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Biomedical subjects

Michael J Edwards

Publications and source records attributed to Michael J Edwards.

At least 19 recordsLinked to original sources

Prospective multi-institutional study of reverse transcriptase polymerase chain reaction for molecular staging of melanoma.

PURPOSE: To evaluate the prognostic significance of molecular staging using reverse transcriptase polymerase chain reaction (RT-PCR) in detecting occult melanoma cells in sentinel lymph nodes (SLNs) and circulating bloodstream. PATIENTS AND METHODS: In this multicenter study, eligibility criteria included patient age 18 to 71 years, invasive melanoma > or = 1.0 mm Breslow thickness, and no clinical evidence of metastasis. SLN biopsy and wide excision of the primary tumor were performed. SLNs were examined by serial-section histopathology and S-100 immunohistochemistry. A portion of each SLN was frozen for RT-PCR. In addition, RT-PCR was performed on peripheral-blood mononuclear cells (PBMCs). RT-PCR analysis was performed using four markers: tyrosinase, MART1, MAGE3, and GP-100. Disease-free survival (DFS), distant-DFS (DDFS), and overall survival (OS) were analyzed. RESULTS: A total of 1,446 patients with histologically negative SLNs underwent RT-PCR analysis. At a median follow-up of 30 months, there was no difference in DFS, DDFS, or OS between the RT-PCR-positive (n = 620) and RT-PCR-negative (n = 826) patients. Analysis of PBMC from 820 patients revealed significant differences in DFS and DDFS, but not OS, for patients with detection of more than one RT-PCR marker in peripheral blood. CONCLUSION: In this large, prospective, multi-institutional study, RT-PCR analysis on SLNs and PBMCs provides no additional prognostic information beyond standard histopathologic analysis of SLNs. Detection of more than one marker in PBMC is associated with a worse prognosis. RT-PCR remains investigational and should not be used to direct adjuvant therapy at this time.

Adult↗

Determinants of early distant metastatic disease in elderly patients with breast cancer.

BACKGROUND: The purpose of this analysis was to determine predictors of early distant metastasis in elderly breast cancer patients receiving hormonal therapy. METHODS: We analyzed data from 938 patients in the North American Fareston Tamoxifen Adjuvant Trial>or=65 years old to determine predictors of early metastatic disease. RESULTS: The median patient age was 73 (range 65 to 100). With a median follow-up of 34 months, 17 patients (1.8%) developed distant metastases. The median time to distant metastasis was 21 months. On univariate analysis, significant predictors of distant metastatic disease were as follows: progesterone receptor status (P=.032), lymphovascular invasion (P=.020), tumor grade (P=.007), tumor size (P<.01), and number of metastatic nodes (P<.01). On multivariate analysis, only the number of positive nodes (P=.029) remained significant. Patients with >or=4 positive nodes were more likely to develop early metastases than those with 0 to 3 positive nodes (odds ration 20.304; 95% confidence interval 2.777-148.456, P=.003). CONCLUSIONS: Lymph node status in the elderly breast cancer patient treated with hormonal therapy alone is a strong predictor of early distant recurrence.

Aged↗

Gender-related differences in outcome for melanoma patients.

OBJECTIVE: To better understand the factors associated with the well-established gender difference in survival for patients with melanoma. SUMMARY BACKGROUND DATA: Gender is an important factor in patients with cutaneous melanoma. Male patients have a worse outcome when compared with females. The reasons for this difference are poorly understood. METHODS: This prospective multi-institutional study included patients aged 18 to 70 years with melanomas > or =1.0 mm Breslow thickness. Wide excision and sentinel lymph node (SLN) biopsy was performed in all patients. Clinicopathologic factors, including gender, were assessed and correlated with disease-free survival (DFS), distant disease-free survival (DDFS), and overall survival (OS). RESULTS: A total of 3324 patients were included in the covariate analyses; 1829 patients had follow-up data available and were included in the survival analyses. Median follow-up was 30 months. On univariate analysis, men (n = 1906) were more likely than women to be older than 60 years (P < 0.0001), have thicker melanomas (P < 0.0001), have primary tumor regression (P = 0.0054), ulceration (P < 0.0001), and axial primary tumor location (P < 0.0001). On multivariate analysis, age (P = 0.0002), thickness (P < 0.0001), ulceration (P = 0.015), and location (P < 0.0001) remained significant in the model. There was no difference in the rate of SLN metastasis between men and women (P = 0.37) on multivariate analysis. When factors affecting survival were considered, the prognosis was worse for men as validated by lower DFS (P = 0.0005), DDFS (P < 0.0001), and OS (P < 0.0001). CONCLUSIONS: Male gender is associated with a greater incidence of unfavorable primary tumor characteristics without an increased risk for nodal metastasis. Nonetheless, gender is an independent factor affecting survival.

