Biomedical subjects

A Cantor

Publications and source records attributed to A Cantor.

At least 19 recordsLinked to original sources

PubMed2006

A global genome damage score predictive of lung cancer patients outcome.

Genome damage is a hallmark of human cancer. Efforts at assessing the impact of genome damage on tumor phenotype and patients outcome have focused on measurements of the relative DNA content in tumor cells compared to normal cells and the assessment of allelic loss at single or multiple selected loci that are thought to harbor genes important in cancer biology. We adapted a global, high-resolution genotyping method for determination of global and unbiased allelic loss. We generated a score, termed global genome damage score (GGDS), that is a continuous variable from zero to one and a measure of the extent of damaged DNA in individual tumors. In 71 patients with completely resected non-small-cell lung cancer, the GGDS ranged from 0.0006 to 0.5530 with a median value of 0.0401 indicating that between 0.06 and 55.3% of the genome has allelic loss. Patients with high scores (>0.04) had a significantly worse outcome than those with low scores (median overall survival time 35.5 vs >120.0 months, P=0.006 log-rank test; median disease-free survival 28.3 vs >120.0 months, P=0.003 log-rank test). This suggests that the clinical behavior of lung tumors with low GGDS is relatively benign whereas tumors with high GGDS are aggressive resulting in early death of patients.

Adult↗

PubMed2004

A multi-institutional study of orthotopic neobladders: functional results in men and women.

OBJECTIVES: To analyse the incidence of diurnal incontinence (DI) and nocturnal incontinence (NI), the need for intermittent catheterization (IC),and the rate of ureteric obstruction (UO) among a group of men and women with ileal and colonic orthotopic neobladders in four countries. PATIENTS AND METHODS: In all, 138 patients (113 men and 25 women) had an orthotopic neobladder constructed after radical cystectomy for carcinoma. The mean(range) age was 61.3 (28-76) years and the follow-up 41 (6-144) months. All patients underwent surgery by experienced surgeons associated with the Confederation of American Urology. A retrospective evaluation was designed to review the functional results and the incidence of UO. The technique of orthotopic neobladder construction was at each surgeon's discretion. Various detubularized bowel segments were used, including ileum, colon or sigmoid. Patients were followed by chart reviews and personal interviews at 1, 3 and 6 months after surgery and then every 6 months, and were evaluated by a physical examination, urine analysis, cytology and renal ultrasonography. RESULTS: An ileal or colonic neobladder was constructed in 74 and 64 patients, respectively. Five (7%), 23 (31%), 10 (14%) and 14(9.6%) with an ileal neobladder developed DI, NI, IC and UO, respectively; the respective values for patients with a colonic neobladder were eight (12%), 19 (30%), seven (11%)and 15 (12%). Statistical analysis by Fisher's exact test showed no significant differences between the ileal and colonic neobladder groups or with gender. CONCLUSIONS: Using this specific protocol for evaluating many men and women with ileal and colonic orthotopic neobladders showed no significant differences in the incidence of DI, NI, IC or UO. Neobladders constructed from detubularized bowel, irrespective of bowel segment(s) used, can provide satisfactory diurnal results. A moderate incidence of NI and UO continue to be a problem.

Adult↗

PubMed2001

Effect of fractionated regional external beam radiotherapy on peripheral blood cell count.

PURPOSE: The purpose of this study was to assess the need for obtaining weekly complete blood count (CBC) values and to identify the pattern of changes in CBC during regional conventional fractionated radiotherapy. METHODS AND MATERIALS: A retrospective analysis of CBC data on 299 adult cancer patients who received definitive conventional radiotherapy to head and neck (n = 95), chest (n = 96), and pelvis (n = 108) was performed. Temporal patterns and magnitude of change in white blood cells, neutrophils, lymphocytes, and platelets during radiotherapy were examined. RESULTS: There were statistically significant declines in all counts, albeit not clinically significant. Notable differences between disease sites were found. The greatest weekly interval change in counts occurred during the first week of radiotherapy for all groups of patients. The mean WBC nadir values during treatment were 5.8 for head & neck, 6.8 for chest, and 5.4 for pelvis. The nadirs for all counts occurred toward the middle-to-end of radiotherapy. Lymphocytes were found to be more sensitive to radiotherapy than other leukocyte subcomponents. CONCLUSION: Our study suggests that weekly CBC monitoring is not necessary for all patients undergoing standard fractionated radiotherapy. Baseline blood counts may be used to determine an optimal schedule for monitoring CBCs in patients receiving conventional radiation alone. Reduced monitoring of CBC may result in significant financial savings.

