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Biomedical subjects

C Vecchio

Publications and source records attributed to C Vecchio.

At least 19 recordsLinked to original sources

The role of axillary lymph node dissection in breast cancer patients with sentinel lymph node micrometastases.

AIM: To identify by means of clinical and histopathological features a subset of breast cancer patients with sentinel lymph-node (sN) micrometastases and metastatic disease confined only to the sN in order to spare them an unnecessary axillary lymph node dissection (ALND). MATERIALS AND METHODS: From January 1998 to December 2004, 116 patients with sN micrometastases underwent standard ALND for early-stage (T1-2 N0 M0) invasive breast cancer; clinical and histopathologic parameters were prospectively collected and evaluated by means of univariate and logistic regression analysis in order to identify which patients with sN micrometastases were free of metastasis in axillary non-sN. RESULTS: Sixteen of 116 patients with sN micrometastases had tumour involvement of non-sN, with six and 10 patients having non-sN micrometastases and macrometastases, respectively. None of 19 patients with primary tumour measuring </= 10 mm had tumour-positive non-sN; moreover, none of 15 patients with G1 tumours had non-sN metastases. The mean tumour size in patients with non-sN involvement was 21.3 mm (range, 12-40 mm). Univariate test of association between clinical and histopathologic features and non-sN status showed that the primary tumour size (P=0.005) and the presence of lymphovascular invasion (P=0.000) were the only significant predictors of non-sN involvement. By logistic regression, primary tumour size (P=0.011), lymphovascular invasion (P=0.001), and size of sN micrometastases were the only variables remaining into the model, although the latter parameter was not statistically significant. CONCLUSIONS: In patients with sN micrometastases, primary tumour size and lymphovascular invasion significantly predict non-sN status; notably, no patient with T1a-T1b and/or G1 tumours had non-sN metastases so that they could be spared an unnecessary ALND.

Adult↗

Technical issues and pathologic implications of sentinel lymph node biopsy in early-stage breast cancer patients.

BACKGROUND AND OBJECTIVES: Recent studies have demonstrated that the sentinel lymph node (sN) can be considered a reliable predictor of axillary lymph node status in breast cancer patients. However, some important issues, such as optimization of the technique for the intraoperative identification of the sN, and the clinical implications of sN metastasis as regards the surgical management of the axilla still require further elucidation. The objectives of this study was to assess (1) the feasibility of sN identification with a combined approach (vital blue dye lymphatic mapping and radioguided surgery, RGS) and the specific contribution of either techniques to the detection of the sN, and (2) the correlation between the size of sN metastasis (micrometastasis < or = 2 mm; macrometastasis > 2), primary tumour size, and the status of nonsentinel nodes (nsN) in the axilla. METHODS: Between October of 1997 and December of 1999, 212 patients with breast cancer (average age: 61 years; range, 40-79 years) underwent sN biopsy before performing standard axillary dissection. In a subset of 153 patients, both vital blue dye (Patent Blue-V) lymphatic mapping and RGS were used to identify the sN, and the relative contribution of each of the two techniques was assessed. RESULTS: Overall, the sN was identified in 206 of 212 patients (97.1%); at histologic examination of all dissected nodes, 77 of 206 patients had positive nodes (37.3%). The false-negative rate was 6.5% (5/77), the negative predictive value was 96.3% (129/134), and accuracy was 97.6% (201/206). Among 72 patients with positive sN, micrometastases were detected in 21 cases and macrometastases in 51. When micrometastases only were observed, the sN was the exclusive site of nodal metastasis in 17 of 21 cases (80.9%); in the remaining 4 cases (19.1%), nsN metastases were detected in 3 of 14 pT1c patients (21.5%), and 1 of 5 pT2 patients (20%). Macrometastases were detected in patients with tumors classified as pT1b or larger: the sN was the exclusive site of metastasis in 3 of 4 pT1b patients (75%), in 14 of 29 pT1c patients (48.2%), and in 3 of 18 pT2 patients (16.6%). The specific contribution of the two different techniques used in the identification of the sN was evaluated; the detection rate was 73.8% (113 of 153) with Patent Blue-V alone, 94.1% (144 of 153) with RGS alone, and 98.7% (151 of 153) with Patent Blue-V combined with RGS (P < 0.001). Noteworthy, whenever the sN was identified, the prediction of axillary lymph node status was remarkably similar (93-95% sensitivity; 100% specificity; 95-97% negative predictive value, and 97-98% accuracy) with each of the three procedures (Patent Blue-V alone, RGS alone, or combined Patent Blue-V and RGS). CONCLUSIONS: Sentinel lymphadenectomy can better be accomplished when both procedures (lymphatic mapping with vital blue dye and RGS) are used, due to the significantly higher sN detection rate, although the prediction of axillary lymph node status remains remarkably similar with each one of the methods assessed. That patients with small tumours (<1 cm) and sN micrometastasis are very unlikely to harbour metastasis in nsN should be considered when planning randomised clinical trials aimed at defining the effectiveness of sN guided-axillary dissection.

