Search

Frankia sp. strain EI5c is a member of Frankia lineage III, which is able to reinfect plants of the Eleagnaceae, Rhamnaceae, Myricaceae, and Gymnostoma, as well as the genus Alnus Here, we report the 6.6-Mbp draft genome sequence of Frankia sp. strain EI5c with a G+C content of 72.14 % and 5,458 candidate protein-encoding genes., (Copyright © 2016 D’Angelo et al.)

Thymol is a natural monoterpene, whose antioxidant and antimicrobial properties suggest a potential use in topical formulations. A simple, precise and selective HPLC method for thymol determination in skin penetration studies was developed and validated in this paper. Separation was achieved with a RP-C18 column, mobile phase comprised of acetonitrile:water (35:65v/v), flow rate of 1.5mL/min, oven temperature at 40°C, injection volume of 30μL and UV detection at 278nm. The validation procedure certified the method was selective for thymol determination even when extracted from skin matrix extracts. It was also linear in a range from 0.5 to 15.0μg/mL, robust, precise and accurate, with recovery rates from the skin layers higher than 90%. Limits of detection and quantification were 0.05 and 0.14μg/mL, respectively. The method showed, therefore, to be adequate for use in further skin permeation studies employing thymol topical formulations., (Copyright © 2016 Elsevier B.V. All rights reserved.)

Purpose: The aim of this article is to correlate the radiological features of pleuro-pulmonary damage caused by inhalation of pumice (an extrusive volcanic rock classified as a non-fibrous, amorphous, complex silicate) with exposure conditions., Materials and Methods: 36 subjects employed in the pumice quarries were evaluated for annual follow-up in a preventive medical surveillance program including spirometry, chest CT lasting from 1999 to 2014. They were only male subjects, mean age 56.92 ± 16.45 years. Subjects had worked in the quarries for an average of 25.03 ± 9.39 years. Domestic or occupational exposure to asbestos or other mineral dusts other than pumice was excluded. Subjects were also classified as smokers, former smokers and nonsmokers., Results: Among the 36 workers examined, we identified four CT patterns which resulted to be dependent on exposure duration and intensity, FVC, FEV1 and FEF25-75, but not on cigarette smoking. The most common symptoms reported by clinical examination were dyspnoea, cough and asthenia. In no case it was proven an evolution of CT findings during follow-up for 10 years., Conclusions: Liparitosis, caused by pumice inhalation, can be considered a representative example of pneumoconiosis derived by amorphous silica compounds, which are extremely widespread for industrial manufacturing as well as for applicative uses, such as nano-materials. Moreover, being pumice free of quartz contamination, it can represent a disease model for exposure to pure non-fibrous silicates.

Peritoneal inclusion cystarises when fluid produced by ovary is trapped within peritoneal adhesions. In this article, we describe a case series of patients affected by Crohn's disease, undergoing to magnetic resonance enterography, in whom it was possible not only to monitor the pathological findings of small bowel but also to primarily diagnose the presence of peritoneal inclusion cysts. The current knowledge of peritoneal inclusion cyst concomitant to Crohn's disease is still limited, often leading radiologists to misdiagnose it., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Multidetector computed tomography (CT) and volumetric rendering techniques have always been a useful support for the anatomical and pathological study of the maxillofacial district. Nowadays accessibility to multidetector CT scanners allows the achievement of images with an extremely thin collimation and with high spatial resolution, not only along the axial plane but also along the patient's longitudinal axis. This feature is the main theoretical assumption for multiplanar imaging and for an optimal 3-dimensional postprocessing. Multiplanar reconstruction (MPR) techniques permit images along any plane in the space to be obtained, including curved planes; this feature allows the representation in a single bidimensional image of different anatomical structures that develop on multiple planes. For this reason MPR techniques represent an unavoidable step for the study of traumatic pathology as well as of malformative, neoplastic, and inflammatory pathologies. Among 3-dimensional techniques, Maximum Intensity Projection and Shaded Surface Display are routinely used in clinical practice. In addition, volumetric rendering techniques allow a better efficacy in representing the different tissues of maxillofacial district. Each of these techniques give the radiologist an undoubted support for the diagnosis and the characterization of traumatic and malformative conditions, have a critical utility in the neoplastic evaluation of primary or secondary bone involvement, and are also used in the planning of the most modern radiosurgical treatments. The aim of this article is to define the main technical aspects of imaging postprocessing in maxillofacial CT and to summarize when each technique is indicated, according to the different pathologies of this complex anatomical district., (Copyright © 2015 Canadian Association of Radiologists. Published by Elsevier Inc. All rights reserved.)

