Publications by authors named "Davide Maria Donati"

84 Publications

Porous tantalum acetabular cups for reconstructions after peri-acetabular resections of primary bone tumours.

Hip Int 2021 Apr 8:11207000211001552. Epub 2021 Apr 8.

IRCCS Policlinico di Sant'Orsola, Bologna, Italy.

Introduction: Periacetabular reconstruction after resection of primary bone tumour is a very demanding procedure. They are frequently associated with scarce functional results and a high rate of complications. We report a series of patients with periacetabular resections for primary bone tumours and reconstruction with a porous tantalum (PT) acetabular cup (AC).

Materials And Methods: 27 patients (median age 30 years) were included, being affected by primary bone tumours of the pelvis and treated with peri-acetabular resection and reconstruction with a PT AC. The diagnoses were 13 osteosarcomas, 7 chondrosarcomas and 7 Ewing sarcomas. Function was assessed with the Harris Hip Score and complications were classified according to Zeifang.

Results: The median follow-up was 70 months. 1 patient required removal of the PT AC because of implant associated infection 55 months after surgery. There was 1 hip dislocation and no case of aseptic loosening. At final follow-up, the median HHS was 81 points (range 48-92).

Conclusions: The used PT AC had good medium-term survival rates and good functional results. This technique is a viable reconstructive option after resections of periacetabular primary bone sarcomas.
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http://dx.doi.org/10.1177/11207000211001552DOI Listing
April 2021

The role of imaging in computer assisted tumor surgery of the sacrum and pelvis.

Curr Med Imaging 2021 Mar 2. Epub 2021 Mar 2.

IRCCS Policlinico di Sant'Orsola, Bologna. Italy.

The use of a navigation system allows precise resection of a tumor and accurate reconstruction of the resultant defect thereby sparing important anatomical structures and preserving function. It is an "image-based" system where the imaging (computed tomography and magnetic resonance imaging) is required to supply the software with data. The fusion of the preoperative imaging provides pre-operative information about local anatomy and extent of the tumor, so that it allows an accurate preoperative planning. Accurate pre-operative imaging is mandatory in order to minimize CATS errors, thus performing accurate tumor resections.
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http://dx.doi.org/10.2174/1573405617666210303105735DOI Listing
March 2021

What Is the Survival of the Telescope Allograft Technique to Augment a Short Proximal Femur Segment in Children After Resection and Distal Femur Endoprosthesis Reconstruction for a Bone Sarcoma?

Clin Orthop Relat Res 2021 Feb 26. Epub 2021 Feb 26.

S. Hindiskere, Department of Musculoskeletal Oncology, HCG Hospital, Bangalore, India.

Background: Large, malignant bone tumors and revision limb salvage procedures often result in the resection of extensive lengths of the involved bone segment, leaving a residual segment of bone that may be too short to support a standard intramedullary stem for endoprosthetic reconstruction. Telescope allografting, in which an allograft is used to augment the remaining bone segment by telescoping it into the residual bone segment, was described for situations in which residual bone stock is insufficient after tumor resection or prosthetic revision. Apart from one study that first described the procedure [15], there are no other studies reporting the outcome of this telescopic concept for restoring bone stock.

Questions/purposes: For patients younger than 18 years who underwent the telescopic allograft technique to augment a short segment of the proximal femur after resection of bone sarcomas who also underwent endoprosthesis reconstruction of the distal femur, we asked: (1) What is the survivorship free from removal of the telescopic allograft and the endoprosthetic stem at 7 years after surgery? (2) What proportion of these reconstructions will heal to the host bone without delayed union or nonunion? (3) What is the functional outcome based on the Musculoskeletal Tumor Society (MSTS) score?

