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1.  Cyclin D1 as a diagnostic immunomarker for endometrial stromal sarcoma with YWHAE-FAM22 rearrangement 
Endometrial stromal sarcoma (ESS) characterized by YWHAE-FAM22 genetic fusion is histologically higher-grade and clinically more aggressive than ESS with JAZF1-SUZ12 or equivalent genetic rearrangements, hence it is clinically important to recognize this subset of ESS. To identify diagnostic immunomarkers for this biologically-defined ESS subset, we compared gene expression profiles from YWHAE-FAM22 ESS, JAZF1-rearranged ESS and uterine leiomyosarcomas. These studies showed consistent upregulation of cyclin D1 in YWHAE-FAM22 ESS compared to JAZF1-SUZ12 ESS. Immunohistochemically, the high-grade round cell component of all 12 YWHAE-FAM22 ESS demonstrated diffuse (≥70%) moderate-to-strong nuclear cyclin D1 staining and this diffuse positivity was not seen in 34 ESS with JAZF1 and equivalent genetic rearrangements or in 21 low-grade ESS with no demonstrable genetic rearrangements. In a series of 243 non-ESS pure uterine mesenchymal and mixed epithelial-mesenchymal tumors, only 2 of 8 undifferentiated endometrial sarcomas with nuclear uniformity and 1 of 80 uterine leiomyosarcomas demonstrate diffuse cyclin D1 immunoreactivity. Both cyclin D1-positive undifferentiated endometrial sarcomas showed diffuse strong CD10 staining, which is consistently absent in the high-grade round cell component of YWHAE-FAM22 ESS. The low-grade spindle cell component of YWHAE-FAM22 ESS showed a spatially heterogeneous cyclin D1 staining pattern that was weaker and less diffuse overall. Our findings indicate that cyclin D1 is a sensitive and specific diagnostic immunomarker for YWHAE-FAM22 ESS. When evaluating high-grade uterine sarcomas, cyclin D1 can be included in the immunohistochemical panel as an indicator of YWHAE-FAM22 ESS.
PMCID: PMC3444748  PMID: 22982899
Endometrial stromal sarcoma; round cell; YWHAE-FAM22; cyclin D1; JAZF1-SUZ12
2.  Endometrial stromal sarcoma arising in vaginaEndometrial stromal sarcoma arising in vagina 
Endometrial stromal sarcoma (ESS) arising in the vagina is an extremely rare extrauterine endometrial stroma sarcoma, with only 4 cases reported in the literature up to date. Here we report a case of neoplasm originating from vagina. A 32-year-old woman complained of intermittent vaginal bleeding especially after intercourse. A mass with a diameter of 1.0 cm was found in the middle and upper segments of the right posterior vaginal wall. Biopsy showed ESS. Total abdominal hysterectomy, unilateral salpingo-oophorectomy (right) and partial vaginectomy were performed. No ESS lesion was found in endometrium. The patient received six courses of platinum-containing combination chemotherapy after surgery and was free of tumor 18 months after the diagnosis of ESS. The diagnosis of ESS relies on pathologic examination. CD10 is the most useful immunohistochemical marker for the diagnosis of this tumor. The mainstay treatment of ESS is surgery. Local excision and ovarian retaining may be considered in premenopausal women.
PMCID: PMC3843284  PMID: 24294390
Extrauterine sarcoma; endometrial stromal; vagina; immunohistochemistry
3.  Conservative management of endometrial stromal sarcoma at stage III: A case report 
Oncology Letters  2014;8(3):1234-1236.
Endometrial stromal sarcoma (ESS) is a rare malignant tumor of the uterus. The standard treatment is surgery, such as total hysterectomy with bilateral salpingo-oophorectomy. The use of adjuvant treatment, including chemotherapy, radiation therapy and endocrine therapy, remains controversial, so it is uncommon for conservative management to be performed in patients with low-grade ESS. The present study reports the case of a 19-year-old female with ESS at stage III who underwent a local mass resection by laparoscopic surgery. A high dose of progestin (medroxyprogesterone acetate) therapy was then administered. Conservative management resulted in complete remission of the low-grade ESS, with no sign of recurrence at the 33-month follow-up.
PMCID: PMC4114611  PMID: 25120695
endometrial stromal sarcoma; conservative management; progestin therapy
4.  Liver metastasis of endometrial stromal sarcoma 
World Journal of Hepatology  2012;4(12):415-418.
Resection of liver metastases from gynaecological tumours is uncommon. Endometrial stromal sarcomas (ESS) are low incidence gynecological tumours which can originate in previous sites of endometriosis or following metaplasia of the pelvic peritoneal wall, and which are exceptionally associated with liver metastasis. We present a 68-year-old woman with a ESS and metachronic liver metastasis treated by liver resection. There is very little literature on clinical management about liver metastasis from ESS, but extrapolating the data obtained with liver metastasis from sarcomas and uterine tumours, we should recommend resection as this is considered a resectable extrauterine metastasis. In cases with more sites of extrauterine disease, liver resection should also be performed if the other sites are resectable.
PMCID: PMC3554809  PMID: 23355923
Sarcoma; Stromal; Endometrial; Liver; Metastasis; Review
5.  Metastatic low-grade endometrial stromal sarcoma of the sigmoid colon three years after hysterectomy 
A 49-year-old woman, who had undergone hysterectomy for low-grade endometrial stromal sarcoma (ESS) 3 years ago, presented with a 2-wk history of lower abdominal pain. Barium enema and sigmoidoscopy disclosed a polypoid submucosal tumor. Histopathologic features of biopsy specimens from the lesion were similar to those of the resected uterine ESS. Under the diagnosis of metastatic ESS of the sigmoid colon, sigmoidectomy was performed. Microscopic examination demonstrated dense proliferation of spindle cells with little nuclear atypia, which were sometimes arranged in whorled pattern around abundant arterioles. Mitotic count is below 1 in 10 high-power fields. Immunohistochemically, the neoplastic cells were strongly positive for vimentin, estrogen receptor and progesterone receptor but negative for α-smooth muscle actin, S-100 protein and CD34. Thus, a final diagnosis of low-grade ESS metastasis to the sigmoid colon was made. Her postoperative course was uneventful and hormonal therapy with progestational agents is entertained.