Adult↗

PubMed2001

Learning curves and breast cancer lymphatic mapping: institutional volume index.

INTRODUCTION: To date, studies of breast cancer lymphatic mapping (LM) have analyzed success with respect to individual surgeons. However, LM and sentinel lymph node biopsy (SLNBx) are procedures that require institutional multidisciplinary cooperation between the departments of radiology, pathology, and surgery. Thus, it is important to evaluate these procedures with respect to the institution. This study examines 30 institutions to clarify the value of the institutional volume index (IVI) (cases/month) to the outcome of LM and SLNBx in breast cancer. METHODS: From July 1997 to July 1999, 30 institutions participated in the Department of Defense national breast LM trial. All participants underwent a 2-day training course for surgeons, nuclear medicine physicians, and pathologists. The records for each institution were prospectively accrued and submitted to a database. The false negatives, failure rates, and IVI were calculated for each institution. A logistic regression model plots the relationship between IVI and institutional failure rate. Using a multivariate analysis, mapping failure was analyzed as a function of case number with respect to the individual surgeon and the institution as a whole. RESULTS: False negative results were demonstrated in only 5 (4%) cases among all institutions and were excluded from further analysis due to small numbers. Mapping failures were found in all but 7 of the 30 institutions whose data were complete. There were 71 mapping failures among 74 surgeons over 555 cases, which yielded an overall failure rate of 12.79% (71 555). The logistic regression model revealed an inverse relationship between IVI and institutional failure rate. However, the multivariate analysis revealed that the individual surgeon performance was the most significant factor in determining institutional mapping success. CONCLUSION: Failure to map can be a function of multiple factors including surgical skill, surgical volume index, and injection method of the SLN patient, all under the quality control of an institution. The surgical failure rate on the other hand is a function of surgical skill, surgical volume, and injection methods. While differences in mapping success exist across institutions, this disparity is not due to factors associated with the institution as a whole, but lie with the individual surgeon.

Breast Neoplasms↗

PubMed2001

Characteristics of the sentinel lymph node in breast cancer predict further involvement of higher-echelon nodes in the axilla: a study to evaluate the need for complete axillary lymph node dissection.

BACKGROUND: Sentinel lymph node (SLN) biopsy techniques provide accurate nodal staging for breast cancer. In the past, complete lymph node dissection (CLND) (levels 1 and 2) was performed for breast cancer staging, although the therapeutic benefit of this more extensive procedure has remained controversial. HYPOTHESIS: It has been demonstrated that if the axillary SLN has no evidence of micrometastases, the nonsentinel lymph nodes (NSLNs) are unlikely to have metastases. OBJECTIVE: To determine which variables predict the probability of NSLN involvement in patients with primary breast carcinoma and SLN metastases. METHODS: An analysis of 101 women with SLN metastases and subsequent CLND was performed. Variables included size of the primary tumor, tumor volume in the SLN, staining techniques used to initially identify the micrometastases (cytokeratin immunohistochemical vs hematoxylin-eosin), number of SLNs harvested, and number of NSLNs involved with the metastases. Tumor size was determined by the invasive component of the primary tumor. Patients with ductal carcinoma in situ who were upstaged with cytokeratin staining were considered to have stage T1a tumors. RESULTS: Sentinel lymph node micrometastases (<2 mm) detected initially by cytokeratin staining were associated with a 7.6% (2/26) incidence of positive CLND compared with a 25% (5/20) incidence when micrometastases were detected initially by routine hematoxylin-eosin staining. Sentinel lymph node micrometastases, regardless of identification technique, inferred a risk of 15.2% (7/46) for NSLN involvement. As the volume of tumor in the SLN increased (ie, <2 mm, >2 mm, grossly visible tumor), so did the risk of NSLN metastases (P<.001). CONCLUSIONS: Our study demonstrated that patients with micrometastases detected initially by cytokeratin staining had low-volume disease in the SLN with a small chance of having metastases in higher-echelon nodes in the regional basin other than the SLN. Characteristics of the SLN can provide information to determine the need for a complete axillary CLND. Complete lymph node dissection may not be necessary in patients with micrometastases detected initially by cytokeratin staining since the disease is confined to the SLN 92.4% of the time. However, the therapeutic value of CLND in breast cancer remains to be determined by further investigation.