We compare the deformation patterns produced by sand and a sand mica mixture (14:1 ratio of sand to mica by weight) while simulating basin fill in extension and inversion models to analyze the potential of the sand mica mixture for applications that require a strong elasto-frictional plastic analogue material in physical models. Sand and the sand mica mixture have nearly equal angles of internal friction, but the sand mica mixture deforms at a significantly lower level of peak shear stress. In extension, the sand mica mixture basin fill experiments show fewer normal faults. During inversion, the most striking difference between the sand and the sand mica mixture basin fill experiments is related to the internal deformation in fault-propagation folds, which increases with an increase in the basal friction. We conclude that our strongly elasto-frictional plastic sand mica mixture may be used to simulate folds in experiments that focus on mild inversion in the brittle crust.

Renal cell carcinoma can recur at any time after nephrectomy, and it is not unusual to detect late metastases even decades after surgical excision of the primary tumor. Despite being infrequently reported, head and neck metastases may be linked to renal cell carcinoma in up to 15% of cases. We present an unusual case of a single metachronous renal cell carcinoma metastasis in the infratemporal fossa, with a 13-year late onset from the primary., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Introduction: Bone regenerates mainly by periosteal and endosteal humoral and cellular activity, which is given only little concern in surgical techniques and choice of bone grafts for guided bone regeneration. This study investigates on a clinical level the biomechanical stability of augmented sites in maxillary bone when a new class of moldable, self-hardening calcium-phosphate biomaterials (SHB) is used with and without the addition of Platelet Rich Fibrin (aPRF) in the Piezotome-enhanced subperiosteal tunnel-technique (PeSPTT)., Material and Methods: 82 patients with horizontal atrophy of anterior maxillary crest were treated with PeSPTT and randomly assigned biphasic (60% HA/40% bTCP) or monophasic (100% bTCP) SHB without or with addition of aPRF. 109 implants were inserted into the augmented sites after 8.3 months and the insertion-torque-value (ITV) measured as clinical expression of the (bio)mechanical stability of the augmented bone and compared to ITVs of a prior study in sinus lifting., Results: Significant better results of (bio)mechanical stability almost by two-fold, expressed by higher ITVs compared to native bone, were achieved with the used biomaterials and more constant results with the addition of aPRF., Conclusion: The use of SHB alone or combined with aPRF seems to be favourable to achieve a superior (bio)mechanical stable restored alveolar bone.

Neoplasms of retromolar trigone have important peculiarities due to their spatial relationships with the surrounding structures. Tumours that involve this area can extend to nearby muscles; adipose spaces; and other anatomic structures, such as the soft palate, the tonsillar fossa, the parapharyngeal space, and the floor of the mouth. In spite of a relatively quick diagnosis, the real extent of these tumours is typically underestimated at clinical examination. Our purpose was to propose a systematic approach to the use of multiplanar computed tomography reconstructions to evaluate normal retromolar trigone anatomy and the main pathways of spread for tumours that arise in this area. To our knowledge, only few reports exist in literature about this topic and none are about the usefulness of multidetector computed tomography and multiplanar reconstructions., (Copyright © 2014 Canadian Association of Radiologists. Published by Elsevier Inc. All rights reserved.)