PMCID: PMC4305830  PMID: 15818757
Endometrial stromal sarcoma; Metastasis; Sigmoidectomy
6.  Endometrial Stromal Sarcoma Presented as an Incidental Lung Mass with Multiple Pulmonary Nodules 
Low-grade endometrial stromal sarcoma (ESS) is an uncommon gynecologic malignancy of mesodermal origin. Pulmonary metastasis of low-grade ESS can occur years and decades after the treatment of the primary disease. Low-grade ESS is frequently mistaken as benign uterine neoplasm like uterine leiomyoma, which can potentially lead to a misdiagnosis. We present a case of a 42-year-old woman with low-grade ESS, that initially presented as an incidental lung mass with multiple pulmonary nodules, seven years after an uterine myomectomy. A 6.9×5.8 cm-sized intrapelvic mass suspected of uterine origin was discovered while searching for potential extrathoracic primary origin. A pelviscopy and simultaneous thoracoscopic lung biopsy were conducted for pathologic diagnosis. Finally, the diagnosis was confirmed as low-grade ESS with lung metastasis based on the histopathologic examination with immunohistochemical stain, which was showed positive for CD10 and hormone receptor markers (estrogen and progesterone receptors) in both pelvic and lung specimens.
PMCID: PMC3982240  PMID: 24734101
Sarcoma, Endometrial Stromal; Multiple Pulmonary Nodules; Neoplasm Metastasis
7.  Can Proliferation Biomarkers Reliably Predict Recurrence in World Health Organization 2003 Defined Endometrial Stromal Sarcoma, Low Grade? 
PLoS ONE  2013;8(10):e75899.
An estimated 1500–3000 invasive Endometrial Stromal Sarcomas (ESS) cases annually occur worldwide. Before 2003, ESS was divided as low and high grade ESS based on mitotic activity. In 2003 the WHO changed the names, excluded mitoses and made nuclear atypia and necrosis the essential diagnostic criteria to distinguish ESS, Low Grade (ESS-LG, recurrence-free survival >90%) and Undifferentiated Endometrial Sarcoma (UES, poor prognosis). We have evaluated in WHO2003 defined ESS-LG whether proliferation biomarkers predict recurrence. Using survival analysis, the prognostic value of classical mitosis counts (Mitotic Activity Index, MAI) in haematoxyllin-eosin (H&E) sections, and immunohistochemical proliferation biomarkers (Ki-67 and PhosphoHistone-3 (PPH3)) were examined in 24 invasive endometrial stromal sarcomas. Three of 24 (12.5%) ESS-LG recurred. The MAI, PPH3 and Ki-67 were all prognostic (P = 0.001, 0.002 and 0.03). MAI values were >3 in the recurrent cases, but never exceeded 10 (the classical threshold for low and high grade). Non-recurrent cases had 0≤MAI≤3. PPH3 and Ki67 counts can be easier to perform than MAI and therefore helpful in the diagnosis of ESS, Low Grade. In conclusion, in this small study of WHO2003 defined ESS-LG, high levels of proliferation as measured by MAI, PPH3 and Ki-67 are predictive of recurrence. Larger studies are required to confirm these results.
PMCID: PMC3795675  PMID: 24146786
8.  A case of eosinophilic chronic rhinosinusitis associated with optic neuropathy 
We report a case of eosinophilic chronic rhinosinusitis (ECRS) associated with optic neuropathy. The visual acuity in the right eye was suddenly reduced to no light perception on awakening in the morning. Fundus examination of both eyes on the same day showed no remarkable changes. Emergency computed tomography showed pan-sinusitis bilaterally and a partial defect of the sphenoid bone on the right side. From the clinical findings, the case was diagnosed as optic neuropathy associated with chronic sinusitis. Endoscopic sinus surgery (ESS) was performed on the same day, and all of the major sinuses were found to be filled with highly viscous fluid. Part of the optic canal had a defect probably due to inflammatory invasion from the adjacent sphenoid bone. Steroid therapy was started immediately postoperatively. Histopathological examination of excised polyps showed that numerous eosinophils had invaded the polyps but no hyphae were present. The patient reported that he had bronchial asthma and had had nasal polypectomy. Six months after the ESS and steroid therapy, the patient had a recurrence of the sinusitis. At that time, laboratory examination showed an elevation of total IgE and eosinophil numbers. From the clinical findings and course, this case was diagnosed as ECRS accompanied by optic neuropathy. Although ECRS rarely has ocular complications, the inflammation can spread and the optic nerve can be affected.
PMCID: PMC3132999  PMID: 21760710
optic neuropathy; eosinophilic chronic rhinosinusitis; chronic sinusitis; allergic fungal rhinosinusitis
9.  Percutaneous posterior-lateral lumbar interbody fusion for degenerative disc disease using a B-Twin expandable spinal spacer 
European Spine Journal  2009;19(2):325-330.