Methods: We retrospectively studied our institutional database and identified 127 patients younger than 18 years who underwent surgery for a primary malignant bone tumor of the distal femur between December 2008 and October 2018. After excluding 16 patients undergoing amputation and rotationplasty and 57 patients undergoing recycled autograft/allograft reconstruction, 54 patients who underwent primary or revision distal femur endoprosthesis reconstruction were identified. Among these patients, we considered 15 patients who underwent telescopic allograft augmentation of the femur for analysis. One patient was lost to follow-up before 2 years but was not known to have died, leaving 14 for analysis at a median (range) 49 months (24 to 136 months) of follow-up. The indications for telescopic allograft augmentation of the femur in our institution were a proximal femur length of less than 120 mm after resection or resection of more than two-thirds of the total length of the femur. Ten of 14 patients underwent telescopic allograft augmentation as a revision procedure (distal femur resorption in five patients, endoprosthesis stem loosening in three patients, implant fracture in one patient, and infection in one patient), and the remaining four patients underwent telescopic allograft augmentation as a primary limb salvage procedure for large malignant bone tumors of the distal femur. The histologic diagnosis in all patients was osteosarcoma. At the time of telescopic allograft augmentation and reconstruction, the median age of the patients was 14 years (7 to 18 years). The size and the type of bone allograft to be used (femoral shaft or proximal femur) was planned before surgery, with consideration of the extent of resection, level of osteotomy, diameter of the host bone at the osteotomy site, and approximate diameter of the endoprosthesis stem to be used. The segment of the cylindrical allograft used for telescoping was thoroughly washed, prepared, and impacted onto the native femur to achieve telescoping and overlap. Serial digital radiographs were performed once a month for the first 6 months after the procedure, every 2 months until 1 year, and then every 6 months thereafter. Two surgeons in the department (at least one of which was involved in the surgery) retrieved and reviewed clinical notes and radiographs to determine the status of the telescopic allograft and endoprosthesis stem. We defined delayed union as radiological union at the osteotomy site more than 6 months after the procedure without additional surgery; we defined nonunion as no radiological evidence of callus formation at the osteotomy site 9 months after the procedure, necessitating additional surgery. The reviewers did not disagree about the definition of healing time. None of the patients missed radiographic follow-up. Kaplan-Meier survivorship free from removal of telescopic allograft and the endoprosthesis stem at 7 years after surgery was estimated. Patient function was assessed using the 1993 version of the MSTS [9], as determined by chart review of the institutional database performed by one of the surgeons from the department.

Results: The survivorship free from removal of the telescopic allograft and endoprosthesis stem at 7 years after surgery was 80% (95% confidence interval 22% to 96%). The allograft united with the host bone in 100% (14 of 14) of the patients. Though 21% (3 of 14) had delayed union, no nonunions were seen. The median (range) MSTS score at the final follow-up interval was 27 (22 to 30).

Conclusion: Although this is a small group of patients, we believe that allograft segments help augment short bone stock of the proximal femur after long-segment resections, and the telescopic technique seems to be associated with a low proportion of nonunion or delayed union, which is one of the most common complications of allografts. Maintaining an adequate length of the proximal femur is important in preserving the hip, and this technique may be especially useful for young individuals who may undergo repeated revision procedures.

Level Of Evidence: Level IV, therapeutic study.
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http://dx.doi.org/10.1097/CORR.0000000000001686DOI Listing
February 2021

Computer Navigation and 3D Printing in the Surgical Management of Bone Sarcoma.

Cells 2021 Jan 20;10(2). Epub 2021 Jan 20.

Orthopaedic Oncology Surgeon, Royal Orthopaedic Hospital, Birmingham B15 2TT, UK.

The long-term outcomes of osteosarcoma have improved; however, patients with metastases, recurrence or axial disease continue to have a poor prognosis. Computer navigation in surgery is becoming ever more commonplace, and the proposed advantages, including precision during surgery, is particularly applicable to the field of orthopaedic oncology and challenging areas such as the axial skeleton. Within this article, we provide an overview of the field of computer navigation and computer-assisted tumour surgery (CATS), in particular its relevance to the surgical management of osteosarcoma.
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http://dx.doi.org/10.3390/cells10020195DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7909290PMC
January 2021

Does the Addition of a Vascularized Fibula Improve the Results of a Massive Bone Allograft Alone for Intercalary Femur Reconstruction of Malignant Bone Tumors in Children?