Rationale and Objectives: To investigate the value of diffusion-weighted (DW), perfusion-sensitive, and dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI) techniques in assessing the response of bone metastases from breast cancer to radiotherapy, with particular emphasis on the role of intravoxel incoherent motion (IVIM)-DW parameters as a potential valuable imaging marker of tumor response., Materials and Methods: Fifteen women having breast cancer and bone metastases underwent MRI before and after radiotherapy (3 weeks [time 1], 2 months [time 2], and 4 months [time 3]), consisting of DW, perfusion-sensitive (IVIM), and DCE acquisitions. MR-based DW and perfusion parameters, including water diffusivity (D), perfusion fraction (f), pseudodiffusion (D*), total apparent diffusion coefficient (ADC-total), fractionated ADCs (ADC-high and ADC-low), and initial area under the gadolinium concentration curve after the first 60 seconds (IAUGC60), were determined. The morphologic MRI findings were also recorded. A one-way repeated measures analysis of variance was used to compare the value of MR-based parameters at the different time points., Results: A significant variation between pretreatment (time 0) and post-treatment (times 1, 2, and 3) was found for ADC-total and D parameters (P < .001). A statistically significant reduction was also found for IAUGC60 values between times 0 and 3 (P < .001). A significant change across the different time points was observed for D* and IAUGC60 parameters (P < .001). On the contrary, there was no statistically significant change over time for parameters ADC-total, D, f, and IAUGC60 comparing response between each metastasis, that is, the response to therapy was similar for each metastasis., Conclusions: DW, IVIM, and DCE-MRI techniques show effectiveness in assessing the response to radiotherapy in bone metastases from breast cancer., (Copyright © 2014 AUR. Published by Elsevier Inc. All rights reserved.)

Nablus mask-like facial syndrome (NMLFS) is a rare microdeletion syndrome characterized by a mask-like facial appearance. NMLFS has been reported in only 6 patients and has a recognizable facial appearance, along with other clinical features. The first case of NMLFS has been described by Teebi in 2000, in a 4-year-old Palestinian boy. Three years later, Salpietro et al reported a second example of NMLFS in a 21-month-old girl. The same patient recently came to our hospital to undergo a computed tomography (CT) study to evaluate the degree of development of the zygomatic-maxillary region for orthodontic treatment and orthognathic surgery. To the best of our knowledge, no reports have previously illustrated the maxillofacial CT findings of NMLFS in the radiologic data. We report the multidetector CT (MDCT) facial characteristics/abnormalities of this syndrome, emphasizing the usefulness of multiplanar reformations (MPRs) in preoperative planning., (Copyright © 2014 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: Negative attitudes to disability among physiotherapy students in paediatric placements might be addressed by providing clinical placement opportunities for students early in their course. The aim of this qualitative research study was to explore what physiotherapy students reported learning from an innovative paediatric placement option., Design: Qualitative research with in-depth interviews., Participants: Seventeen first and second year physiotherapy students (15 women, 2 men; mean age 19.9 (SD 1.4) years) who took part in the clinical education experience., Interventions: The experience comprised a student-led progressive resistance training programme performed twice a week for 10 weeks at a community gymnasium with an adolescent with Down syndrome., Methods: In-depth interviews were completed after the 10-week programme and were audio-recorded, transcribed verbatim and independently coded by two researchers. Data were analysed using thematic analysis., Results: Two themes emerged from the data, one about being a student mentor and the second about skill development and application. The physiotherapy students indicated the programme was a challenging yet rewarding experience, and that they gained an increased appreciation of disability. They reported developing and applying a range of communication, professional and physiotherapy specific skills., Conclusions: The results suggest that the clinical experience provided physiotherapy students with opportunities to learn clinical skills, generic professional skills, and better understand disability in young people. Many of the learning outcomes identified by the participating students align with desired graduate capabilities and required professional competencies., (Copyright © 2012 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.)

