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Update Breast Cancer 2019 Part 5 - Diagnostic and Therapeutic Challenges of New, Personalised Therapies in Patients with Advanced Breast Cancer.

Significant advancements have been made in recent years in advanced breast cancer and nearly all of them have been in the field of targeted therapy. Pertuzumab and trastuzumab-emtansine (T-DM1) have been able to be introduced in HER2-positive breast cancer. Now other anti-HER2 therapies are being developed (e.g. margetuximab, DS-8201a, pyrotinib) which can overcome other resistance mechanisms in the HER2 signalling pathway. In the field of hormone-receptor-positive breast cancer, an mTOR inhibitor and CDK4/6 inhibitors were introduced in the past. Now the introduction of the first PI3K inhibit

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… | Letrozole | Fulvestrant Fulvestrant/OFS | Letrozole | Fulvestrant | Letrozole/OFS | Fulvestrant Fulvestrant/OFS | NSAI Median dose intensity | Palbociclib: 94% | Palbociclib: 93% Letrozole: 100% Placebo: 100% | Palbociclib: 86% 55 Placebo: 98% 55 | Ribociclib: 87.5% 57 Letrozole: 100% 57 Placebo: … versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study Lancet Oncol 2015 16 25 35 25524798 10.1016/S1470-2045(14)71159-3 54 Finn R S Martin M Rugo H S Palbociclib and Letrozole in Advanced Breast …

Palbociclib: A New Option for Front-Line Treatment of Metastatic, Hormone Receptor-Positive, HER2-Negative Breast Cancer.

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… Pulmonary embolism has been reported at a higher rate with the combination of palbociclib and letrozole (4% vs. < 1%). … The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. The Lancet. …

Impact of a New Cost-Effectiveness Threshold Implementation on Cancer Formulary Decisions in Jordan.

Rising prices of novel cancer medications are increasing the economic burden from cancer in Jordan, risking the ability of cancer patients to access lifesaving and life-extending treatments. Furthermore, in the absence of a national health technology assessment (HTA) framework, medication prices in Jordan are set based on manufacturers' pricing considerations and not a value proposition. In response to these challenges, King Hussein Cancer Center (KHCC), the de facto national cancer institute, developed a first-in-country, cancer-specific, cost-effectiveness threshold (CET) to aid institutiona

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… Submitted by manufacturer/adapted by CDPTA 138,984 Financial risk-sharing agreement was reached Recommended Palbociclib for first-line treatment of hormonal positive post-menopausal breast cancer Letrozole Submitted by manufacturer/adapted by CDPTA 283,772 Financial risk-sharing agreement was not reached … | Submitted by manufacturer/adapted by CDPTA | 138,984 | Financial risk-sharing agreement was reached | Recommended Palbociclib for first-line treatment of hormonal positive post-menopausal breast cancer | Letrozole | Submitted by manufacturer/adapted by CDPTA | 283,772 | Financial risk-sharing agreement …

Role of Cyclin-Dependent Kinase Inhibitors in Endometrial Cancer.

Endometrial Cancer (EC) is an important cause of death in women worldwide. Despite early diagnosis and optimal treatment of localized disease, relapsed patients have few therapeutic options because after first line therapy, currently no standard of care exists. On the basis of endocrine positivity of most endometrioid ECs, Endocrine Therapy (ET) is a reasonable and widely accepted option. Better knowledge of molecular mechanisms involved in cancer highlighted the deregulated activity of Cyclin-Dependent Kinases (CDKs) in the cell cycle as a hallmark of carcinogenesis supporting the development

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… + Palbociclib/Letrozole +placebo | Metastatic EC | No more than 1 prior line of ET | PFS | II | Recruiting | NCT02730429 Palbociclib + Gedatolisib | Solid tumours | na | %AEs, DLT, RP2D | I | Recruiting | NCT03065062 RIBOCICLIB Ribociclib +Letrozole | OC and EC | na | %PFS at 12 weeks | II | Active, … Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann. Oncol. 2018;29:1541–1547. doi: 10.1093/annonc/mdy155. 70. Fang H., Huang D., Yang F., Guan X. …

Hormone receptor-positive, HER2-negative, metastatic breast cancer responded well to abemaciclib and exemestane after palbociclib and fulvestrant failure: A case report and literature review.

