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Background Improvements to autologous fat grafting for soft tissue augmentation are needed to overcome the unpredictable volume retention. Approaches such as fat harvesting and processing, injection technique, preparation of the recipient site, and supplemental biologics are topics of ongoing research. Here, an energy-based device was investigated as a stimulatory tool for recipient site preparation for improving fat graft retention. Objective The objective was to measure the stimulatory responses in fat grafts after 4 weeks when using a helium-based radiofrequency device to pretreat the recipient tissue. Methods Using an autologous fat grafting mouse model, the inguinal fat pad was grafted in a small cranial pocket after either a saline injection alone (control) or a saline injection followed by pretreatment (treated). The fat pad was resected after 4 weeks, sectioned and stained with immunofluorescence markers to investigate tissue remodeling. Results Pretreatment resulted in higher viability of adipocytes, a higher concentration of viable ASCs in areas of adipose tissue regeneration, and localized macrophages in the areas of regeneration when compared to the control. There was no observable difference in vascularity or angiogenesis. The staining for ASCs was higher in the pretreated group in comparison with the control group (5.0% vs. 3.3%, p=0.36) when using a pixel classifier in QuPath in the viable adipose tissue regions. Conclusions The use of a helium-based radiofrequency device as a pretreatment tool appears to increase the viability of the adipose tissue likely due to higher concentration of ASCs. The apparent increase in viable ASCs may be due to enhanced proliferation or paracrine recruitment of these cells in response to the helium-based radiofrequency treatment. No Level Assigned This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 . Bullet List of Important Points: Pretreatment of the fat graft recipient site increases the viability of the adipose tissue after 4 weeks in comparison with the control grafts. The increased viability is likely due to the observed increase in adipose-derived stem cells in the pretreated group. Pretreatment enhanced the adipose tissue remodeling as colocalization of adipose-derived stem cells and macrophages showed an active remodeling, whereas the control group exhibited more necrotic and fibrotic tissue.

The anti-EGFR monoclonal antibodies panitumumab and cetuximab are effective in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer. We assessed the efficacy and toxicity of panitumumab versus cetuximab in these patients. For this randomised, open-label, phase 3 head-to-head study, we enrolled patients (from centres in North America, South America, Europe, Asia, Africa, and Australia) aged 18 years or older with chemotherapy-refractory metastatic colorectal cancer, an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less, and wild-type KRAS exon 2 status. Using a computer-generated randomisation sequence, we assigned patients (1:1; stratified by geographical region and ECOG performance status, with a permuted block method) to receive panitumumab (6 mg/kg once every 2 weeks) or cetuximab (initial dose 400 mg/m2; 250 mg/m2 once a week thereafter). The primary endpoint was overall survival assessed for non-inferiority (retention of ≥50% of the cetuximab treatment effect; historical hazard ratio [HR] for cetuximab plus best supportive care vs best supportive care alone of 0·55). The primary analysis included patients who received one or more dose of panitumumab or cetuximab, analysed per allocated treatment. Recruitment for this trial is closed. The trial is registered with ClinicalTrials.gov, number NCT01001377. Between Feb 2, 2010, and July 19, 2012, we enrolled and randomly allocated 1010 patients, 999 of whom began study treatment: 499 received panitumumab and 500 received cetuximab. For the primary analysis of overall survival, panitumumab was non-inferior to cetuximab (Z score −3·19; p=0·0007). Median overall survival was 10·4 months (95% CI 9·4–11·6) with panitumumab and 10·0 months (9·3–11·0) with cetuximab (HR 0·97; 95% CI 0·84–1·11). Panitumumab retained 105·7% (81·9–129·5) of the effect of cetuximab on overall survival seen in this study. The incidence of adverse events of any grade and grade 3–4 was similar across treatment groups. Grade 3–4 skin toxicity occurred in 62 (13%) patients given panitumumab and 48 (10%) patients given cetuximab. The occurrence of grade 3–4 infusion reactions was lower with panitumumab than with cetuximab (one [<0·5%] patient vs nine [2%] patients), and the occurrence of grade 3–4 hypomagnesaemia was higher in the panitumumab group (35 [7%] vs 13 [3%]). We recorded one treatment-related fatal adverse event: a lung infection in a patient given cetuximab. Our findings show that panitumumab is non-inferior to cetuximab and that these agents provide similar overall survival benefit in this population of patients. Both agents had toxicity profiles that were to be expected. In view of the consistency in efficacy and toxicity seen, small but meaningful differences in the rate of grade 3–4 infusion reactions and differences in dose scheduling can guide physician choice of anti-EGFR treatment. Amgen Inc.