Clin Orthop Relat Res 2021 Jan 26. Epub 2021 Jan 26.

C. Errani, M. Colangeli, D. M. Donati, M. Manfrini, Orthopaedic Service, Musculoskeletal Oncology Department, Istituto di Ricerca e Cura a Carattere Scientifico, Istituto Ortopedico Rizzoli, Bologna, Italy.

Background: Massive bone allograft with or without a vascularized fibula is a potentially useful approach for femoral intercalary reconstruction after resection of bone sarcomas in children. However, inadequate data exist regarding whether it is preferable to use a massive bone allograft alone or a massive bone allograft combined with a vascularized free fibula for intercalary reconstructions of the femur after intercalary femur resections in children. Because the addition of a vascularized fibula adds to the time and complexity of the procedure, understanding more about whether it reduces complications and improves the function of patients who undergo these resections and reconstructions would be valuable for patients and treating physicians.

Questions/purposes: In an analysis of children with bone sarcomas of the femur who underwent an intercalary resection and reconstruction with massive bone allograft with or without a vascularized free fibula, we asked: (1) What was the difference in the surgical time of these two different surgical techniques? (2) What are the complications and number of reoperations associated with each procedure? (3) What were the Musculoskeletal Tumor Society scores after these reconstructions? (4) What was the survival rate of these two different reconstructions?

Methods: Between 1994 and 2016, we treated 285 patients younger than 16 years with a diagnosis of osteosarcoma or Ewing sarcoma of the femur. In all, 179 underwent resection and reconstruction of the distal femur and 36 patients underwent resection and reconstruction of the proximal femur. Additionally, in 70 patients with diaphyseal tumors, we performed total femur reconstruction in four patients, amputation in five, and a rotationplasty in one. The remaining 60 patients with diaphyseal tumors underwent intercalary resection and reconstruction with massive bone allograft with or without vascularized free fibula. The decision to use a massive bone allograft with or without a vascularized free fibula was probably influenced by tumor size, with the indication to use the vascularized free fibula in longer reconstructions. Twenty-seven patients underwent a femur reconstruction with massive bone allograft and vascularized free fibula, and 33 patients received massive bone allograft alone. In the group with massive bone allograft and vascularized fibula, two patients were excluded because they did not have the minimum data for the analysis. In the group with massive bone allograft alone, 12 patients were excluded: one patient was lost to follow-up before 2 years, five patients died before 2 years of follow-up, and six patients did not have the minimum data for the analysis. We analyzed the remaining 46 children with sarcoma of the femur treated with intercalary resection and biological reconstruction. Twenty-five patients underwent femur reconstruction with a massive bone allograft and vascularized free fibula, and 21 patients had reconstruction with a massive bone allograft alone. In the group of children treated with massive bone allograft and vascularized free fibula, there were 17 boys and eight girls, with a mean ± SD age of 11 ± 3 years. The diagnosis was osteosarcoma in 14 patients and Ewing sarcoma in 11. The mean length of resection was 18 ± 5 cm. The mean follow-up was 117 ± 61 months. In the group of children treated with massive bone allograft alone, there were 13 boys and eight girls, with a mean ± SD age of 12 ± 2 years. The diagnosis was osteosarcoma in 17 patients and Ewing sarcoma in four. The mean length of resection was 15 ± 4 cm. The mean follow-up was 130 ± 56 months. Some patients finished clinical and radiological checks as the follow-up exceeded 10 years. In the group with massive bone allograft and vascularized free fibula, four patients had a follow-up of 10, 12, 13, and 18 years, respectively, while in the group with massive bone allograft alone, five patients had a follow-up of 10 years, one patient had a follow-up of 11 years, and another had 13 years of follow-up. In general, there were no important differences between the groups in terms of age (mean difference 0.88 [95% CI -0.6 to 2.3]; p = 0.26), gender (p = 0.66), diagnosis (p = 0.11), and follow up (mean difference 12.9 [95% CI-22.7 to 48.62]; p = 0.46). There was a difference between groups regarding the length of the resection, which was greater in patients treated with a massive bone allograft and vascularized free fibula (18 ± 5 cm) than in those treated with a massive bone allograft alone (15 ± 4 cm) (mean difference -3.09 [95% CI -5.7 to -0.4]; p = 0.02). Complications related to the procedure like infection, neurovascular compromise, and graft-related complication, such as fracture and nonunion of massive bone allograft or vascularized free fibula and implant breakage, were analyzed by chart review of these patients by an orthopaedic surgeon with experience in musculoskeletal oncology. Survival of the reconstructions that had no graft or implant replacement was the endpoint. The Kaplan-Meier test was performed for a survival analysis of the reconstruction. A p value less than 0.05 was considered significant.