Adult↗

[The use of evidence-based medicine data].

Although the basic concepts behind evidence-based medicine (EBM) have been largely accepted, some aspects regarding its theoretical background and its methodological characteristics and practical applications (mainly concerning the therapeutic choices) in daily clinical practice are still subject of debate. This is a real problem, and we have not yet found a fully satisfactory solution. With regard to the theoretical point of view, the most radical antagonists of EBM contest that it is an "abstract building" which has lost contact with the day-to-day clinical reality. In spite of these criticisms, at present the medical community largely considers EBM as a real improvement in the methodology of clinical research and as a helpful support for medical practice. However, in applying the principles of EBM, a dangerous mistake has to be avoided: the meaning and benefit of EBM consist of the fact that it suggests but does not impose rational medical options. The practice of EBM must respect the liberty of the doctors and try to increase their professional and ethical responsibilities. These principles require wisdom and caution in drafting the guidelines generated by EBM and compel us to take into account some psychological side-effects of its diffusion among the physicians and common people.

Evidence-Based Medicine↗

Influence of formulation and process parameters on pellet production by powder layering technique.

The goal of the present study was to evaluate the influence of the formulation and operating conditions on pellet preparation by pan technique. To this end, a new pelletization process, typified by the application of powdered drug on sugar-based cores using the GS coating system was studied. Inert cores were intermittently treated with micronized drug powder and adhesive solution. This treatment led to the formation of multiple layers of drug particles around an inert core resulting in the production of pellets that can further be coated by different polymers to obtain modified release formulations. Different procedures have been used to evaluate a series of important parameters such as initial core weight; speed of powder application; speed, type, and position of the atomizers; atomization degree; temperature; and air cap. Good yield of drug layering was obtained by adjusting the quantity of both the drug powder to apply and the binder solution. Pellets obtained following the optimal operating conditions (defined in a pre-formulation study) were film coated with the acrylic polymer Eudragit L30D in order to produce a model formulation consisting of enteric polymer-coated pellets containing ibuprofen. During its preparation, the formulation showed no degradation of the drug; moreover, a low percentage of residual humidity was obtained, indicating that this system is very efficient for the production of highly stable formulations. This study showed the good performance of the GS automated pan-coating system in obtaining enteric coated pellets prepared by powder layering technique using aqueous solutions.

Chemistry, Pharmaceutical↗

Sentinel lymph node mapping in early-stage breast cancer: technical issues and results with vital blue dye mapping and radioguided surgery.

BACKGROUND AND OBJECTIVES: Axillary lymph node status is the most important prognostic factor in patients with operable breast cancer. Recent studies have demonstrated the possibility of identifying the sentinel lymph node (sN) as a reliable predictor of axillary lymph node status in both cutaneous melanoma and breast cancer. Sentinel lymph node identification proved feasible by either peritumoral dye injection (Patent Blue-V) or radiodetection, with identification rates of 65-97% and 92-98%, respectively. However, some important issues need further definition, namely (a) optimization of the technique for intraoperative detection of the sN, (b) predictive value of the sN with regard to axillary lymph node status, and (c) reliability of intraoperative histology of the sN. We reviewed our experience in sN detection in patients with stage I-II breast cancer to assess the feasibility and accuracy of lymphatic mapping, by vital blue dye or radioguided surgery, and sN histology as a predictor of axillary lymph node status. METHODS: Two groups of patients (55 and 48) were recruited between May 1996 and May 1997 and between October 1997 and February 1998; the patients of the first series underwent vital blue dye lymphatic mapping only, whereas those of the second series had a combined approach with both vital blue dye mapping and radioguided detection of the sN. RESULTS: In the first set of patients, the sN was identified in 36/55 patients (65.4%); sN histology predicted axillary lymph node status with a 77% sensitivity (10/13), a 100% specificity (23/23), an 88.5% negative predictive value (23/26), and an overall 91.5% accuracy (33/36). The sN was the quasi-elective site of lymph node metastases because in clinically N0 patients nodal involvement was 20-fold more likely at histology in sN than in non-sN (30% and 1.5%, respectively). In the second set of patients, 49 lymphadenectomies were performed because 1 patient had bilateral breast cancer; the sN was identified in 45/49 lymphadenectomies (92%). The sN was intraoperatively negative at frozen-section examination in 33 cases, and final histology confirmed the absence of metastases in 31/33 cases (94%), whereas in 2 cases (6%) micrometastases only were detected. Final histology of the sN predicted axillary lymph node status with an 87.5% sensitivity (14/16), a 100% specificity (29/29), a 93.5% negative predictive value (29/31), and an overall 95.5% accuracy (43/45). CONCLUSIONS: Sentinel lymphadenectomy can be better accomplished when both mapping techniques (vital blue dye and radioguided surgery) are used. In this group of patients, agreement of intraoperative histology of the sN with the final diagnosis was 94%, and sN histology accurately predicted axillary lymph node status in 43/45 lymphadenectomy specimens (95.5%) in which an sN was identified.