Adolescent↗

Complex venous and arterial reconstruction with deep vein after pelvic exenterative surgery: a case report.

Effective local regional control for solid tumor malignancies is dependent upon prerequisite surgical excision with negative margins. Invasion of contiguous adjacent structures, particularly in anatomical spaces of limited size, may preclude the surgical goal of histologically negative margins. From a historical perspective, the invasion of vascular structures in the pelvis has proved to be a significant limitation in achieving local regional disease control with surgical resection. In recent years, advances in the field of vascular surgery have caused us to reassess the historical criteria of resectability when blood vessels are focally invaded by malignancy. En bloc resection of adjacent vessels has been reported primarily with head and neck extirpations and increasingly with hepatobiliary and pancreatic lesions. In many cases, where the local vasculature is invaded or impinged by the tumor, venous structures are often ligated while arteries are bypassed with an appropriate conduit. In pelvic exenterative surgery, significant morbidity from chronic limb edema and deep venous thrombosis may result from the ligation of larger veins. This is especially the case when multiple major venous structures such as the common and the external iliac vein, as well as the hypogastric vein, are all simultaneously interrupted. To the best of our knowledge, there is no prior report examining venous reconstruction using the femoral vein for pelvic exenterative surgery requiring major iliac artery and venous resection. Herein we describe a case of a complex vascular reconstruction after pelvic exenterative surgery in a patient with recurrent rectal cancer invading multiple adjacent contiguous structures, including the iliac vessels.

Aged↗

Image-guided breast surgery.

With recent advances in technology and increased use of ultrasound, breast surgery has dramatically changed its approach towards nonpalpable lesions. Several image-guided diagnostic and therapeutic procedures have been implemented for the treatment of breast disease. Some of these modalities, including percutaneous image-guided biopsy techniques, were developed for the management of nonpalpable lesions, and they have been incorporated as the current standard of practice. Other innovating image-guided technologies, such as radiofrequency ablation and cryoablation therapy, are being explored in clinical protocols as promising new treatment modalities. In this article, the authors review the indications, advantages, and application techniques of the most common and current image-guided procedures performed today for the approach of breast pathology.

Biopsy↗

Surgical benefits conveyed by biopsy site marking system using ultrasound localization.

BACKGROUND: With vacuum-assisted biopsy technology all, or most, of a breast lesion may be removed during the initial biopsy; in such cases a metallic marker is often inserted at the site of the biopsy for future localization. The aim of this study was to evaluate the efficacy and impact of the Gel Mark Ultra biopsy site marking system (SenoRx, Aliso Viejo, CA) on the practice of needle localization breast biopsy. METHODS: We retrospectively analyzed the experience of 45 general surgeons across the United States in a variety of practice settings using the Gel Mark Ultra clip. Imaging-guided biopsy technique, localization quality, surgeon confidence, and margin status were assessed and compared against the broad data reported in the literature. RESULTS: A total of 432 records of patients who underwent imaging-guided breast biopsy with placement of Gel Mark Ultra clip were reviewed. Of these, 63 (15%) patients required definitive surgical intervention, for which 41 cases were localized with ultrasound and assessed for margin clearance. Clear margins were achieved in 37 (90%) of the 41 cases. These results are statistically superior (P < .01) to positive margins rates reported in the literature. CONCLUSIONS: The Gel Mark Ultra biopsy site marking system is a new localization device that provides a safe and effective alternative to traditional localization methods with a significant reduction in the percentage of positive margins, as well as advantages in terms of surgical approach, time, and patient comfort.

Biopsy, Needle↗

Interim results from the FibroAdenoma Cryoablation Treatment Registry.

