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Background A significant number of patients with a previous submuscular breast augmentation require a revision surgical procedure during their long-term follow-up period that involves changing the implant pocket from submuscular to subglandular. Reduced soft tissue thickness represents a major concern, discouraging surgeons from undertaking this approach. Objectives The aim of this study was to determine whether a synthetic resorbable mesh used as a supplemental covering device was safe and yielded improved soft tissue thickness and protection against capsular contracture in patients undergoing implant plane shift to subglandular. Methods A retrospective review of 34 patients who underwent revision of a previous breast augmentation involving implant change in a subglandular pocket and upper pole GalaFLEX (Galatea Surgical, BD; Franklin Lakes, NJ) mesh coverage was conducted. Onset of minor and major complications was recorded during short- and medium-term follow-up. Patient satisfaction was assessed via an anonymous questionnaire administered 6 months postoperatively. Results During the follow-up period, which ranged from a minimum of 6 months to a maximum of 28 months, no minor or major complications were reported. In particular, no wrinkling/rippling or significant capsular contracture onset was observed. High levels of patient satisfaction were determined, according to self-reporting questionnaires. Conclusions The initial results of this preliminary report from this case series demonstrate the safety of GalaFLEX as a supplemental device in terms of improved soft tissue coverage of the implant for complex revisional cases in breast augmentation. Level of Evidence: 4

Direct-to-implant prepectoral breast reconstruction in the last years demonstrated to be a feasible and advantageous method in selected cases because it respects chest wall musculature integrity and avoids animation deformity. Current approaches involve implant wrapping with Acellular Dermal Matrix (ADM) or synthetic mesh to guarantee implant coverage and stability and reduce complications. Prepectoral polyurethane implant positioning without further coverage is an alternative breast reconstruction method poor described in literature.A single-institution retrospective analysis was performed on 453 patients, extending our previous preliminary experience, who underwent nipple-sparing mastectomy (NSM) and prepectoral polyurethane implant positioning between December 2017 and June 2021. Follow-up included postoperative complications record and self-reported patient's satisfaction.A total of 784 mastectomies were performed in 453 patients. 331 were bilateral procedures (73.1%) and 122 were unilateral (26.9%). Minimum follow-up time was 6 months and maximum was 42 months. No major complications were reported. Contour defects and excessive implant visibility occurred in 82 patients (18.1%) and was successfully managed with autologous fat grafting.Nipple-sparing mastectomy with immediate prepectoral polyurethane implant reconstruction without the need for ADM or mesh is a feasible and safe option. Accurate patient selection and respectful mastectomy technique is crucial to achieve optimal outcomes with this approach. Fat grafting is a useful refinement procedure to improve cosmetic results in this setting.

