The efficacy of 'Radio guided Occult Lesion Localization' (ROLL) versus 'Wire-guided Localization' (WGL) in breast conserving surgery for non-palpable breast cancer: A randomized clinical trial – ROLL study

<p>Abstract</p> <p>Background</p> <p>With the increasing number of non palpable breast carcinomas, the need of a good and reliable localization method increases. Currently the wire guided localization (WGL) is the standard of care in most countries. Radio guided occult lesion localization (ROLL) is a new technique that may improve the oncological outcome, cost effectiveness, patient comfort and cosmetic outcome. However, the studies published hitherto are of poor quality providing less than convincing evidence to change the current standard of care.</p> <p>The aim of this study is to compare the ROLL technique with the standard of care (WGL) regarding the percentage of tumour free margins, cost effectiveness, patient comfort and cosmetic outcome.</p> <p>Methods/design</p> <p>The ROLL trial is a multi center randomized clinical trial. Over a period of 2–3 years 316 patients will be randomized between the ROLL and the WGL technique. With this number, the expected 15% difference in tumour free margins can be detected with a power of 80%. Other endpoints include cosmetic outcome, cost effectiveness, patient (dis)comfort, degree of difficulty of the procedures and the success rate of the sentinel node procedure.</p> <p>The rationale, study design and planned analyses are described.</p> <p>Trial Registration</p> <p>(<url>http://www.clinicaltrials.gov</url>, study protocol number NCT00539474)</p

The Hybrid SPECT/CT as an Additional Lymphatic Mapping Tool in Patients with Breast Cancer

Background Conventional lymphoscintigraphy does not always define the exact anatomic location of a sentinel node. The lymphatic drainage pattern may be unusual or may not be shown at all. The recently introduced hybrid SPECT/CT imaging could help overcome these difficulties. SPECT is a tomographic version of conventional lymphoscintigraphy and the images have better contrast and resolution. When fused with the anatomical details provided by CT into one image, a meaningful surgical ‘‘roadmap’’ can be created. So far, there is little literature on the use of hybrid SPECT/CT in lymphatic mapping in patients with breast cancer. The purpose of this review was to report on these publications, including our own experience, focusing on patient selection, SPECT/CT settings, anatomic localization, and the detection of additional sentinel nodes. Methods The majority of investigators did not formulate indications for additional SPECT/CT after conventional imaging but scanned all patients eligible for sentinel node biopsy. The SPECT/CT settings used in the studies of this review were mostly similar, but the methods used for conventional imaging were more variable. Results All studies demonstrated an improved anatomical localization by performing additional SPECT/CT; sentinel nodes outside the axilla or nodes close to the injection sit

Questionnaire of chronic illness care in primary care-psychometric properties and test-retest reliability

<p>Abstract</p> <p>Background</p> <p>The Chronic Care Model (CCM) is an evidence-based approach to improving the structure of care for chronically ill patients with multimorbidity. The Assessment of Chronic Illness Care (ACIC), an instrument commonly used in international research, includes all aspects of the CCM, but cannot be easily extended to the German context. A new instrument called the "Questionnaire of Chronic Illness Care in Primary Care" (QCPC) was developed for use in Germany for this reason. Here, we present the results of the psychometric properties and test-retest reliability of QCPC.</p> <p>Methods</p> <p>A total of 109 family doctors from different German states participated in the validation study. Participating physicians completed the QCPC, which includes items concerning the CCM and practice structure, at baseline (T0) and 3 weeks later (T1). Internal consistency reliability and test-retest reliability were evaluated using Cronbach's alpha and Pearson's r, respectively.</p> <p>Results</p> <p>The QCPC contains five elements of the CCM (decision support, delivery system design, self-management support, clinical information systems, and community linkages). All subscales demonstrated moderate internal consistency and moderate test-retest reliability over a three-week interval.</p> <p>Conclusions</p> <p>The QCPC is an appropriate instrument to assess the structure of chronic illness care. Unlike the ACIC, the QCPC can be used by health care providers without CCM training. The QCPC can detect the actual state of care as well as areas for improvement of care according to the CCM.</p

Enzyme therapy and immune response in relation to CRIM status: the Dutch experience in classic infantile Pompe disease