Results: The surgery was longer in patients treated with a massive bone allograft and vascularized free fibula than in patients treated with a massive bone allograft alone (10 ± 0.09 and 4 ± 0.77 hours, respectively; mean difference -6.8 [95% CI -7.1 to -6.4]; p = 0.001). Twelve of 25 patients treated with massive bone allograft and vascularized free fibula had one or more complication: allograft fracture (seven), nonunion (four), and infection (four). Twelve of 21 patients treated with massive bone allograft alone had the following complications: allograft fracture (five), nonunion (six), and infection (one). The mean functional results were 26 ± 4 in patients with a massive bone allograft and vascularized free fibula and 27 ± 2 in patients with a massive bone allograft alone (mean difference 0.75 [95% CI -10.6 to 2.57]; p = 0.39). With the numbers we had, we could not detect a difference in survival of the reconstruction between patients with a massive bone allograft and free vascularized fibula and those with a massive bone allograft alone (84% [95% CI 75% to 93%] and 87% [95% CI 80% to 94%], respectively; p = 0.89).

Conclusion: We found no difference in the survival of reconstructions between patients treated with a massive bone allograft and vascularized free fibula and patients who underwent reconstruction with a massive bone allograft alone. Based on this experience, our belief is that we should reconstruct these femoral intercalary defects with an allograft alone and use a vascularized fibula to salvage the allograft only if a fracture or nonunion occurs. This approach would have resulted in about half of the patients we treated not undergoing the more invasive, difficult, and risky vascularized procedure.Level of Evidence Level III, therapeutic study.
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http://dx.doi.org/10.1097/CORR.0000000000001639DOI Listing
January 2021

Is percutaneous injection of bone marrow concentrate, demineralized bone matrix and PRF an alternative to curettage and bone grafting for treating aneurysmal bone cyst?

J Tissue Eng Regen Med 2021 Mar 3;15(3):269-278. Epub 2021 Feb 3.

Orthopaedic and Traumatologic Clinic Prevalently Oncologic, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.

To determine the efficacy and safety of a single injection with autologous bone marrow concentrate (BMC) combined with demineralized bone matrix (DBM) and platelet-rich fibrin (PRF) compared to curettage and bone grafting for treating aneurysmal bone cysts (ABC). Two hundred thirty-nine patients were treated with curettage and bone grafting (Curettage Group), and 21 with percutaneous injection of DBM associated with autologous BMC and PRF (DBM + BMC + PRF Group). All patients attended the outpatient clinic to assess ABC healing and clinical results at the first 3, 6, 9 and 18 months after surgery and then annually in the absence of symptoms. The mean follow-up was 42 months for the Curettage Group (range 6-180 months) and 28 months for the DBM + BMC + PRF Group (range, 6-85 months). Out of the 21 patients who had injection with BMC, DBM, and PRF, 17 (80%) require no additional treatment and they were considered healed. Of the 239 patients treated with curettage and bone grafting after core needle or open biopsy, 177 (74%) were considered healed after the first treatment. Injection in comparison with curettage presented the same risk for local recurrence. The overall rate of local recurrence for all patients was 25%. Univariate and multivariate analyses showed a significant difference in local recurrence rates in patients younger than 15 years, and for the cyst located in the long bones of the lower limbs than the cyst located in the long bones of the upper limbs.
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http://dx.doi.org/10.1002/term.3175DOI Listing
March 2021

Upfront surgery is not advantageous compared to more conservative treatments such as observation or medical treatment for patients with desmoid tumors.