There is uncertainty regarding the usefulness of CDK4/6-inhibitor-based therapy for hormone receptor positive (HR+), human epidermal grow factor receptor 2 negative (HER2-), metastatic breast cancer (MBC), when CDK4/6 inhibitor treatment had previously failed. Furthermore, a biomarker for abemaciclib resistance has not been identified. Herein, we reported outcomes for an HR+/HER2- MBC patient diagnosed with multiple myeloma and treated with abemaciclib and exemestane, who had cancer progression after treatment with palbociclib and fulvestrant. Thalidomide was used in conjunction with all treat

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… decrease serum levels of leptin while letrozole cannot ( 17 ). … Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol (2018) 29:1541–7. doi: 10.1093/annonc/mdy155 6. …

Palbociclib as an Antitumor Drug: A License to Kill.

Neoplastic cells are characterized by uncontrolled cell divisions caused by cell cycle dysregulation. Key regulatory proteins governing the transition from the G1 to the S phase are the CDK4 and CDK6 kinases, which are controlled by D-type cyclins. The CDK4/6 kinases enable the use of these proteins as targets for anticancer therapy because they prevent the growth and the development of malignant cells by inhibiting their activity. This paper surveys the clinical trial results concerning palbociclib, the first in-class FDA-approved anticancer drug for hormone-dependent breast cancer. It discus

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… with palbociclib than letrozole alone [ 33 ]. … The median PFS obtained in this clinical trial was 21.5 and 13.9 months for the palbociclib–letrozole and placebo–letrozole groups, respectively. …

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS, AMERICAN COLLEGE OF ENDOCRINOLOGY, AND ANDROGEN EXCESS AND PCOS SOCIETY DISEASE STATE CLINICAL REVIEW: GUIDE TO THE BEST PRACTICES IN THE EVALUATION AND TREATMENT OF POLYCYSTIC OVARY SYNDROME - PART 2.

Polycystic ovary syndrome (PCOS) is recognized as the most common endocrine disorder of reproductive-aged women around the world. This docum … with PCOS and anovulatory infertility should begin with an oral agent such as clomiphene citrate or letrozole, an aromatase inhibitor.

Pharmacologic management of bone-related complications and bone metastases in postmenopausal women with hormone receptor-positive breast cancer.

There is a high risk for bone loss and skeletal-related events, including bone metastases, in postmenopausal women with hormone receptor-positive breast cancer. Both the disease itself and its therapeutic treatments can negatively impact bone, resulting in decreases in bone mineral density and increases in bone loss. These negative effects on the bone can significantly impact morbidity and mortality. Effective management and minimization of bone-related complications in postmenopausal women with hormone receptor-positive breast cancer remain essential. This review discusses the current underst

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… The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. … Bone effect of adjuvant tamoxifen, letrozole or letrozole plus zoledronic acid in early-stage breast cancer: the randomized phase 3 HOBOE study. Ann Oncol. 2012;23(8):2027–2033. doi: 10.1093/annonc/mdr600. 67. Coleman R, De BR, Eidtmann H, et al. …

Bone loss induced by cancer treatments in breast and prostate cancer patients.