BACKGROUND: Enzyme-replacement therapy (ERT) in Pompe disease—an inherited metabolic disorder caused by acid α-glucosidase deficiency and characterized in infants by generalized muscle weakness and cardiomyopathy—can be complicated by immune responses. Infants that do not produce any endogenous acid α-glucosidase, so-called CRIM-negative patients, reportedly develop a strong response. We report the clinical outcome of our Dutch infants in relation to their CRIM status and immune response. METHODS: Eleven patients were genotyped and their CRIM status was determined. Antibody formation and clinical outcome were assessed for a minimum of 4 years. RESULTS: ERT was commenced between 0.1 and 8.3 months of age, and patients were treated from 0.3 to 13.7 years. All patients developed antibodies. Those with a high antibody titer (above 1:31,250) had a poor response. The antibody titers varied substantially between patients and did not strictly correlate with the patients’ CRIM status. Patients who started ERT beyond 2 months of age tended to develop higher titers than those who started earlier. All three CRIM-negative patients in our study succumbed by the age of 4 years seemingly unrelated to the height of their antibody titer. CONCLUSION: Antibody formation is a common response to ERT in classic infantile Pompe disease and counteracts the effect of treatment. The counteracting effect seems determined by the antibody:enzyme molecular stoichiometry. The immune response may be minimized by early start of ERT and by immune modulation, as proposed by colleagues. The CRIM-negative status itself seems associated with poor outcome. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s10545-014-9707-6) contains supplementary material, which is available to authorized users

Evaluation of lymphatic drainage patterns to the groin and implications for the extent of groin dissection in melanoma patients

INTRODUCTION: Early conventional lymphoscintigrams can distinguish sentinel nodes from second-tier nodes and the new SPECT/CT technology shows their precise anatomical location. The purpose of the study was to analyze lymphatic drainage patterns to the groin using these techniques and to determine the implications for a potential groin dissection. METHODS: Fifty-five groins in 50 patients were analyzed using lymphoscintigrams and SPECT/CT. The superficial groin was divided in five Daseler-zones, and the pelvic region in three zones. RESULTS: A total of 106 sentinel nodes were depicted: 10% in the superior lateral, 13% superior medial, 42% inferior medial, 26% central, and 8% in the external iliac zone. The second-tier nodes were mostly visualized in the external iliac zone (54%). No drainage at all was seen to the inferior lateral zone. In lower trunk melanoma, 81% of the sentinel nodes were in the superior and central zones, and no second-tier nodes were observed in the inferior zones. Twelve sentinel nodes were involved: ten in the inferior medial and two in the central zone. CONCLUSIONS: Most (involved) sentinel nodes were found in the inferior medial and central zones. The high frequency of pelvic second-tier nodes indicates the need for a deep completion groin dissection in the majority of patients with positive sentinel nodes. In none of the patients, lymphatic drainage was seen to the inferior lateral zone, which suggests that this area need not be included in a completion dissection. In patients with lower trunk melanoma, the inferior medial zone may not need to be removed eithe

Comparison of three micromorphometric pathology classifications of melanoma metastases in the sentinel node

OBJECTIVE: The purposes of this study were to determine which classification best predicts additional lymph node disease and survival, and to suggest a threshold below which a completion dissection may be omitted. SUMMARY BACKGROUND DATA: Three micromorphometric parameters of melanoma sentinel node metastases were compared: invasion depth from the capsule (Starz-classification), maximum diameter (Rotterdam-criteria), and location within the node (Dewar-classification). METHODS: The pathology slides of 116 patients with tumor-positive sentinel nodes were reviewed. The follow-up data were obtained from the prospectively kept database. The median follow-up duration was 53 months. RESULTS: Metastases with an invasion depth under 0.3 mm or diameter less than 0.1 mm were not associated with additional involved nodes. Four percent of the patients with metastases with an invasion depth of 0.3 to 1.0 mm had other involved nodes and 3% of the patients with metastases with a diameter of 0.1 to 1.0 mm. Other nodes were involved in 3% of subcapsular metastases, 9% of both subcapsular and parenchymal metastases, and 33% in case of multifocal or extensive disease. The smallest tumor invasion depth and diameter associated with additional involved nodes was 0.4 mm. Only 5-year overall survival in the 3 successive invasion depth categories were statistically significant: 92%, 83%, and 68%. Five-year overall survival was 81% in patients with one involved sentinel node and 60% if there were more. CONCLUSIONS: Invasion depth and diameter of the metastasis correlate best with the presence of additional nodal disease. Invasion depth best predicts overall survival. It seems justified to refrain from completion dissection in patients with a sentinel node tumor invasion depth up to 0.4 m

Reevaluation of the locoregional recurrence rate in melanoma patients with a positive sentinel node compared to patients with palpable nodal involvement

