We are analyzing https://link.springer.com/article/10.1007/s10549-014-2939-1.

Title:
A phase IIa, nonrandomized study of radium-223 dichloride in advanced breast cancer patients with bone-dominant disease | Breast Cancer Research and Treatment
Description:
Radium-223 dichloride (radium-223) mimics calcium and emits high-energy, short-range alpha-particles resulting in an antitumor effect on bone metastases. This open-label, phase IIa nonrandomized study investigated safety and short-term efficacy of radium-223 in breast cancer patients with bone-dominant disease. Twenty-three advanced breast cancer patients with progressive bone-dominant disease, and no longer candidates for further endocrine therapy, were to receive radium-223 (50 kBq/kg IV) every 4 weeks for 4 cycles. The coprimary end points were change in urinary N-telopeptide of type 1 (uNTX-1) and serum bone alkaline phosphatase (bALP) after 16 weeks of treatment. Exploratory end points included sequential 18F-fluorodeoxyglucose positron emission tomography and computed tomography (FDG PET/CT) to assess metabolic changes in osteoblastic bone metastases. Safety data were collected for all patients. Radium-223 significantly reduced uNTX-1 and bALP from baseline to end of treatment. Median uNTX-1 change was −10.1 nmol bone collagen equivalents/mmol creatinine (−32.8 %; P = 0.0124); median bALP change was −16.7 ng/mL (−42.0 %; P = 0.0045). Twenty of twenty-three patients had FDG PET/CT identifying 155 hypermetabolic osteoblastic bone lesions at baseline: 50 lesions showed metabolic decrease (≥25 % reduction of maximum standardized uptake value from baseline) after 2 radium-223 injections [32.3 % metabolic response rate (mRR) at week 9], persisting after the treatment period (41.5 % mRR at week 17). Radium-223 was safe and well tolerated. Radium-223 targets areas of increased bone metabolism and shows biological activity in advanced breast cancer patients with bone-dominant disease.
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28 years and 1 months (reg. 1997-05-29).

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Keywords {🔍}

bone, radium, patients, cancer, treatment, study, metastases, baseline, breast, article, week, therapy, fdg, petct, patient, google, scholar, change, disease, pubmed, weeks, end, untx, serum, balp, research, pain, table, cas, tomography, showed, drug, bonedominant, median, creatinine, administration, phase, clinical, safety, included, metabolic, lesions, decrease, performed, received, dichloride, full, coleman, period, bisphosphonates,

Topics {✒️}

technetium-99m methylene diphosphonate study-specific pet/ct scans sequential fdg pet/ct short-range alpha-particles resulting fda-approved alpha-emitting pharmaceutical high-energy alpha-particles early-stage breast cancer hormone-refractory prostate cancer bone-dominant metastatic disease fdg pet/ct image castration-resistant prostate cancer article download pdf wilcoxon signed-rank test chest–abdominal pelvic ct beta-emitting radioisotopes samarium-153 50 kbq/kg body weight nmol bce/nmol creatinine double-strand dna breaks nmol bce/mmol creatinine 20–50 nmol bce/mmol creatinine progressive bone-dominant disease bpi short-form questionnaire serum n-terminal propeptide alpha-emitter 223ra metastatic breast cancer 18f-fluorodeoxyglucose additional exclusion criteria metastatic prostate cancer similar calcium-mimicking affinity alpha-emitting 223ra correlative bone scintigraphy anne-kirsti aksnes alpha-emitting pharmaceutical unequivocal visceral metastases alpha emitter radium-223 multiple bone metastases fdg pet/ct beta-emitter 89sr osteoblastic bone metastases alpha-particle-emitting bone-dominant disease emits high-energy bone-targeted therapy exploratory end point bone alkaline phosphatase privacy choices/manage cookies advanced cancer setting 99mtc-mdp spect/ct alpha-emitting radium-223 breast cancer patients

Questions {❓}

Bruland OS, Nilsson S, Fisher DR, Larsen RH (2006) High-linear energy transfer irradiation targeted to skeletal metastases by the alpha-emitter 223Ra: adjuvant or alternative to conventional modalities?

