Clinical and cost outcomes of a polyethylene glycol (PEG)-coated patch versus drainage after axillary lymph node dissection in breast cancer: results from a multicentre randomized clinical trial.

BACKGROUND: The aim of this study was to compare the clinical outcomes between breast cancer patients who underwent axillary lymph node dissection with postoperative management using a polyethylene glycol-coated patch versus axillary drainage. The direct costs associated with both postoperative management strategies were also evaluated. METHODS: This was a multicentre RCT in women with breast cancer who underwent axillary lymph node dissection (ClinicalTrials.gov identifier: NCT04487561). Patients were randomly assigned (1 : 1) to receive either drainage or a polyethylene glycol-coated patch as postoperative management. The primary endpoints were the need for an emergency department visit for any event related to the surgery and the rate of seroma development. RESULTS: A total of 227 patients were included , 115 in the patch group (50.7 per cent) and 112 (29.4 per cent ) in the drainage group. The incidence of emergency department visits was significantly greater for patients with drainage versus a polyethylene glycol-coated patch (incidence rate difference 26.1 per cent, 95 per cent c.i. 14.5 to 37.7 per cent; P < 0.001). Conversely, the seroma rate was significantly higher in the polyethylene glycol-coated patch group (incidence rate difference 22.8 per cent, 95 per cent c.i. 6.7 to 38.9 per cent; P < 0.0055). Compared with drainage, using a polyethylene glycol-coated patch resulted in cost savings of €100.41 per patient. An incremental cost-effectiveness ratio analysis found that drainage was associated with an incremental cost-effectiveness ratio of €7594.4 for no need for hospital admission and €491.7 for no need for an emergency department visit. CONCLUSION: Compared with patients who received drainage after axillary lymph node dissection, the use of a polyethylene glycol-coated patch resulted in a higher rate of seroma, but a lower number of postoperative outpatient or emergency department visits and thus a reduction in overall costs.

Correlation between MAMMI-PET findings and anatomopathological outcomes in breast cancer patients.

OBJECTIVE: Imaging tests are a key element in the preoperative diagnosis of patients with breast cancer. Whole-body PET-computed tomography (PET/CT) breast studies have a limited spatial resolution, although dedicated breast PET (dbPET) devices such as the Mammography with Molecular Imaging PET (MAMMI-PET), have an increased sensitivity to detect tumor foci, especially those smaller than 2 cm. The purpose of this study is to define the validity and reliability of this new device. METHODS: A prospective and analytical observational study was carried out in a sample of patients with histologically confirmed breast cancer who were treated at our hospital between January 2017 and November 2018. The anatomopathological study findings for the surgical pieces were used as gold standards and we calculated their concordance with the findings from the MAMMI-PET as well as the validity and reliability parameters for this test. RESULTS: Data from 32 patients and 44 lesions (36 malignant and 8 benign) were evaluated. The mean patient age was 51.50 ± 11.68 years. Twenty patients had received neoadjuvant chemotherapy (NACT). The technique concordance rate was weak ( K = 0.349, P = 0.001) and was 84.3% for benign lesions and 62.6% for malignant ones. The MAMMI-PET sensitivity was 75%, whereas its specificity was 57.1%; the positive predictive value was 81.8% and the negative predictive value was 47.1%, with an overall precision of 70%. The MAMMI-PET sensitivity was higher in patients who had not undergone NACT and was significantly higher in patients with luminal B breast cancer compared to the luminal A subtype. CONCLUSION: The MAMMI-PET device had acceptable sensitivity and a high positive predictive value for the preoperative evaluation of patients with breast cancer; it was especially useful for lesions whose diagnosis with other imaging tests had been doubtful.

Major ambulatory surgery in breast diseases. / Cirugía mayor ambulatoria en patología mamaria.