Adult↗

Pattern of lymphatic drainage to the sentinel lymph node in breast cancer patients.

BACKGROUND AND OBJECTIVE: We performed a pilot study on 30 consecutive patients undergoing sentinel node (sN) biopsy by radioguided surgery and vital blue dye mapping to determine whether there is a single sN for each breast independent of tumor site or an sN specifically related to the site of the breast neoplasm. METHODS: There were 6 groups of 5 patients; each patient had a subdermal injection of radiotracer on the tumor site plus a second injection of radiotracer that was changed in every subset of patients to test whether modifying the site or the route of injection could have impaired the proper detection of the sN. RESULTS: "False" sN were detected only in patients who had a second injection of radiotracer away from the tumor site; this occurred in 2 of 5 patients (40%) in group I, in 3 of 5 patients (60%) in group II, in all patients in group III, and in 3 of 5 patients (60%) in group IV. The different route of injection (peritumoral or subdermal) always on the tumor site that was tested in groups V and VI did not impair the proper detection of the sN. CONCLUSIONS: Our findings support the hypothesis of a precise topographic correspondence between the primary tumor and its specific sN more than the existence of a first sN in the axillary basin, which indiscriminately drains all quadrants of the breast, like "a neck of a bottle." This should be considered for the proper selection of the injection site of either vital blue dye or radiopharmaceuticals.

Adult↗

Mapping sentinel lymph node in breast cancer by combined lymphoscintigraphy, blue-dye, and intraoperative gamma-probe.

The purpose of the present work was two-fold: 1) to evaluate the predictive value of the sentinel lymph node (sLN) versus the axillary-node status in patients with T1-T2 breast cancer, and 2) to form an experimental basis for a randomized trial in which one group of patients with non-metastatic sLN will not have axillary dissection. Of a group of 284 patients considered for this analysis, 264 had a T1 cancer (16 T1a, 37 T1b and 211 T1c), while 20 had a T2 cancer; 243 patients were in clinical stage N0 and 41 were N1. All patients underwent lymphoscintigraphy 18 hr before surgery: 10 MBq in 0.15 mL of 99mTc-human albumin nanocolloids (particle size between 50-80 nm) was injected subdermally at the cutaneous projection of the tumor. Static gamma-camera images were acquired every 10-15 minutes until scintigraphic identification of the sLN. At surgery, 1-2 mL of Patent-Blue Violet was injected subdermally, and the sLN was searched by gamma-probe and by the dye method. The surgically isolated sLN was processed for intraoperative Hematoxylin & Eosin (H&E) histology, then for delayed histological and immunohistochemical examinations. The sLN was successfully identified by the combined radioisotopic procedure and Patent-Blue dye technique in 278/284 cases (97.9%). The Patent-Blue dye technique alone identified fewer sLNs than the radioisotopic procedure alone (56.3% versus 97.2%). Analysis of the predictive value of the sLN as to the status of axillary lymph nodes was limited to 197 patients undergoing standard axillary dissection irrespective of the sLN status. Overall, 63/191 (33%) identified sLNs were metastatic, the sLN alone being involved in 37/63 (58.7%) patients; a positive axilla status with negative sLN was found in 10/73 patients with metastatic involvement (13.7% false-negative rate). In conclusion, subdermal lymphoscintigraphy was confirmed to be an effective technique for sLN mapping; the addition of Patent-Blue dye minimally improved intra-surgical identification of the sLN. There was a high, but not absolute, correlation between a negative sLN and a negative axilla.

