Patterns of treatment (tx) with bone-modifying agents (BMA) in patients with bone metastases (mets).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20690-e20690
Author(s):  
Jane M Quigley ◽  
Rohini Khorana Hernandez ◽  
Karynsa Cetin ◽  
Melissa A. Pirolli ◽  
David Quach ◽  
...  

e20690 Background: Bone mets can lead to serious and debilitating skeletal-related events (SREs: fracture, spinal cord compression, and surgery or radiation to bone). Three BMAs are approved in the US for prevention of SREs in cancer patients (pts) with bone mets: 2 intravenous bisphosphonates (IV BP) with recommended dosing every 3-4 weeks (pamidronate [PAM] and zoledronic acid [ZA]), and 1 RANK ligand inhibitor with subcutaneous injection every 4 weeks (denosumab). Monitoring real-world tx trends is important, particularly as low persistence has been linked to higher rates of SREs (Hatoum et al 2008). Methods: A retrospective cohort was defined from the Oncology Services Comprehensive Electronic Records (OSCER) database, which includes medical records from >500K pts treated at 76 US oncology practices. Adult solid tumor pts with bone mets who initiated tx with a BMA between Jan 2011 and Oct 2011 were included and followed for 12 mos after tx initiation. Pts were either naïve (no BMA in previous 6 mos) or transition (different BMA received in previous 6 mos). Results: The cohort was composed of 1445 denosumab pts (62% naïve) and 1807 IV BP pts (99% naïve). Pt characteristics were similar, although denosumab pts were somewhat more likely to have prostate cancer than IV BP pts (30% vs 25%). Denosumab pts were more likely to receive regular tx during follow-up and less likely to switch tx than IV BP pts (Table). Trends were consistent across tumor types and for naïve vs transition pts. Conclusions: This descriptive analysis reports on tx patterns for pts with bone mets since the availability of denosumab in Dec 2010. Denosumab represented almost half (44%) of pts initiating a BMA and one-third of pts naïve to tx. Uninterrupted tx was more common for denosumab pts than IV BP pts, regardless of tumor type. Trends, including reasons for and consequences of tx interruption, should be monitored as the pt experience develops. [Table: see text]

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 12020-12020
Author(s):  
Deborah Schrag ◽  
Hajime Uno ◽  
Rachel Pam Greenerger Rosovsky ◽  
Cynthia Rutherford ◽  
Kristen Marie Sanfilippo ◽  
...  

12020 Background: Previous randomized trials in cancer patients suggest that DOACs are non-inferior to LMWH for preventing recurrent VTE but have higher risk of bleeding. However, the balance of benefits and burdens remains uncertain. Objective: The CANVAS pragmatic trial compared recurrent VTE, bleeding and death in cancer patients following an initial VTE treated with either DOAC or LMWH therapy. Methods: CANVAS was an unblinded hybrid comparative effectiveness non-inferiority trial, with randomized and preference cohorts. Between 12/16 and 4/20, 671 participants were randomized and followed for 6-months. Between 12/16 and 12/17, 140 participants declined randomization, chose their preferred anticoagulant and were followed for 6-months. The preference cohort was closed when predetermined stopping criteria were met. Final follow-up was 11/30/20. Randomized patients were assigned 1:1 to receive either a DOAC or a LMWH. If assigned to LMWH, transitions to warfarin were allowed. Physicians and patients could choose among any DOAC or LMWH. Doses were suggested based on FDA-approved labeling but not mandated. Patients from 67 practices in the US with any invasive solid tumor, lymphoma, multiple myeloma or CLL and a diagnosis of symptomatic or radiographically detected VTE within 30 days of enrollment were eligible. The 1° analysis was conducted in the randomized modified-into to treat popululation, (all subjects who received study drug). The 1° outcome was recurrent VTE. The aim was to establish noninferiority of anticoagulation with a DOAC as defined by the upper limit of the 2-sided 90% CI for the difference in the event rate at 6 months of < 3%. Secondary outcomes included death and bleeding. Hypothesis testing included only the randomized cohort but propensity score adjusted results for the preference and combined cohorts are also shown. Results: The non-inferiority criteria for recurrent VTE was met. Conclusions: Among adult cancer patients with VTE, the use of a DOAC compared with a LMWH resulted in a noninferior risk of recurrent VTE with no differences in rates of bleeding or death in randomized patients. Clinical trial information: NCT02744092. [Table: see text]


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4614-4614 ◽  
Author(s):  
J. S. Chan ◽  
C. W. Ryan ◽  
P. M. Venner ◽  
D. P. Petrylak ◽  
G. S. Chatta ◽  
...  