Purpose The noninterventional, prospective NIMES‐ROC phase IV study (NCT02825420) evaluated trabectedin plus pegylated liposomal doxorubicin (PLD) in real‐life clinical practice. Patients and Methods Eligible participants included adults with platinum‐sensitive recurrent ovarian cancer (PS‐ROC) who had received one or more cycles of trabectedin/PLD before inclusion according to the marketing authorization. The primary endpoint was progression‐free survival (PFS) according to investigator criteria. Results Two hundred eighteen patients from five European countries were evaluated, 72.5% of whom were pretreated with at least two prior chemotherapy lines and received a median of six cycles of trabectedin/PLD (range: 1–24). Median PFS was 9.46 months (95% confidence interval [CI], 7.9–10.9), and median overall survival (OS) was 23.56 months (95% CI, 18.1–34.1). Patients not pretreated with an antiangiogenic drug obtained larger median PFS (p < .007) and OS (p < .048), largely owning to differences between the two populations. Twenty‐four patients (11.0%) had a complete response, and 57 patients (26.1%) achieved a partial response for an objective response rate (ORR) of 37.2%. Fifty‐nine patients (27.1%) had disease stabilization for a disease control rate of 64.2%. No statistically significant difference in PFS, OS, or ORR was observed by BRCA1/2 status and platinum sensitivity. Most common grade 3/4 adverse events (AEs) were neutropenia (30.3%), anemia (6.4%), thrombocytopenia (5.5%), and asthenia (5.0%). No deaths attributed to treatment‐related AEs or unexpected AEs occurred. Conclusion The combination of trabectedin/PLD represents a clinically meaningful and safe option for patients with PS‐ROC regardless of prior treatment with an antiangiogenic drug, being comparable with previously observed outcomes in selected and less pretreated patients from clinical trials. Implications for Practice This noninterventional, prospective study, conducted in 57 reference sites across Europe, consistently confirmed that trabectedin plus pegylated liposomal doxorubicin (PLD) in routine clinical practice represents a clinically meaningful and safe option for women with platinum‐sensitive recurrent ovarian cancer. Although the study population represented a heterogeneous, older, and more pretreated population than those in prospective clinical trials, the combination of trabectedin plus PLD induced comparable clinical benefits, with a similar and manageable safety profile. Overall, these findings show that trabectedin in combination with PLD maintains antitumor activity when administered to heavily pretreated patients in real‐life clinical practice., This clinical trial evaluated the use of trabectedin plus pegylated liposomal doxorubicin (PLD) in patients with platinum‐sensitive recurrent ovarian cancer and its efficacy and safety in routine clinical practice in five European countries.

Background/aim We evaluated the efficacy of neoadjuvant chemotherapy (NACT) in reducing locally-advanced breast cancer (LABC) size, thus improving breast-conserving surgery (BCS) rates, as well as its long-term outcome. Patients and methods We analyzed 59 patients treated between 1999-2017 with NACT and subsequent surgery for LABC. Results We observed a tumor size reduction in 95% of cases, resulting in downstaging in 62.7%. The average tumor shrinkage was 49%. Women with a reduction in tumor size >50% after NACT had better 10-year OS rates than women with a reduction ≤50% (p=0.025). NACT allowed to perform BCS in 44% cases, whereas the remaining 56% cases underwent mastectomy. Overall, we observed recurrences in 37.2% patients. Recurrence rates after BCS and mastectomy were 30.7% (6 loco-regional and 2 distant cases) and 42.4% (5 loco-regional and 9 distant cases), respectively (p=0.07). Conclusion NACT confirmed its effectiveness in reducing mastectomy rates by approximately 50%, without increasing the risk of local or distant recurrences.

In light of recent US current events that saw a domestic terrorist attack by the far right on the day of President Biden's electoral vote confirmation at Capitol Hill, Tony Sampson’s A Sleepwalker’...

In the literature, several classifications of breast asymmetries and treatment protocols have been proposed over time, which are mainly based on etiological or morphological characteristics of the deformity. The aim of this study was to present our new classification, based on patient’s self-consciousness of breast asymmetry, a simple and reliable treatment algorithm is also presented. The case series included 343 patients treated between January 2006 and January 2015. Only patients presenting with developmental breast asymmetries were included in the study. All patients underwent prior classification in three groups based on the patient's degree of awareness of their asymmetry. A specific treatment algorithm was associated with each group according to breast size, grade of ptosis, and patient’s desire. At the 48-month follow-up appointment, patients completed an anonymous questionnaire that addressed satisfaction with breast shape, size, and symmetry, scar appearance, body perception, self-esteem, perceived attractiveness, intimate life, and overall feelings about their breasts. Mean patient age was 24.6 years (range 18–57 years). Mean follow-up was 54.4 months (6 months to 9 years). At the 48-month follow-up, 66.7% of the patients completed a visual analog scale (VAS) satisfaction questionnaire. An overall satisfaction rate of 77.0% was reported, and a statistically significant difference in the distribution of the overall satisfaction between groups was found. No patient expressed complete dissatisfaction. The proposed classification and the surgical algorithm is a simple, applicable, and reliable method to assess and treat breast asymmetries with a high satisfaction rate as confirmed from our results. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to Table of Contents or the online Instructions to Authors www.springer.com/00266.