OBJECTIVE: The aim of this prospective study was to assess the intermediate- (6 months) and longer-term (12 months) follow-up of patients with breast fibroadenomas treated by cryoablation in community-based practice settings. METHODS: The FibroAdenoma Cryoablation Treatment (FACT) registry was created to systematically collect procedural and follow-up data for patients with fibroadenomas treated by cryoablation without subsequent excision. This report summarizes the experience from 55 different practice settings across the United States. Baseline and follow-up clinical data at 6 months and 12 months were tabulated for all patients. RESULTS: Data from 444 treated fibroadenomas were analyzed. The mean tumor diameter was 1.8 cm. Before cryoablation, 75% of fibroadenomas were palpable by the patient. Follow-up at 6- and 12-month intervals revealed palpability of the treated site in 46% and 35%, respectively. When fibroadenomas were grouped by size, for lesions </=2 cm, residual cryoablation induce changes were visible by ultrasound in 35% of patients at 6 months. The treatment area was palpable in 31% of cases at this time. Visibility by ultrasound was 27%, and palpability was 28% at 12 months follow-up in these patients with smaller fibroadenomas. For lesions >2 cm, residual cryoablation induce changes were visible by ultrasound in 39% of the patients at 6 months. The treatment area was palpable in 78% of the cases at the same time. Visibility by ultrasound was 32%, and palpability was 59% at 12 months follow-up. Patient satisfaction with the procedure was rated as high at 91% and 88% at 6 and 12 months follow-up, respectively. CONCLUSIONS: Before implementing this technique, patients should be apprised of the likely persistence of a palpable mass of the treated site for a prolonged period that will reabsorb over time. Palpability of the treated site persists for a substantially longer period of time for lesions greater than 2 cm in diameter. For patients with a fibroadenoma smaller than 2 cm, complete resolution can be expected in two thirds and three quarters of the patients at 6 and 12 months, respectively. We will continue to follow these patients to better define the length of time and factors influencing the resolution of the treatment induced physical and radiographic findings.

Breast Neoplasms↗

Is incisional biopsy of melanoma harmful?

BACKGROUND: In the era of sentinel lymph node (SLN) biopsy, there has been concern that manipulation, injection, and massage of intact primary melanomas (after incisional or shave biopsy) could lead to an artifactual increased rate of SLN micrometastases or an actual increased risk of recurrence. The aim of this study was to evaluate the difference in the incidence of SLN metastasis, locoregional recurrence (LRR), disease-free survival (DFS), distant disease-free survival (DDFS), or overall survival (OS) for patients who undergo excisional versus incisional versus shave biopsy. METHODS: Analysis of database from a multicenter prospective randomized study from centers across the United States and Canada. Eligible patients were 18 to 71 years old, with cutaneous melanoma > or = 1.0 mm Breslow thickness. All patients underwent SLN biopsy using blue dye and radioactive colloid injection. SLNd were evaluated by serial histological sections with S100 immunohistochemistry. Statistical analysis was performed using univariate and multivariate analyses with a significance level of P < .05; survival analysis was performed by the Kaplan-Meier method with the log-rank test. RESULTS: A total of 2,164 patients were evaluated; 382 patients were excluded for lack of biopsy information. Positive SLNs were found in 220 of 1,130 (19.5%), 58 of 281 (20.6%), and 67 of 354 (18.9%) of patients with excisional, incisional, or shave biopsy, respectively (no significant difference). There were significant differences among the 3 biopsy types in ulceration (P = .018, chi2) and regression (P = .022, chi2); there were no differences in age, gender, Breslow thickness, Clark level, lymphovascular invasion, tumor location, or histologic subtype. Biopsy type did not significantly affect LRR, DFS, DDFS, or OS. CONCLUSIONS: The concern that incomplete excision of primary melanomas may result in an increased incidence of SLN micrometastases, artifactual or real, is unfounded. Similarly, there is no evidence that biopsy type adversely affects locoregional or distant recurrence. Although shave biopsy is generally discouraged because it may lead to inaccurate tumor thickness measurements, it does not appear to affect overall patient outcome.

Adolescent↗

Clinicopathologic factors associated with false-negative sentinel lymph-node biopsy in breast cancer.