Axilla↗

PubMed2001

Expression of early lung cancer detection marker: hnRNP-A2/B1 and its relation to microsatellite alteration in non-small cell lung cancer.

We have reported that a mouse monoclonal antibody, 703D4, which recognizes heterogeneous nuclear ribonucleoprotein A2/B1 (hnRNP-A2/B1) can frequently detect lung cancer in exfoliated sputum epithelial cells 1-2 years earlier than routine chest X-ray or sputum cytomorphology. We along with others have shown that microsatellite alteration (MA) at selected loci can be recognized in sputum cells prior to clinical lung cancer. The present study was undertaken to determine how frequently the expression of hnRNP-A2/B1 message is associated with neoplastic clonal expansion as shown by MA in 41 cases of non-small cell lung cancer (NSCLC). We used Northern blotting to evaluate hnRNP-A2/B1 mRNA expression in lung tumor and remote noninvolved lung. We evaluated microsatellite instability (i.e. shifts; MI) or loss of heterozygosity (LOH) with a panel of 13 microsatellite markers at loci identified previously as susceptible in NSCLC. Of the 41 tumors, 25 (61%) over-expressed hnRNP-A2/B1 and 33 (80%) demonstrated MA in at least one of 13 loci (58% in at least two loci). The association between MA (one locus) and the overexpression of hnRNP-A2/B1 is statistically significant (P=0.0082), and those lung tumors with MA at two or more loci were significantly more likely to over-express hnRNP-A2/B1 mRNA (P=0.004). MA of loci on 3p were the only MA statistically associated with hnRNP-A2/B1 message overexpression (P=0.001). We conclude that lung tumor cells undergoing clonal expansion frequently upregulate hnRNP-A2/B1.

Adult↗

PubMed2001

Learning curves for breast cancer sentinel lymph node mapping based on surgical volume analysis.

BACKGROUND: Implementation of new procedures, including lymphatic mapping for breast cancer, must be done and overseen by the medical community in a responsible way to ensure that the procedures are performed correctly. This study addresses the issues of adequacy of training and certification of surgeons performing lymphatic mapping. Ensuring quality in surgical care requires outcomes measures that are described in this study. STUDY DESIGN: Sixteen surgeons performed lymphatic mapping in 2,255 patients with breast cancer using a combination blue dye and Tc99m-labeled sulfur colloid to identify the sentinel lymph nodes (SLNs). All participants were trained in a 2-day CME-accredited course. The Cox learning curve model (total number of mapping failures/total number of mapping cases) for a consecutive series of lymphatic mapping cases is described. The relationship of the Surgical Volume Index, the cases performed in a 30-day period, to the failure rate for each surgeon was modeled as a logistic regression curve (y = e(a+bx)/[1 + e(a+bx)]). RESULTS: Surgeons performing less than three SLN biopsies per month had an average success rate of 86.23% +/- 8.30%. Surgeons performing three to six SLN biopsies per month had a success rate of 88.73% +/- 6.36%. Surgeons performing more than six SLN biopsies per month had a success rate of 97.81% +/- 0.44%. CONCLUSIONS: This experience defines a learning curve for lymphatic mapping in breast cancer patients. Data suggest that increased volumes lead to decreased failure rates. These data provide surgeons performing SLN biopsy with a new paradigm for assessing their skill and adequacy of training and describes the relationship between volume of cases performed and success rate of SLN detection.

Breast Neoplasms↗

PubMed2001

Importance of lymphatic mapping in ductal carcinoma in situ (DCIS): why map DCIS?