INTRODUCTION: The use of ambulatory surgery (AS) for breast pathology (BP) has increased. The objective of this study is to analyse a group of patients treated surgically for breast pathology in order to evaluate its quality and security in a MAS setting in 2017. METHODS: A retrospective review of all patients undergoing breast surgery was conducted within an AS programme from January to December 2017 in Consorcio Hospital General Universitario of Valencia (CHGUV). The study analysed the number of patients, exclusion reasons, type of surgical procedures, evolution of substitution rate (SR), rate and causes of conversion to admission, postoperative complications, motives for not being included in the ambulatory programme and the satisfaction rate of the patients treated with ambulatory surgery. This has been compared with a 2013 group. RESULTS: In 2017, 396 procedures for BP were performed: 170 for benign and 226 for malignant disease. The SR for the global mammary pathology was 72.8%. The SR for benign pathology was 93.4% and the SR for malignant pathology was 57.2%, which has increased in recent years from 45.4% in 2013. The unexpected hospitalization rate (HR) of malignant pathologies was 14.1%, while the HR in benign pathologies was 0.6%. Patients hospitalized for malignant pathologies presented higher complications (17%) than ambulatory patients (8.5%) and benign pathologies (6.5%). CONCLUSIONS: At the CHGUV, the SR has steadily increased in malignant pathologies. The unexpected hospitalization rate is determined by perioperative sentinel lymph node biopsy results. AS for the treatment of mammary pathology is efficient and safe.

Popliteal lymphadenectomy on sentinel lymph node melanoma metastasis.

Popliteal lymph node dissection is a procedure that surgeons rarely perform and, therefore, scarcely represented in bibliography. In this paper we present the case of a patient with melanoma metastasis to popliteal sentinel lymph nodes showing the surgical procedure and discussing some epidemiological and technical issues.

Protocol for the implantation of a venous access device (Port-A-Cath System). The complications and solutions found in 560 cases.

INTRODUCTION: The cannulation of suitable peripheral veins may be a very painful experience. Implantable venous access systems have to some degree relieved this problem and help to provide an improvement in terms of quality of life. MATERIAL AND METHODS: We have evaluated 560 patients during a follow up period of two years. A low overall complication percentage of 7.32% was seen when using the venous access device. RESULTS: Complications and treatments were: pneumothorax; portal rotation or infection; catheter infection; embolism and migration; extravasation; partial or total obstruction of the device; rupture of the catheter or the membrane. CONCLUSIONS: There is no other system that allows repeated venous access on such a long term basis. Placing the devices completely under the skin allows the patient to conduct a normal life style, and its maintenance does not need any special care, with the exception of the monthly heparinised serum infusion. The preferred option is to insert the catheter through the cephalic vein in the delto pectoral groove.

[Oncoplastic surgery for thoracic wall tumours]. / Cirugía oncoplástica en tumores de pared torácica.

INTRODUCTION: Surgical treatment of tumours of the chest wall (primary or metastatic) requires special skills by the thoracic and the plastic surgeons, from the functional as well as the aesthetic perspective (oncoplastic surgery), when the treatment requires surgical reconstruction. MATERIAL AND METHODS: We present a series of 14 patients who needed extensive resection of the thoracic wall (external and/or 3 or more ribs) with disease-free margins and reconstruction with prostheses (7 with polytetrafluoroethylene [PTFE(R)] and 7 with the Sandwich Marlex-Methyl Metacrylate) technique with additional covering with muscle-skin flaps (6 pectoral, 5 recto-anterior, 3 dorsal) pedicled during the same surgical intervention. RESULTS: The aetiology of the extirpated tumours, following pathology assessment, were: 4 chondrosarcoma, 3 metastatic sternum, 2 breast cancer relapse, 1 desmoid tumour, 1 neurofibrosarcoma, 1 rhabdomiosarcoma, 1 malignant schwannoma and 1 radiation induced sarcoma. One patient died from complications and another 4 from disease progression before the conclusion of the study follow-up (3-22 months). CONCLUSIONS: Extensive resection of tumours of the chest wall with reconstruction using prostheses and muscle-skin flaps is a safe method that can be performed in the same surgical intervention period when combining the skills of the thoracic surgeon with that of the plastic surgeon.

Malignant eccrine breast spiradenoma. A case report and literature review.

