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Evofosfamide is a hypoxia-activated prodrug of bromo-isophosphoramide mustard. We aimed to assess the benefit of adding evofosfamide to doxorubicin as first-line therapy for advanced soft-tissue sarcomas. We did this international, open-label, randomised, phase 3, multicentre trial (TH CR-406/SARC021) at 81 academic or community investigational sites in 13 countries. Eligible patients were aged 15 years or older with a diagnosis of an advanced unresectable or metastatic soft-tissue sarcoma, of intermediate or high grade, for which no standard curative therapy was available, an Eastern Cooperative Oncology Group performance status of 0–1, and measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1. Patients were randomly assigned (1:1) to receive doxorubicin alone (75 mg/m2 via bolus injection administered over 5–20 min or continuous intravenous infusion for 6–96 h on day 1 of every 21-day cycle for up to six cycles) or doxorubicin (given via the same dose procedure) plus evofosfamide (300 mg/m2 intravenously for 30–60 min on days 1 and 8 of every 21-day cycle for up to six cycles). After six cycles of treatment, patients in the single-drug doxorubicin group were followed up expectantly whereas patients with stable or responsive disease in the combination group were allowed to continue with evofosfamide monotherapy until documented disease progression. A web-based central randomisation with block sizes of two and four was stratified by extent of disease, doxorubicin administration method, and previous systemic therapy. Patients and investigators were not masked to treatment assignment. The primary endpoint was overall survival, analysed in the intention-to-treat population. Safety analyses were done in all patients who received any amount of study drug. This study was registered with ClinicalTrials.gov, number NCT01440088. Between Sept 26, 2011, and Jan 22, 2014, 640 patients were enrolled and randomly assigned to a treatment group (317 to doxorubicin plus evofosfamide and 323 to doxorubicin alone), all of whom were included in the intention-to-treat analysis. The overall survival endpoint was not reached (hazard ratio 1·06, 95% CI 0·88–1·29; p=0·527), with a median overall survival of 18·4 months (95% CI 15·6–22·1) with doxorubicin plus evofosfamide versus 19·0 months (16·2–22·4) with doxorubicin alone. The most common grade 3 or worse adverse events in both groups were haematological, including anaemia (150 [48%] of 313 patients in the doxorubicin plus evofosfamide group vs 65 [21%] of 308 in the doxorubicin group), neutropenia (47 [15%] vs 92 [30%]), febrile neutropenia (57 [18%] vs 34 [11%]), leucopenia (22 [7%] vs 17 [6%]), decreased neutrophil count (31 [10%] vs 41 [13%]), and decreased white blood cell count (39 [13%] vs 33 [11%]). Grade 3–4 thrombocytopenia was more common in the combination group (45 [14%]) than in the doxorubicin alone group (four [1%]), as was grade 3–4 stomatitis (26 [8%] vs seven [2%]). Serious adverse events were reported in 145 (46%) of 313 patients in the combination group and 99 (32%) of 308 in the doxorubicin alone group. Five (2%) patients died from treatment-related causes in the combination group (sepsis [n=2], septic shock [n=1], congestive cardiac failure [n=1], and unknown cause [n=1]) versus one (<1%) patient in the doxorubicin alone group (lactic acidosis [n=1]). The addition of evofosfamide to doxorubicin as first-line therapy did not improve overall survival compared with single-drug doxorubicin in patients with locally advanced, unresectable, or metastatic soft-tissue sarcomas and so this combination cannot be recommended in this setting. Threshold Pharmaceuticals.