Previous trials have shown that the combination of fluorouracil-based chemotherapy and cetuximab is active when used as salvage treatment in patients with metastatic colorectal cancer; the present trial shows activity of this combination as first-line treatment as well. The trial also found that for cetuximab to be active, an unmutated KRAS gene in the tumor was required. This trial shows activity of the combination of fluorouracil-based chemotherapy and cetuximab as first-line treatment. The trial also found that for cetuximab to be active, an unmutated KRAS gene in the tumor was required. Colorectal cancer is the third most common cancer worldwide. 1 Approximately 25% of patients with colorectal cancer present with overt metastatic disease, and metastatic disease develops in 40 to 50% of newly diagnosed patients. Standard first-line treatments include fluorouracil with leucovorin and irinotecan 2 , 3 or oxaliplatin, 4 alone or combined with bevacizumab. 5 The immunoglobulin G1 monoclonal antibody against the epidermal growth factor receptor (EGFR), cetuximab (Erbitux), is effective in combination with irinotecan in patients with metastatic colorectal cancer or as a single agent in patients with metastatic colorectal cancer that progresses even when irinotecan is used. 6 , 7 Phase 1 and 2 studies . . .

This paper examines the practice of using a helium plasma radiofrequency (RF) device for contracting subcutaneous soft tissue following liposuction in all body areas. A review of the data from 6 industry-sponsor-initiated retrospective studies was performed, wherein 483 real-world patients underwent liposuction followed by contraction of the subcutaneous soft tissue with the helium plasma RF system. These data were evaluated to determine if any new or increased risks were introduced compared to the risks of liposuction alone. The totality of the real-world data demonstrates there are no new or increased risks for helium plasma RF procedures following liposuction compared to liposuction alone. These data support the safety of helium plasma RF for subcutaneous soft-tissue contraction following liposuction. There are currently no alternative therapies specifically cleared by the FDA that can claim use following liposuction for the purpose of contracting the subcutaneous soft tissue. Level of Evidence: 3

Reported breast cancer incidence is rising in South Africa, where some women are diagnosed late and have poor outcomes. We studied patient and provider factors associated with clinical stage at diagnosis among women diagnosed at the Chris Hani Baragwanath Academic Hospital in Soweto, Johannesburg in 2015-2016. From face-to-face interviewer-administered questionnaires we compared self-reported socioeconomics, demographics, comorbidities, risk factors, personal and health system barriers, and from patient clinical records, clinical staging, receptor subtype, and tumor grade among 499 consecutive women newly diagnosed with advanced stage (III/IV) breast cancer versus those diagnosed early (stage 0/I/II). Logistic regression models were used to identify factors associated with advanced stage at diagnosis. Among the women, 243 (49%) were diagnosed at early and 256 (51%) at advanced stages. In the multiple logistic regression adjusted model, completion of high school or beyond (odds ratio (OR) 0.59, and greater breast cancer knowledge and awareness (OR 0.86) were associated with lower stage of breast cancer at presentation. Advanced stage was associated with Luminal B (OR 2.25) and triple-negative subtypes (OR 3.17) compared to luminal A, with delays >3 months from first breast symptoms to accessing the health system (OR 2.79) and with having more than 1 visit within the referral health system (OR 3.19) for 2 visits; OR 2.73 for ≥3 visits). Limited patient education, breast cancer knowledge and awareness, and health system inefficiencies were associated with advanced stage at diagnosis. Sustained community and healthcare worker education may down-stage disease and improve cancer outcomes.