Introduction: Chronic benign prostate diseases are very common and certainly feature significantly in urological practice.The treatment of chronic benign prostate diseases is a common problem in clinical practice: few studies have been conducted in routine clinical practice to evaluate the efficacy of the treatments for this clinical condition. The objective of this study was to evaluate the efficacy of an extract of Serenoa repens (Permixon) in the treatment of lower urinary tract symptoms (LUTS) in patients with chronic benign prostate diseases with associated inflammation, also taking into consideration the influence of treatment on sexual function and, therefore, on patients' quality of life., Materials and Methods: All the 591 eligible subjects were evaluated on entering the study; after a screening visit, including medical history, physical examination, physical examination and digital rectal examination (DRE) and laboratory tests, the patients underwent uroflowmetry. The subjects under investigation were also asked to complete the IPSS, NIH-CPSI and IIEF-5 questionnaires, for the purpose of evaluating urinary symptoms and erectile function in relation to sexual activity in the previous 6 months., Results: The analysis of the uroflowmetry results showed that treatment with extract of Serenoa repens distinctly improves bladder voiding and lower urinary tract symptoms, as highlighted also by the improvement in the scores for the IPSS and NIH-CPSI questionnaires which serve as a basis for evaluating the urinary symptoms of patients with prostatic hyperplasia and chronic prostatitis respectively. The results also suggest that using an extract of Serenoa repens for 6 months in patients with chronic benign prostate diseases gives rise to an improvement in erectile function, as demonstrated by the increase in the scores for the IIEF-5 questionnaire after 6 months of treatment., Conclusions: The results of this study demonstrate how treatment for 6 months with an extract of Serenoa repens in routine clinical practice gives rise to a statistically significant improvement in Qmax values and in the IPSS, NHI-CPSI and IIEF-5 questionnaire scores, resulting not only in an improvement in urinary symptoms but also in an overall improvement in patients' quality of life.

Background: In Italy, vaccination against hepatitis B virus infection was strongly recommended for healthcare workers since 1985. Update findings on vaccination coverage are lacking., Aim: To assess current vaccination coverage against hepatitis B in this job category., Methods: In 2006, 1,632 healthcare workers randomly selected in 15 Italian public hospitals completed a self-administered precoded questionnaire., Results: The overall vaccination coverage was 85.3%, a figure higher than the 64.5% observed in 1996. Vaccine coverage showed a significant downtrend (p<0.01) from the Northern (93.1%) to the Southern (77.7%) areas. Logistic regression analysis showed that residence in the North (Odds ratio 4.2; 95% confidence interval 2.6-6.7) and youngest age (Odds ratio 4.5; 95% confidence interval 2.6-7.8), both were independent predictors of vaccine acceptance., Conclusions: Ten years apart, vaccine coverage has markedly increased, closely paralleling the downtrend in the incidence of acute B hepatitis among healthcare workers in Italy.

Data regarding the observance of infection control practices in ambulatory healthcare settings is scarce. This type of data is important since the health care system has evolved in such a way that hospital stays are now briefer and there is an increased provision of healthcare in outpatient settings, such as day surgery, day hospital and ambulatory care services. Studies have shown that transmission of infectious diseases in outpatient health care settings is often associated with lack of, or insufficient adherence to, evidence-based preventive measures. Outpatients have less risk factors for nosocomial infections than inpatients, nevertheless, some high risk settings include physicians' waiting rooms (airborne and droplet transmission) and outpatient settings in which invasive procedures are performed. Preventive strategies consist in verifying the adherence to infection control guidelines (this should be done by specifically trained personnel), developing disinfection and sterilization protocols for medical devices (that are comparable to those used in hospitals), training of healthcare personnel, and development of efficacy-based infection control protocols for outpatient settings.