Cancer and cancer therapies are a major factor risk for osteoporosis due to bone loss and deterioration of bone microarchitecture. Both factors contribute to a decrease in bone strength and, consequently, increased bone fragility and risk of fracture. Cancer-associated bone loss is a multifactorial process, and optimal interdisciplinary management of skeletal health, accurate assessment of bone density, and early diagnosis are essential when making decisions aimed at reducing bone loss and fracture risk in patients who have received or are receiving treatment for cancer. In this document, a mu

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… In the Z-FAST study, 602 postmenopausal women with early BC who received adjuvant letrozole were randomized to receive upfront or delayed-start intravenous ZOL treatment. … Zaman K, Thurlimann B, Huober J, Schonenberger A, Pagani O, Luthi J, Simcock M, Giobbie-Hurder A, Berthod G, Genton C, Brauchli P, Aebi S, Swiss Group for Clinical Cancer Bone mineral density in breast cancer patients treated with adjuvant letrozole, tamoxifen, or sequences of letrozole and tamoxifen …

Relationship between Medication-Related Osteonecrosis of the Jaw and CDK4/6 Inhibitors in Breast Cancer.

OBJECTIVE: We aimed to evaluate the use of CDK4/6 inhibitors as a risk factor for medication-related osteonecrosis of the jaw (MRONJ) in a cohort of patients with metastatic breast cancer treated with denosumab. METHODS: This was a multicentre, retrospective, observational study. All patients with breast cancer treated with denosumab (January 2011-December 2022) were included. The relationship between CDK4/6 inhibitors and MRONJ was analysed. RESULTS: A total of 243 patients were included, ninety-five (44.2%) of whom used a CDK4/6 inhibitor. There were 21 patients with MRONJ. In patients tre

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… Ribociclib in combination with letrozol was approved by the FDA based on a phase III study [ 25 ] in which the PFI was 25.3 months (95% CI: 23.0–30.3). … Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann. Oncol. 2018;29:1541–1547. doi: 10.1093/annonc/mdy155. Erratum in Ann. Oncol. 2019, 30, 1842. 26. …

Multi-antigen-targeted T-cell therapy to treat patients with relapsed/refractory breast cancer.

PurposeAdoptively transferred, ex vivo expanded multi-antigen-targeted T cells (multiTAA-T) represent a new, potentially effective, and nontoxic therapeutic approach for patients with breast cancer (BC). In this first-in-human trial, we investigated the safety and clinical effects of administering multiTAA T cells targeting the tumor-expressed antigens, Survivin, NY-ESO-1, MAGE-A4, SSX2, and PRAME, to patients with relapsed/refractory/metastatic BC.Materials and methodsMultiTAA T-cell products were generated from the peripheral blood of heavily pre-treated patients with metastatic or locally r

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… + palbociclib - Fulvestrant + palbociclib - Liposomal doxorubicin | 1 | PD (1 months) | Deceased (1 months) 8 | 61 | IDC, ER+ PR+ HER2− | Breast, LNs, bones, liver | - Letrozole - Fulvestrant + palbociclib - Capecitabine | 2 | PD (2 months) | Deceased (20 months) 9 | 62 | IDC, ER+, PR+ HER2− | Lungs … , liver, pleural effusion and bones | - 5FU + doxorubicin + cyclophosphamide - Tamoxifen - Anastrazole + OS - Fulvestrant - Letrozole - Everolimus + exemestane - Letrozole + palbociclib - Capecitabine - High-dose estradiol - Paclitaxel | 5 | SD (5 months) | Deceased (27 months) 10 | 63 | ILC, ER+ PR+ …

E2112: randomized phase iii trial of endocrine therapy plus entinostat/placebo in patients with hormone receptor-positive advanced breast cancer.

Endocrine therapies are effective in the treatment of hormone receptor (HR)-positive breast cancer, however, de novo or acquired treatment resistance is a significant clinical problem. A potential mechanism of resistance involves changes in gene expression secondary to epigenetic modifications, which might be reversed with the use of histone deacetylase (HDAC) inhibitors such as entinostat. The ENCORE 301 phase II randomized, placebo-controlled study demonstrated a significant improvement in progression-free survival (PFS) and overall survival (OS), with the addition of entinostat to exemestan

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… Several therapeutic options exist and include selective estrogen receptor modulators (e.g., tamoxifen), the aromatase inhibitors (AIs; anastrozole, letrozole, exemestane) and selective estrogen receptor down-regulators (e.g., fulvestrant). … Finn RS The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study Lancet Oncol. 2015 16 25 35 10.1016/S1470-2045 …

Prioritising systemic cancer therapies applying ESMO's tools and other resources to assist in improving cancer care globally: the Kazakh experience.