BMC Musculoskelet Disord 2021 Jan 5;22(1):12. Epub 2021 Jan 5.

Department of Orthopaedic Oncology, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136, Bologna, Italy.

Background: This study compared the clinical and functional outcomes of patients initially treated with observation or medical treatment with those of patients treated with local treatment (surgery alone or surgery with adjuvant radiotherapy) to confirm whether observation or medical treatment is an appropriate first-line management approach for patients with desmoid tumors.

Methods: We retrospectively reviewed the medical records of 99 patients with histologically confirmed primary desmoid tumors treated between 1978 and 2018. The median follow-up period was 57 months. We evaluated event-free survival, defined as the time interval from the date of initial diagnosis to the date of specific change in treatment strategy or recurrence or the last follow-up.

Results: An event (specific change in treatment strategy or recurrence) occurred in 28 patients (28.3%). No significant difference in event-free survival was found between the first-line observation/medical treatment and local treatment groups (p = 0.509). The median Musculoskeletal Tumor Society score of the patients treated with first-line local treatment was 29 (interquartile range [IQR], 23-30), whereas that of the patients managed with first-line observation or medical treatment was 21 (IQR, 19-29.5). First-line observation or medical treatment was more frequently chosen for larger tumors (p = 0.045). In the patients treated with local treatment, local recurrence was not related to the surgical margin (p = 0.976).

Conclusion: Upfront surgery is not advantageous compared to more conservative treatments such as observation or medical treatment for patients with desmoid tumors.
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http://dx.doi.org/10.1186/s12891-020-03897-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7784367PMC
January 2021

High Dose Ifosfamide in Relapsed and Unresectable High-Grade Osteosarcoma Patients: A Retrospective Series.

Cells 2020 10 31;9(11). Epub 2020 Oct 31.

Chemotherapy Unit, IRCCS Istituto Ortopedico Rizzoli, 40136 Bologna, Italy.

: The evidence on high-dose ifosfamide (HD-IFO) use in patients with relapsed osteosarcoma is limited. We performed a retrospective study to analyze HD-IFO activity. : Patients with osteosarcoma relapsed after standard treatment [methotrexate, doxorubicin, cisplatin +/- ifosfamide (MAP+/-I)] with measurable disease according to RECIST1.1 were eligible to ifosfamide (3 g/m/day) continuous infusion (c.i.) days 1-5 q21d. RECIST1.1 overall response rate (ORR) (complete response (CR) + partial response (PR)), progression-free survival at 6-month (6m-PFS), duration of response (DOR), and 2-year overall survival (2y-OS) were assessed. PARP1 expression and gene mutations were tested by immunohistochemistry and next-generation sequencing. : 51 patients were included. ORR was 20% (1 CR + 9 PR). Median DOR was 5 months (95%CI 2-7). Median PFS, 6m-PFS, OS, and 2y-OS were 6 months (95%CI 4-9), 51%, 15 months (10-19), and 30%, respectively. A second surgical complete remission (CR2) was achieved in 26 (51%) patients. After multivariate analysis, previous use of ifosfamide (HR 2.007, = 0.034) and CR2 (HR 0.126, < 0.001) showed a significant correlation with PFS and OS, respectively. No significant correlation was found between outcomes and PARP1 or gene mutations. : HD-IFO should be considered as the standard first-line treatment option in relapsed osteosarcoma and control arm of future trial in this setting.
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http://dx.doi.org/10.3390/cells9112389DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7692098PMC
October 2020

Innovative Options for Bone Metastasis Treatment: An Extensive Analysis on Biomaterials-Based Strategies for Orthopedic Surgeons.