Background Implant-based breast reconstruction after nipple-sparing mastectomy has been the most common breast reconstruction procedure performed, for both breast cancer treatment and prophylactically. Subpectoral implant placement with partial detachment of the pectoralis major muscle has been the procedure of choice for staged reconstruction and direct-to-implantation. Prepectoral implant placement has recently increased in popularity among plastic surgeons owing to the high rates of animation deformity, loss of muscle function, and chronic pain observed with submuscular implant placement. Acellular dermal matrices or synthetic meshes have been used for implant coverage and support to avoid capsular contracture and implant visibility. In the present study, we have introduced breast reconstruction actualized in nipple-sparing mastectomy and direct-to-implant with prepectoral polyurethane positioning (BRAND4P). Patients and Methods A total of 34 nipple-sparing mastectomies and immediate direct-to-implant breast reconstructions with prepectoral polyurethane-coated implant placement were performed in 21 patients (13 bilateral and 8 unilateral). The implant was placed subcutaneously in the exact place of the excised breast parenchyma with no further coverage. Results After a mean follow-up of 4 months, no major complications had been observed. No patient presented with animation deformity or grade III-IV capsular contracture. Patient satisfaction, assessed using the BREAST-Q, was excellent. Conclusions The BRAND4P method represents a novel prepectoral approach and a feasible alternative to subpectoral implant placement among the available implant-based breast reconstruction techniques.

Although NAC has been shown to be very effective in down staging of the axillary cavity and a complete pathological response (pCR) has been observed in 40-70% of cases (above all in triple negative and Her2+ patients), it was assumed that a pathological response of the tumor alter axillary lymphatic rainage for lymphatic canal fibrosis with cellular debris, reducing the probability of sentinel node (SLN) idetification, with a likely increase in the percentage of false negatives rate (FNR), which as shown by SENTINA trial, where it stands at values of 16%, with a detection rate (DR) of 80%. In light of these observations, different surgical strategies have been put in place to reduce the FNR rate, in order to imporve the number of sentinel/parasentinel nodes and the identification rate (IR) during SNLB in c N+ yc N0 patients, such as the use of double tracer (like vital dye or superparamagnetic iron oxide- SPIO, in association with Tc99), the clip placement in nodes involved before NAC and intraoperative ultrasound (IOUS). Here we will report our experience about the detection rate (DR) and the feasibility of the double tracers, SPIO (Magtrace) + Tc99. We enrolled 20 patients with diagnosis of invasive breast cancer with axillary metastasis, undergoing neodjuvant chemiotherapy and in axillary response after this (cN+ycN0). The overall lymph nodes removed were n°64 between sentinel and parasentinel nodes (52 with Magtrace and 29 with technetium, p-value 0.05). In 12/20 patients (60% of cases) the complementary use of Magtrace allowed us to reach a number of identified lymph nodes ≥ 3, avoinding axillary node dissection in 15/20 (75% of all patients). As demonstrated by our experience, still limited in number of cases, Magtrace® is a valid support in finding the SLN post NAC, both in terms of non-inferiority compared to Tc99, and as a complementary means to the latter in the 'to help us find a number ≥ 3 of LS, essential for breaking down the FNR.

Background and aim of the work. Psychosocial needs in cancer patients seem to be underestimated and undertreated. The present research was designed to explore under-considered psychosocial needs (e.g., stressful life events, perceived social support, sense of mastery and depressive/anxious symptoms) of a female cancer group. The aim of the study was to test an assessment psycho-oncological model for female cancer patients. An assessment model of psychosocial needs and Stressful Life Events was operationalized and tests its predictive power. Methods. We used Discriminant Analysis to test predictive power of the model and of the single variables included in it. 236 oncological patients (mean age 55.50 ± 13.09) were matched with 232 healthy control groups in the study. The following instruments were chosen: the Florence Psychiatric Interview, Hospital Anxiety Depression Scale, Multidimensional Scale of Perceived Social Support, Beck Depression Inventory I, and Sense of Mastery. Results. The model satisfied the assumption criteria and was significant (Ʌ= .680, X2 = 109.73, p< .001). Conclusions. Stressful events, depression and anxiety were adequate markers of the assessment psycho-oncological model proposed for female cancer patients. The present study provides contributions in a clinical perspective: the results support the relevance of considering an assessment psychosocial model to use in female oncology for an accurate estimation of the women’s needs. Women affected by female cancer with an history of Stressful Early and Recent life events and high level of anxiety and depression could positively benefit from a psychotherapy treatment. (www.actabiomedica.it)

