المؤلفون: Rugo, H.S., Van Poznak, C.H., Neven, P., Danielewicz, I., Lee, S.C., Campone, M., Chik, J.Y.K., Vega Alonso, E., Naume, B., Brain, E., Siegel, J.M., Li, R., Uema, D., Wagner, V.J., Coleman, R.E.

الوصف: Background Most women with advanced breast cancer have skeletal metastases. Radium-223 is an alpha-emitting radionuclide that selectively targets areas of bone metastases. Methods Two double-blind, placebo-controlled studies of radium-223 were conducted in women with hormone receptor-positive (HR+), bone-predominant metastatic breast cancer. All patients received endocrine therapy (ET), as a single agent of the investigator’s choice (Study A) or exemestane + everolimus (Study B). Patients were randomized to receive radium-223 (55 kBq/kg) or placebo intravenously every 4 weeks for six doses. Accrual was halted following unblinded interim analyses per protocol amendments, and both studies were terminated. We report pooled analyses of symptomatic skeletal event-free survival (SSE-FS; primary endpoint), radiologic progression-free survival (rPFS) and overall survival (OS; secondary), and time to bone alkaline phosphatase (ALP) progression (exploratory). Results In total, 382 patients were enrolled, and 196 SSE-FS events (70% planned total) were recorded. Hazard ratios (95% confidence intervals) and nominal p values for radium-223 + ET versus placebo + ET were: SSE-FS 0.809 (0.610–1.072), p = 0.1389; rPFS 0.956 (0.759–1.205), p = 0.7039; OS 0.889 (0.660–1.199), p = 0.4410; and time to bone ALP progression 0.593 (0.379–0.926), p = 0.0195. Radium-223- or placebo-related treatment-emergent adverse events were reported in 50.3% versus 35.1% of patients (grade 3/4: 25.7% vs. 8.5%), with fractures/bone-associated events in 23.5% versus 23.9%. Conclusions In patients with HR+ bone-metastatic breast cancer, numeric differences favoring radium-223 + ET over placebo + ET for the primary SSE-FS endpoint were suggestive of efficacy, in line with the primary outcome measure used in the underlying phase 2 studies. No similar evidence of efficacy was observed for secondary progression or survival endpoints. Adverse events were more frequent with radium-223 + ET versus placebo + ET, but the safety profile of the combination was ...

وصف الملف: text

العلاقة: https://eprints.whiterose.ac.uk/210818/1/s10549-023-07147-z.pdfTest; Rugo, H.S. orcid.org/0000-0001-6710-4814 , Van Poznak, C.H. orcid.org/0000-0001-5523-6908 , Neven, P. orcid.org/0000-0002-1434-9460 et al. (12 more authors) (2024) Radium-223 in women with hormone receptor-positive bone-metastatic breast cancer receiving endocrine therapy: pooled analysis of two international, phase 2, randomized, double-blind, placebo-controlled trials. Breast Cancer Research and Treatment, 204 (2). pp. 249-259. ISSN 0167-6806

الإتاحة: https://doi.org/10.1007/s10549-023-07147-zTest
https://eprints.whiterose.ac.uk/210818Test/
https://eprints.whiterose.ac.uk/210818/1/s10549-023-07147-z.pdfTest

المؤلفون: Yentz, S.E., Van Poznak, C.H.

المصدر: Breast Diseases: A Year Book Quarterly ; volume 27, issue 4, page 309-310 ; ISSN 1043-321X

مصطلحات موضوعية: Oncology, Surgery

الإتاحة: https://doi.org/10.1016/j.breastdis.2016.10.020Test
https://api.elsevier.com/content/article/PII:S1043321X16301692?httpAccept=text/plainTest
https://api.elsevier.com/content/article/PII:S1043321X16301692?httpAccept=text/xmlTest

المؤلفون: Rizzoli, R, Body, J-J, Brandi, M.L., Cannata-Andia, J, Chappard, Daniel, El Maghraoui, A., Glüer, C.-C., Kendler, D, Napoli, N., Papaioannou, A, Pierroz, D.D., Rahme, M, van Poznak, C.H., de Villiers, T, Fuleihan El Hajj, G.