E5564 (alpha-D-glucopyranose) is a synthetic antagonist of bacterial endotoxin that has been shown to completely block human endotoxin response. Low doses of E5564 (0.35-3.5 mg) have a long pharmacokinetic half-life, but a surprisingly short ex vivo and in vivo pharmacodynamic half-life (generally less than several hours). To determine whether extended antagonistic activity can be achieved in vivo, this study assesses the pharmacodynamic activity of 4- and 72-h infusions of E5564 into normal volunteers. Administration of 3.5 mg of E5564/h x 72 h completely blocked effects of endotoxin challenge at the end of dosing (72 h), and at 48 and 72 h postdosing. Similarly, a 4-h infusion of E5564, 3 mg/h completely blocked endotoxin administered 8 h postdosing. A lower dose of E5564, 0.5 mg/h x 4 h, ameliorated but did not block most effects of endotoxin 8 h postdosing (p <0.05). Finally, the effect of varying plasma lipoprotein content on E5564 activity was studied in subjects having high or low cholesterol levels (>180 or <140 mg/dl) after 72-h infusion of 252 mg of E5564. No differences were observed. These results demonstrate that E5564 blocks the effects of endotoxin in a human model of clinical sepsis and indicate its potential in the treatment and/or prevention of clinical sepsis.

E5564 is a second-generation synthetic analogue of the lipid A component of endotoxin (lipopolysaccharide [LPS]). The ability of E5564 to block the toxic activity of LPS was assessed in a double-blind, placebo-controlled study. A bolus infusion of endotoxin (4 ng/kg) was administered to healthy subjects to induce a mild transient syndrome similar to clinical sepsis. Single E5564 doses of 50-250 microg ameliorated or blocked all of the effects of LPS in a dose-dependent manner. All E5564 dose groups had statistically significant reductions in elevated temperature, heart rate, C-reactive protein levels, white blood cell count, and cytokine levels (tumor necrosis factor-alpha and interleukin-6), compared with placebo (P<.01). In doses of > or = 100 microg, E5564 acted as an LPS antagonist and completely eliminated these signs. E5564 also blocked or ameliorated LPS-induced fever, chills, headache, myalgia, and tachycardia (P<.01). These results demonstrate that E5564 blocks the effects of LPS in a human model of clinical sepsis and indicate its potential in the treatment and/or prevention of clinical sepsis.

The frequency of Bromeliaceae and other plant breeding places where Aedes aegypti can be found is reported during two consecutive operational cycles (focal treatment) in the city of Rio de Janeiro. These cycles took place from November 12 2000 to March 9 2001 and from March 12 2001 to June 15 2001. This study concentrates on the epidemiological implications resulting from the growing use of these plants as decorative living objects.

Penile Mondor's disease (superficial thrombophlebitis of the dorsal vein of the penis) is an important clinical diagnosis that every family practitioner should be able to recognize. Although penile Mondor's disease is rare, proper diagnosis and consequent reassurance can help to dissipate the anxiety typically experienced by patients with the disease. This article describes the symptomatology, diagnosis, and treatment of superficial thrombophlebitis of the dorsal vein of the penis.

Background: Breast-conservation therapy for early-stage breast cancer is now an accepted treatment, but there is still controversy about its comparability with mastectomy. Between 1979 and 1987, the National Cancer Institute conducted a randomized, single-institution trial comparing lumpectomy, axillary dissection, and radiation with mastectomy and axillary dissection for stage I and II breast cancer. We update the results of that trial after a median potential follow-up of 10.1 years., Methods: Two hundred forty-seven patients with clinical stage I and II breast cancer were randomly assigned to undergo either modified radical mastectomy or lumpectomy, axillary dissection, and radiation therapy. The 237 patients who actually underwent randomization have been followed for a median of 10.1 years. The primary end points were overall survival and disease-free survival., Results: At 10 years overall survival was 75 percent for the patients assigned to mastectomy and 77 percent for those assigned to lumpectomy plus radiation (P = 0.89). Disease-free survival at 10 years was 69 percent for the patients assigned to mastectomy and 72 percent for those assigned to lumpectomy plus radiation (P = 0.93). The rate of local regional recurrence at 10 years was 10 percent after mastectomy and 5 percent after lumpectomy plus radiation (P = 0.17) after recurrences successfully treated by mastectomy were censored from the analysis., Conclusions: In the management of stage I and II breast cancer, breast conservation with lumpectomy and radiation offers results at 10 years that are equivalent to those with mastectomy.