BackgroundIn Kazakhstan, cancer is the second leading cause of death with a major public health and economic burden. In the last decade, cancer care and cancer medicine costs have significantly increased. To improve the efficiency and efficacy of cancer care expenditure and planning, the Kazakhstan Ministry of Health requested assistance from the World Health Organization (WHO) and the European Society for Medical Oncology (ESMO) to review its systemic cancer treatment protocols and essential medicines list and identify high-impact, effective regimens.Materials and methodsESMO developed a four

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… + palbociclib Metastatic HR-positive, HER2-negative first line 3 21 Letrozole + palbociclib Metastatic HR-positive, HER2-negative first line 3 b 22 Letrozole + ribociclib First line metastatic post-menopause ER/PR positive 3 23 Capecitabine + lapatinib Second line metastatic after trastuzumab failure … + palbociclib | Metastatic HR-positive, HER2-negative first line | 3 | 21 Letrozole + palbociclib | Metastatic HR-positive, HER2-negative first line | 3 b | 22 Letrozole + ribociclib | First line metastatic post-menopause ER/PR positive | 3 | 23 Capecitabine + lapatinib | Second line metastatic after …

A Review of Approaches to Potentiate the Activity of Temozolomide against Glioblastoma to Overcome Resistance.

A glioblastoma (GBM) is one of the most aggressive, infiltrative, and treatment-resistant malignancies of the central nervous system (CNS). The current standard of care for GBMs include maximally safe tumor resection, followed by concurrent adjuvant radiation treatment and chemotherapy with the DNA alkylating agent temozolomide (TMZ), which was approved by the FDA in 2005 based on a marginal increase (~2 months) in overall survival (OS) levels. This treatment approach, while initially successful in containing and treating GBM, almost invariably fails to prevent tumor recurrence. In addition to

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… Letrozole effectively penetrates the BBB and localizes in the tumoral region in orthotopic GBM tumor-bearing rats, and also has no pharmacokinetic drug–drug interactions with TMZ [ 17 , 66 , 67 ]. … Preclinical pharmacological evaluation of letrozole as a novel treatment for gliomas. Mol. Cancer Ther. 2015;14:857–864. doi: 10.1158/1535-7163.MCT-14-0743. 66. Dave N., Gudelsky G.A., Desai P.B. …

Erchen Decoction ameliorates the rat model of polycystic ovary syndrome by regulating the steroid biosynthesis pathway.

BACKGROUND: Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder associated with chronic inflammation and metabolic … prague-Dawley rats were assigned to control (Con) and PCOS model groups. The latter was induced via letrozole (Femara) gavage (1 mg/kg) combined with a high-fat diet. The PCOS group was then subdivided for 28 days of intervention. Body weight was recorded, ovarian morphology was assessed through hematoxylin and eosin staining, and serum hormones were quanti …

Chemotherapy de-escalation using an 18F-FDG-PET-based pathological response-adapted strategy in patients with HER2-positive early breast cancer (PHERGain): a multicentre, randomised, open-label, non-comparative, phase 2 trial.

BACKGROUND: Several de-escalation approaches are under investigation in patients with HER2-positive, early-stage breast cancer. We assessed … rtuzumab (group B). Hormone receptor-positive patients allocated to group B were additionally given letrozole if postmenopausal (2·5 mg/day orally) or tamoxifen if premenopausal (20 mg/day orally). Centrally reviewed 18F-FDG-PET scans were done before randomisation and after two treatment cycles. Patients assigned to group A completed six cycles of treatmen …

IVF characteristics and the molecular luteal features of random start IVF cycles are not different from conventional cycles in cancer patients.