4614 Background: Docetaxel prolongs survival in AIPC patients and zoledronic acid (ZA) reduces the incidence of SREs. The SRE incidence of patients treated with docetaxel-based chemotherapy has not previously been reported. Methods: ASCENT was a randomized clinical trial that compared weekly DN-101 (calcitriol, 45 μg p.o. on day 1) plus docetaxel (36 mg/m2 iv on day 2 for 3 weeks of a 4-week cycle) to placebo plus docetaxel in patients with chemotherapy-naïve metastatic AIPC. ZA use was not restricted. SRE-free survival was described for the entire group and then compared for patients randomly assigned to DN-101 or placebo and stratified by ZA use. Statistical comparisons were conducted using Cochran-Mantel-Haenszel for incidence and log-rank for SRE-free survival. Results: With a median follow-up of 18.3 months, 33% of subjects experienced at least one SRE and the overall median SRE-free survival was 13 (95% CI 10.5–14.3) months. The incidence of SRE by type was: radiation to bone (18.8%), fracture (10%), spinal cord compression (4%), surgery to bone (0.4%). Eighty-five (34%) patients received ZA. The study was not adequately powered to measure the impact of DN-101 or ZA on SRE endpoints. Exploratory analyses showed a trend for an increase in SRE-free survival (HR 0.78, p = 0.13) of DN-101-treated patients. SRE-free survival and incidence for subgroups were examined ( Table ). Conclusions: This is the first report of SRE incidence in a large, prospective study of docetaxel-based therapy. Improved therapies for reducing SREs in AIPC are needed because the risk of SREs remains high despite the use of modern chemotherapy and ZA. [Table: see text] [Table: see text]


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e13583-e13583
Author(s):  
Andrew Jacob Brenner ◽  
Raul Collazo ◽  
Catherine A. Schnabel ◽  
F Anthony Greco

e13583 Background: Nearly 200,000 patients are diagnosed with brain metastases in the US annually. Advances in targeted therapies make definitive diagnosis of the primary tumor type important but can be challenging in many patients. The 92-gene assay is a validated gene expression classifier of 50 tumor types/subtypes for patients with uncertain diagnoses. Results from a clinical series of brain biopsies and potential impact on treatment were evaluated. Methods: An IRB-approved, de-identified database of clinical and molecular information from biopsies (N = 24,486) submitted for testing with the 92-gene assay (CancerTYPE ID, Biotheranostics, Inc.) as part of routine care were reviewed. Descriptive analysis included patient demographics and molecular diagnoses. Results: Analysis included 464 brain biopsies. A molecular diagnosis was provided in 433 (93.3%) tested ( < 5% assay failure rate) with 24 different tumor types. Six primary tumor types made up the majority (67.4%) with almost one-third of the molecular predictions being Lung (31.2%), followed by Neuroendocrine (NET) (9.9%), Sarcoma (7.9%), Skin (6.4%), Gastroesophageal (6.2%), and Urinary bladder (5.8%). All of these 6 tumor types, for which activity in the CNS has been documented, have immune checkpoint inhibitors or other targeted therapies approved in selected cases by the US Federal Drug Administration (FDA) (Table). Conclusions: Molecular classification of brain metastases can identify distinct tumor types for which there are FDA approved targeted medications. Improving diagnostic precision with the 92-gene assay helps identify a subset of therapy-responsive metastatic brain tumors, thus improving therapy and possibly providing better outcomes and survival. [Table: see text]


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e16035-e16035
Author(s):  
Marianne Ulcickas Yood ◽  
Teresa Maria Zyczynski ◽  
Karen Wells ◽  
Deborah Casso ◽  
Benjamin Gutierrez ◽  
...  