As a means of defining the role of chemotherapy after radical resection of colorectal liver metastases, a follow-up study of consecutive cases referred to three different surgical clinics, between June 1977 and December 1990 was performed. Data were collected from medical records and recorded on standardized forms. Analysis focused on the impact of treatment on survival of the study population by Cox multivariate analysis. One hundred and twenty-four primary colon cancer cases were reviewed and 102 were fully evaluable. Forty of the 102 were given 5FU based chemotherapy. According to multivariate survival analysis, time to hepatic metastasis (synchronous vs metachronous, RR = 0.41, 95%, C.I. = 0.21-0.78; P = 0.007) and sex (female vs male, RR = 0.48, 95% C.I. = 0.25-0.93; P = 0.029) were significantly associated with better survival. The relative risk of dying associated with treatment was 0.53 (95% C.I. = 0.27-1.05; P = 0.0675). This study suggests that chemotherapy may have an impact on survival, although the size of the effect is not precise. Multicentric randomized clinical trials are required to define the risk/benefit profile of adjuvant chemotherapy.

Purpose: To assess the prognostic importance of c-erb B-2 expression in early stage breast cancer., Methods and Materials: Immunohistochemical analysis for c-erb B-2 over-expression was retrospectively performed on 107 paraffin-embedded specimens of women with Stage I or II breast cancer entered in a randomized trial. Results were correlated with known prognostic factors such as pathologic axillary involvement, T-size, estrogen and progesterone receptor status, and nuclear grade. Immunohistochemical staining for c-erb B-2 protein expression was also correlated with breast/chest wall failure as well as survival without evidence of disease (NED) and overall survival., Results: C-erb B-2 overexpression was positive in 21% of the biopsy specimens. A significant association was found between c-erb-2 positivity and lesions containing an intraductal component, with 62% of lesions staining positively for c-erb B-2 having an intraductal component compared to only 36% of lesions with an intraductal component staining negatively for the c-erb B-2 protein (p2 = .031). A significant correlation between c-erb B-2 protein over-expression and axillary nodal status, primary tumor size, nuclear grade, and estrogen and progesterone receptor status was not identified. Cox proportional hazards model did not show a significant effect of c-erb B-2 expression for NED or overall survival., Conclusion: Our study did not find over-expression of c-erb B-2 to reliably predict for recurrent disease in early stage breast cancer. This data can be added to other series comparing erb B-2 expression and disease outcome among node-positive and node-negative women with carcinoma of the breast.

Glutathione (GSH) combines with several xenobiotics and its electrophilic metabolites enhancing their elimination in bile and urine. Thus protects cells by preventing binding of these labile intermediary with vital molecules. Some individuals may be susceptible to this deleterious effect according to the intracellular GSHB concentration. In the present study we intend to determine the extent and nature of interindividual variation of human lymphocyte glutathion contents, after oxidative stress with paracetamol. Intracellular basal GSH was measured after one hour of incubation in a cell culture medium additioned with rat liver microsomes and NADPH at 37 degrees C. Each time two batches of lymphocytes were measured in parallel, one without paracetamol (basal) and the other with paracetamol (paracetamol-depleted). In 90 normal adult Caucasians, mean basal GSH concentration of lymphocytes (22.3 mumol/10(7) cells) were higher than in a comparable group of 20 Chinese (19.1 mumol/10(7) cells) or 20 Blacks (17.9 mumol/10(7) cells) subjects. Paracetamol treated lymphocytes were depleted of GSH at the same rate in each group, thus the same differences seen in basal conditions persist post oxidative stress. Probit analysis of values for each ethnic group revealed only a single mode. In otherwise normal Caucasians males with Down's syndrome, mean basal GSH concentration (29.7 mumol/10(7) cells) were higher than those of Caucasians, Chinese and Blacks.