Front Bioeng Biotechnol 2020 6;8:589964. Epub 2020 Oct 6.

Unit of Orthopaedic Pathology and Osteoarticular Tissue Regeneration, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.

Bone is the third most frequent site of metastasis, with a particular incidence in breast and prostate cancer patients. For example, almost 70% of breast cancer patients develop several bone metastases in the late stage of the disease. Bone metastases are a challenge for clinicians and a burden for patients because they frequently cause pain and can lead to fractures. Unfortunately, current therapeutic options are in most cases only palliative and, although not curative, surgery remains the gold standard for bone metastasis treatment. Surgical intervention mostly provides the replacement of the affected bone with a bioimplant, which can be made by materials of different origins and designed through several techniques that have evolved throughout the years simultaneously with clinical needs. Several scientists and clinicians have worked to develop biomaterials with potentially successful biological and mechanical features, however, only a few of them have actually reached the scope. In this review, we extensively analyze currently available biomaterials-based strategies focusing on the newest and most innovative ideas while aiming to highlight what should be considered both a reliable choice for orthopedic surgeons and a future definitive and curative option for bone metastasis and cancer patients.
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http://dx.doi.org/10.3389/fbioe.2020.589964DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7573123PMC
October 2020

MRI Features as Prognostic Factors in Myxofibrosarcoma: Proposal of MRI Grading System.

Acad Radiol 2020 Sep 11. Epub 2020 Sep 11.

Department of Orthopaedics, AOSP Sant'Orsola Malpighi, Bologna, Italy.

Rationale And Objectives: Myxofibrosarcoma (MFS) is a common soft tissue sarcoma in the elderly patients with both clinical and magnetic resonance imaging (MRI) peculiar features: very high recurrence rate, relatively low risk of distant metastases. On MRI it shows an infiltrative pattern ("tail sign") and high myxoid matrix content with water-like appearance on fluid-sensitive sequences. Due to these unusual characteristics, we propose a specific MRI grading system to stratify the risk of local recurrence (LR) and offer other prognostic information.

Materials And Methods: Two expert radiologists retrospectively and blindly reviewed preoperative MRI of 150 patients affected by MFS of the extremities treated at a single Institution. Myxoid matrix component and contrast enhancement of the tumor were evaluated and graded with a semiquantitative method. The presence of an infiltrative pattern, the depth of the tumor (deep and/or superficial) and tumor sizes were also recorded. MRI features were analyzed separately and correlated to LR risk, sarcoma specific survival and distant metastases rate. Then, according to the statistical significance of the correlation between MRI features and prognosis a 3-grade scoring system was proposed and evaluated to assess the risk of LR.

Results: Mean age was 66.1 ± 14.4 years; mean follow-up was 16 ± 28.3 months. The MRI features most associated with higher risk of LR resulted to be: lesion sizes (both volume and maximum diameter with a cut-off of 20 cm - p = 0.01), the "tail sign" (p = 0.045), and high myxoid matrix content with MRI water-like appearance (p = 0.0493). Ninety-four patients (94 of 150- 62.7%) were grade 1, 33 (22.0%) grade 2, and 23 (15.3%) grade 3. Interobserver agreement was substantial with K= 0.779 (95%CI 0.685-0.874). Higher grades of MRI grading system proposed were significantly associated with an increased LR risk, hazard ratio = 2.031 (95%CI 1.366-3.019; p < 0.001).

Conclusion: This is the largest series evaluating MRI features as prognostic factors for MFS. The MRI grading system proposed is significantly able to stratify the risk of LR in MFS of the extremities. The system is applicable to all the standard MRI studies protocols, might help in surgical planning, and may offer prognostic information.
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http://dx.doi.org/10.1016/j.acra.2020.08.018DOI Listing
September 2020

Silver-coated megaprosthesis in prevention and treatment of peri-prosthetic infections: a systematic review and meta-analysis about efficacy and toxicity in primary and revision surgery.