Adult↗

Biological activity of all-trans-retinoic acid with and without tamoxifen and alpha-interferon 2a in breast cancer patients.

In addition to suppressing breast cancer cell growth, retinoids potentiate growth inhibition in human breast cancer when tested in vitro and in vivo with tamoxifen and/or interferon. The purpose of this study was to ascertain the biologic effects of all-trans-retinoic acid (ATRA) administered alone and with tamoxifen +/- interferon and to identify the relationship between ATRA plasma concentrations and optimal biological dose (the lowest dose that produces a biological response). Three consecutive groups of 15 patients with locally advanced operable breast cancer were treated, in accordance with good clinical practice (GCP) requirements, with ATRA at 3 dose levels alone or with tamoxifen +/- alpha-interferon 2a at flat doses. After 3 weeks, the tumors were surgically removed. Biological parameters measured at the beginning (in biopsy tissue) and end (in surgical tissue) of the study were compared. The optimal biological dose for ATRA was 15 mg/m2/day. Treatments influenced tumor grade but not cell cycle kinetics (G0-G1 phase) or proliferation (Ki67 levels). ATRA induced progesterone receptors independent of dose level and co-administered drugs, but did not induce estrogen receptors when administered alone. Retinoic acid receptor (RAR)-alpha was not affected by treatment and RAR-alpha was moderately influenced whereas RAR-beta (concomitantly with transforming growth factor-beta) was induced in 33% of patients by ATRA alone. ATRA pharmacokinetics were dose- and time-dependent. Neither the ATRA + tamoxifen nor the ATRA + tamoxifen + interferon combinations potentiated the ATRA-induced biological changes. Future studies evaluating the role of RAR-beta as a biological marker of retinoid activity are warranted.

Aged↗

[Against free market in health].

Universalism is a basic philosophical concept peculiar to the Italian National Health System and as such guarantees free health care for everyone in any public medical structure. On the contrary, liberalism suggests that the medical care system should be based on privately managed health care structures and governed by the laws of the market. In a liberalist society, health care totally depends on each individual's economic possibilities. Money rules the life and health of everyone. The author believes that this fact is ethically unacceptable and incoherent with the culture and social theories of European justice. At present, the revival of liberalism is threatening the universalistic foundation of the Italian National Health System. It is the moral duty of physicians working within any public medical structure, particularly ANMCO associates, to preserve and defend the system. ANMCO should utilize the prestige gained in the past years from its techno-scientific initiatives in a "politically" significant manner to maintain universalism as a philosophical, ethical and juridical principle of the Italian National Health System in the interest of the whole Italian population.

Delivery of Health Care↗

[Health and the market].

The main problem facing the health systems in all western countries is the curbing of their rising costs. This fact represents a serious risk for the stability of any health system. Free-trade solutions, founded on market-driven systems, do not seem to be capable of preserving the peculiarity of all the national European health systems, characterized by universalism and public management, together with efficacy and effectiveness. The market spurs the demand but does not reduce the costs. Its main social danger is that it may give rise to a two-level health system: the first, of good quality but more expensive, managed by private companies and possible only for the upper and middle classes; the second, of poor quality but naturally less expensive, managed by the Public Health Service for the lower classes. Solidarity, responsibility, and equity are three civil virtues that must be deeply rooted in all European National Health Services (particularly the Italian National Health Service) so that their historical capacity of guaranteeing a sure and effective protection against disease can be consolidated.

Cost Control↗

Long-term prospective assessment of left ventricular thrombus in anterior wall acute myocardial infarction and implications for a rational approach to embolic risk.

