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  • 1
    Online Resource
    Online Resource
    Novel risk factors for osteonecrosis of the jaw in multiple myeloma: A RADAR report.
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. 6623-6623
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 6623-6623
    Abstract: 6623 Background: Osteonecrosis of the jaw (ONJ) was identified in 2001 and is commonly seen in multiple myeloma (MM). The objective of this study is to evaluate novel risk factors in MM cases from a retrospective database. We hypothesized that ONJ may be related to stem cell transplant, chronic kidney disease and active smoking. Methods: We conducted a retrospective case-control study of 231 MM cases (from January 1, 1998 to September 30, 2010) identified from the electronic data warehouse (EDW) at Northwestern University (NU). The EDW is cross-institutional and integrates clinical data across NU. It comprises more than 2.3TB of data on roughly 2 million patients. The search terms used were: bisphosphonates, pamidronate, zoledronic acid, multiple myeloma, plasma cell disorders, osteonecrosis of the jaw, jaw abscess, dental abscess, among other terms described in literature. Data was abstracted onto a standardized form by 2 trained abstractors and validated by a clinician reviewer (BJE). Known and hypothesized new risk factors were abstracted, including duration of myeloma, treatment used, duration of bisphosphonate use, renal function indices, chemotherapy (vincristine, doxorubicin (A), dexamethasone (D) , thalidomide (T), cisplatin (P), cyclophosphamide (C), etoposide (E), novel agents [bevacizumab, sorafenib, angiostatin]) GCSF, smoking, and MM clinical stage. Analyses included T test, Wilcoxon, and log rank analysis. Results: ONJ occurring after MM diagnosis was identified in 33 cases out of a total of 233 cases of MM. ZOL, VAD, DT-PACE, and diabetes were more common in ONJ cases. Log rank analysis identified 2 risk factors for ONJ, the use of DT-PACE (p= 0.003), and complete and partial remission (p=0.007). Stem cell transplant and chronic kidney disease were not associated with ONJ. Conclusions: We identified novel risk factors for ONJ in MM, mainly partial or complete remission and use of DT-PACE. These results should prompt clinicians to heightened awareness and increased surveillance for the symptoms of ONJ for patients treated with DT-PACE.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.15_suppl.6623
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
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  • 2
    Online Resource
    Online Resource
    Pediatric nephrogenic systemic fibrosis is rarely reported: a RADAR report
    Springer Science and Business Media LLC ; 2014
    In:  Pediatric Radiology Vol. 44, No. 2 ( 2014-2), p. 173-180
    Details
    In: Pediatric Radiology, Springer Science and Business Media LLC, Vol. 44, No. 2 ( 2014-2), p. 173-180
    Type of Medium: Online Resource
    ISSN: 0301-0449 , 1432-1998
    URL: Article
    DOI: 10.1007/s00247-013-2795-x
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2014
    detail.hit.zdb_id: 1463007-2
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  • 3
    Online Resource
    Online Resource
    Bisphosphonates and esophageal cancer: A RADAR report.
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. 4063-4063
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 4063-4063
    Abstract: 4063 Background: In 2009, the US Food and Drug Administration (FDA) reported on 23 patients who had developed distal esophageal cancer, with alendronate (ALN) within 2 years of initiation of therapy. Similarly, 31 cases of esophageal cancer were reported from Europe and Japan. Esophagitis has been associated with oral BPs. Erosive esophagitis and persistent mucosal abnormalities have been noted with crystalline material (similar to ground ALN). Our objective was to assess the FDA Adverse event reporting system (FDA AERS) for a safety signal. Methods: The FDA Adverse Event Reporting System (AERS) database was searched using terms related to esophageal cancer combined with all drug names for bisphosphonates (search period:1996-2010). Disproportionality ratios were calculated: Proportional reporting ratio (PRR) and Empiric Bayes Geometric Mean (EBGM) determining that the esophageal cancer cases were more common with bisphosphonates than with other drugs in the database. Results: We identified 128 cases of bisphosphonate-associated esophageal cancer; 114 (89%) female and 14 male (11%), mean age 72 ± 12 yrs; the drugs included alendronate (n=96, 75%), risedronate sodium (n=14, 11%), ibandronic acid (n=10, 7.8%), zoledronic acid (n=7, 5.4%) and pamidronate (n=1, 1%). Barrett’s esophagus was listed in 3 cases of esophageal carcinoma. A significant safety signal was found only for alendronate with a PRR= 6.4 (95% C.I. 5.29, 7.730; p=0.001), EBGM = 6.3 (95% C.I. 5.1, 7.6 p=0.001). Conclusions: Our analysis of FDA AERS identifies a larger number of cases of esophageal cancer than previously described, and a significant safety signal with alendronate use. Avoidance of oral bisphosphonates in patients with Barrett’s esophagus, and persistent mucosal abnormalities is recommended. Increased awareness and vigilance is needed for patients receiving oral bisphosphonate therapy.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.15_suppl.4063
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
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  • 4
    Online Resource
    Online Resource
    Association of breast cancer in men with exposure to 5-α reductase inhibitors: A RADAR report.