Eur J Orthop Surg Traumatol 2021 Feb 5;31(2):201-220. Epub 2020 Sep 5.

Azienda ospedaliera Sant'Orsola Malpighi, Bologna, Italy.

Aim: Prosthetic joint infection (PJI) is a common complication following orthopedic megaprosthetic implantations (EPR), estimated up to 50%. Silver coatings were introduced in order to reduce the incidence of PJI, by using the antibacterial activity of silver. Three different silver coatings are available: MUTARS (Implantcast), Agluna (Accentus Medical), PorAg (Waldemar Link). The aim of this review is to provide an overview on efficacy and safety of silver-coated EPR both in primary and revision surgery, comparing infection rate according to the type of implant.

Methods: Through an electronic systematic search, we reviewed the articles concerning silver-coated EPRs. Infection rate, silver-related complications, local and blood concentrations of the silver were evaluated. Meta-analyses were performed to compare results from each study included.

Results: Nineteen studies were included. The overall infection rate in patients with silver-coated implants was 17.6% (133/755). Overall infection rate in primary silver-coated EPR was been 9.2% (44/445), compared to 11.2% (57/507) of non-silver-coated implants. The overall infection rate after revisions was 13.7% (25/183) in patients with silver-coated EPR and 29.2% (47/161) when uncoated EPR were used, revealing a strength statistically significative utility of silver coatings in preventing infections in this group (p: 0.019). Generally, the use of MUTARS EPR had produced an almost constant decrease in the incidence of primary PJI but there are few data on the effectiveness in revisions. The results from the use of Agluna in both primary and revisions implants are inconstant. Conversely, PorAg had proven to be effective both in PJI prevention but, especially, when used in PJI revision settings. Local argyria was reported in 8 out of 357 patients (2.2%), while no systemic complications were described. Local and blood concentrations of silver were always reported very far to the threshold of toxicity, with the lowest concentration found using PorAg.

Conclusions: Silver-coated EPRs are safe and effective in reduction in PJI and re-infection rate, in particular when used in higher risk patients and after two-stage revisions to fight PJI.
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http://dx.doi.org/10.1007/s00590-020-02779-zDOI Listing
February 2021

Sarcoma European and Latin American Network (SELNET) Recommendations on Prioritization in Sarcoma Care During the COVID-19 Pandemic.

Oncologist 2020 10 23;25(10):e1562-e1573. Epub 2020 Sep 23.

Department of Medical Oncology, Centre León Bérard, Lyon, France.

Background: The COVID-19 outbreak has resulted in collision between patients infected with SARS-CoV-2 and those with cancer on different fronts. Patients with cancer have been impacted by deferral, modification, and even cessation of therapy. Adaptive measures to minimize hospital exposure, following the precautionary principle, have been proposed for cancer care during COVID-19 era. We present here a consensus on prioritizing recommendations across the continuum of sarcoma patient care.

Material And Methods: A total of 125 recommendations were proposed in soft-tissue, bone, and visceral sarcoma care. Recommendations were assigned as higher or lower priority if they cannot or can be postponed at least 2-3 months, respectively. The consensus level for each recommendation was classified as "strongly recommended" (SR) if more than 90% of experts agreed, "recommended" (R) if 75%-90% of experts agreed and "no consensus" (NC) if fewer than 75% agreed. Sarcoma experts from 11 countries within the Sarcoma European-Latin American Network (SELNET) consortium participated, including countries in the Americas and Europe. The European Society for Medical Oncology-Magnitude of clinical benefit scale was applied to systemic-treatment recommendations to support prioritization.