To prospectively assess the predictive value of left ventricular (LV) thrombus anatomy for defining the embolic risk after acute myocardial infarction (AMI), 2 comparable groups of patients with a first anterior AMI (group A, 97 thrombolysed patients; group B, 125 patients untreated with antithrombotic drugs [total 222]) underwent prospective serial echocardiography (follow-up 39 +/- 13 months) at different time periods. LV thrombi were detected in 26 patients in group A (27%) and in 71 in group B (57%; p <0.005). Embolism occurred in 12 patients (5.4%; 1 in group A [1%] vs 11% in group B [9%], p < 0.04). At multivariate analysis, thrombus morphologic changes were the most powerful predictor of embolism (p <0.001), followed by protruding shape (p <0.01) and mobility (p <0.02). In patients untreated with thrombolysis, a higher occurrence of thrombus morphologic changes (48% vs 8%, p <0.002) and protruding shape (69% vs 31%, p <0.002) were observed, whereas thrombus mobility was similar in the 2 groups (18% vs 8%, p = NS). Thrombus resolution occurred more frequently in thrombolysed patients (85% vs 56%, p <0.002). Thus, after anterior AMI, changes in LV thrombus anatomy frequently occur and appear the most powerful predictor of embolization. A minor prevalence of thrombus, a more favorable thrombus anatomy, and a higher resolution rate may contribute to reduce embolic risk after thrombolysis.

Adult↗

[2 medicines].

Explore the source record for details and available documents.

Culture↗

[Malignant phyllodes tumor with liposarcomatous differentiation. Description of a clinical case].

Sarcoma of the breast are a rare group of neoplasms representing less than 5% of Soft Tissue Sarcomas (STS). Between 1980 and 1995 in the National Institute foe Cancer Research (IST) of Genoa, 2188 patients were submitted to surgery for breast cancer. Seven of them were found to be affected by sarcoma, confirmed by histologic diagnosis. All the patients were between 39 and 87 years-old. Surgical treatments were: wide excision (1 case), total mastectomy (2 cases), radical mastectomy following Halsted (4 cases). A case of a 53 year-old woman with a phyllodes tumor initially transforming in to liposarcoma is reported. The patient was submitted to surgery (total mastectomy) and nowadays is alive and free of disease after 29 months. All authors agree that the treatment for sarcoma of the breast is early and complete surgical excision of the mass. The role of chemotherapy and radiotherapy is still uncertain. Outcome is based on histologic type, degree of differentiation and tumor size.

Adult↗

Italian population data on thirteen short tandem repeat loci: HUMTH01, D21S11, D18S51, HUMVWFA31, HUMFIBRA, D8S1179, HUMTPOX, HUMCSF1PO, D16S539, D7S820, D13S317, D5S818, D3S1358.

A population study on thirteen short tandem repeat (STR) loci was performed on 223 unrelated Italian Caucasians. The DNA was amplified by PCR. Separation and detection of the amplified STR fragments was carried out by use of 377 automated system (Applied Biosystems Division/Perkin Elmer). All loci meet Hardy-Weinberg expectations, and the data show only five departures out of seventy-eight pairwise locus tests which is close to expectations of 5% (5/78 = 6.4%). When correcting for multiple tests, there is little evidence for departures from expectations between loci. The combined Power of Exclusion for the thirteen STR loci is 0.99999270. The results demonstrate that these loci will be very useful for human identification in forensic cases in Italy.

Alleles↗

Myocardial scintigraphy in acute myocardial infarction treated with systemic thrombolysis: how far are we from obtaining reliable information for rescue PTCA?

All noninvasive tests have an unsatisfactory accuracy in assessing patency of the infarct related vessel after systemic thrombolysis. In large infarctions, the prompt knowledge of the amount of jeopardized myocardium, as well as the eventual success of thrombolysis on the culprit lesion are major clinical needs in the subsequent decision making process, including the indication to rescue PTCA. Several reasons preclude a meaningful use of thallium scintigraphy in this setting: the most important one is the need to perform pre-thrombolytic images before the administration of the active agent, implying a delay in the administration of thrombolysis that is clinically not acceptable. SestaMIBI perfusion scintigraphy at rest seems more suitable in this regard. SestaMIBI practically does not redistribute in the myocardium, and this implies that after an administration at admission in the CCU, the pre-thrombolysis images can be acquired later, without any interference with the therapeutic schedule. The estimate of myocardial salvage can be obtained by the comparison of the perfusion pattern derived from a later sestaMIBI injection with the pre-lysis images. Both planar and tomographic reconstructions have satisfactory positive and negative predictive accuracy for the patency of the culprit vessel. Difficulties are related with the necessity of having this information timely; we describe a few protocols, appeared in the literature, that might contribute in solving such problems. SestaMIBI imaging in patients with acute myocardial infarction should be encouraged and extended, given its potential to represent one of the best tool to judge the amount of jeopardized myocardium, the obtained salvage, and to guide the decision making after systemic thrombolysis.

Angioplasty, Balloon, Coronary↗