The appropriateness of sentinel lymph node biopsy in the management of patients with biopsy diagnoses of ductal carcinoma in situ (DCIS) or DCIS with microinvasion (DCISM) has not been established. Three hundred forty-one patients presented with a biopsy diagnosis of DCIS or DCISM. Two hundred forty (70%) underwent sentinel node biopsy at their definitive procedure. All clinical and pathologic data were collected prospectively. Of 224 patients with a biopsy diagnosis of DCIS 23 (10%) were upstaged to infiltrating ductal carcinoma (IDC) at their definitive therapy and of 16 patients with a biopsy diagnosis of DCISM seven (44%) were upstaged to IDC. Excisional biopsies were no more sensitive for detecting IDC than was core biopsy. Lymph node metastases were detected in 26 of 195 (13%) patients with a definitive diagnosis of DCIS, in three of 15 (20%) with a definitive diagnosis of DCISM, and in eight of 30 (27%) with a definitive diagnosis of IDC. Sentinel lymph node biopsy is a valuable tool in the treatment of patients with DCIS and DCISM and is particularly needed in those undergoing mastectomy. No "high-risk" group of patients can be identified for selective sentinel lymph node biopsy.

Breast Neoplasms↗

PubMed2000

The uncertainty principle and industry-sponsored research.

BACKGROUND: Reporting of pharmaceutical-industry-sponsored randomised clinical trials often result in biased findings, either due to selective reporting of studies with non-equivalent arms or publication of low-quality papers, wherein unfavourable results are incompletely described. A randomised trial should be conducted only if there is substantial uncertainty about the relative value of one treatment versus another. Studies in which intervention and control are thought to be non-equivalent violates the uncertainty principle. METHODS: We examined the quality of 136 published randomised trials that focused on one disease category (multiple myeloma) and adherence to the uncertainty principle. To evaluate whether the uncertainty principle was upheld, we compared the number of studies favouring experimental treatments over standard ones. We analysed data according to the source of funding. FINDINGS: Trials funded solely or in part by 35 profit-making organisations had a trend toward higher quality scores (mean 2.94 [SD 1.3]; median 3) than randomised trials supported by 95 governmental or other non-profit organisations (2.4 [0.8]; 2; p=0.06). Overall, the uncertainty principle was upheld, with 44% of randomised trials favouring standard treatments and 56% innovative treatments (p=0.17); mean and median preference evaluation scores were 3.7 (1.0) and 4. However, when the analysis was done according to the source of funding, studies funded by non-profit organisations maintained equipoise favouring new therapies over standard ones (47% vs 53%; p=0.608) to a greater extent than randomised trials supported solely or in part by profit-making organisations (74% vs 26%; p=0.004). INTERPRETATION: The reported bias in research sponsored by the pharmaceutical industry may be a consequence of violations of the uncertainty principle. Sponsors of clinical trials should be encouraged to report all results and to choose appropriate comparative controls.

Bias↗

PubMed2000

Android obesity at diagnosis and breast carcinoma survival: Evaluation of the effects of anthropometric variables at diagnosis, including body composition and body fat distribution and weight gain during life span,and survival from breast carcinoma.

BACKGROUND: Although a large body of research exists concerning pathologic prognostic indicators of the rate of incidence and survival from breast carcinoma, to the authors' knowledge very few studies have examined the effects of anthropometric variables such as height, obesity, weight gain in adulthood, timing of weight gain, and body composition to survival, although these variables are related to the incidence rate. METHODS: The survival status of 166 patients diagnosed with primary breast carcinoma and followed for at least 10 years was obtained from the Cancer Center's registry, and significant anthropometric and other known prognostic indicators regarding survival after diagnosis were determined by Cox proportional hazards analysis. RESULTS: Eighty-three of 166 breast carcinoma patients (50%) with up to 10 years of follow-up died of disease. Android body fat distribution, as indicated by a higher suprailiac:thigh ratio, was a statistically significant (P < 0.0001) prognostic indicator for survival after controlling for stage of disease, with a hazards ratio of 2.6 (95% confidence interval [95% CI], 1.63-4.17). Adult weight gain, as indicated specifically by weight at age 30 years, was a statistically significant (P < 0.05) prognostic indicator for survival with a hazards ratio of 1.15 (95% CI, 1.0-1.28). In addition, the authors observed the Quatelet Index, a negatively significant (P < 0.01) prognostic indicator for survival with a hazards ratio of 0.92 (95% CI, 0.87-0.98). Other markers of general obesity such as weight at diagnosis, percent body fat, and body surface area were not significant markers influencing survival. Similarly, height; triceps, biceps; subscapular, suprailiac, abdominal, and thigh skinfolds; waist and hip circumferences; family history; and reproductive and hormonal variables at the time of diagnosis showed no apparent significant relation to survival. CONCLUSIONS: The results of the current study provide some evidence that android body fat distribution at diagnosis and increased weight at age 30 years increases a woman's risk of dying of breast carcinoma.