e16035 Background: Skeletal related events (SREs) occur in men with prostate cancer and may result from both bone metastases and exposure to androgen deprivation therapy (ADT). The objective of this study was to quantify the incidence of SREs in patients with prostate cancer treated with ADT or orchiectomy in clinical practice. Methods: Prostate cancer patients served by Henry Ford Health System (HFHS) were identified via the HFHS tumor registry. Eligible patients were newly diagnosed with prostate cancer between 2004 and 2010 and treated with ADT or orchiectomy. Comprehensive population-based data were compiled using tumor registry with linkages to pharmacy, laboratory results, and healthcare encounter databases. SREs included spinal cord compression, surgery to bone, pathologic fracture and radiation to bone. Disease progression and metastases were identified by medical record review. Results: We identified 702 patients with prostate cancer and receipt of ADT or orchiectomy; 57.6% were >70 years of age and 43.7% were African American. 56.3% of patients were initially diagnosed at AJCC stage II, 9.8% at stage III, 22.1% at stage IV, and 11.8% had missing or unknown stage. A total of 93 patients (13.2%) had one or more SREs: radiation to bone (8.5%) and spinal cord compression (3.1%) were the most common SREs. We then limited the cohort to patients initially diagnosed with or progressing to AJCC stage IV prostate cancer (N=207). Among this group, 47.8% were >70 years of age. The mean time from stage IV diagnosis to end of follow-up was 35.6 months. In this subgroup, 16.4% of patients were initially diagnosed at AJCC stage II, 8.2% at stage III, 69.6% at stage IV, and 5.8% had missing or unknown stage. 57 patients (27.5%) had one or more SREs. Conclusions: Some clinical trials have found 36-41% of high-risk metastatic prostate cancer patients developed SREs during 3 years of follow-up. In this population-based cohort of patients with prostate cancer receiving ADT or orchiectomy and treated in real-world clinical practice, we found the incidence of SREs to be lower than what has been reported in clinical trials. Additional analyses exploring the incidence of SREs in patients diagnosed with metastatic castrate resistant prostate cancer will be presented.


2013 ◽  
Vol 31 (28) ◽  
pp. 3592-3599 ◽  
Author(s):  
Dawn L. Hershman ◽  
Jason D. Wright ◽  
Emerson Lim ◽  
Donna L. Buono ◽  
Wei Yann Tsai ◽  
...  

Purpose Drugs are approved on the basis of randomized trials conducted in selected populations. However, once approved, these treatments are usually expanded to patients ineligible for the trial. Patients and Methods We used the SEER-Medicare database to identify subjects older than 65 years with metastatic breast, lung, and colon cancer, diagnosed between 2004 and 2007 and undergoing follow-up to 2009, who received bevacizumab. We defined a contraindication as having at least two billing claims before bevacizumab for thrombosis, cardiac disease, stroke, hemorrhage, hemoptysis, or GI perforation. We defined toxicity as first development of one of these conditions after therapy. Results Among 16,085 metastatic patients identified, 3,039 (18.9%) received bevacizumab. Receipt of bevacizumab was associated with white race, later year of diagnosis, tumor type, and decreased comorbid conditions. Of patients who received bevacizumab, 1,082 (35.5%) had a contraindication. In multivariate analysis, receipt of bevacizumab with a contraindication was associated with black race (odds ratio [OR] = 2.6; 95% CI, 1.4 to 4.9), increased age, comorbidity, later year of diagnosis, and lower socioeconomic status. Patients with lung (OR = 1.7; 95% CI, 1.1 to 2.4) and colon cancer (OR = 1.4; 95% CI, 1.1 to 1.9) were more likely to have a contraindication. In the group with no contraindication, 30% had a complication after bevacizumab; black patients were more likely to have a complication than were white patients (OR = 1.9; 95% CI, 1.21 to 2.93). Conclusion Our study demonstrates widespread use of bevacizumab among patients who had contraindications. Black patients were less likely to receive the drug, but those who did were more likely to have a contraindication. Efforts to understand toxicity and efficacy in populations excluded from clinical trials are needed.


2019 ◽  
Vol 21 (2) ◽  
pp. 152 ◽  
Author(s):  
Chunping Ning ◽  
Ja Seung Koo ◽  
Eun-Kyung Kim ◽  
Suji Lee

Aim: To summarize the clinical, ultrasonographic (US) and pathological characteristics of Warthin-like variant papillary thyroid carcinomas (WVPTC).Material and methods: Medical records and US images of 32 cases of WVPTCs diagnosed between December, 2006 and September, 2018 were reviewed. Clinical, pathological and US characteristics of these cases were collected and summarized. ACR TI-RADS was followed during the analysis of the US features of the lesions. Results: Totally, 32 patients with 33 WVPTC nodules were reviewed. WVPTC was more often seen in female patients (27/32,84.4%) with a relatively high age (mean age, 51.0±10.8 years old). Hyperthyroidism was observed in 14 patients; 2 patients were diagnosed as subclinical hyperthyroidism and 1 patient as subclinical hypothyroidism. Abnormal thyroglobulin antibody was detected in 22 patients. Mean size of the nodule was 1.2±0.5 cm (range, 0.5~2.99 cm) on US. Pathologically, tumor margin of 63.6% carcinomas were infiltrative but most (72.9%) of the enrolled carcinomas were intra-thyroidal. Lymphocytic thyroiditis was detected in 87.5% (28/32) patients. On US, most WVPTCs were solid or almost complete solid (32/33, 97.0%) and very hypoechoic (26/33, 78.8%). Taller-than-wide shape (6/33, 18.2%) and punctate echogenic foci (9/33, 27.3%) were not popular. All the nodules were scored higher than 5 points according to the ACR TI-RADS, including 9 nodules that were classified into TR4 and 24 nodules as TR5. Follow-up information was available in 31 patients and no recurrence or distal metastasis was detected.Conclusions: WVPTC is a rare variant of PTCs with favorable outcomes. Very hypoechoic echogenicity, solid or almost complete solid composition are the vital indicators for biopsy, even though the nodule may be wider-than-tall and have a lack of punctuate echoic foci.


Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3755-3755
Author(s):  
Daniel Shasha ◽  
Fitzroy Dawkins ◽  
Francois E. Wilhelm

AbstractAnemia is reported at rates approaching 40% in cancer pts not receiving CT or RT. In two previous studies in anemic cancer pts not receiving CT or RT, epoetin alfa administered at 40,000 U sc once weekly1 or 60,000 U sc every two weeks2 was shown to be both safe and effective (hematopoietic response [HR] rates of 76.9% and 76.8%, respectively) in treating anemia. The primary objective of the current study was to evaluate the HR to epoetin alfa 80,000 U SC Q3W in this population; transfusions and quality of life were evaluated as well. Eligible pts had a non-myeloid malignancy, baseline hemoglobin (Hb) ≤ 11 g/dL, no CT administration within 8 weeks or RT within 4 weeks of study entry, and no plans to receive these therapies during the study period. Study drug was to be administered at Weeks 1, 4, 7, and 10, with follow-up continuing to Week 13. Epoetin alfa dose was reduced for Hb > 12 g/dL or Hb increase > 1.5 g/dL in any 3-week period; dose was withheld for Hb > 13 g/dL, then reduced when Hb ≤ 12 g/dL. All pts were to receive supplemental ferrous sulfate 325 mg po qd as tolerated. The primary efficacy endpoint was the proportion of pts achieving HR, defined as a ≥ 2 g/dL Hb increase and/or Hb ≥ 12 g/dL during the study, independent of transfusion within 28 days. 51 pts were enrolled (safety population) and 49 met the criteria for efficacy analyses (received ≥ 1 dose of epoetin alfa and had ≥ 1 post-baseline Hb value). Mean age was 71.0 ± 10.5 years, 53% of pts were female, 94% of pts had baseline ECOG status of 0 or 1, and mean baseline Hb was 10.3 ± 0.6 g/dL. The most common tumor types were breast (n=12, 24.5%) and prostate (n=12, 24.5%). HR was achieved in 37/49 (75.5%) pts. Mean time to first HR was 5.76 weeks. Hb change from baseline ≥ 1 g/dL was achieved in 39/49 (79.6%) pts, in a mean 3.77 weeks. 24 of 51 pts (47.1%) had at least one dose reduction or withhold. From Day 29 to end of study, 2/49 (4.1%) pts received PRBC transfusion. Statistically significant quality of life improvements from baseline in all 3 LASA scales (Energy Level, Daily Activities, and overall Quality of Life) were noted at Weeks 7 and 13/WD. Improvements were also seen with the FACT-An subscales, although not all changes were statistically significant at Weeks 7 and 13/WD. Adverse events occurring in ≥ 5% of the safety population were arthralgia (5 of 51 pts, 9.8%), back pain (3 of 51 pts, 5.9%), and vomiting (3 of 51 pts, 5.9%). One non-clinically relevant thrombotic vascular event of chest pain was reported. One pt died during the study, and 2 pts died during study follow-up; all deaths were considered unrelated to epoetin alfa therapy. In this population of cancer pts with anemia not receiving CT or RT, epoetin alfa 80,000 U sc administered Q3W safely increases Hb and improves pt quality of life. This extended dosing regimen further expands the flexible dosing options for epoetin alfa in this pt population.


2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 192-192
Author(s):  
Lois Lamerato ◽  
Andrew Glass ◽  
Kathryn E. Richert-Boe ◽  
John Edelsberg ◽  
Greg G. Wolff ◽  
...  