The trustees of a health and welfare plan may choose to delegate monitoring of the plan's financial operations. Still, it is important that they have a basic understanding of welfare plan financial statements.

Recent data suggest that prognosis is similar for women with primary breast cancer whether they receive modified radical mastectomy (MRM) or local excision and axillary dissection with radiation (XRT). The effects of either of these treatments on arm mobility, pain, or edema have not been compared. To assess the impact of MRM or XRT on mobility, pain, or edema, we evaluated patients treated in a prospective randomized trial designed to assess prognosis following MRM or XRT. All were provided a standardized physical therapy program including arm mobilization, shoulder strengthening, prevention and treatment of upper extremity edema, and education about arm function. Patients were evaluated for chest wall pain, arm motion, muscle strength, and edema as determined by circumferential measurements at the wrist, forearm, and arm. Evaluations were performed preoperatively and at yearly anniversaries of their surgery. Women receiving XRT had more chest wall tenderness at 1 and 2 years after surgery than those receiving MRM (p2 less than 0.0001 and p2 = 0.0007 respectively). Those receiving MRM were slower to reach their preoperative range of motion (ROM) (p2 = 0.043). Incidence of muscle weakness was similar in both groups. The few patients with local recurrence of tumor had more upper extremity edema than those who did not recur (p2 = 0.085) at 1 year and (p2 = 0.02) at 2 years. In patients who did not develop local recurrence, those who had received XRT had greater but nonsignificant increases in upper extremity circumferential measures compared with those receiving MRM at any anniversary evaluation. Patients receiving MRM and XRT are likely to have some differences in functional outcome.(ABSTRACT TRUNCATED AT 250 WORDS)

In 1979, a prospective, randomized trial was begun at the National Cancer Institute comparing lumpectomy, axillary dissection, and radiation therapy (XRT) to modified radical mastectomy for the treatment of invasive breast cancer, clinical stage T1-2, N0-1, M0. Treatment in the radiation arm consisted of full axillary dissection and gross removal of the tumor, followed by 4500 to 5000 cGy to the whole breast and a boost to the tumor bed of 1500 to 2000 cGy. Patients with positive axillary dissections received radiation to the supraclavicular nodes, in addition to cyclophosphamide and doxorubicin. Two hundred thirty-seven patients entered in the trial between 1979 and 1987 are available for analysis, 116 in the mastectomy arm and 121 in the radiation arm. With a median follow-up of 67.7 months, there are no significant differences in 5-year overall survival (85% vs 89%, mastectomy vs radiation) or 5-year disease-free survival (82% vs 72%, mastectomy vs radiation). Patients in the radiation arm had an actuarial in-breast recurrence rate of 12% at 5 years and 20% at 8 years. There were no major differences between complication rates in the treatment arms. The results of the study indicate that patients with invasive breast cancer, stage I and II, can be treated with lumpectomy, axillary dissection, and radiation therapy with results comparable to those with modified radical mastectomy.

Ninety women with recently diagnosed stage I or stage II breast cancer who had been admitted to the NIH Clinical Center and were participating in a randomized trial were entered onto this behavioral immunology protocol. Patients were immunologically and psychosocially assessed at baseline (approximately 5 days after surgery) and again at 3 and 15 months post surgery. All of the patients were followed up for a minimum of 5 years, and 60% of the patients were followed for 7 years or longer. Twenty-nine women in the study group reported disease recurrences over the entire follow-up period. Causal path modeling statistical techniques showed that natural killer (NK) cell activity was a strong predictor of disease outcome when the outcome variable was defined as recurrence v nonrecurrence of disease (chi 2 = 6.9, p less than .001). Higher NK cell activity at follow-up predicted disease-free survival over the follow-up period. When the disease outcome variable was operationally defined as time to recurrent disease, the psychosocial factors were more strongly predictive of the rate of disease progression for those who had a recurrence (chi 2 = -4.1, p less than .01), but NK cell activity was seemingly less relevant in this latter case. Overall, these findings suggest that including mood and potentially relevant immunological variables, along with important biological prognostic variables, in multivariate and prospective models such as those examined in this study, potentially contributes more to the explanation of greater outcome variance of early-stage breast cancer than has been believed in the past.