Leiomyosarcomas represent the most common variant of uterine sarcomas, and are also considered to be the least chemosensitive. To date, adriamycin and ifosfamide are believed to be the most effective drugs for its treatment, in addition to docetaxel and gemcitabine. Recently, the introduction of trabectedin has provided clinicians with another treatment option, and the drug may have some benefits for patients as it may allow for long-term treatment. We present the case of a patient who previously failed multiple cycles of chemotherapy and who was subsequently treated with 30 cycles of trabectedin as third-line therapy for multiple metastases of uterine leiomyosarcoma. During the treatment period, the dosage and dose interval of trabectedin were optimized because of the appearance of grade 4 hematological and gastrointestinal toxicity. Dose adjustments led to acceptable tolerability. Trabectedin was associated with a very good partial response, especially at the pulmonary and pancreatic levels, and stable disease was achieved at all metastatic sites. The patient is currently continuing treatment with trabectedin and has clinically stable disease after 2 years of therapy. This case report provides further evidence that trabectedin is a valid and well-tolerated therapeutic option that can be used in the long term in uterine leiomyosarcoma.

Introduction/Background The non-interventional NIMES-ROC phase IV trial (NCT02825420) evaluated trabectedin (Yondelis®)+pegylated liposomal doxorubicin (PLD) in real-life clinical practice, given in accordance with the marketing authorization to women with platinum-sensitive recurrent ovarian cancer (PSROC) regardless of prior anti-angiogenic treatment. Methodology We report the results of an interim analysis of the data from patients with PSROC treated with trabectedin+PLD within the approved schedule (PLD 30 mg/m² followed by 1.1 mg/m² trabectedin as 3-h/every 3 weeks). Eligible were adults with PSROC who have received ≥1 cycle of trabectedin+PLD before inclusion. The primary endpoint was to assess the progression-free survival (PFS) according to investigator criteria. Results Overall, 158 adult patients from 50 sites across Spain, Italy, Germany, France and Belgium were evaluated. Median number of trabectedin+PLD cycles received per patient was 6, with 95 patients (50.6%) receiving ≥6 cycles and up 34 cycles. Median treatment duration and cycle duration were 22.2 weeks (range: 3–124) and 25.5 days (range: 21.0–73.0), respectively, with ≥63% of patients treated on an outpatient basis. Twenty-two patients received prior PLD or doxorubicin with no reported safety issues due to retreatment with trabectedin+PLD. With 73 PFS events and 32 deaths recorded, median PFS and overall survival were 11.4 months (95% CI: 10–14) and not reached (16.8-nr), respectively. The objective response rate was 38%, while 28.5% of patients had disease stabilization for a disease control rate of 66.5%. A total of 108 trabectedin-emergent adverse reactions (TEARs) occurred. Most common grade 3/4 TEARs were neutropenia (25%) and asthenia (4%). Conclusion Acknowledging the interim results from observational studies need to be interpreted with caution, our preliminary data confirm that trabectedin+PLD is effective and safe in patients with PSROC. Our data favourably compare with those of the pivotal OVA-301 trial (NCT00113607; i.e. median PFS 9.2 months), even with more pretreated patient population (NIMES-ROC: 39.9% with ≥3 prior chemotherapy lines). Disclosure Nothing to disclose.