Objectives To assess the feasibility, safety and preliminary efficacy of magnetic resonance-guided focused ultrasound (MRgFUS) for the treatment of extra-abdominal desmoid tumours. Methods Fifteen patients with desmoid fibromatosis (six males, nine females; age range, 7–66 years) were treated with MRgFUS, with seven patients requiring multiple treatments (25 total treatments). Changes in viable and total tumour volumes were measured after treatment. Efficacy was evaluated using an exact one-sided Wilcoxon test to determine if the median reduction in viable tumour measured immediately after initial treatment exceeded a threshold of 50 % of the targeted volume. Median decrease after treatment of at least two points in numerical rating scale (NRS) worst and average pain scores was tested with an exact one-sided Wilcoxon test. Adverse events were recorded. Results After initial MRgFUS treatment, median viable targeted tumour volume decreased 63 %, significantly beyond our efficacy threshold ( P  = 0.0013). Median viable total tumour volume decreased (105 mL [interquartile range {IQR}, 217 mL] to 54 mL [IQR, 92 mL]) and pain improved (worst scores, 7.5 ± 1.9 vs 2.7 ± 2.6, P  = 0.027; average scores, 6 ± 2.3 vs 1.3 ± 2, P  = 0.021). Skin burn was the most common complication. Conclusions MRgFUS significantly and durably reduced viable tumour volume and pain in this series of 15 patients with extra-abdominal desmoid fibromatosis. Key Points • Retrospective four-centre study shows MRgFUS safely and effectively treats extra-abdominal desmoid tumours • This non-invasive procedure can eradicate viable tumour in some cases • Alternatively, MRgFUS can provide durable control of tumour growth through repeated treatments • Compared to surgery or radiation, MRgFUS has relatively mild side effects

Background Whether current postoperative surveillance regimes result in improved overall survival (OS) of patients with extremity sarcomas is unknown. Questions/purposes We hypothesized that a less intensive followup protocol would not be inferior to the conventional followup protocol in terms of OS. We (1) assessed OS of patients to determine if less intensive followup regimens led to worsened survival and asked (2) whether chest radiograph followup group was inferior to CT scan followup group in detecting pulmonary metastasis; and (3) whether less frequent (6-monthly) followup interval was inferior to more frequent (3-monthly) followup in detecting pulmonary metastasis and local recurrence. Methods A prospective randomized single-center noninferiority trial was conducted between January 2006 and June 2010. On the basis of 3-year survival of 60% with intensive, more frequent followup, 500 nonmetastatic patients were randomized to demonstrate noninferiority by a margin (delta) of 10% (hazard ratio [HR], 1.36). The primary end point was OS at 3 years. The secondary objective was to compare disease-free survival (DFS) (time to recurrence) at 3 years. At minimum followup of 30 months (median, 42 months; range, 30–81 months), 178 deaths were documented. Results Three-year OS and DFS for all patients was 67% and 52%, respectively. Three-year OS was 67% and 66% in chest radiography and CT groups, respectively (HR, 0.9; upper 90% confidence interval [CI], 1.13). DFS rate was 54% and 49% in chest radiography and CT groups, respectively (HR, 0.82; upper 90% CI, 0.97). Three-year OS was 64% and 69% in 6-monthly and 3-monthly groups, respectively (HR, 1.2; upper 90% CI, 1.47). DFS was 51% and 52% in 6-monthly and 3-monthly groups, respectively (HR, 1.01; upper 90% CI, 1.2). Almost 90% of local recurrences were identified by patients themselves. Conclusions Inexpensive imaging detects the vast majority of recurrent disease in patients with sarcoma without deleterious effects on eventual outcomes. Patient education regarding self-examination will detect most instances of local recurrence although this was not directly assessed in this study. Although less frequent visits adequately detected metastasis and local recurrence, this trial could not conclusively demonstrate noninferiority in OS for a 6-monthly interval of followup visits against 3-monthly visits. Level of Evidence Level I, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Background Successfully restoring facial contours continues to pose a significant challenge for surgeons. This study aims to utilize head-mounted display-based augmented reality (AR) navigation technology for facial soft tissue defect reconstruction and to evaluate its accuracy and effectiveness, exploring its feasibility in craniofacial surgery. Methods Hololens 2 was utilized to construct the AR guidance system for facial fat grafting. Twenty artificial cases with facial soft tissue defects were randomly assigned to Group A and Group B, undergoing filling surgeries with the AR guidance system and conventional methods, respectively. All postoperative three-dimensional models were superimposed onto virtual plans to evaluate the accuracy of the system versus conventional filling methods. Additionally, procedure completion time was recorded to assess system efficiency relative to conventional methods. Results The error in facial soft tissue defect reconstruction assisted by the system in Group A was 2.09 ± 0.56 mm, significantly lower than the 3.23 ± 1.15 mm observed with conventional methods in Group B ( p  < 0.05). Additionally, the time required for facial defect filling reconstruction using the system in Group A was 25.45 ± 2.58 min, markedly shorter than the 37.05 ± 3.34 min needed with conventional methods in Group B ( p  < 0.05). Conclusion The visual navigation offered by the fat grafting AR guidance system presents obvious advantages in facial soft tissue defect reconstruction, facilitating enhanced precision and efficiency in these filling procedures.