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. 2532-2532
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 2532-2532
    Abstract: 2532 Background: Breast cancers in men (BCM) account for 〈 1% of all breast cancers. Dihydrotestosterone (DHT) inhibits proliferation of normal and neoplastic mammary tissue and constrains the effect of estrogens. Finasteride (F) and dutasteride (D) are 5-α reductase inhibitors (5-αRIs) that reduce systemic and local dihydrotestosterone and cause gynecomastia in 1–3% of men. The package inserts for F and D state, “the relationship between long-term use of (finasteride/dutasteride) and male breast neoplasia is currently unknown.” F and D are marketed for treatment of symptomatic benign-prostatic hyperplasia. F is marketed for treatment of androgenetic alopecia. Methods: To detect disproportionality in the FDA MedWatch dataset, we calculated the empiric Bayes geometric mean (EBGM) for association of BCM with F or D. We also calculated the attributable risk of BCM exposed to F or D among men at an urban academic hospital (Northwestern Memorial Hospital) and at a rural healthcare system (Marshfield Clinic). Results: In the MedWatch dataset, we identified 33 reports of F-associated BCM and 5 reports of D-associated BCM. For F–associated BCM, the EBGM was 58.95 (95% CI 24.47-81.76; p=0.0001). For D-associated BCM, the EBGM was 15.79 (95% CI 4.57-35.49; p=0.0001). The mean age for BCM after 5-αRI exposure was 70±11 years; 11/38 (29%) had gynecomastia. There were 38 cases of BCM associated with 5-αRI in the combined Northwestern and Marshfield cohort (see table below). Conclusions: We found a highly significant association between BCM and 5-αRI exposure in each of 6 separate analyses (3 sources X 2 drugs), with an estimated 1 extra BCM per 564 men exposed to 5-αRIs. We now plan to assess BRCA status and other risk factors. Given that 5-αRIs are marketed for control of lower urinary tract symptoms or for cosmetic purposes, it is not immediately obvious that use of finasteride or dutasteride for their labeled indications would provide any net benefit. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.15_suppl.2532
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
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  • 5
    Online Resource
    Online Resource
    Bone mineral density and FRAX as predictors of fracture risk in women with breast cancer.
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 26_suppl ( 2013-09-10), p. 121-121
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 26_suppl ( 2013-09-10), p. 121-121
    Abstract: 121 Background: The number of cancer survivors is rising in the USA, the 2007 CDC analysis of the SEER database estimated 11 million cancer survivors, with 90% being over the age of 65 years. Of these, 70% are women, and the most common cancer in survivors is breast cancer. Cancer therapy induced bone loss (CTIBL) contributes to an increase in fracture risk in women with breast cancer. Fractures are responsible for considerable morbidity, disability, hopitalizations and mortality in older adults. Fractures are often the cause for nursing home placement in seniors. Our objective was to analyze the prevalence of fractures after breast cancer therapy and to assess the effect of cancer therapy, clinical risk factors, bone density and the World Health Oragnization (WHO) fracture risk assessment [FRAX] as predictors of fracture occurrence. Methods: The study population consisted of breast cancer patients with invasive breast cancer who participated in a genetic databank within a NCI-Comprehensive Cancer Center. Demographic and clinical characteristics were abstracted from the EMR. Participants were followed for 6-12 years. Results: A total of 439 women with breast cancer were assessed; 79 had sustained fractures during the observation period (116 fractures), fractures occurred at multiple skeletal sites in 27 cases. The prevalence of fractures was 18%. Baseline characteristics revealed that women who sustained fractures were mostly Caucasian (91%, p=0.08), and had a family history of osteoporosis (36.9%, p=0.03). The time to fracture was 4.0 years (range 0-12 years) from diagnosis. Fracture cases had lower BMD at the femoral neck 0.86 ± 0.13 gm/cm2 (T-score= -1.0, p=0.04) than non- fracture cases, although BMD was in the low normal range. Eight cases of hip fractures were identified with a median age of 55 years (32-67 years) Median T-score -0.75. Cox proportional hazard analysis failed to identify any specific risk factors for fractures. Conclusions: Fractures occur shortly after commencing cancer therapy. BMD and FRAX risk calculation were not able to identify women who fractured. Occurrence of fractures in breast cancer raises the possibility of cancer-induced impairment in bone quality.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.26_suppl.121
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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