INTRODUCTION: Eccrine spiradenomas are rare adnexal tumours of the skin that originate in the sweat glands. There are only three cases, including ours, diagnosed as malignant transformation in the breast. PRESENTATION OF CASE: We present a case of an asymptomatic 48 year old woman in whom the lesion was detected on the basis of breast cancer prevention programme. The metastatic study detection and the sentinel lymph node biopsy were negative so wide excision of the mass was performed with no further treatment. After 32 months of follow-up, there is no evidence of recurrent or metastatic disease in our patient. DISCUSSION: The lesions usually show a typical history of a long-standing unchanged cutaneous solitary nodule that becomes enlarged. The imaging findings of breast eccrine spiradenomas have not been clearly demonstrated. Diagnosis is based in histopathological findings of malignant focus. A large list of uncommon dermatological skin malignancies and breast benign lesions can mimic malignant eccrine spiradenomas (MES); therefore, determination of inmunophenotype allows narrowing differential diagnosis. Distant metastases portend an ominous prognosis. The mainstay of treatment is surgical removal with wide excision margins. Radiation and hyperthermic chemotherapy can also be administered to prevent focal recurrence. Due to the high risk of developing metastases, close follow up of these patients for early detection of recurrence should be carried out. CONCLUSION: Eccrine spiradenomas are rare adnexal tumours of the skin. Intraparenquimatous breast location is especially infrequent. Diagnosis is based on histopathological examination. MES metastasizes (40%), so a close follow up is recommended.

Tumor bed segmentation: first step for partial breast irradiation.

INTRODUCTION: In breast IMRT simultaneous integrated boost (SIB) treatment and accelerated partial breast irradiation (APBI), proper delineation of the tumor bed is necessary. Conservative oncoplastic surgery causes changes in peritumoral breast tissue that complicates locating the site of the tumor. Nevertheless, there are still centers that do not use surgical clips to delineate the site. This study aims to show how the lack of clips affects the techniques of SIB and APBI in terms of dose distribution and safety margins in the tumor bed. MATERIALS AND METHODS: On 30 patients, the defining of the tumor bed obtained from the pre-surgery CT scan to that outlined on the basis of clips on the post-surgery CT was compared. Tumor bed deviation from the original tumor site was quantified. In addition, the margins to the original tumor site necessary to guarantee the coverage of the tumor bed were calculated. RESULTS: Variations were detected in the distances between geometric centers of the PTV (minimum 0.5-maximum 3 cm). The maximum margin necessary to include the entire tumor bed was 4.5 cm. Lesions located in the upper outer quadrant required the widest margins. If margins are not added, the tumor bed volume defined with clips will be underdosed. CONCLUSIONS: The definition of the tumor bed based on studies before surgery does not have the necessary accuracy. Clips need to be placed in the surgical bed to identify the changes occurring after the restorative mammoplasty. Without clips, SIB and APBI are not safe.

Phase II trial with letrozole to maximum response as primary systemic therapy in postmenopausal patients with ER/PgR[+] operable breast cancer.

PURPOSE: Letrozole is superior to tamoxifen in terms of response and breast preservation rates as primary systemic therapy (PST) in postmenopausal women with ER-positive early breast cancer. However, the optimum duration of endocrine PST remains uncertain. METHODS: A phase 2 multicentre, open-label trial was conducted to evaluate the efficacy of letrozole over a preoperative period of 4 months to 1 year. Seventy postmenopausal patients (over 65 years) were recruited in four centers. The primary endpoint was to establish the optimal duration of treatment defined as the time required to attain the maximum response by clinical palpation. RESULTS: The median age of the group was 79 years (66-91) and the median tumour size 35 mm (range 25-100 mm). No severe adverse events were reported. Fifty-six patients were evaluable for the primary objective. A total of 43 patients (76.8%) achieved an objective response; 29 (51.8%) being partial and 14 (25.0%) complete. The median time to objective response was 3.9 months (95% CI, 3.3-4.5) and the median time to maximum response was 4.2 months (95% CI, 4.0-4.5), although 20 (37.1%) patients achieved the maximal response within 6-12 months. CONCLUSIONS: Letrozole shows a high activity and excellent tolerability as neoadjuvant therapy in elderly patients with endocrine-dependent breast cancer. Four to six months of letrozole as PST is an optimum duration with modest benefits thereafter.