We examined the relationship of axillary level of lymph node metastases from clinical stage I and II breast cancer to overall survival and disease-free survival rates in 135 patients who underwent complete axillary lymph node dissection to determine if anatomic level of axillary involvement (I vs II vs III) is an independent prognostic factor. All patients underwent either modified radical mastectomy or lumpectomy with axillary dissection and whole breast radiotherapy for breast cancer. Median follow-up was 6.9 years. We found no difference in overall survival or disease-free survival between patients whose highest or only level of axillary involvement was level I compared with patients whose highest or only level was II. Although patients whose highest level of nodal involvement was III had significantly worse overall survival and disease-free survival rates than patients whose highest nodal involvement was I or II, when patients were stratified by the total number of positive nodes (one to three vs four or more), there was no difference in overall survival or disease-free survival rates between levels I, II, and III. These findings indicate that the level of axillary involvement for stage II breast cancer is not of independent prognostic significance.

Breast reconstruction options are available to virtually all women undergoing mastectomy. Breast reconstruction may increase the woman's self-esteem and foster a more positive body image. Tissue expansion provides a means of developing breast symmetry with minimal surgical intervention. It can be used when the skin and soft tissue remaining after mastectomy are of good quality but inadequate quantity. The nurse's role encompasses physical and psychological support and patient education.

We conducted a randomized prospective trial in 19 disease-free soft tissue sarcoma patients with doxorubicin-induced cardiomyopathy identified by ECG radionuclide angiography at rest and during exercise to determine the efficacy of the free radical scavenger, N-Acetyl Cysteine (NAC), in reversing the drug's cardiotoxic effect. Of the 19 patients, 11 received oral NAC (5.5 gm/m2 daily for 30 days) and eight patients served as controls. Patients were stratified for age less than greater than 45 years, time from final dose of doxorubicin to randomization less than greater than 8 months, and history of treatment with mediastinal irradiation. The two groups were well-matched for all parameters. Cumulative mean doxorubicin dose (523 mg/m2 and 532 mg/m2) and range 500-600 mg/m2 was comparable. Left ventricular (LV) ejection fraction before randomization was not significantly different between the two groups either at rest (39 +/- 10% control, 38 +/- 13% NAC) or during exercise (38 +/- 12% control, 35 +/- 11% NAC). Neither rest nor exercise ejection fraction values changed significantly in either group between prerandomization and 1-month postrandomization studies. Late studies performed in seven NAC patients 3-5 months after randomization revealed no difference in LV ejection fraction compared to 1-month postrandomization values. Clinical course in patients with overt congestive heart failure was similar in both groups. LV function did not return to normal in any patient in either group. We conclude that N-Acetyl Cysteine has no effect in reversing long standing doxorubicin-induced cardiomyopathy.

Primary radiotherapy as a means of managing stage I and II breast cancer is receiving increasing attention. In a prospectively randomized trial comparing modified radical mastectomy to lumpectomy followed by definitive radiotherapy, we evaluated whether radiotherapy has a deleterious effect on the ability to administer adjuvant doxorubicin and cyclophosphamide to patients with histologically positive axillary lymph nodes. All patients were treated with an identical regimen, and doses were escalated to the same degree until myelosuppression occurred. There were no significant differences in the amount of chemotherapy administered to either treatment group. Patients in both groups received approximately 100% of the predicted dose of doxorubicin and approximately 117% of the predicted dose of cyclophosphamide. At present, we have no evidence that there are differences in recurrence rates as a function of the quantity of drug received, although longer follow-up is required.