المساهمون: Groupe d'Études Remodelage Osseux et bioMatériaux (GEROM), Université d'Angers (UA)

المصدر: ISSN: 0937-941X.

مصطلحات موضوعية: Antineoplastic Agents, Bone Density Conservation Agents, Bone Diseases, Bone Neoplasms, Humans, Hypogonadism, Neoplasms, osteoporosis, Osteoporotic Fractures, Risk Assessment, [SDV]Life Sciences [q-bio]

الوصف: for the International Osteoporosis Foundation Committee of Scientific Advisors Working Group on Cancer-Induced Bone Disease ; International audience ; Bone is commonly affected in cancer. Cancer-induced bone disease results from the primary disease, or from therapies against the primary condition, causing bone fragility. Bone-modifying agents, such as bisphosphonates and denosumab, are efficacious in preventing and delaying cancer-related bone disease. With evidence-based care pathways, guidelines assist physicians in clinical decision-making. Of the 57 million deaths in 2008 worldwide, almost two thirds were due to non-communicable diseases, led by cardiovascular diseases and cancers. Bone is a commonly affected organ in cancer, and although the incidence of metastatic bone disease is not well defined, it is estimated that around half of patients who die from cancer in the USA each year have bone involvement. Furthermore, cancer-induced bone disease can result from the primary disease itself, either due to circulating bone resorbing substances or metastatic bone disease, such as commonly occurs with breast, lung and prostate cancer, or from therapies administered to treat the primary condition thus causing bone loss and fractures. Treatment-induced osteoporosis may occur in the setting of glucocorticoid therapy or oestrogen deprivation therapy, chemotherapy-induced ovarian failure and androgen deprivation therapy. Tumour skeletal-related events include pathologic fractures, spinal cord compression, surgery and radiotherapy to bone and may or may not include hypercalcaemia of malignancy while skeletal complication refers to pain and other symptoms. Some evidence demonstrates the efficacy of various interventions including bone-modifying agents, such as bisphosphonates and denosumab, in preventing or delaying cancer-related bone disease. The latter includes treatment of patients with metastatic skeletal lesions in general, adjuvant treatment of breast and prostate cancer in particular, and the prevention of ...

العلاقة: hal-03350010; https://univ-angers.hal.science/hal-03350010Test; OKINA: ua10365; PUBMEDCENTRAL: PMC5104551

الإتاحة: https://doi.org/10.1007/s00198-013-2530-3Test
https://univ-angers.hal.science/hal-03350010Test

المؤلفون: Van Poznak, C.H., Brown, J.E.

المصدر: Breast Diseases: A Year Book Quarterly ; volume 21, issue 1, page 72-74 ; ISSN 1043-321X

مصطلحات موضوعية: Oncology, Surgery

الإتاحة: https://doi.org/10.1016/s1043-321xTest(10)79468-6
https://api.elsevier.com/content/article/PII:S1043321X10794686?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S1043321X10794686?httpAccept=text/plainTest

المؤلفون: Van Poznak, C.H.

المصدر: Breast Diseases: A Year Book Quarterly ; volume 20, issue 4, page 426-428 ; ISSN 1043-321X

مصطلحات موضوعية: Oncology, Surgery

الإتاحة: https://doi.org/10.1016/s1043-321xTest(09)79434-2
https://api.elsevier.com/content/article/PII:S1043321X09794342?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S1043321X09794342?httpAccept=text/plainTest

المؤلفون: Van Poznak, C.H.

المصدر: Breast Diseases: A Year Book Quarterly ; volume 17, issue 1, page 95-96 ; ISSN 1043-321X

مصطلحات موضوعية: Oncology, Surgery

الإتاحة: https://doi.org/10.1016/s1043-321xTest(06)80396-6
https://api.elsevier.com/content/article/PII:S1043321X06803966?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S1043321X06803966?httpAccept=text/plainTest