STUDY QUESTION: Are the IVF parameters and the steroidogenic luteal characteristics of random-start IVF cycles different from conventional c … rolled in the study. For patients with breast cancer and endometrial cancer the aromatase inhibitor letrozole was used with gonadotropin stimulation. Ovarian stimulation was initiated conventionally at EFP in 22 patients and served as control while it was started at LFP in 20, and mid-LP in the other 20 patients. The luteinized granulosa cells (GCs) were re …

Predicting and Quantifying Antagonistic Effects of Natural Compounds Given with Chemotherapeutic Agents: Applications for High-Throughput Screening.

Natural products have been used for centuries to treat various human ailments. In recent decades, multi-drug combinations that utilize natural products to synergistically enhance the therapeutic effects of cancer drugs have been identified and have shown success in improving treatment outcomes. While drug synergy research is a burgeoning field, there are disagreements on the definitions and mathematical parameters that prevent the standardization and proper usage of the terms synergy, antagonism, and additivity. This contributes to the relatively small amount of data on the antagonistic effect

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… However, it has also been shown to directly inhibit the anti-cancer activity of the chemotherapy drugs tamoxifen, letrozole, and palbociclib/letrozole combination therapy in breast cancer models [ 30 , 31 , 32 , 33 ]. … Genistein was reported to prevent the anti-cancer activity of the aromatase inhibitor letrozole and stimulated tumor growth both alone and in combination with letrozole therapy in an MCF-7Ca xenograft model at concentrations that were consistent with dietary exposure levels [ 31 ]. …

Bone Effects of Anti-Cancer Treatments in 2024.

Considerable progress has been made in the management of cancer patients in the last decade with the arrival of anti-cancer immunotherapies (immune checkpoint inhibitors) and targeted therapies. As a result, a broad spectrum of cancers, not just hormone-sensitive ones, have seen several patients achieve profound and prolonged remissions, or even cures. The management of medium- and long-term side-effects of treatment and quality of life of patients are essential considerations. This is especially true for bone, as bone fragility can lead to increased fractures and loss of autonomy, ultimately

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… , Llombart A, Davidson N, Neven P et al (2013) Zoledronic acid (zoledronate) for postmenopausal women with early breast cancer receiving adjuvant letrozole (ZO-FAST study): final 60-month results. … L, Vogel C, Seidler C et al (2012) Final 5-year results of Z-FAST trial: adjuvant zoledronic acid maintains bone mass in postmenopausal breast cancer patients receiving letrozole. …

Diffuse Bone Marrow Metastasis as the Initial Presentation of an Occult Breast Cancer.

IntroductionBreast cancer is one of the malignancies which tend to involve the bone marrow, but initial presentation with diffuse bone marrow metastasis from an occult breast cancer is very rare. Prognosis is generally very poor for marrow metastasis from solid tumors except that breast cancer is a treatable disease even in such a dismal condition.CaseA 64-year-old woman's headache was found to result from diffuse adenocarcinoma metastasis in the bone marrow from an unknown primary site. Intensive immunohistochemistry study of bone marrow biopsy specimen confirmed the disease nature to be an e

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… Despite the absence of benefit upon adding an anti-MUC1 antibody to letrozole for hormone receptor-positive metastatic breast cancer when compared with letrozole alone in a phase II trial [ 25 ], we do hope other therapeutic modalities against MUC1 might turn out to be helpful for patients like ours … Randomized phase II trial of letrozole plus anti-MUC1 antibody AS1402 in hormone receptor–positive locally advanced or metastatic breast cancer. Clinical Cancer Research. 2011;17(21):6822–6830. doi: 10.1158/1078-0432.CCR-11-1151. …