Adult↗

PubMed2000

Minimally invasive treatment for localized adenocarcinoma of the prostate: review of 1048 patients treated with ultrasound-guided palladium-103 brachytherapy.

PURPOSE: To assess the effectiveness of palladium-103 brachytherapy in stage T1 and T2 adenocarcinoma of the prostate. PATIENTS AND METHODS: The charts of 1048 patients treated between 1991 and 1999 with transperineal realtime ultrasound-guided (103)Pd (Theraseed) implants were reviewed to assess the effects on serum prostate specific antigen (PSA) values and tissue (biopsy). Of the 1048 patients, 780 had sufficient data for this report. Preoperative total androgen blockade (leuprolide and flutamide) was used selectively in patients whose prostate size was >50 cc and those whose tumors had a Gleason score of >7. RESULTS: At 1 year, 86% of the evaluable 766 patients had stable PSA concentration <1.5 ng/mL; at 5 years, 86% of the 166 patients with data available had stable PSA values <1.5 ng/mL. Biopsies were negative in 92% of the patients studied at 2 years. Patients with pretreatment PSA values <10 ng/mL had the best outcomes, and those treated with (103)Pd plus hormone ablation achieved PSA reduction more rapidly than those treated with radioisotope monotherapy. There was one disease-related death; the principal morbidity was short-term bladder and bowel irritation without permanent sequelae. Impotence occurred in approximately 15% of patients, and incontinence occurred in 5% of those who had undergone prior transurethral resection of the prostate. CONCLUSION: The technique used in this study proved effective in reducing PSA concentrations to <1.5 ng/mL and in producing negative biopsies 1 and 2 years postoperatively. These results are comparable to those of external-beam radiation therapy and radical prostatectomy while demonstrating a significant reduction in morbidity.

Adenocarcinoma↗

PubMed2000

Does prosthetic covering of nitinol stents alter healing characteristics or hemodynamics?

PURPOSE: To evaluate placement of polyester (Dacron) coverings on nitinol stents implanted in the canine aorta to determine the effect on cross-sectional lumen area, development of intimal hyperplasia, device endothelialization, and flow hemodynamics. METHODS: Ten polyester-covered and 10 uncovered nitinol stents (60-mm length, 10- or 12-mm diameter) were deployed percutaneously in the normal infrarenal aorta of 20 adult mongrel dogs using random assignment. Angiography, intravascular ultrasound (IVUS), and duplex ultrasound performed at device deployment and before explantation at 6 weeks were used to measure aorta/device diameter and cross-sectional area. Pressure-perfusion-fixed aortic segments were compared for surface endothelialization (CD31 staining) and for thickness of neointimal formation. RESULTS: All 20 endoluminal devices were accurately positioned in the infrarenal aorta without early or delayed evidence of device thrombosis, significant lumen narrowing, or device deformity. IVUS and duplex scanning identified no anatomical stenosis in either the covered or the bare devices by duplex ultrasound; peak systolic velocity measurements were similar (106+/-25 cm/s in the covered stent versus 96+/-25 cm/s for bare stents, p > 0.05). Mean neointimal thickness was significantly greater (p < 0.005) in the covered (326+/-145 microm) compared with the bare (219+/-62 microm) stents. Intima-to-media height ratios were greater in the covered stents (3.0+/-1.1 compared with 1.1+/-0.2, p < 0.003). Mean surface area endothelialization in the proximal, middle, and distal sections of each device was similar (p > 0.05) in covered (59%, 56%, and 69%) and bare (59%, 65%, and 53%) stents. CONCLUSIONS: Deployment and balloon dilation of a covered nitinol stent in a nondiseased canine aorta increased neointimal development compared with an uncovered stent, but overall lumen cross-sectional area was preserved. No differences in device patency, intradevice thrombus formation, flow hemodynamics, or luminal endothelialization were demonstrated, despite a thicker intradevice neointima induced by the polyester covering.