SUMMARY BACKGROUND DATA: Previous studies have suggested a variety of factors that may affect the false negative (FN) rate for sentinel lymph node (SLN) biopsy in breast cancer. Because FN results are relatively rare, no prior studies have had sufficient sample size to allow detailed statistical analysis of factors predicting FN results. METHODS: Patients with clinical stage T1-2, N0 invasive breast cancer were enrolled in a prospective, multicenter study. All patients underwent SLN biopsy, followed by planned completion axillary dissection regardless of the SLN results, to assess the FN rate. SLN biopsy was performed using radioactive colloid injection in combination with isosulfan blue dye in 94% of cases. Dermal, subdermal, peritumoral, or subareolar radioactive colloid injection techniques were used at the discretion of each institution. Univariate and multivariate analyses were performed to identify factors associated with a FN result. RESULTS: SLNs were identified in 3870 of 4117 patients (94%). There were 1243 true positive, 2521 true negative, and 106 FN results. Age, histologic subtype, the number of non-SLN removed, tumor palpability, type of breast biopsy, and SLN injection technique were not significant factors. On multivariate analysis, tumor size <2.5 cm, upper outer quadrant tumor location, removal of only a single SLN, minimal surgeon experience, presence of a single positive axillary LN, and use of immunohistochemistry (IHC) for SLN analysis were independently associated with an increased risk of FN results. CONCLUSIONS: Surgeon experience, tumor size and location, and the number of SLN removed are preoperative and intraoperative factors that independently predict the risk of a FN result. In contrast to suggestions from other smaller studies, age does not affect the likelihood of a FN result; a lesser, rather than greater, number of positive axillary nodes was associated with an increased likelihood of a FN result; and IHC analysis of the SLN increases, rather than decreases, the risk of FN results.

Adult↗

Validation of subareolar and periareolar injection techniques for breast sentinel lymph node biopsy.

HYPOTHESIS: Subareolar or periareolar injection of radioactive technetium sulfur colloid is equivalent to other injection techniques for breast cancer sentinel lymph node (SLN) biopsy. DESIGN AND SETTING: Prospective, multicenter clinical trial. PATIENTS: A total of 3961 individuals with clinical stage I and II breast cancer. INTERVENTIONS: All patients underwent attempted SLN biopsy followed by completion axillary dissection. Injection technique was determined by the preference of each participating surgeon. Most surgeons had little or no experience with SLN biopsy before participation in this study. MAIN OUTCOME MEASURES: The SLN identification and false-negative rates. RESULTS: An SLN biopsy was performed in 3961 patients using blue dye alone or radioactive colloid plus blue dye. Subareolar and periareolar radioactive colloid injection techniques were associated with SLN identification rates of 99.3% and 95.6%, respectively, with false-negative rates of 8.3% and 8.9%, respectively. The identification rates were significantly higher for these 2 techniques than for peritumoral injection of radioactive colloid (91.1%) or the use of blue dye alone (88.5%) (P<.001). The false-negative rates were similar for all techniques. CONCLUSIONS: Although many medical centers have adopted subareolar and periareolar radioactive colloid injections because of their simplicity and convenience, a paucity of data from a few single-institutional studies has existed to substantiate the false-negative rates associated with these techniques. The results of this multicenter study establish the validity of subareolar and periareolar radioactive colloid injections and support the hypothesis that the lymphatic drainage of the entire breast is to the same few SLNs.

Adult↗

Progressive adoption of cryoablative therapy for breast fibroadenoma in community practice.

BACKGROUND: Cryoablation is a recent technological advance and has been used for the percutaneous treatment of breast fibroadenomas. Herein, we provide a retrospective summary of the early experience from a nationwide group. METHODS: We organized a national registry to document the community practice and adoption of an office-based system of cryoablation for breast fibroadenoma. Data were abstracted during the first 6 weeks after the procedure to assess acute outcome and potential complications. At 6-and 12-month follow-up intervals, additional data were collected regarding fibroadenoma resolution, cosmesis, and patient satisfaction. RESULTS: Fifty-three sites ablated 310 fibroadenomas. Early follow-up data on 256 lesions showed that the procedure was well tolerated with infrequent minor complications immediately after the procedure. At 6 and 12 months postprocedure, the remaining fibroadenoma volume progressively involuted. At both intervals, cosmesis was excellent, and patient satisfaction was rated high. CONCLUSIONS: An early community experience with office-based cryoablation of breast fibroadenomas is encouraging and comparable to the initial experience of high-volume tertiary centers. More follow-up is necessary to determine long-term results and residual mammographic changes.

