Loop ileostomy versus loop colostomy for fecal diversion after colorectal or coloanal anastomosis: a meta-analysis.

BACKGROUND: Sphincter-saving surgery for the treatment of middle and low rectal cancer has spread considerably when total mesorectal excision became standard treatment. In order to reduce leakage-related complications, surgeons often perform a derivative stoma, a loop ileostomy (LI), or a loop colostomy (LC), but to date, there is no evidence on which is the better technique to adopt. METHODS: We performed a systematic review and meta-analysis of all randomized controlled trials until 2007 and observational studies comparing temporary LI and LC for temporary decompression of colorectal and/or coloanal anastomoses. Clinically relevant events were grouped into four study outcomes: general outcome measures: dehydratation and wound infection GOM construction of the stoma outcome measures: parastomal hernia, stenosis, sepsis, prolapse, retraction, necrosis, and hemorrhage closure of the stoma outcome measures: anastomotic leak or fistula, wound infection COM, occlusion and hernia functioning of the stoma outcome measures: occlusion and skin irritation. RESULTS: Twelve comparative studies were included in this analysis, five randomized controlled trials and seven observational studies. Overall, the included studies reported on 1,529 patients, 894 (58.5%) undergoing defunctioning LI. LI reduced the risk of construction of the stoma outcome measure (odds ratio, OR = 0.47). Specifically, patients undergoing LI had a lower risk of prolapse (OR = 0.21) and sepsis (OR = 0.54). LI was associated with an excess risk of occlusion after stoma closure (OR = 2.13) and dehydratation (OR = 4.61). No other significant difference was found for outcomes. CONCLUSION: Our overview shows that LI is associated with a lower risk of construction of the stoma outcome measures.

Partial breast irradiation with interstitial high-dose-rate brachytherapy in early breast cancer: results of a phase II prospective study.

AIM: To investigate, in a phase II prospective study, the efficacy of partial breast irradiation administered with high-dose-rate brachytherapy. METHODS: After conservative surgery 80 patients with low-risk early-stage breast cancer received 4 Gy twice a day for 4 days (total dose 32 Gy). Catheter implantation was performed during surgery in 15 cases and postoperatively, at a median of 8 weeks from surgery, in 65 patients. Adjuvant therapy was chemotherapy (8) and/or hormone therapy (61). RESULTS: Cosmetic results were good/excellent in 79 patients. Perioperative toxicity was very low. Acute skin toxicity developed in seven cases (six G1; one G2); late G3 cutaneous toxicity in one patient and late subcutaneous toxicity in five (three G1; two G2). Grade 1 teleangiectasia occurred in eight patients and grade 2 in one. Fat necrosis was symptomatic in one patient and asymptomatic in five. Only one patient presented pain after brachytherapy. A significantly (p=0.001) higher frequency of late toxicity was observed in patients implanted during surgery, the group, which included the only patient with a fair cosmetic result. No local or regional relapses have occurred to date. The median follow-up was 30 months (range 3-52). CONCLUSION: This strategy is a viable option in selected patients with early-stage breast cancer as it is feasible, reproducible and associated with very low perioperative and acute toxicity. The low incidence of late side effects will probably change as follow-up lengthens.

Upgraded diagnostic value of Gen-Probe PACE 2 assay for detection of Chlamydia trachomatis infection.

In this study, we evaluate the performance of a nucleic acid amplification assay, COBAS AMPLICOR (Roche Molecular systems) (PCR), compared to non-amplified DNA probe assay PACE2 (Gen-Probe Inc.) for the detection of C. trachomatis in a total of 2,916 samples (2,114 females and 802 males) consecutively collected in two different clinical pathology laboratories, over a period of three years. In the females, the endocervical swabs showed a similar range of detection when using the two different methods: out of 1,581 females processed with PACE 2, 1.4% (2005), 0.9% (2006), 0.5% (2007), resulted positive for C. trachomatis; out of 533 females processed with PCR, 1.3% (2005), 1.5% (2006) and 1.2% (2007), resulted positive. However, in the male subjects we found an increased positivity of Chlamydia detection on urethral swabs by using PACE 2: 4.8% (2005), 1.9% (2006) and 2.9% (2007), compared to urine specimen processed by PCR: 1% (2005), 1.4% (2006) and 0% (2007). Even if PCR should be considered a most promising tool for routine diagnosis of Chlamydia infection, Gen Probe allowed us to better identify Chlamydia trachomatis (in 4.8% of urethral swabs compared to urine) leading to a hypothesis that extracellular EB forms of Chlamydia could be absent in urine in persistent infectious.