Alloys↗

PubMed2000

Evolution of techniques for ultrasound-guided palladium 103 brachytherapy in 950 patients with prostate cancer.

PURPOSE: Brachytherapy is an effective, low-morbidity, cost-effective treatment for adenocarcinoma of the prostate. Although both iodine 125 and palladium 103 have been used extensively over the last 14 years, 103Pd (Theraseed) provides a more rapid initial dose and therefore better control of higher Gleason grade tumors. We assessed a highly refined methodology for 103Pd brachytherapy in patients with prostate cancer and compared outcomes before and after making adjustments in technique. MATERIALS AND METHODS: Standard brachytherapy techniques were modified to include combination of preplanning with real-time adjustment, placing all needles at once to minimize prostate movement, using monitored anesthesia control sedation during preoperative volume study and cystoscopy, and several other small but important changes. Charts were reviewed from 950 patients treated with 103Pd implants from 1991 through 1999. Prostate-specific antigen (PSA) and biopsy data before and after 1993 were compared for 733 patients whose data qualified for analysis. RESULTS: At 1 and 5 years after treatment, 85-88% of patients had stable PSA <1.5 ng/mL. Biopsies were negative in 90-94% at 2 years. CONCLUSION: The modification in techniques provides positive results that remain stable over time.

Adenocarcinoma↗

PubMed2000

Do cytokeratin-positive-only sentinel lymph nodes warrant complete axillary lymph node dissection in patients with invasive breast cancer?

The small number of nodes harvested with lymphatic mapping and sentinel lymph node (SLN) biopsy has allowed a more detailed pathologic examination of those nodes. Immunohistochemical stains for cytokeratin (CK-IHC) have been used in an attempt to minimize the false negative rate for SLN mapping. This study examines the value of CK-IHC positivity in predicting further lymph node involvement in the axillary basin. From April 1998 through May 1999, 519 lymphatic mappings and SLN biopsies were performed for invasive breast cancer. SLNs were examined by imprint cytology, hematoxylin and eosin (H&E), and CK-IHC. Patients with evidence of metastatic disease by any of the above techniques were eligible for complete axillary node dissection (CAND). The frequency with which these modalities predicted further lymph node involvement in the axillary basin was compared. Of the 519 lymphatic mappings, 39 patients (7.5%) had a CK-IHC-positive-only SLN. Five (12.8%) of these 39 patients had at least 2 SLNs positive by CK-IHC. Twenty-six of the CK-IHC-positive-only patients underwent CAND. Three of these 26 patients (11.5%) had additional metastases identified after CAND. The sensitivity levels with which each modality detected further axillary lymph node involvement were as follows: CK-IHC, 98 per cent; H&E, 94 per cent; and imprint cytology, 87 per cent. A logistic regression to compare the prognostic value of the three modalities was performed. All were significant, with odds ratios of 19.1 for CK-IHC (P = 0.015), 5.3 for H&E (P = 0.033), and 3.86 for imprint cytology (P = 0.0059). These data validate the enhanced detection of CK-IHC for the evaluation of SLNs. Detection of CK-IHC-positive SLNs appears to warrant CAND in patients with invasive breast cancer. However, the therapeutic value of CAND or adjuvant therapies based on CK-IHC-positive SLNs would be best answered by prospective randomized trials.

Breast Neoplasms↗

PubMed1999

Surgical and endovascular intervention for infrainguinal vein graft stenosis.