The majority of patients with ovarian cancer will experience relapse and thus require second-line therapy. While platinum-based therapies are the primary treatments for refractory disease other options are required, particularly for those with partially platinum-sensitive disease as their response rates are lower. Agents that can resensitize relapsed ovarian cancers to platinum, including trabectedin, are therefore of increasing interest. Trabectedin is a multitarget agent that has a complex, novel mechanism of action and has exhibited promising results in platinum-sensitive ovarian cancer when in combination with pegylated liposomal doxorubicin (PLD). The present study conducted retrospective analysis involving 11 cases (median age 60 years; range 45-75 years) of recurrent ovarian tumors and partial platinum sensitivity undergoing treatment with trabectedin + PLD. The cohort consisted of 7 serous carcinomas, 1 endometrial carcinoma, 2 undifferentiated carcinomas, and 1 mucinous carcinoma. Of the 11 patients, 4 exhibited a complete response, 3 achieved stable disease, and 4 had progression of disease. Mean overall survival was 32.42 months and median progression-free survival was 5.9 months. Trabectedin in combination with PLD was well tolerated in terms of gastrointestinal and hematological toxicity; Grade 3 cutaneous toxicity and grade 3 neutropenia were each observed in 18.2% of patients. There were no grade 4 events. Thus, the present study supports the use of trabectedin + PLD in patients with relapsed ovarian cancer and partial platinum sensitivity, with predictable and manageable toxicity.

Isolated parenchymal splenic lesions are very rare and may occur as recurrences in the form of epithelial tubo-ovarian cancer (ETOC). We report a case of solitary parenchymal splenic recurrence of ETOC, which developed 50 months after the initial treatment. A 66-year-old woman underwent laparotomic primary cytoreduction in 2008. After platinum-based chemotherapy, she developed recurrences; thus, she underwent secondary and tertiary cytoreduction in 2011 and 2012 respectively. In April 2013, CT scan documented a solitary parenchymal splenic lesion and it was confirmed by FDG PET/CT. She underwent quaternary cytoreduction by laparoscopic splenectomy. Histopathological evaluation revealed metastatic parenchymal disease consistent with recurrent ETOC. She was alive and disease-free for ten months since splenectomy. In literature there are 35 cases of isolated spleen parenchymal metastasis of ETOC and our report is the first case of laparoscopic splenectomy in the setting of quaternary cytoreduction. Laparoscopic splenectomy as quaternary cytoreduction is safe and feasible and could be congruent to the well-established experiences already reported for the primary, secondary or even tertiary cytoreduction where the absence of residual disease has been translated in a significant survival benefit.

It has been estimated that there are 50–100 million nomads and semi-nomads in the developing world, over 60% living in Africa. In Ethiopia, pastoral land covers about 60% of the total land area with an estimation of 8 million pastoralists. Nomads have the least access to the healthcare delivery system, due to their traditional lifestyles entailing seasonal movements and spread settlement patterns. Moreover being also strongly affected by extreme weather conditions, nomadic pastoralists enact different strategies aimed at maintaining the health status of their household groups. The main purpose of this research was to identify and analyse pastoralists’ needs, perceptions and behaviours towards human and animal health, in relation to the local socio-ecological context. A special attention was given to the strategies of adaptation to the environment also in relation to climate change. In the last years, developments in remote sensing technologies, cartographic services and GPS applications have enabled the creation of Geographic Information Systems (GIS) capable to integrate spatial data with climatological products. This paper presents a methodology to collect and integrate environmental and social data to strengthen the monitoring capacity of stakeholders working close to the nomadic community in Filtu Woreda, Ethiopia. Data collected in the field (e.g. human and animal health services, water sources, precipitation) using mobile and portable devices are integrated with satellite data into a GIS, to enable stakeholders to generate an effective database for the analysis of pastoralists and livestock health behaviours, according to seasonal movements and to climatological variations.