Degenerative disc disease (DDD) causes gradual intervertebral space collapse, concurrent discogenic or facet-induced pain, and possible compression radiculopathy. A new minimal invasion procedure of percutaneous posterior-lateral lumbar interbody fusion (PPLIF) using a B-Twin stand-alone expandable spinal spacer (ESS) was designed to treat this disease and evaluated by follow-up more than 1 year. 12 cases with chronic low back pain and compressive radiculopathy due to DDD refractory were selected to conservative treatment. Under fluoroscopy in the posterior-lateral position, a K-wire was advanced into the intervertebral space and a dilator and working cannula were introduced into the disc space step by step. Discectomy and endplate scratching were performed through the cannula using pituitary forceps and endplate curettage. An ESS was inserted into the intervertebral space by a B-Twin expandable spinal delivery system after some bone graft chips implanted into the disc space. The ongoing study includes intraoperative difficulties, complications, radiologic evidence of fusion and clinical outcome as scored by pre- and postoperative questionnaires pertaining to pain intensity and degree of disability. The 12 procedures of lumbar interbody fusion using stand-alone expandable spinal system through percutaneous approach were successful. Radiologic study demonstrated fusion in a total of 11 cases and only 1 exception after more than 1 year visiting. The values of Visual Analog Scale (VAS) on movement and Oswestry Disability Index (ODI) dropped by more than 80 and 67.4%, respectively. Disk space heights averaging 9.0 mm before procedure were increased to 11.5 mm 1 month (a significant difference compared with preprocedure, P < 0.01) after surgery and stabilized at 10.8 mm upon final follow-up (a significant difference compared with preprocedure, P < 0.01). The results demonstrated that the percutaneous approach for posterior-lateral lumbar interbody fusion using expandable spinal system is a valuable micro-invasion method for the DDD patients and can achieve the same outcome as with other methods.
PMCID: PMC2899821  PMID: 19784677
Disk degenerative disease; Percutaneous; Lumbar interbody spinal fusion; Expandable spinal spacer; Stand-alone; B-Twin
10.  Pulmonary Metastases of Uterine Endometrial Stromal Sarcoma: Diffuse Micronodular and Ground Glass Opacities: A Case Report 
Journal of Korean Medical Science  2004;19(6):901-903.
Pulmonary metastases of uterine endometrial stromal sarcoma (ESS) are uncommon. The patterns of uterine ESS metastasis to the lung are multiple pulmonary nodules, single nodule, or cystic lesions. Pulmonary intraalveolar micronodular metastases of uterine ESS are unusual and have not been reported. We experienced a case of metastatic uterine ESS presenting as pulmonary diffuse micronodules with ground glass opacities on chest computed tomography of a 37-yr-old woman who previously underwent hysterectomy due to low grade ESS of the uterus four years ago. The histologic findings of video assisted thoracotomy biopsy showed numerous intraalveolar polypoid micronodules protruding from the alveolar septums. All tumor nodules were composed of short spindle cells arranged in ill-defined whorls, and nuclear feature and sparse cytoplasm were seen in uterine ESS. Immunohistochemically, these cells showed strong nuclear staining for estrogen receptor and progesterone receptor, and diffuse cytoplasmic staining for CD10.
PMCID: PMC2816287  PMID: 15608407
Sarcoma, Endometrial Stromal; Neoplasm Metastasis; Lung Neoplasms
11.  Clinical study investigating the role of lymphadenectomy, surgical castration and adjuvant hormonal treatment in endometrial stromal sarcoma 
British Journal of Cancer  2007;97(9):1194-1199.
The objective of this study is to assess the therapeutic importance of surgical castration, adjuvant hormonal treatment and lymphadenectomy in endometrial stromal sarcoma (ESS). A retrospective and multicentric search was performed. Clinicopathologic data were retrieved from cases that were confirmed to be ESS after central pathology review. The protocol was approved by the Ethical Committee. ESS was confirmed histopathologically in 34 women, but follow-up data were available in only 31 women. Surgical treatment (n=31) included hysterectomy with or without bilateral salpingo-oophorectomy (BSO) in 23 out of 31 (74%) and 8 out of 31 (26%) cases, respectively. Debulking surgery was performed in 6 out of 31 cases (19%). Stage distribution was as follows: 22 stage I, 4 stage III and 5 stage IV. Women with stage I disease recurred in 4 out of 22 (18%) cases. Among stage I women undergoing hormonal treatment with or without BSO, 3 out of 15 (20%) and 1 out of 7 (14%) relapsed, respectively. Among stages III–IV women receiving adjuvant hormonal treatment or not, 1 out of 5 (20%) and 3 out of 4 (75%) relapsed, respectively (differences=55.0%, 95% CI=−6.8–81.2%). Kaplan–Meier curves show comparable recurrence rates for stage I disease without adjuvant hormonal treatment when compared to stages III–IV disease treated with surgery and adjuvant hormonal treatment. Furthermore, women taking hormones at diagnosis have a better outcome when compared to women not taking hormonal treatment. Three out of 31 (9%) patients had a systematic lymphadenectomy whereas 3 out of 31 (9%) had a lymph node sampling. In one case, obvious nodal disease was encountered at presentation. Isolated retroperitoneal recurrence occurred in 1 out of 31 (3%) of all cases and in 1 out of 8 (13%) recurrences. This single woman later also developed lung and abdominal metastases. Leaving lymph nodes in situ does not appear to alter the clinical outcome of ESS. Although numbers are low, the retrospective data suggest that the need for surgical castration (BSO) in premenopausal women with early-stage disease should be discussed with the patient on an individual basis. The data support the current practice in some centres to administer adjuvant hormonal treatment.
PMCID: PMC2360466  PMID: 17895898
endometrial; stromal; sarcoma; adenosarcoma; hormonal; lymphadenectomy
12.  Endometrial Stromal Sarcomas: A Retrospective Analysis of 28 Patients, Single Center Experience for 20 Years 
The aim of this study was to evaluate the behavior of endometrial stromal sarcomas (ESSs) in relation to their clinical and pathogenic features, and to determine the optimal treatment strategy.
Materials and Methods
A retrospective analysis was performed involving 28 patients with histologic-proven ESSs treated at our institution between 1987 and 2006.