Facial soft tissue injuries, often resulting in scarring, pose a challenge in reconstructive and aesthetic surgery due to the need for functional and aesthetic restoration. This study evaluates the efficacy of recombinant human growth factors (rhGFs) in scar remodelling for such injuries. A retrospective evaluation was conducted from January 2020 to January 2023, involving 100 patients with facial soft tissue injuries. Participants were divided equally into a control group, receiving standard cosmetic surgical repair, and an observation group, treated with rhGFs supplemented cosmetic surgery. The study assessed scar characteristics (pigmentation, pliability, vascularity, height), hospital stay duration, tissue healing time, complication rates and patient satisfaction. The observation group demonstrated significant improvements in all scar characteristics, with notably better pigmentation, pliability, vascularity and height compared with the control group. The rhGF treatment also resulted in reduced hospital stay duration and faster tissue healing. Notably, the total complication rate was significantly lower in the observation group (10%) compared with the control group (34%). Additionally, patient satisfaction levels were higher in the observation group, with 98% combined satisfaction compared with 76% in the control group. The application of rhGFs in treating facial soft tissue injuries significantly enhances scar remodelling, expedites healing, reduces complications and improves patient satisfaction. These findings establish rhGFs as a valuable tool in the management of facial soft tissue injuries, highlighting their potential in improving both functional and aesthetic outcomes.

Objective The surgical team in this study examined the efficacy of a modified reverse sural neurocutaneous flap repair in treating soft tissue defects of the ankle and foot caused by accidents. Methods This study enrolled 89 patients treated for soft tissue defects of the ankle or foot between January 2007 and December 2023. The patients were divided into two groups: 44 patients underwent a modified reverse sural neurocutaneous flap repair, while 45 received traditional treatment. The modified technique involved repairing various anatomical structures, including fascia, the saphenous nerve, the great saphenous vein, subcutaneous tissue, and skin, with flap sizes ranging from 14 to 152 cm². In the traditional treatment group, the distal perforator of the peroneal artery was identified 5 cm above the lateral malleolus. Island fasciocutaneous flaps were designed along the sural nerve and lesser saphenous vein, elevated subfascially, rotated 180 degrees, and inset without tension. Donor sites were closed with grafts or direct sutures. Results Of the 44 patients, who underwent the modified technique, 35 were male and 9 were female. Follow-up periods ranged from 2 to 24 weeks to monitor outcomes and recovery. The average size of the affected soft tissue was 71 cm 2 . Thirty-nine flaps survived completely, while three experienced partial necrosis and two had marginal necrosis. No cases of severe venous congestion were reported. The complication rate was lower with the modified method compared to the traditional repair ( p  < 0.05). Conclusion The modified reverse neurocutaneous flap repair is a reliable and structured approach to treating soft tissue defects of the ankle and foot. This method has demonstrated favorable patient outcomes and presents a promising avenue for future studies and clinical practice.

MR imaging appearances of different types of reconstructive muscle flaps following reconstructive surgery of the lower extremity with associated post-surgical changes due to altered anatomy, radiation, and potential complications, can be challenging. A multidisciplinary therapeutic approach to tumors allows for limb salvage therapy in a majority of the patients. Decision-making for specific types of soft tissue reconstruction is based on the body region affected, as well as the size and complexity of the defect. Hematomas and infections are early complications that can jeopardize flap viability. The local recurrence of a tumor within six months after a complete resection with confirmed tumor-free margins and adjuvant radiation therapy is rare. Identification of a new lesion similar to the initial tumor favors a finding of tumor recurrence.