Pediatric nuclear medicine refers to imaging examinations performed in babies, young children, and teenagers. Carrying out nuclear medicine procedure on children requires a completely different approach than on adults. The complexity of the examination varies depending on the age of the patient, the degree of cooperation, clinical conditions, and duration of scintigraphic acquisition. Depending on the increasing complexity of pediatric nuclear medicine studies, a higher level of department expertise is necessary for the delivery of good quality examination and safe patient care.

This paper describes a newly designed Sun and Aureole Measurement (SAM) aureolegraph and the first results obtained with this instrument. SAM measurements of solar aureoles produced by cirrus and cumulus clouds were taken at the Atmospheric Radiation Measurement Program (ARM) Central Facility in Oklahoma during field experiments conducted in June 2007 and compared with simultaneous measurements from a variety of other ground-based instruments. A theoretical relationship between the slope of the aureole profile and the size distribution of spherical cloud particles is based on approximating scattering as due solely to diffraction, which in turn is approximated using a rectangle function. When the particle size distribution is expressed as a power-law function of radius, the aureole radiance as a function of angle from the center of the solar disk also follows a power law, with the sum of the two powers being −5. This result also holds if diffraction is modeled with an Airy function. The diffraction approximation is applied to SAM measurements with optical depths ≲2 to derive the effective radii of cloud particles and particle size distributions between ∼2.5 and ∼25 μm. The SAM results yielded information on cloud properties complementary to that obtained with ARM Central Facility instrumentation. A network of automated SAM units [similar to the Aerosol Robotic Network (AERONET) system] would provide a practical means to gain fundamental new information on the global statistical properties of thin (optical depth ≲ 10) clouds, thereby providing unique information on the effects of such clouds upon the earth’s energy budget.

Introduction The occurrence of preeclampsia before the 20th week of gestation is rare and it has been associated with hydatidiform molar pregnancy. Objectives We describe a case of first trimester eclampsia which occurred in a patient with hydatidiform mole. Methods Case report. Results A 16-year-old woman came to emergency service for abdominal pain and vaginal bleeding. She had been suffering of vomiting after meals and complaining for abdominal mass for 2months, without consulting her physician. The last reported period was 1month before; the patient told her periods were regular and the only disease she reported was chronic HBV hepatitis. Vital parameters were all normal. Urine pregnancy test resulted always negative. The gynecological exam reported an increased uterus and a little bleeding, so serum bhCG was performed because of the exam findings and resulted 110,5317UI/L. The transvaginal ultrasound showed images consistent with gestational trophoblastic disease. Computed tomography (CT) scan revealed the presence of an uterine mass and three lung nodules, reported as possibly metastatic. A few days later, the patient underwent dilation and curettage (D&C). Second grade hydatiform mole was diagnosed by histology. After D&C, the serum bhCG was 202,511UI/L. The day after, the patient presented bilateral acute blindness, followed by incoming general seizures, concurrent hypertension and tachycardia. Intravenous diazepam, levetiracetam and mannitol controlled the seizures, but the conscious state of the patient remained critical. Temperature reached 40°C, with concurrent leukocytosis. Then, a lumbar puncture was performed but it resulted negative for inflammatory/infective processes. A head CT was performed the same day and showed a posterior reversible encephalopathy syndrome (PRES). Intravenous methylprednisolone was started. Long term therapy with methylprednisolone and levetiracetam was effective and the patient's status improved and stabilized. A subsequent chemotherapy with EMA/CO regimen (etoposide, methotrexate, actinomycin D, cyclophosphamide, vincristine/oncovine) was performed for six cycles, until serum bhCG resulted negative and the abdomen/pelvis ultrasound, head NMR and chest X-ray resulted normal. Conclusion Preeclampsia and eclampsia are regarded as common causes of PRES, which is considered to be the result of vasogenic brain edema. Clinical and imaging findings are usually reversible. Early diagnosis and elimination of possible causes are important in order to avoid permanent visual or brain injury. Imaging (especially MRI) should be carried out in eclamptic patients with visual disturbance in order to exclude other causes of blindness. Molar pregnancy is a rare but important cause of eclampsia, and it has always to be considered in case of early manifestations.