Evaluation of serum HER2 extracellular domain in early breast cancer patients: correlation with clinicopathological parameters and survival.

BACKGROUND: We explored the correlation between serum human epidermal growth factor receptor-2 (HER2) extracellular domain (ECD) and tissue HER2 status, their relationship with clinicopathological parameters and their impact on disease-free survival (DFS) and overall survival in early breast cancer patients. PATIENTS AND METHODS: This prospective trial included patients with stage I-III breast cancer. Serum HER2 ECD levels were measured by two enzyme-linked immunosorbent assays before surgical treatment. Tissue HER2 status was analyzed by immunohistochemistry (IHC) in all tumors; FISH assay was utilized in HER2 2+ tumors by IHC. RESULTS: From May 2000 to July 2005, 256 consecutive stage I-III breast cancer patients were included in this study. High serum HER2 ECD levels (>or=15 ng/ml) were reported in 23 patients (9.0%) and HER2-positive status in tumor tissue was observed in 42 patients (16.4%) with a concordance of 87.1%. High HER2 ECD levels were significantly associated with high histological grade (P = 0.003), stage III (P = 0.008), lymph node involvement (P = 0.035) and negativity of both estrogen (P = 0.016) and progesterone (P = 0.007) receptors. At multivariate analysis, high serum HER2 ECD levels were a significant independent prognostic factor of worse DFS (P = 0.009). CONCLUSIONS: A statistically significant association was observed between high serum HER2 ECD levels and worse DFS in early breast cancer patients.

Nipple-sparing mastectomy. Preliminary results.

Nipple-sparing mastectomy (NSM) combines a skin-sparing mastectomy with preservation of the Nipple Areola Complex (NAC), intraoperative pathological assessment of the nipple tissue core, and immediate reconstruction, thereby permitting better cosmesis for patients undergoing total mastectomy. Radiotherapy of the NAC was carried out in every single patient after surgery. The procedure was first performed on selected patients following a clinical research protocol. From January 2003 to June 2004, 10 patients underwent nipple sparing mastectomy followed by reconstruction (4 of them decided also to undergo a prophylactic mastectomy on the other breast) at the Breast Unit, Policlinico Monteluce, Perugia, Italy. Patients had been accurately selected before the operation following some criteria previously assessed by a team of specialists including the breast surgeon, the oncological physician, the radiotherapist and the plastic surgeon. Histology of the 10 NSMs confirmed invasive carcinoma in 3 cases and in situ carcinoma in the remainder. Superficial necrosis of the NAC that settled down spontaneously without consequences occurred in 2 cases; loss of sensitivity of the NAC in 4 patients; 1 patient developed haematoma. No asymmetry was reported. All women were clear of cancer after the treatment. Nipple-sparing mastectomy is the procedure of choice on selected patients.

A population survival model for breast cancer.

Breast cancer is a major health problem, and disease control depends on an effective healthcare system. A registry-based tool to monitor the quality of breast cancer care could be useful. The aim of this study was to develop a population survival model for breast cancer based on the Nottingham Prognostic Model (NPM). To this end, 1452 cases of breast cancer diagnosed in the Umbria Region, Italy, during the period 1994-1996 were studied. An extensive search for routinely available variants in prognosis and treatment was performed. In about 80% of cases complete information on factors included in the NPM was available. The Cox model was used to assess the prognostic value of study factors. Nodal stage was the most important prognostic factor. In women who did not undergo axillary dissection (17%) the risk of death was twice that in women with no affected nodes, but they received chemotherapy with the same frequency. Radiotherapy was also less frequently used in this group. Grading was a significant prognostic factor only when women over 80 were excluded. Population survival models based on data from cancer registries may provide a tool that can be used to evaluate healthcare systems and the effectiveness of interventions. The inclusion of older women in our models decreased the significance of many established prognostic factors because of the frequency of incomplete evaluation and less aggressive treatment in these patients. Not undergoing surgical axillary dissection was associated with a worse prognosis and with less aggressive treatment.

Avoiding axillary dissection in breast cancer surgery: a randomized trial to assess the role of axillary radiotherapy.

