). …

A Real-World Evidence Primer for Advanced Practice Providers: Integrating P-Reality X Into Shared Decision-Making for People With HR+/HER2- Metastatic Breast Cancer.

Advanced practice providers in oncology are now likely to encounter real-world data (RWD) studies in addition to data from randomized controlled trials (RCTs) in their practice. Real-world evidence derived from RWD can provide important information about a therapeutic agent's effectiveness outside of the confines of RCTs. It is important to understand how these studies are conducted and how data from these two types of studies can be interpreted and integrated for practical clinical use and shared decision-making. The goal of this manuscript is to provide an overview of the fundamental aspects

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… In 2016, palbociclib received a second approval for the combination with fulvestrant to treat HR+/HER2– advanced or mBC in women with disease progression following endocrine therapy ( FDA, 2017 ). …

The updated landscape of tumor microenvironment and drug repurposing.

Accumulating evidence shows that cellular and acellular components in tumor microenvironment (TME) can reprogram tumor initiation, growth, invasion, metastasis, and response to therapies. Cancer research and treatment have switched from a cancer-centric model to a TME-centric one, considering the increasing significance of TME in cancer biology. Nonetheless, the clinical efficacy of therapeutic strategies targeting TME, especially the specific cells or pathways of TME, remains unsatisfactory. Classifying the chemopathological characteristics of TME and crosstalk among one another can greatly b

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… -mutated solid tumors NCT02496741 Completed Omega-3 fatty acids Early stage breast cancer NCT02278965 Active, not recruiting Vitamin C Hepatocellular cancer, pancreatic cancer, gastric cancer, colorectal cancer NCT04033107 Recruiting Statin Targeted therapy (sorafenib, erlotinib, anti-HER2 therapy, fulvestrant … tumors | NCT02496741 | Completed Omega-3 fatty acids | Early stage breast cancer | NCT02278965 | Active, not recruiting Vitamin C | Hepatocellular cancer, pancreatic cancer, gastric cancer, colorectal cancer | NCT04033107 | Recruiting Statin | Targeted therapy (sorafenib, erlotinib, anti-HER2 therapy, fulvestrant …