Intravenous pembrolizumab 400 mg every 6 weeks was approved across tumor types based on pharmacokinetic modeling, which showed exposures consistent with previous standard dosing of 200 mg or 2 mg/kg every 3 weeks, and early results of cohort B of the phase 1 KEYNOTE-555 study. Results after ≥1 year of potential follow-up for all patients in cohort B of KEYNOTE-555 are presented. Patients aged ≥18 years with previously untreated stage III/IV melanoma received pembrolizumab 400 mg every 6 weeks for ≤18 cycles. The primary endpoint was objective response rate per RECIST v1.1 by blinded independent central review. Secondary endpoints included duration of response, progression-free survival, pharmacokinetics, and safety. Overall, 101 patients received pembrolizumab. Median projected follow-up was 21.9 months (range, 17.0–25.7). The objective response rate was 50.5% (95% CI: 40.4–60.6; 19 complete responses, 32 partial responses). Median duration of response was not reached (NR; range, 2.4+ to 21.0+ months). Median progression-free survival was 13.8 months (95% CI: 4.1–NR). Observed pharmacokinetic exposures were consistent with model predictions for pembrolizumab 400 mg every 6 weeks and other approved and tested schedules (2 mg/kg or 200 mg every 3 weeks). Grade 3–4 treatment-related adverse events occurred in 13 patients (12.9%). No deaths were considered treatment related. These results support the pharmacokinetic modeling and demonstrate that the benefit-risk profile of pembrolizumab 400 mg Q6W is consistent with that of 200 mg or 2 mg/kg every 3 weeks. Clinically meaningful objective response rate and durable progression-free survival within the expected range for first-line pembrolizumab were observed. Clinical trial registry: ClinicalTrials.gov, NCT03665597 .

Background The introduction of medical advancements requires ongoing critical evaluation of clinical practice and patient outcomes to improve results and safety. Since the development of minimally invasive, energy-based devices, this process has been occurring throughout the field of aesthetic medicine. Objectives To collect retrospective procedure and safety data of liposuction procedures with or without adjunct utilization of a helium-based plasma device, compare 3 groups, and delineate the learning curve. Methods A retrospective chart review at a single site included healthy patients ≥18 years of age treated by the principal investigator (PI). A total of 50 patients had an ultrasonic-assisted liposuction procedure, 50 patients had a liposuction procedure with the utilization of the helium-based plasma device, and 50 of the PI's most recent patients had a liposuction procedure with the utilization of the helium-based plasma device. All patients had at least 6 months of documented postoperative follow-up care. Results Totally, 150 patients were enrolled in the study. Most patients had multiple body areas treated, primarily hips and abdomen. Treatment settings varied, with significant relationships found between pain and treatment groups (P = .013). No serious or unexpected adverse events (AEs) were reported, and all AE resolved before the final follow-up. Conclusions The data collected support that patient outcomes and safety improve with continued use of the helium-based plasma device by the PI. The data also support the use of a helium-based plasma device as safe when used in combination with liposuction procedures. Level of Evidence: 4 (Therapeutic)