The median follow-up was 54.7±63.1 months and the 5-year survival rate was 82.0%. Twenty-two (81.5%) and 5 patients (18.5%) had low- and high-grade disease, respectively. Univariate analysis revealed that the histologic grades, based on mitotic count, were associated with longer survival (p=0.004). However, among those patients with low-grade tumors, 5/20 patients (25%) had a recurrence and 2/21 patients (9.5%) had distant metastasis during the follow-up period. With the exception of 2 patients, 26 patients with ESSs underwent hysterectomy as primary treatment. Adjuvant treatment after surgery was administered to 14/26 patients (53.8%). Hormone therapy with progesterone, chemotherapy, and/or radiotherapy did not influence overall survival. However, the postoperative adjuvant therapy group, regardless of the treatment modality, was associated with relatively increased overall survival when compared to the surgery only group (p=0.054).
The preoperative differential diagnosis of ESSs from other benign gynecologic diseases is often difficult. We recommend adjuvant therapy be administered after hysterectomy in patients with ESS to prevent recurrence or distant metastasis.
PMCID: PMC2699082  PMID: 19688058
Endometrial; Stromal; Sarcoma; Radiotherapy; Chemotherapy; Treatment outcome
13.  Artificial Discs for Lumbar and Cervical Degenerative Disc Disease –Update 
Executive Summary
To assess the safety and efficacy of artificial disc replacement (ADR) technology for degenerative disc disease (DDD).
Clinical Need
Degenerative disc disease is the term used to describe the deterioration of 1 or more intervertebral discs of the spine. The prevalence of DDD is roughly described in proportion to age such that 40% of people aged 40 years have DDD, increasing to 80% among those aged 80 years or older. Low back pain is a common symptom of lumbar DDD; neck and arm pain are common symptoms of cervical DDD. Nonsurgical treatments can be used to relieve pain and minimize disability associated with DDD. However, it is estimated that about 10% to 20% of people with lumbar DDD and up to 30% with cervical DDD will be unresponsive to nonsurgical treatments. In these cases, surgical treatment is considered. Spinal fusion (arthrodesis) is the process of fusing or joining 2 bones and is considered the surgical gold standard for DDD.
Artificial disc replacement is the replacement of the degenerated intervertebral disc with an artificial disc in people with DDD of the lumbar or cervical spine that has been unresponsive to nonsurgical treatments for at least 6 months. Unlike spinal fusion, ADR preserves movement of the spine, which is thought to reduce or prevent the development of adjacent segment degeneration. Additionally, a bone graft is not required for ADR, and this alleviates complications, including bone graft donor site pain and pseudoarthrosis. It is estimated that about 5% of patients who require surgery for DDD will be candidates for ADR.
Review Strategy
The Medical Advisory Secretariat conducted a computerized search of the literature published between 2003 and September 2005 to answer the following questions:
What is the effectiveness of ADR in people with DDD of the lumbar or cervical regions of the spine compared with spinal fusion surgery?
Does an artificial disc reduce the incidence of adjacent segment degeneration (ASD) compared with spinal fusion?
What is the rate of major complications (device failure, reoperation) with artificial discs compared with surgical spinal fusion?
One reviewer evaluated the internal validity of the primary studies using the criteria outlined in the Cochrane Musculoskeletal Injuries Group Quality Assessment Tool. The quality of concealment allocation was rated as: A, clearly yes; B, unclear; or C, clearly no. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used to evaluate the overall quality of the body of evidence (defined as 1 or more studies) supporting the research questions explored in this systematic review. A random effects model meta-analysis was conducted when data were available from 2 or more randomized controlled trials (RCTs) and when there was no statistical and or clinical heterogeneity among studies. Bayesian analyses were undertaken to do the following:
Examine the influence of missing data on clinical success rates;
Compute the probability that artificial discs were superior to spinal fusion (on the basis of clinical success rates);
Examine whether the results were sensitive to the choice of noninferiority margin.
Summary of Findings
The literature search yielded 140 citations. Of these, 1 Cochrane systematic review, 1 RCT, and 10 case series were included in this review. Unpublished data from an RCT reported in the grey literature were obtained from the manufacturer of the device. The search also yielded 8 health technology assessments evaluating ADR that are also included in this review.
Six of the 8 health technology assessments concluded that there is insufficient evidence to support the use of either lumbar or cervical ADR. The results of the remaining 2 assessments (one each for lumbar and cervical ADR) led to a National Institute for Clinical Excellence guidance document supporting the safety and effectiveness of lumbar and cervical ADR with the proviso that an ongoing audit of all clinical outcomes be undertaken owing to a lack of long-term outcome data from clinical trials.
Regarding lumbar ADR, data were available from 2 noninferiority RCTs to complete a meta-analysis. The following clinical, health systems, and adverse event outcome measures were synthesized: primary outcome of clinical success, Oswestry Disability Index (ODI) scores, pain VAS scores, patient satisfaction, duration of surgery, amount of blood loss, length of hospital stay, rate of device failure, and rate of reoperation.
The meta-analysis of overall clinical success supported the noninferiority of lumbar ADR compared with spinal fusion at 24-month follow-up. Of the remaining clinical outcome measures (ODI, pain VAS scores, SF-36 scores [mental and physical components], patient satisfaction, and return to work status), only patient satisfaction and scores on the physical component scale of the SF-36 questionnaire were significantly improved in favour of lumbar ADR compared with spinal fusion at 24 months follow-up. Blood loss and surgical time showed statistical heterogeneity; therefore, meta-analysis results are not interpretable. Length of hospital stay was significantly shorter in patients receiving the ADR compared with controls. Neither the number of device failures nor the number of neurological complications at 24 months was statistically significantly different between the ADR and fusion treatment groups. However, there was a trend towards fewer neurological complications at 24 months in the ADR treatment group compared with the spinal fusion treatment group.