BACKGROUND: The main aims of this study were to evaluate the occurrence of the various forms of locoregional recurrence in sentinel node-positive melanoma patients, to determine whether the different definitions that are being used to describe in-transit metastases influence this rate, and to identify factors associated with locoregional recurrence. A comparison was made with the rate of locoregional recurrence in patients who underwent lymph node dissection for palpable metastases. METHODS: Between December 1993 and December 2008, a total of 141 patients underwent completion lymph node dissection because of a tumor-positive sentinel node. In the same period, 178 patients underwent a regional lymph node dissection for palpable nodal metastases. RESULTS: In the sentinel node-positive patients, the local recurrence rate was 5%, the rate of satellite metastasis was 2%, and for in-transit metastasis, it was 15%. In patients with palpable nodal involvement, these values were 3%, 2%, and 14%, respectively. There was no statistically significant difference in locoregional recurrence-free rates between these two groups of node-positive patients (P = .172). Breslow thickness was the only predictive factor for locoregional recurrence (P = .015). CONCLUSIONS: The rate of locoregional metastases in patients with a tumor-positive sentinel node and patients with palpable nodal involvement is similar. The present study refutes the suggestion that a positive sentinel node indicates a predisposition for developing in-transit metastase

Is completion lymph node dissection needed in case of minimal melanoma metastasis in the sentinel node?

OBJECTIVE: The purpose of this study was to evaluate the micromorphometric Starz-classification in melanoma patients. SUMMARY BACKGROUND DATA: The micromorphometric Starz-classification suggests that melanoma patients with a sentinel node metastasis invading no more than 0.3 mm (S-I) or 0.31 to 1.0 mm (S-II) below the capsular level can be spared further surgery, while invasion of the metastasis of more than 1.0 mm (S-III) implies a need for completion dissection. METHODS: Seventy patients with sentinel node metastases were studied. Twenty patients with an S-I or S-II classification were spared further surgery and 50 S-III patients underwent completion dissection. The median follow-up time was 33 months. RESULTS: No lymph node recurrences were detected in the 20 S-I, II patients. Six of the 50 S-III patients (12%) had additional involved nodes in the dissection specimen. In these patients no recurrences developed in the cleared regional basins. Overall 3-year survival was 100% in the S-I, II patients and 80% in the S-III patients (P = 0.04). Three-year disease-free survival rates were 83% and 60%, respectively (P = 0.40). CONCLUSIONS:: This study suggests that further surgery is unnecessary in S-I and S-II patients, while it does seem prudent to carry out completion dissection in S-III patients. The distinct survival difference between the 2 groups of patients suggests that the S-classification also has prognostic implication

The hidden sentinel node and SPECT/CT in breast cancer patients

PURPOSE: In a minority of breast cancer patients, lymphoscintigraphy shows no lymphatic drainage and 'hidden' sentinel nodes may remain undiscovered. The purpose of this study was to explore the additional value of the recently introduced hybrid SPECT/CT in breast cancer patients with axillary non-visualisation on planar images. The role of blue dye and careful palpation of the axilla was evaluated in patients in whom axillary sentinel nodes remained hidden after SPECT/CT. METHODS: Fifteen breast cancer patients with non-visualisation on planar lymphoscintigraphy and 13 women with only extra-axillary sentinel nodes underwent SPECT/CT following late planar imaging without re-injection of the radiopharmaceutical. RESULTS: SPECT/CT visualised lymphatic drainage in eight of the 15 patients (53%) with non-visualisation on planar imaging, depicted nine of the 14 harvested sentinel nodes (64%) and three of five tumour-positive sentinel nodes. In two of the 13 patients (15%) with only extra-axillary sentinel nodes on their planar lymphoscintigram, SPECT/CT showed an axillary sentinel node that appeared to be uninvolved. Careful exploration of the axilla with the combined use of blue dye, a gamma probe and intra-operative palpation revealed an axillary sentinel node in the remaining 18 patients. SPECT/CT showed the exact anatomical location of all visualised sentinel nodes. CONCLUSION: SPECT/CT discovered 'hidden' sentinel nodes in the majority of patients with non-visualisation, but was less valuable in patients with only extra-axillary lymphatic drainage on the planar images. Exploration of the axilla in patients with persistent non-visualisation improved the identification of axillary (involved) sentinel node

SPECT/CT for sentinel lymph node mapping in head and neck melanoma

BACKGROUND.: The additional value of single photon emission computed tomography with CT (SPECT/CT) for detection and localization of sentinel nodes in patients with a melanoma of the head and neck was determined. METHODS.: Thirty-eight patients received conventional lymphoscintigraphy followed by hybrid SPECT/CT. The number of sentinel nodes visualized and anatomic information provided were analyzed. Changes in surgical approach due to additional information from the SPECT/CT were evaluated in 20 patients. RESULTS.: SPECT/CT visualized a mean of 2.6 sentinel nodes per patient (range, 1-6). SPECT/CT depicted an additional sentinel node in 16% of the patients and clearly showed the anatomic location of the hot nodes in all patients. The surgical approach was adjusted on the basis of SPECT/CT images in 11 patients (55%). CONCLUSION.: SPECT/CT visualizes more sentinel nodes than conventional images and shows their anatomic location. SPECT/CT is recommended in patients with a melanoma in the head or neck. © 2010 Wiley Periodicals, Inc. Head Neck, 201