Ambulatory Surgical Procedures↗

Morbidity of adjuvant hepatic arterial infusion pump chemotherapy in the management of colorectal cancer metastatic to the liver.

BACKGROUND: Surgical resection remains the treatment of choice for patients with colorectal cancer metastatic to the liver. Hepatic arterial infusion pump (HAIP) chemotherapy in combination with surgical resection has been demonstrated in a recent study to improve disease-free and overall survival for patients with colorectal cancer metastatic to the liver. Other reports, however, have indicated significant toxicity related to HAIP chemotherapy in the form of biliary sclerosis. Thus, the value of adjuvant HAIP chemotherapy following hepatic resection or ablation remains controversial. The aim of this study was to examine the survival and toxicity in a single institutional experience with adjuvant HAIP chemotherapy. METHODS: Review of a prospective hepatobiliary database was performed. HAIP were placed in the standard technique following resection and/or radiofrequency ablation (RFA) of all liver metastases. Patients received floxuridine (FUDR) via the HAIP at standard doses. Complications were graded according to a standard 5-point grading scale. Statistical analysis was performed by chi(2) test. RESULTS: Thirty-four of 86 patients underwent placement of HAIP at the time of hepatic resection or ablation between January 1999 and November 2002. The HAIP group demonstrated a significantly greater (P <0.05) number (median 5 vs. 2) and size (median 5 cm vs. 3 cm) of hepatic lesions compared to the group without HAIP. The HAIP group experienced a greater frequency of complications (53% vs. 33%), with 6 (18%) patients in the HAIP group demonstrating biliary sclerosis. There were no deaths within 30 days of surgery. Median survival was similar in both groups (HAIP 20 months, no HAIP 24 months). CONCLUSIONS: Patients in the HAIP group had significantly worse overall predictors of outcome in metastatic colorectal cancer, yet the median overall survival in both groups was similar. However, adjuvant HAIP chemotherapy was associated with significantly greater morbidity. Given the availability of newer active systemic agents and regimens, the value of adjuvant HAIP chemotherapy remains controversial.

Adult↗

Enhancing the clinical skills of surgical residents through structured cancer education.

OBJECTIVE: To assess the short and long-term educational value of a highly structured, interactive Breast Cancer Structured Clinical Instruction Module (BCSCIM). SUMMARY BACKGROUND DATA: Cancer education for surgical residents is generally unstructured, particularly when compared with surgical curricula like the Advanced Trauma Life Support (ATLS) course. METHODS: Forty-eight surgical residents were randomly assigned to 1 of 4 groups. Two of the groups received the BCSCIM and 2 served as controls. One of the BCSCIM groups and 1 of the control groups were administered an 11-problem Objective Structured Clinical Examination (OSCE) immediately after the workshop; the other 2 groups were tested with the same OSCE 8 months later. The course was an intensive multidisciplinary, multistation workshop where residents rotated in pairs from station to station interacting with expert faculty members and breast cancer patients. RESULTS: Residents who took the BCSCIM outperformed the residents in the control groups for each of the 7 performance measures at both the immediate and 8-month test times (P < 0.01). Although the residents who took the BCSCIM had higher competence ratings than the residents in the control groups, there was a decline in the faculty ratings of resident competence from the immediate test to the 8-month test (P < 0.004). CONCLUSIONS: This interactive patient-based workshop was associated with objective evidence of educational benefit as determined by a unique method of outcome assessment.

Breast Neoplasms↗

Correlation between prognostic factors and increasing age in melanoma.