BACKGROUND: The need to dissect axillary nodes in patients with early breast cancer and clinically negative axilla remains controversial. The aim of the study was to assess the role of axillary radiotherapy (RT) in reducing axillary metastases in patients with early breast cancer who did not receive axillary dissection. PATIENTS AND METHODS: From 1995 to 1998, 435 patients over 45 years old with breast cancer up to 1.2 cm and no palpable axillary nodes were randomized 214 to breast conservation without axillary treatment and 221 to breast conservation plus axillary RT. RESULTS: After a median follow-up of 63 months, overt axillary metastases were fewer than expected: three cases in the no axillary treatment group (1.5%) and one in the RT group (0.5%). Expected cases were 43 in the no axillary treatment group and 10 in the RT group. Rates of distant metastases and local failures were low, and 5-year disease free survival was 96.0% (95% confidence interval, 94.1%-97.9%) without significant differences between the two arms. CONCLUSIONS: This study suggests that occult axillary metastases might never become clinically overt and axillary dissection might be avoided in patients with small carcinomas and a clinically negative axilla. Axillary RT seems to protect the patients from axillary recurrence almost completely.

Phase II study of weekly paclitaxel and trastuzumab in anthracycline- and taxane-pretreated patients with HER2-overexpressing metastatic breast cancer.

Synergism between anti-HER2 monoclonal antibody (trastuzumab) and paclitaxel has been shown in vitro and in vivo. In previous experiences, weekly administration of trastuzumab and paclitaxel has shown significant activity in metastatic breast cancer. In this phase II study, we evaluated the activity and the toxicity of this weekly regimen in anthracycline- and taxane-pretreated patients with HER2-overexpressing metastatic breast cancer. Between November 1999 and July 2001, 25 patients were treated with trastuzumab (4 mg kg(-1) i.v. loading dose followed by 2 mg kg(-1) i.v. week(-1)) and paclitaxel (60-90 mg m(-2) h(-1) i.v. infusion week(-1)). The treatment was planned to continue until disease progression or prohibitive toxicity; in patients with responsive or stable disease, after 6 months of therapy, the decision to stop paclitaxel while continuing weekly trastuzumab was left to the physicians' judgement. At the median follow-up of 19.6 months (range 9.2-38.1), all patients are evaluable for response and toxicity. We obtained four (16%) complete responses (CR), 10 (40%) partial responses (PR), four (16%) stable diseases and seven (28%) disease progressions. The response rate (CR+PR) was 56% (95% CI, 36.5-75.5%). The median duration of response was 10.4 months (range 4.1-24.2+). Median time to progression was 8.6 months (range 2.5-24.2+). The toxicity was mild; five patients experienced fever and chills during the first infusion of trastuzumab (20%); leukopenia grade 2 was recorded in one patient (4%). Two patients (8%) came off study for grade 3 cardiotoxicity (after 9 and 17 weeks of treatment, respectively): both had already received anthracyclines and taxanes. Onycholysis grade 2 was observed in five patients (20%). These results confirm that weekly administration of trastuzumab and paclitaxel is active in anthracycline- and taxane-pretreated metastatic breast cancer patients HER2-overexpressing. Since cardiac disfunctions grade 3 were observed (8%), we recommend that cardiac function should be monitored in these patients.

[Rectosigmoid junction neoplasms: our experience]. / Le neoplasie della giunzione sigma-retto: esperienze personali.

The Authors report their experience with 25 patients operated for colorectal junction neoplasms from January 1998 to December 2002 in the Section of Oncological Surgery, at Perugia University. According to the international literature, the Authors maintain the absolute functional and anatomical individuality of this part of the large bowel, underlining the peculiarity of the sigmoidal junction neoplasms respect all the others colic sites regarding clinical manifestations, symptoms developing and biological behaviour. The characteristics seem also capable of changing the surgical choice as well as the prognosis of the disease.

Evaluation of level I and II axillary nodes included in the standard breast tangential fields and calculation of the administered dose: results of a prospective study.

PURPOSE: To evaluate if Level I and II axillary nodes are included in the standard breast tangential fields, and to calculate the dose administered. METHODS AND MATERIALS: In 35 patients treated with conservative surgery and axillary dissection, three clips were surgically positioned: one at the beginning of Level I, one between Level I and II, and another at the end of Level II. The breast was irradiated with two tangential fields. On simulation films, the volume between the clips was scored as "entirely included" or "not entirely included" in the treatment fields. Computed tomography (CT) scans were performed; CT data were imported into a treatment planning system, and three-dimensional plans were devised. Axillary Levels I and II were delineated on CT slices on the basis of anatomic landmarks. Fields and isodose curves previously obtained were superimposed to calculate the dose administered to the first two axillary node levels and to 90% of both volumes. RESULTS: On X-rays, the volume between clips corresponding to Level I was completely included in the medial field in 66.7% of cases and in the lateral field in 63.7% of cases, whereas the volume of Level II was entirely included in the medial field in 54.5% of cases and in the lateral field in 45.4% of cases. The median dose administered to Level I and II was 38.58 Gy +/- 11.01 (range 3.46-47.14) and 20.65 Gy +/- 14.07 (range 0.95-38.94), respectively. The median dose to 90% of both volumes of Level I and II was 6.75 Gy +/- 14.01 (range 1.9-39) and 1.75 Gy +/- 9.72 (range 0.8-29), respectively. CONCLUSION: The standard tangential fields do not entirely include Levels I and II axillary nodes.