PURPOSE: The purpose of this study was to evaluate the stenosis-free patency of open repair (vein-patch angioplasty, interposition, jump grafting) and percutaneous transluminal balloon angioplasty (PTA) of 144 vein graft stenoses that were detected during duplex scan surveillance after infrainguinal vein bypass grafting. METHODS: Patients who underwent revision of an infrainguinal vein bypass graft were analyzed for type of vein conduit, vascular laboratory findings leading to revision, repair techniques, assisted graft patency rate, procedure mortality rate, and restenosis of the repair site. RESULTS: The time of postoperative revision ranged from 1 day to 133 months (mean, 13 months). One hundred eighteen primary and 26 recurrent stenoses (peak systolic velocity, >300 cm/s) in 52 tibial and 35 popliteal vein bypass grafts were identified by means of duplex scanning. The repairs consisted of 77 open procedures (vein-patch angioplasty, 28; vein interposition, 33; jump graft, 9; primary repair, 3) and 67 PTAs. No patient died as a result of intervention. Cumulative assisted graft patency rate (life-table analysis) was 91% at 1 year and 80% at 3 years. At 2 years, cumulative assisted graft patency rate was comparable for saphenous vein grafts (reversed, 94%; in situ, 88%; nonreversed, 63%) and alternative vein grafts (89%). Stenosis-free patency rate at 2 years was identical (P =.55) for surgical intervention (63%) and endovascular intervention (63%) but varied with type of surgical revision (P =.04) and time of intervention (<4 months, 45%; >4 months, 71%; P =.006). The use of duplex scan-monitored PTA to treat focal stenoses (<2 cm) and late-appearing stenoses (>3 months) was associated with a stenosis-free patency rate that was 89% at 1 year. After intervention, the alternative vein bypass grafts necessitated twice the reinterventions per month of graft survival (P =.01). Bypass graft to the popliteal versus infrageniculate arteries, site of graft stenosis (vein conduit, anastomotic region), and repair of a primary versus a recurrent stenosis did not influence the outcome after intervention. CONCLUSION: The revision of duplex scan-detected vein graft stenosis with surgical or endovascular techniques was associated with an excellent patency rate, including when intervention on alternative vein conduits or treatment of restenosis was necessary. When PTA was selected on the basis of clinical and duplex scan selection criteria, the endovascular treatment of focal vein graft stenosis was effective, durable, and comparable with the surgical revision of more extensive lesions.

Adult↗

PubMed1999

Lymphatic mapping and sentinel lymph node biopsy in patients with melanoma of the lower extremity.

Lymphatic mapping and sentinel lymph node biopsy is a new technique used in the surgical treatment of patients with malignant melanoma. The purpose of this study was to evaluate the results of this approach for patients with melanoma of the lower extremity. Between May of 1994 and June of 1997 at the H. Lee Moffitt Cancer Center and Research Institute, 85 consecutive patients with clinical stage I and II melanoma of the lower extremity underwent lymphatic mapping and sentinel lymph node biopsy. These nodes were identified in all 85 patients by intraoperative lymphatic mapping with both radiolymphoscintigraphy and a vital blue dye injection. Eleven patients (12.9 percent) had histologically positive sentinel lymph nodes, and 10 patients underwent inguinal complete lymph node dissections. All 10 patients had no further histologically positive lymph nodes confirmed by subsequent complete dissection. Among 74 patients with histologically negative sentinel lymph nodes, only 2 patients (2.7 percent) developed inguinal nodal metastases during a mean follow-up period of 21.8 months (range, 13.5 to 58.3 months). The sensitivity of lymphatic mapping and sentinel lymph node biopsy in this series was 100 percent and the specificity was 97.3 percent. Therefore, we conclude that the use of lymphatic mapping and sentinel lymph node biopsy can accurately stage patients with melanoma of the lower extremity and provide a rational surgical approach for these patients.