BACKGROUND: Age of patients with melanoma varies directly with mortality and inversely with the presence of sentinel lymph node (SLN) metastasis. To gain further insight into this apparent paradox, we analyzed the relationship between age and other major prognostic factors. METHODS: The Sunbelt Melanoma Trial is a prospective, randomized study with 79 institutions involving SLN biopsy for melanoma. Eligible patients were 18 to 70 years old with melanoma of > or = 1.0-mm Breslow thickness and clinically N0 regional lymph nodes. SLNs were evaluated by serial histological sections and immunohistochemistry for S-100 protein. RESULTS: A total of 3076 patients were enrolled in the study, with a median follow-up of 19 months. Five age groups were examined: 18 to 30, 31 to 40, 41 to 50, 51 to 60, and 61 to 70 years. Trends between age and several key prognostic factors was identified: as age group increased, so did Breslow thickness (analysis of variance; P <.001), the incidence of ulceration and regression, and the proportion of male patients (each variable: chi2, P <.001). The incidence of SLN metastasis, however, declined with increasing age (chi2; P <.001). CONCLUSIONS: As age increases, so does Breslow thickness, the incidence of ulceration and regression, and the proportion of male patients-all poor prognostic factors. However, the frequency of SLN metastasis declines with increasing age. It is not known whether this represents a decreased sensitivity (higher false-negative rate) of the SLN procedure in older patients or a different biological behavior (hematogenous spread) of melanomas in older patients.

Adolescent↗

Refined measurement of outcome for adjuvant breast carcinoma therapy.

BACKGROUND: Traditional nonparametric statistical methods do not provide a quantitative measure of the lifetime benefit from adjuvant therapy. This deficiency makes it difficult to determine the long-term difference in impact between the two treatment arms of a clinical trial. METHODS: To assess the impact of breast carcinoma recurrence, parametric survival models were derived from two randomized, controlled clinical trials of adjuvant therapy for Stage II breast carcinoma. To assess time to death from causes other than breast carcinoma, actuarial models derived from 1980 Census data were used. These two models were then combined to estimate the mean time to event (MTE) as a function of patient age, with the event being either recurrence or death from other causes. The MTE was then used to measure the differential benefit between two arms of a clinical trial. RESULTS: In the first trial, differences in MTE between treatment groups varied from 2.7 years for 35-year-old patients to 1.4 years for 75-year-old patients. For this trial, the mechanism of survival benefit was an increase in time to recurrence. In the second trial, differences in MTE varied from 7.6 to 1.6 years over the same age ranges. For this trial, the mechanism of survival benefit was an increase in the likelihood of cure, i.e., an increase in the asymptote of the curve that represents proportion of patients without relapse. CONCLUSIONS: When applied to data from controlled clinical trials, MTE offers a quantitative measure of long-term outcome from adjuvant therapy. The greatest benefit is achieved when therapy that increases the likelihood of cure is provided to young patients.

Actuarial Analysis↗

Who are we and what do we think?

BACKGROUND: The American Society of Breast Surgeons was founded on the principal of professional and practical development of its members. The Society undertook a survey of its members to identify issues and concerns and to guide future action. METHODS: The survey was prepared by the membership committee and a website was created for responses and analysis. The survey was posted on the website and mailed to 1530 members. Overall there was a 31% response. RESULTS: Demographic data regarding practice patterns, technology utilization, and current problems showed a diverse Society with varying needs and problems. CONCLUSIONS: The Society will pursue professional development in ultrasonography training, coding and reimbursement, and emerging technologies. The Society is committed to providing regional training programs, certification, and professional interaction. The Society will continue to look to the members for feedback and guidance.

Breast↗

Complications associated with sentinel lymph node biopsy for melanoma.

BACKGROUND: Sentinel lymph node (SLN) biopsy has become widely accepted as a method of staging the regional lymph nodes for patients with melanoma. Although it is often stated that SLN biopsy is a minimally invasive procedure associated with few complications, a paucity of data exists to specifically determine the morbidity associated with this procedure. This analysis was performed to evaluate the morbidity associated with SLN biopsy compared with completion lymph node dissection (CLND). METHODS: Patients were enrolled in the Sunbelt Melanoma Trial, a prospective multi-institutional study of SLN biopsy for melanoma. Patients underwent SLN biopsy and were prospectively followed up for the development of complications associated with this technique. Patients who had evidence of nodal metastasis in the SLN underwent CLND. Complications associated with SLN biopsy alone were compared with those associated with SLN biopsy plus CLND. RESULTS: A total of 2120 patients were evaluated, with a median follow-up of 16 months. Overall, 96 (4.6%) of 2120 patients developed major or minor complications associated with SLN biopsy, whereas 103 (23.2%) of 444 patients experienced complications associated with SLN biopsy plus CLND. There were no deaths associated with either procedure. CONCLUSIONS: SLN biopsy alone is associated with significantly less morbidity compared with SLN biopsy plus CLND.

Adult↗