Results of the Bayesian analyses indicated that the influence of missing data on the outcome measure of clinical success was minimal. The Bayesian model indicated that the probability for ADR being better than spinal fusion was 79%. The probability of ADR being noninferior to spinal fusion using a -10% noninferiority bound was 92%, and using a -15% noninferiority bound was 94%. The probability of artificial discs being superior to spinal fusion in a future trial was 73%.
Six case series were reviewed, mainly to characterize the rate of major complications for lumbar ADR. The Medical Advisory Secretariat defined a major complication as any reoperation; device failure necessitating a revision, removal or reoperation; or life-threatening event. The rates of major complications ranged from 0% to 13% per device implanted. Only 1 study reported the rate of ASD, which was detected in 2 (2%) of the 100 people 11 years after surgery.
There were no RCT data available for cervical ADR; therefore, data from 4 case series were reviewed for evidence of effectiveness and safety. Because data were sparse, the effectiveness of cervical ADR compared with spinal fusion cannot be determined at this time.
The rate of major complications was assessed up to 2 years after surgery. It was found to range from 0% to 8.1% per device implanted. The rate of ASD is not reported in the clinical trial literature.
The total cost of a lumbar ADR procedure is $15,371 (Cdn; including costs related to the device, physician, and procedure). The total cost of a lumbar fusion surgery procedure is $11,311 (Cdn; including physicians’ and procedural costs).
Lumbar Artificial Disc Replacement
Since the 2004 Medical Advisory Secretariat health technology policy assessment, data from 2 RCTs and 6 case series assessing the effectiveness and adverse events profile of lumbar ADR to treat DDD has become available. The GRADE quality of this evidence is moderate for effectiveness and for short-term (2-year follow-up) complications; it is very low for ASD.
The effectiveness of lumbar ADR is not inferior to that of spinal fusion for the treatment of lumbar DDD. The rates for device failure and neurological complications 2 years after surgery did not differ between ADR and fusion patients. Based on a Bayesian meta-analysis, lumbar ADR is 79% superior to lumbar spinal fusion.
The rate of major complications after lumbar ADR is between 0% and 13% per device implanted. The rate of ASD in 1 case series was 2% over an 11-year follow-up period.
Outcome data for lumbar ADR beyond a 2-year follow-up are not yet available.
Cervical Artificial Disc Replacement
Since the 2004 Medical Advisory Secretariat health technology policy assessment, 4 case series have been added to the body of evidence assessing the effectiveness and adverse events profile of cervical ADR to treat DDD. The GRADE quality of this evidence is very low for effectiveness as well as for the adverse events profile. Sparse outcome data are available.
Because data are sparse, the effectiveness of cervical ADR compared with spinal fusion cannot be determined at this time.
The rate of major complications was assessed up to 2 years after surgery; it ranged from 0% to 8.1% per device implanted. The rate of ASD is not reported in the clinical trial literature.
PMCID: PMC3379529  PMID: 23074480
14.  Endometrial stromal sarcoma: a population-based analysis 
British Journal of Cancer  2008;99(8):1210-1215.
To determine independent prognostic factors for the survival of patients with endometrial stromal sarcoma (ESS), data were abstracted from the Surveillance, Epidemiology, and End Results (SEER) database of the National Cancer Institute from 1988 to 2003. Kaplan–Meier and Cox proportional hazards models were used for analyses. Of 831 women diagnosed with ESS, the median age was 52 years (range: 17–96 years). In total, 59.9% had stage I, 5.1% stage II, 14.9% stage III, and 20.1% had stage IV disease. Overall, 13.0, 36.1, and 34.7% presented with grades 1, 2, and 3, respectively. Patients with stage I–II vs III–IV disease had 5 years DSS of 89.3% vs 50.3% (P<0.001) and those with grades 1, 2, and 3 cancers had survivals of 91.4, 95.4, and 42.1% (P<0.001). In multivariate analysis, older patients, black race, advanced stage, higher grade, lack of primary surgery, and nodal metastasis were independent prognostic factors for poorer survival. In younger women (<50 years) with stage I–II disease, ovarian-sparing procedures did not adversely impact survival (91.9 vs 96.2%; P=0.1). Age, race, primary surgery, stage, and grade are important prognostic factors for ESS. Excellent survival in patients with grade 1 and 2 disease of all stages supports the concept that these tumors are significantly different from grade 3 tumors. Ovarian-sparing surgeries may be considered in younger patients with early-stage disease.
PMCID: PMC2570503  PMID: 18813312
endometrial stromal sarcoma; prognostic factors; survival
15.  Cervicothoracic Multisegmental Transpinal Evoked Potentials in Humans 
PLoS ONE  2013;8(10):e76940.
The objectives of this study were to establish the neurophysiological properties of the transpinal evoked potentials (TEPs) following transcutaneous electric stimulation of the spine (tsESS) over the cervicothoracic region, changes in the amplitude of the TEPs preceded by median nerve stimulation at group I threshold, and the effects of tsESS on the flexor carpi radialis (FCR) H-reflex in thirteen healthy human subjects while seated. Two re-usable self-adhering electrodes, connected to function as one electrode (cathode), were placed bilaterally on the clavicles. A re-usable electrode (anode) was placed on the cervicothoracic region covering from Cervical 4 – Thoracic 2 and held under constant pressure throughout the experiment. TEPs were recorded bilaterally from major arm muscles with subjects seated at stimulation frequencies of 1.0, 0.5, 0.33, 0.2, 0.125, and 0.1 Hz, and upon double tsESS pulses delivered at an inter-stimulus interval of 40 ms. TEPs from the arm muscles were also recorded following median nerve stimulation at the conditioning-test (C-T) intervals of 2, 3, 5, 8, and 10 ms. The FCR H-reflex was evoked and recorded according to conventional methods following double median nerve pulses at 40 ms, and was also conditioned by tsESS at C-T intervals that ranged from −10 to +50 ms. The arm TEPs amplitude was not decreased at low-stimulation frequencies and upon double tsESS pulses in all but one subject. Ipsilateral and contralateral arm TEPs were facilitated following ipsilateral median nerve stimulation, while the FCR H-reflex was depressed by double pulses and following tsESS at short and long C-T intervals. Non-invasive transpinal stimulation can be used as a therapeutic modality to decrease spinal reflex hyper-excitability in neurological disorders and when combined with peripheral nerve stimulation to potentiate spinal output.