Lung cancer is the highest incident cancer globally and is associated with significant morbidity and mortality particularly if identified at a late stage. Poor patient outcomes in low- and middle-income countries (LMIC's) might reflect contextual patient and health system constraints at multiple levels, that act as barriers to prevention, disease recognition, diagnosis, and treatment. Lung cancer screening, even for high-risk patients, is not available in the public health sector in South Africa (SA), where the current HIV and tuberculosis (TB) epidemics often take precedence. Yet, there has been no formal assessment of the individual and health-system related barriers that may delay patients with lung cancer from seeking and accessing help within the public health care system and receiving the appropriate and effective diagnosis and treatment. This study aimed to derive consensus from health-system stakeholders in the urban Gauteng Province of SA on the most important challenges faced by the health services and patients in achieving optimum lung cancer management and to identify potential solutions. The study was undertaken among 27 participant stakeholders representing clinical managers, clinicians, opinion leaders from the public health sector and non-governmental organisation (NGO) representatives. The study compromised two components: consensus and engagement. For the consensus component, the Delphi Technique was employed with open-ended questions and item ranking from five rounds of consensus-seeking, to achieve collective agreement on the most important challenges faced by patients and the health services in achieving optimal lung cancer management. For the engagement component, the Nominal Group Technique was used to articulate ideas and reach an agreement on the group's recommendations for solution strategies and approaches. Public health sector stakeholders suggested that a lack of knowledge and awareness of lung cancer, and the apparent stigma associated with the disease and its risk factors, as well as symptoms and signs, are critical to treatment delay. Furthermore, delays in up-referral of patients with suspected lung cancer from district health care level were attributed to inadequate knowledge arising from a lack of in-service training of nurses and doctors regarding oncologic symptoms, risk factors, need for further investigation, interpretation of x-rays and available treatments. At a tertiary level, participants suggested that insufficient availability of specialised diagnostic resources (imaging, cytological and pathological services including biomolecular assessment of lung cancer), theatres, cardiothoracic surgeons, and appropriate therapeutic modalities (chemotherapeutic agents and radiation oncology) are the main barriers to the provision of optimal care. It was suggested that a primary prevention programme initiated by the government that involves private-public partnerships may improve lung cancer management nationally. Considerable barriers to the early identification and treatment of lung cancer exist. Finding solutions to overcome both individual and health-system level obstacles to lung cancer screening and management are vital to facilitate early identification and treatment, and to improve survival. Furthermore, research on inexpensive biomarkers for asymptomatic disease detection, the introduction of diagnostic imaging tools that utilise artificial intelligence to compensate for inadequate human resources and improving clinical integration across all levels of the healthcare system are essential.

Background Cancer is one of the major risk factors for venous thromboembolism (VTE). The prevalence of incidental VTE among cancer patients in South Africa is unknown. Aim To determine the presence and location of VTE, find out if VTE is more common in certain cancer types, and to determine the role of human immunodeficiency virus (HIV) in the incidental finding of VTE among cancer patients. Setting This study was conducted at the Radiology Department at the Charlotte Maxeke Johannesburg Academic Hospital located in Johannesburg, South Africa. Methods There were 214 staging computed tomography (CT) scans of eligible adult cancer patients from January 2018 to June 2018. These were identified using a picture archiving and communication system (PACS) and analysed retrospectively by three consultant radiologists. Univariate analysis and multivariable logistic regression models were used to investigate associations between VTE and HIV, age, gender, ethnicity and common cancers. Results The mean age was 53 years (standard deviation [s.d.] 13.98) with the age range being 18–86 years, and 64% of these patients were female. Incidental VTE was 14.9% (95% confidence interval [CI] 10.7% – 20.4%). Pulmonary embolism (PE) accounted for 11.2%, while abdominal deep vein thrombosis (ADVT) accounted for 3.7%. Moreover, HIV-positive cancer patients were three times more likely to have VTE compared to HIV-negative cancer patients, with adjusted odds’ ratio 3.2 (1–10), p = 0.04. There was no association found between cancer type and VTE. Conclusion This study revealed cancer and HIV infection as risk factors for patients developing VTE. Pulmonary embolism was more common than ADVT. Actively search for VTE in cancer patients when reviewing staging CT scans. Contribution This is the first research in South Africa to determine the prevalence of incidental VTE among cancer patients.