Adolescent↗

PubMed1998

Development of a head and neck companion module for the quality of life-radiation therapy instrument (QOL-RTI)

PURPOSE/OBJECTIVE: A review of available head and neck quality of life (QOL) instruments reveals them to inadequately address important radiation related side effects, or to be too cumbersome for routine use. The purpose of this study was to develop a head and neck disease specific module as a companion to the previously developed quality of life - radiation therapy instrument (QOL-RTI). The goal was to create a more complete, yet concise, head and neck site-specific module geared toward patients receiving radiation therapy for head and neck cancer. METHODS AND MATERIALS: This exploratory study included 34 consecutive patients undergoing definitive radiotherapy over a 6-7 week course (60-79.8 Gy). We developed and administered a 14-item questionnaire to all eligible patients treated with radiotherapy for head and neck cancer who were not already registered in another research study assessing quality of life (e.g., RTOG). During the treatment period, the QOL-RTI general tool and the head and neck (H&N) module were administered as follows: at baseline, at week four (for test-retest), and at the end of the treatment period. For validation purposes the QOL-RTI/H&N was compared to the functional assessment cancer tool head and neck (FACT-H&N) questionnaire. The FACT-H&N was administered one time at week 4, on the same day as the QOL-RTI/H&N. This report includes the treatment phase of the study (during the course of radiation). RESULTS: Mean age was 62 years (range 40-75). Internal consistency of the module was satisfactory (Chronbach's alpha = 0.85). Test-retest yielded a correlation coefficient of 0.90 (p < 0.001). Concurrent validity, established by comparing the module to the FACT/H&N , yielded a correlation coefficient of 0.85. Significant changes in quality of life scores during a course of radiation was noted for both general quality of life tool and the site specific module. For the head and neck module, the difference in the mean baseline (7.17) and end of treatment scores (4.20) was 2.94, or 42% change (p < 0.0001). A smaller, yet still significant, difference in scores was seen in the general QOL tool (22 % change, p = 0.001). Item analysis of the module revealed statistically significant (p < 0.05) worsening in quality of life scores in the following areas: pain in throat, swallowing difficulty (meat/bread and liquids), changes in mucous and saliva, changes in taste, difficulty chewing, trouble with coughing, and speech difficulties. Items that were not significant were pain in the mouth, and appearance. CONCLUSION: These initial results suggest that the H&N companion module to the QOL-RTI is a valid and reliable tool that is responsive to changes in QOL during a course of H&N radiation therapy. This tool differs from existing H&N tools by including specific assessments of mucous, saliva, taste, cough, and local pain in a concise format. Significant changes in QOL scores were noted in all of these items. Evaluation of the tool in the post-treatment period (follow-up) is ongoing.

Adult↗

PubMed1998

Treatment of unresectable or metastatic pediatric soft tissue sarcomas with surgery, irradiation, and chemotherapy: a Pediatric Oncology Group study.

BACKGROUND: The objectives of this study were to compare vincristine/actinomycin D/cyclophosphamide/adriamycin (VACA) with VACA/plus imidazole carboxamide (DTIC) (VACAD) therapy in regards to complete/partial response and event free survival rates in children and adolescents with metastatic non-rhabdomyosarcoma soft tissue sarcomas (NRSTS) or previously chemotherapy-naive recurrent NRSTS or locally persistent gross residual tumor after surgery and radiation therapy. PROCEDURES: Between 1986 and March 1994, 75 patients entered this randomized study comparing VACA and VACAD, given at 3 week intervals. Sixty-one patients were considered eligible and received chemotherapy and radiation therapy to the primary tumor and areas of metastases. Thirty-six patients had regional unresected (Group III) disease, and 25 had metastatic disease (Group IV) at time of accession. Thirty-six patients received VACA (11 were not randomized), and 25 received VACAD. RESULTS: With a median follow-up of greater than 4 years, overall and event-free survival for all eligible patients are 30.6% and 18.4% respectively (S.E: 9.5% and 6.8%). There was insufficient evidence that DTIC offered any advantage to event free survival, but there was evidence for better outcome for patients in Group III disease in comparison to patients with Group IV disease, and for patients with a Grade 1 and 2 histology in comparison to Grade 3 lesions. CONCLUSIONS: Combination chemotherapy with VACA and VACAD were insufficient to prevent recurrent or progressive disease in children and adolescents with high stage NRSTS. The use of vincristine/ifosfamide/doxorubicin with cytokine support is under study.

Adolescent↗