PMCID: PMC3838209  PMID: 24282479
16.  Endometrial Stromal Sarcomas: A clinico-pathological analysis of 27 patients 
Objective: To evaluate clinico-pathological features and prognostic valuses of Endometrial stromal sarcomas (ESS) through comparison of the two grade groups (low- and high-grade disease).
Methodology: We retrospectively analyzed the medical records of 27 patients who were diagnosed with ESS at a single institute between March 1988 and November 2009. Our retrospective chart review was approved by our local institutional Review Board (IRB).
Results: The median age of the patients was 44.0 years, the median follow-up period was 101.0 months and the 10-year survival rate was 74.2%. The median uterine weight was 215.0 gm. Twenty-three (70.4%) and four patients (29.6%) had low- and high-grade disease, respectively. As primary treatment, twenty-four (70.4%) and three patients (11.1%) underwent type I hysterectomy and type III hysterectomy, respectively. Total six cases were recurred and two cases of the six-recurred patients were distant metastasis (lung) and four cases were died of the disease. Univariate analysis revealed that the histologic grade and the uterine tumor weight were significantly related with longer disease-free survival (p=0.025 and 0.043 respectively).
Conclusion: ESSs with high-grade or larger tumor size have to be carefully and sufficiently managed, because of its rarity and aggressive behavior. To determine the proper adjuvant treatment of ESS with high risks, further clinical data should be collected and studied.
PMCID: PMC3809180  PMID: 24353511
Endometrial stromal sarcoma; Clinical and pathological features; Rare tumor
17.  Clinicopathological and molecular markers associated with prognosis and treatment effectiveness of endometrial stromal sarcoma: a retrospective study in China 
To evaluate the clinicopathological and immunophenotypic characteristics of endometrial stromal sarcoma (ESS) in China.
Methods and materials
Seventy-two consecutive ESS cases treated between 1995 and 2009 were retrospectively reviewed.
Sixty-three patients received surgical treatment. Forty-one patients underwent pelvic lymphadenectomy. In paraffin-embedded specimens, expression of the following molecular markers was detected: CD10 (27/36), vimentin (37/38), HHF35 (3/32), S-100 (0/25), desmin (2/29), CD117 (0/23), CD34 (2/24), alpha-inhibin (0/17), CK (1/34), CD99 (4/9), smooth muscle actin (5/25), EMA (0/7), estrogen receptor (13/16) and progesterone receptor (13/16). CD10 and vimentin were expressed more frequently in these specimens. Tumor classification, CD10 and surgical procedures were significantly associated with disease-free survival (DFS). Surgical procedures were significantly associated with overall survival (OS). Tumor stage (P = 0.024) and surgical procedure (P = 0.042) were found to be significant independent prognostic factors for DFS. No complete or partial response was observed among patients who received radiotherapy or chemotherapy.
Our results indicate that total hysterectomy with bilateral salpingo-oophorectomy followed by pelvic lymphadenectomy is associated with an improved treatment outcome. CD10-negative expression may contribute to the malignant characteristics and recurrence associated with ESS.
PMCID: PMC3894427  PMID: 23959089
Endometrial stromal sarcoma; Pelvic lymphadenectomy; CD10; Prognosis
18.  Successful pregnancy following conservative management of low-grade endometrial stromal sarcoma: A case report 
Oncology Letters  2014;7(4):1039-1042.
It is uncommon that fertility is preserved in young nulliparous females with low-grade endometrial stromal sarcoma (ESS). Therefore, successful pregnancy following such conservative management has been rarely reported in previous literature. A 25-year-old female (gravida, 0; para, 0) underwent hysteroscopic surgery and was pathologically diagnosed with an endometrial stromal nodule. The patient underwent fertility-preserving local resection and uterine reconstruction, with a final pathological diagnosis of low-grade ESS. Endocrine therapy was then administered. Conservative management resulted in the complete remission of low-grade ESS. The patient naturally conceived and successfully delivered a healthy baby at 42 weeks’ gestation by cesarean section, ~30 months following diagnosis with low-grade ESS. In conclusion, conservative management, including fertility-preserving local mass resection and endocrine therapy, can be effective for low-grade ESS and may yield a favorable outcome for young nulliparous females desiring fertility preservation.
PMCID: PMC3961328  PMID: 24944665
endometrial stromal sarcoma; endocrine therapy; fertility-preserving surgery; pregnancy
19.  Endometrial stromal sarcoma 
Endometrial stromal sarcoma (ESS) is a rare malignant tumor of the endometrium, occurring in the age group of 40–50 years. This is a case of low-grade ESS presenting as rapid enlargement of a fibroid uterus. Because of her secondary infertility, she was planned for myomectomy. However, due to the high degree of suspicion of a sarcomatous change in the fibroid, in view of rapid enlargement of uterus within the last 4 months, we planned for a preoperative endometrial aspiration. It showed low-grade ESS, which was later confirmed by histopathology examination of total hysterectomy specimen. As surgery was the main treatment for ESS, because of the proper preoperative diagnosis, we could plan the treatment accordingly. Despite the rarity of the tumor, one has to consider the possibility of ESS in cases with presentation of rapid enlargement of a fibroid uterus.