Schema {🗺️}

WebPage:
      mainEntity:
         headline:A phase IIa, nonrandomized study of radium-223 dichloride in advanced breast cancer patients with bone-dominant disease
         description:Radium-223 dichloride (radium-223) mimics calcium and emits high-energy, short-range alpha-particles resulting in an antitumor effect on bone metastases. This open-label, phase IIa nonrandomized study investigated safety and short-term efficacy of radium-223 in breast cancer patients with bone-dominant disease. Twenty-three advanced breast cancer patients with progressive bone-dominant disease, and no longer candidates for further endocrine therapy, were to receive radium-223 (50 kBq/kg IV) every 4 weeks for 4 cycles. The coprimary end points were change in urinary N-telopeptide of type 1 (uNTX-1) and serum bone alkaline phosphatase (bALP) after 16 weeks of treatment. Exploratory end points included sequential 18F-fluorodeoxyglucose positron emission tomography and computed tomography (FDG PET/CT) to assess metabolic changes in osteoblastic bone metastases. Safety data were collected for all patients. Radium-223 significantly reduced uNTX-1 and bALP from baseline to end of treatment. Median uNTX-1 change was −10.1 nmol bone collagen equivalents/mmol creatinine (−32.8 %; P = 0.0124); median bALP change was −16.7 ng/mL (−42.0 %; P = 0.0045). Twenty of twenty-three patients had FDG PET/CT identifying 155 hypermetabolic osteoblastic bone lesions at baseline: 50 lesions showed metabolic decrease (≥25 % reduction of maximum standardized uptake value from baseline) after 2 radium-223 injections [32.3 % metabolic response rate (mRR) at week 9], persisting after the treatment period (41.5 % mRR at week 17). Radium-223 was safe and well tolerated. Radium-223 targets areas of increased bone metabolism and shows biological activity in advanced breast cancer patients with bone-dominant disease.
         datePublished:2014-04-13T00:00:00Z
         dateModified:2014-04-13T00:00:00Z
         pageStart:411
         pageEnd:418
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            Breast cancer
            Bone metastases
            Alpha-emitter
            Radiopharmaceutical
            Radium-223 dichloride
            Radiation therapy
            Oncology
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ScholarlyArticle:
      headline:A phase IIa, nonrandomized study of radium-223 dichloride in advanced breast cancer patients with bone-dominant disease
      description:Radium-223 dichloride (radium-223) mimics calcium and emits high-energy, short-range alpha-particles resulting in an antitumor effect on bone metastases. This open-label, phase IIa nonrandomized study investigated safety and short-term efficacy of radium-223 in breast cancer patients with bone-dominant disease. Twenty-three advanced breast cancer patients with progressive bone-dominant disease, and no longer candidates for further endocrine therapy, were to receive radium-223 (50 kBq/kg IV) every 4 weeks for 4 cycles. The coprimary end points were change in urinary N-telopeptide of type 1 (uNTX-1) and serum bone alkaline phosphatase (bALP) after 16 weeks of treatment. Exploratory end points included sequential 18F-fluorodeoxyglucose positron emission tomography and computed tomography (FDG PET/CT) to assess metabolic changes in osteoblastic bone metastases. Safety data were collected for all patients. Radium-223 significantly reduced uNTX-1 and bALP from baseline to end of treatment. Median uNTX-1 change was −10.1 nmol bone collagen equivalents/mmol creatinine (−32.8 %; P = 0.0124); median bALP change was −16.7 ng/mL (−42.0 %; P = 0.0045). Twenty of twenty-three patients had FDG PET/CT identifying 155 hypermetabolic osteoblastic bone lesions at baseline: 50 lesions showed metabolic decrease (≥25 % reduction of maximum standardized uptake value from baseline) after 2 radium-223 injections [32.3 % metabolic response rate (mRR) at week 9], persisting after the treatment period (41.5 % mRR at week 17). Radium-223 was safe and well tolerated. Radium-223 targets areas of increased bone metabolism and shows biological activity in advanced breast cancer patients with bone-dominant disease.
      datePublished:2014-04-13T00:00:00Z
      dateModified:2014-04-13T00:00:00Z
      pageStart:411
      pageEnd:418
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         Breast cancer
         Bone metastases
         Alpha-emitter
         Radiopharmaceutical
         Radium-223 dichloride
         Radiation therapy
         Oncology
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            address:
               name:Oslo University Hospital, Radiumhospitalet, Oslo, Norway
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      name:Camilo Garcia
      affiliation:
            name:Institut Jules Bordet
            address:
               name:Institut Jules Bordet, Brussels, Belgium
               type:PostalAddress
            type:Organization
      name:Guy Jerusalem
      affiliation:
            name:CHU Sart Tilman Liege and Liege University, Domaine Universitaire du Sart Tilman
            address:
               name:CHU Sart Tilman Liege and Liege University, Domaine Universitaire du Sart Tilman, Liège, Belgium
               type:PostalAddress
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      name:Martine Piccart
      affiliation:
            name:Institut Jules Bordet
            address:
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               type:PostalAddress
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      name:Nancy Vobecky
      affiliation:
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            address:
               name:Bayer HealthCare, Whippany, USA
               type:PostalAddress
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      affiliation:
            name:Statisticon AB
            address:
               name:Statisticon AB, Uppsala, Sweden
               type:PostalAddress
            type:Organization
      name:Patrick Flamen
      affiliation:
            name:Institut Jules Bordet
            address:
               name:Institut Jules Bordet, Brussels, Belgium
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      name:Algeta ASA, Oslo, Norway
      name:Oslo University Hospital, Radiumhospitalet, Oslo, Norway
      name:Institut Jules Bordet, Brussels, Belgium
      name:CHU Sart Tilman Liege and Liege University, Domaine Universitaire du Sart Tilman, Liège, Belgium
      name:Institut Jules Bordet, Brussels, Belgium
      name:Bayer HealthCare, Whippany, USA
      name:Statisticon AB, Uppsala, Sweden
      name:Institut Jules Bordet, Brussels, Belgium

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