192 Background: Bone is a common site of metastatic involvement in patients (pts) with prostate cancer (PC). Bony metastases (mets) are associated with skeletal complications, which can cause significant morbidity and mortality. Intravenous bisphosphonates (IV BPs) have been proven to reduce the incidence and onset of skeletal complications. Patterns of use of IV BPs in clinical practice in pts with bone mets due to PC are largely unknown. Methods: Using the tumor registries and electronic data stores at two large US integrated health systems that serve a total of approximately 1.3 million persons, we retrospectively identified all pts aged ≥18 yrs with primary PC and newly diagnosed bone mets between 1/1/95 and 12/31/09. Information on all administrations of IV BPs between date of diagnosis of bone mets and death, loss to follow-up, or end of study was extracted from administrative data stores and electronic medical records, which also were reviewed by trained medical abstractors for evidence of skeletal-related events (SREs) (spinal cord compression, pathologic fracture, surgery to bone, radiation to bone). Results: We identified a total of 461 pts with primary PC and newly diagnosed bone mets. Mean (SD) age was 72.8 yrs (10.7 yrs); 75% were Caucasian, and 21% were African-American. Median duration of follow-up after diagnosis of bone mets was 1.3 yrs. One-fifth (20.2%) of study subjects received IV BPs (92% zoledronic acid, 8% pamidronate) during follow-up--10.8% prior to, and 9.3% after, first on-study SRE. Median time from diagnosis of bone mets to first administration of IV BPs was 1.7 yrs, and the median number of administrations was 3. The percentage of study subjects receiving IV BPs increased steadily over the 15-yr study period--from 7.5% among those newly diagnosed with bone mets in 1995-1999, to 19.8% among those newly diagnosed with bone mets in 2000-2004, to 27.5% among those newly diagnosed with bone mets in 2005-2009. Conclusions: Despite a high risk of SREs in pts with PC and bone mets, most such pts still do not receive IV BPs.


2012 ◽  
Vol 30 (27_suppl) ◽  
pp. 72-72 ◽  
Author(s):  
May Hagiwara ◽  
Karen Chung ◽  
Thomas E. Delea

72 Background: Patients with BMets secondary to BC are predisposed to SREs, defined as spinal cord compression (SCC), pathologic fracture (PF), surgery to bone (SB), and radiation therapy to bone (RT). Information on health care utilization and costs to treat SRE episodes in BC patients are limited. The objective of this study was to document current patterns of healthcare utilization and costs of SRE in patients with BC and BMets. Methods: This was a retrospective, observational study using the Thomson MedStat MarketScan Commercial Claims and Encounters database from 9/2002 to 6/2011. Study subjects included all persons with claims for BC (ICD-9-CM 174.xx) and for BMets (ICD-9-CM 170.xx or 198.5x), and ≥1 claim(s) for SRE. Key inclusion criteria included no other primary cancer and continuous enrollment ≥6 mos prior to BMets diagnosis. Unique SRE episodes were identified based on a gap of ≥90 days without an SRE claim, and classified by treatment setting (inpatient [IP, hospitalized for SRE during episode] or outpatient [OP]) and SRE type (SCC; PF [and no SCC]; SB [and no SCC or PF]; RT [and no SCC, PF, or SB]). Results: Of 22,709 BC patients with BMets, 11,941 had ≥1 SRE. Among 5,809 patients who met all other criteria, there were 7,617 SRE episodes over a mean (SD) follow-up of 17.2 (15.2) mos. The percent of SRE episodes that required IP treatment ranged from 11% (RT) - 76% (SB) (23% overall). On average, IP SCC episodes were most costly; while OP PF episodes were least costly. Of the total SRE costs (mean [SD] $21,072 [$36,462]/episode), 36% were for OP RT and 31% were for IP PF. Conclusions: In patients with BC and BMets, SREs are frequent and associated with high costs and hospitalizations. OP RT and IP PF account for a large share of SRE costs. Treatments that prevent SREs in these patients may reduce these costs. [Table: see text]


2008 ◽  
Vol 44 (3) ◽  
pp. 109-115 ◽  
Author(s):  
Jennipher E. Harris ◽  
Sarit Dhupa

Medical records of six cats diagnosed with lumbosacral intervertebral disk disease were reviewed. Clinical signs included reluctance to jump, low tail carriage, elimination outside the litter box, reluctance to ambulate, pelvic-limb paresis, urinary incontinence, and constipation. All cats had lumbosacral hyperpathia on palpation. Computed tomography in four cats revealed evidence of extradural spinal cord compression at the seventh lumbar (L7) to first sacral (S1) vertebral interspace. Compression was confirmed via myelography in three of these four cats, with confirmation in the fourth cat at the time of decompressive laminectomy. Each of the six cats underwent dorsal decompressive laminectomy at the L7 to S1 interspace. Postoperative clinical follow-up lasted 3 to 35 months, with most cats having excellent outcomes.


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