PMCID: PMC2941598  PMID: 20931016
Endometrial stromal sarcoma; rapid enlargement of fibroid uterus; uterine sarcoma
20.  Endometrial Stromal Sarcoma Presenting as Prevesical Mass Mimicking Urachal Tumor 
Journal of Korean Medical Science  2009;24(3):529-531.
Endometrial stromal sarcoma (ESS) is a mesenchymal neoplasm that usually occurs as a primary tumor of the uterine corpus, but rarely arises in other sites, such as the ovary, pelvic cavity, mesentery, omentum and intestine. Herein, we present a rare case of low-grade ESS presented as prevesical mass. A 60-yr-old woman who had undergone total hysterectomy for endometriosis eleven years ago was presented with incidentally detected prevesical pelvic mass. Since malignant transformation of urachal remnants was possible, the mass was suspected to be a urachal tumor. Extraction of the mass was performed, and the histopathologic diagnosis was low-grade ESS. In summary, prevesical tumor is rare but in patients with endometriosis, we suggest endometriosis and its possible malignant changes should be taken into account in the differential diagnosis of prevesical mass.
PMCID: PMC2698206  PMID: 19543523
Sarcoma, Endometrial Stromal; Endometriosis
21.  Low grade Endometrial Stromal Sarcoma of uterine corpus, a clinico-pathological and survey study in 14 cases 
Endometrial stromal sarcoma (ESS) is a rare disease with probably less than 700 new cases in the USA or Europe per year. The aim of this study was to evaluate the behavior of low-grade endometrial stromal sarcoma (LGESS) in relation to their clinical and pathological features and to identify possible prognostic factors.
Patients and methods
Fourteen patients with histologically proven ESS were included in the analysis. Endometrial stromal sarcoma is characterized by proliferations composed of cells with Endometrial stromal cell differentiation. Low-grade endometrial stromal sarcoma has an infiltrating margin and typically show extensive worm-like vessel invasion.
The median age was 44.35 ± 6 years. The most common presenting symptom was vaginal bleeding, occurring in twelve patients (86%). Diagnosis was made through Fractional dilatation and curettage in four patients (28.5%). Eight patients had a total abdominal hysterectomy and salpingo-ophorectomy (57%). Radiotherapy as adjuvant therapy was administered to four patients (28.5%). The median follow-up time was 45.6 months (range 24–84). The median overall survival of the 14 patients was 45.35 ± 21 months (range 20–83). Three of 14 patients demonstrated a recurrence of disease at 9, 72, and 96 months respectively. The recurrent diseases were treated with surgery, chemotherapy, and radiotherapy. No patient died of the disease. Clinico-pathological parameters did not significantly differ between patients with and without recurrence, but patients with no myometrial invasion and low mitotic count <= 5/HPF showed longer disease-free survival.
Five-year survival rate was 93%. Survival probabilities were calculated by the product limit method of Kaplan and Meier that showed, patients with no myometrial invasion and low mitotic count <= 5/HPF have longer disease-free survival, but P value was not significant.
PMCID: PMC1560376  PMID: 16895611
22.  Pros, cons, and costs of INFUSE in spinal surgery 
INFUSE (recombinant human bone morphogenetic protein-2 [rh-BMP-2]; Medtronic, Memphis, TN, USA) is approved by the Federal Drug Administration (FDA) only for use with the lumbar tapered fusion device (LT Cage; Medtronic) to perform single-level anterior lumbar interbody fusions (ALIF: L2-S1 levels). INFUSE, however, is widely utilized in an “off-label” capacity for anterior and/or posterior cervical, thoracic, and lumbar surgery. Nevertheless, Medicare and other insurance companies, are now increasingly denying reimbursement (average cost of a “large” INFUSE to the hospital without overhead $5000-6000) to hospitals for INFUSE when utilized “off-label”.
This commentary looks at several representative studies citing the cons associated with utilizing INFUSE in spinal surgery, contraindications, complications, and cost factors.
There are multiple cons of utilizing INFUSE in an “off-label” capacity for spinal surgery. Direct contraindications include pregnancy, allergy to titanium, allergy to bovine type I collagen or rhBMP-2, infection, tumor, liver or kidney disease, immunosuppression (e.g., lupus, HIV/AIDS); contraindications are also seen in those receiving radiation, chemotherapy, or steroids. Reported complications include exuberant/ectopic bone formation, paralysis (cord, nerve damage), dural tears, bowel–bladder and sexual dysfunction, respiratory failure, inflammation of adjacent tissues, fetal developmental complications, scar, excessive bleeding, and even death. Complications are so prevalent in the anterior cervical spine, that many surgeons no longer use it in this region. Similarly, INFUSE complications and indications for posterior lumbar interbody fusions (PLIFs) and transforaminal interbody lumbar fusions (TLIFs) should also be reexamined.
More surgeons need to question the safety, efficacy, and appropriate “off-label” use of INFUSE in all spine surgeries.
PMCID: PMC3031052  PMID: 21297932
INFUSE (rhBMP-2); bone morphogenetic protein; spinal surgery; off-label use
23.  Spinal Metastasis of Thymic Carcinoma as a Rare Manifestation: A Summary of 7 Consecutive Cases 
Korean Journal of Spine  2014;11(3):157-161.
Thymic carcinomas are very rare tumors that are often associated with extrathoracic metastasis to other organs. However, it is well known that thymic carcinomas rarely metastasize to the spine, and the prognosis, treatment, and natural course of this disease are not yet standardized.
We describe seven thymic carcinoma patients with spinal metastasis who were diagnosed and treated in our institute from January 2006 to December 2011. We performed surgical treatment and adjuvant chemotherapy and/or radiation therapy, in consideration of each individual disease's course, and we regularly followed up the patients.