BACKGROUND: The treatment of hand soft tissue defects primarily relies on flap reconstruction. However, traditional venous/arterial free flaps have several disadvantages, including damage to the donor site, blood stasis, cyanosis, blister formation, and even necrosis. These issues can significantly affect patient recovery and outcomes. Therefore, there is a need for alternative approaches that minimize these complications and improve overall patient treatment. OBJECTIVES: To compare the efficacy of medial tarsal free venous flaps and traditional venous/arterial free flaps in the reconstruction of hand soft tissue defects, by evaluating various clinical outcomes and patient recovery metrics. MATERIALS AND METHODS: We screened 30 suitable patients with hand soft tissue defects and randomly assigned them to three groups. Patients in each group were transplanted with either medial tarsal free venous flaps or traditional arterial/venous free flaps to achieve coverage and reconstruction of the soft tissue defects. The results were compared and analyzed using the following metrics: operation time, complication rate, pain index, postoperative infection rate, and functional evaluations of both the donor and recipient areas. RESULTS: There was no significant difference in operation time between the medial tarsal free venous flaps and the traditional forearm free venous flaps. The operative time of both types of flaps above was shorter than that of the traditional fibular-side arterial flap of the hallux. The complication rate of the medial tarsal free venous flaps was comparable to that of the fibular-side arterial flaps from the great toes and significantly lower than that of the traditional forearm free venous flaps. In terms of pain, the pain index for the medial tarsal free venous flaps was significantly lower than that of the fibular-side arterial flap from the hallux and comparable to that of the forearm free venous flaps. Regarding postoperative infection rates, the forearm free venous flaps had the highest rate, while there was no significant difference between the medial tarsal free venous flaps and the fibular-side arterial flaps from the great toes. The functional recovery of the medial tarsal free venous flaps was outstanding in both the donor and recipient areas. There was no poor functional performance in the donor areas of the forearm free venous flaps or the recipient areas of the fibular-side arterial flaps of the halluces. CONCLUSIONS: The medial tarsal free venous flaps effectively avoid the disadvantages of traditional venous and arterial free flaps, combining their advantages. This kind of flaps offer shorter operative times, and lower pain indices. They also provide excellent functional recovery in both donor and recipient areas. Thus, medial tarsal free venous flaps represent an ideal solution for reconstructing hand soft tissue defects.

This study investigated the impact of the flap vascular pressurization technique on repairing large-area soft tissue defects in the limbs. This study employed a randomized controlled trial design to enroll patients with large-area skin defects in the limbs, accompanied by exposed deep tissues such as nerves, blood vessels, bones, and tendons, for various reasons between July 2020 to July 2022. The patients were randomly assigned into two groups using a random number table method. The control group (n = 30) underwent traditional anterior lateral thigh flap repair, while the experimental group (n = 30) underwent flap repair using the vascular pressurization technique. Clinical indicators, flap survival, scar formation, and satisfaction were compared between the two groups. There were no significant differences in operation time, intraoperative blood loss, and length of hospital stay between the two groups (P > .05). The flap survival rate in the experimental group (90.00%, 27/30) was significantly higher than that in the control group (66.67%, 20/30) (P < .05). The Manchester Scar Scale (MSS) scores in the experimental group were significantly higher than those in the control group (P < .05). The satisfaction rate in the experimental group (93.33%, 28/30) was significantly higher than that in the control group (73.33%, 22/30) (P < .05). The use of the flap vascular pressurization technique for the repair of soft tissue defects in the limbs can significantly increase flap survival rate, improve scar formation, and enhance patient satisfaction, thereby demonstrating good clinical value. The flap vascular pressurization technique can be promoted as a reliable method for repairing large-area skin defects in the limbs, thereby contributing to the advancement of specialized fields.