Expression of glyoxalase I and II in normal and breast cancer tissues.

The present work aimed to study the activities of glyoxalase system enzymes, glyoxalase I (G I) and glyoxalase II (G II), as well as the expression of their genes in human breast carcinoma. Samples of tumoral tissue and normal counterparts were drawn from several patients during surgery. They served either for preparing extracts to be used in enzyme activity evaluations or for RNA extraction and subsequent northern blot analysis. A far higher activity level of G I and G II occurs in the tumor compared with pair-matched normal tissue, as shown by both spectrophotometrical assay and electrophoretic pattern. Such increased activities of G I and G II likely result from an enhanced enzyme synthesis as a consequence of increased expression of the respective genes in the tumoral tissue, as evidenced by northern blot. The present findings confirm a key-role of glyoxalase system to detoxify cytotoxic methylglyoxal and modulate S-D-lactoylglutathione levels in tumor cells. Moreover, they suggest a possible employment of GI inhibitors as anti-cancer drugs.

[Follow-up of surgical biopsies in microcalcifications of the breast. Comparative analysis of patients submitted to mammography and digitalization of mammographic images]. / Il follow-up delle biopsie chirurgiche per microcalcificazioni della mammella. Analisi comparata tra pazienti sottoposte a mammografia e a digitalizzazione dell'immagine mammografica.

Improvements in the techniques of preoperative needle localization of nonpalpable breast lesions that have been detected at mammography, coupled with surgical biopsy of smaller volumes of breast tissue and the use of local anesthesia have produced a more aggressive attitude toward early biopsy of lesions that are suspected of malignancy. The authors report the follow-up in 92 cases, who underwent breast biopsy for microcalcifications with no palpable lesions. In 46 women the presence of microcalcifications was evaluated through a computerized instrument which allows digitalization of the image.

[Digital imaging in the surgical detection of breast neoplasms]. / La digitalizzazione dell'immagine nella chirurgia di identificazione della mammella.

Microcalcific clusters represent good indicators for breast cancer detection. The Authors evaluated 98 cases of breast microcalcifications in patients with no palpable lesions. The patients had undergone mammography, biopsy and excised specimen's radiography to confirm that the target lesion was adequately removed. The presence of microcalcifications was detected through a computerized instrument which allows the digitalization of the image.

[Myocardium-protective effects of phosphocreatine in experimental ischemia-reperfusion]. / Effetti miocardioprotettivi della fosfocreatina nella ischemia-riperfusione sperimentale.

The protective effects of exogenous phosphocreatine were evaluated in vitro on isolated perfused rat hearts during reperfusion of ischemic myocardium. The hearts were randomly allocated in 2 groups. In the first (n 6) phosphocreatine was added at a concentration of 10 mM. The latter was utilized as control (n 7). In both groups the results showed a slight decrease in the post-ischemic myocardial performance. Aortic systolic pressure and flow respectively decreased on reperfusion by 17% and 12.5% in the phosphocreatine group and by 25.6% and 35% in the control group. Coronary flow was reduced by 10% in the phosphocreatine and by 18% in the control group. No statistically relevant differences were reported within or between the groups. No changes in heart rate occurred in the same period in the phosphocreatine and in the control group. Myocardial enzyme release during reperfusion showed significant lower levels of CK and LDH in the phosphocreatine group compared to controls (p less than 0.001 after 65 min and p less than 0.025 after 75 min between the 2 groups). The occurrence of serious ventricular arrhythmias was considerably higher in controls with respect to the phosphocreatine group. The overall incidence of major rhythm disturbances was 66% in the phosphocreatine group and 100% in the control group. Irreversible ventricular fibrillation (57%) occurred only in control hearts. The present findings indicate that phosphocreatine exerts a protective effect during myocardial ischemia and reperfusion, especially by preventing serious ventricular arrhythmias and by reducing myocardial enzyme release.