Of the seven patients, five were male and two were female. Six had metastases in the thoracic spine, and one had metastases in the lumbar spine. An extradural lesion was found in five patients, and two patients had both extradural and intradural lesions. The period from the primary diagnosis to spinal metastases varied widely (range, 1.23-14 years). After surgery, all patients showed an improvement of back pain and radicular pain. Two patients were lost to follow-up, but the other five maintained ambulatory function until their final follow-up. Four patients died because of pulmonary complications accompanied with the disease's progression. One patient died from uncontrolled brain metastases. After surgery, the median survival was 204±111.43 days.
Because metastasis to the spine from thymic carcinoma is very rare, there are no treatment guidelines. Nevertheless, we suggest that appropriate surgical management of the metastatic lesion is necessary for the preservation of the patient's quality of life during survival.
PMCID: PMC4206972  PMID: 25346762
Thymic carcinoma; Spinal metastasis; Surgical management
24.  Gene expression signatures differentiate uterine endometrial stromal sarcoma from leiomyosarcoma 
Gynecologic oncology  2012;128(2):349-355.
Endometrial stromal sarcoma (ESS) and leiomyosarcoma (LMS) are the two most common uterine sarcomas, but both are rare tumors. The aim of the present study was to compare the global gene expression patterns of ESS and LMS.
Gene expression profiles of 7 ESS and 13 LMS were analyzed using the HumanRef-8 BeadChip from Illumina. Differentially expressed candidate genes were validated using quantitative real-time PCR and immunohistochemistry.
Unsupervised hierarchical clustering using all 54,675 genes in the array separated ESS from LMS samples. We identified 549 unique probes that were significantly differentially expressed in the two malignancies by greater than 2-fold with 1% FDR cutoff using one-way ANOVA with Benjamini–Hochberg correction, of which 336 and 213 were overexpressed in ESS and LMS, respectively. Genes overexpressed in ESS included SLC7A10, EFNB3, CCND2, ECEL1, ITM2A, NPW, PLAG1 and GCGR. Genes overexpressed in LMS included CDKN2A, FABP3, TAGLN, JPH2, GEM, NAV2 and RAB23. The top 100 genes overexpressed in LMS included those coding for myosin light chain and caldesmon, but not the genes coding for desmin or actin. CD10 was not overexpressed in ESS. Results for selected genes were validated by quantitative real-time PCR and immunohistochemistry.
We present the first study in which gene expression profiling was shown to distinguish between ESS and LMS. The molecular signatures unique to each of these malignancies may aid in expanding the diagnostic battery for their differentiation, and may provide a molecular basis for prognostic studies and therapeutic target discovery.
PMCID: PMC4051229  PMID: 23178314
Diagnosis; Gene expression array; Uterine sarcoma
25.  MIS Fusion of the SI Joint: Does Prior Lumbar Spinal Fusion Affect Patient Outcomes? 
Sacroiliac (SI) joint pain is a challenging condition to manage as it can mimic discogenic or radicular low back pain, and present as low back, hip, groin and/or buttock pain. Patients may present with a combination of lumbar spine and SI joint symptoms, further complicating the diagnosis and treatment algorithm [1-3]. SI joint pain after lumbar spinal fusion has been reported in the literature. Both clinical and biomechanical studies show the SI joint to be susceptible to increased motion and stress at the articular surface with up to 40-75% of patients developing significant SI joint degeneration after 5 years.
In a recent case series study of 50 patients who underwent minimally invasive SI joint arthrodesis, 50% had undergone previous lumbar spinal fusion and 18% had symptomatic lumbar spine pathology treated conservatively [4].
The purpose of this study is to determine if history of previous lumbar fusion or lumbar pathology affects patient outcomes after MIS SI joint fusion surgery.
We report on 40 patients with 24 month follow up treated with MIS SI joint fusion using a series of triangular porous plasma coated titanium implants (iFuse, SI-Bone, Inc. San Jose, CA). Outcomes using a numerical rating scale (NRS) for pain were obtained at 3-, 6-, 12- and 24 month follow up intervals. Additionally, patient satisfaction was collected at the latest follow up interval. Patients were separated into 3 cohorts: 1) underwent prior lumbar spine fusion (PF), 2) no history of previous lumbar spine fusion (NF), 3) no history of previous lumbar spine fusion with symptomatic lumbar spine pathology treated conservatively (LP). A repeated measures analysis of variance (rANOVA) was used to determine if the change in NRS pain scores differed across timepoints and subgroups. A decrease in NRS by 2 points was deemed clinically significant [5].
Mean age was 54 (±13) years and varied slightly but not statistically between groups. All subgroups experienced a clinically and statistically significant reduction in pain at all time points (mean change >2 points, p<0.001). There was a statistically significant effect of cohort (p=0.045), with the NF cohort (no prior lumbar spinal fusion) having a somewhat greater decrease in pain (by approximately 1 point) compared to the other 2 groups (PF and LP).Patient reported satisfaction by cohort was: 89% (NF), 92% (PF) and 63% (LP).Overall satisfaction rate was 87%.
Discussion and Conclusion:
Patients with SI joint pain, regardless of prior lumbar spine fusion history, show significant improvement in pain after minimally invasive SI joint fusion. The presence of symptomatic lumbar spine pathology potentially confounds the treatment affect, as patients may not be able to discriminate between symptoms arising from the SI joint and the lumbar spine. These patients expressed a lower satisfaction with surgery. Patients without other confounding lumbar spine pathology and who have not undergone previous spine surgery tend to be younger and experience a greater reduction in pain.
PMCID: PMC3664440  PMID: 23730380
Sacroiliac (SI) joint; lumbar fusion; minimally invasive surgery; MIS arthrodesis.

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