Results: There were 80 SRs, 35 Rs, and 10 NCs among the 125 recommendations issued and completed by 31 multidisciplinary sarcoma experts. The consensus was higher among the 75 higher-priority recommendations (85%, 12%, and 3% for SR, R, and NC, respectively) than in the 50 lower-priority recommendations (32%, 52%, and 16% for SR, R, and NC, respectively).

Conclusion: The consensus on 115 of 125 recommendations indicates a high-level of convergence among experts. The SELNET consensus provides a tool for sarcoma multidisciplinary treatment committees during the COVID-19 outbreak.

Implications For Practice: The Sarcoma European-Latin American Network (SELNET) consensus on sarcoma prioritization care during the COVID-19 era issued 125 pragmatical recommendations distributed as higher or lower priority to protect critical decisions on sarcoma care during the COVID-19 pandemic. A multidisciplinary team from 11 countries reached consensus on 115 recommendations. The consensus was lower among lower-priority recommendations, which shows reticence to postpone actions even in indolent tumors. The European Society for Medical Oncology-Magnitude of Clinical Benefit scale was applied as support for prioritizing systemic treatment. Consensus on 115 of 125 recommendations indicates a high level of convergence among experts. The SELNET consensus provides a practice tool for guidance in the decisions of sarcoma multidisciplinary treatment committees during the COVID-19 outbreak.
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http://dx.doi.org/10.1634/theoncologist.2020-0516DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7543334PMC
October 2020

Nora's Lesion in a Child: A Case of Complete Spontaneous Regression.

Balkan Med J 2021 Jan;38(1):57-58

Department of Musculo-Skeletal Oncology, IRCCS - Istituto Ortopedico Rizzoli, Bologna, Italy.

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http://dx.doi.org/10.4274/balkanmedj.galenos.2020.2020.7.224DOI Listing
January 2021

Trends in Bone Metastasis Modeling.

Cancers (Basel) 2020 Aug 17;12(8). Epub 2020 Aug 17.

Unit of Orthopaedic Pathology and Osteoarticular Tissue Regeneration, IRCCS Istituto Ortopedico Rizzoli, Via di Barbiano 1/10, 40136 Bologna, Italy.

Bone is one of the most common sites for cancer metastasis. Bone tissue is composed by different kinds of cells that coexist in a coordinated balance. Due to the complexity of bone, it is impossible to capture the intricate interactions between cells under either physiological or pathological conditions. Hence, a variety of in vivo and in vitro approaches have been developed. Various models of tumor-bone diseases are routinely used to provide valuable information on the relationship between metastatic cancer cells and the bone tissue. Ideally, when modeling the metastasis of human cancers to bone, models would replicate the intra-tumor heterogeneity, as well as the genetic and phenotypic changes that occur with human cancers; such models would be scalable and reproducible to allow high-throughput investigation. Despite the continuous progress, there is still a lack of solid, amenable, and affordable models that are able to fully recapitulate the biological processes happening in vivo, permitting a correct interpretation of results. In the last decades, researchers have demonstrated that three-dimensional (3D) methods could be an innovative approach that lies between bi-dimensional (2D) models and animal models. Scientific evidence supports that the tumor microenvironment can be better reproduced in a 3D system than a 2D cell culture, and the 3D systems can be scaled up for drug screening in the same way as the 2D systems thanks to the current technologies developed. However, 3D models cannot completely recapitulate the inter- and intra-tumor heterogeneity found in patients. In contrast, ex vivo cultures of fragments of bone preserve key cell-cell and cell-matrix interactions and allow the study of bone cells in their natural 3D environment. Moreover, ex vivo bone organ cultures could be a better model to resemble the human pathogenic metastasis condition and useful tools to predict in vivo response to therapies. The aim of our review is to provide an overview of the current trends in bone metastasis modeling. By showing the existing in vitro and ex vivo systems, we aspire to contribute to broaden the knowledge on bone metastasis models and make these tools more appealing for further translational studies.
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http://dx.doi.org/10.3390/cancers12082315DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7464021PMC
August 2020

Systemic Inflammation Is Associated with Oncological Outcome in Patients with High-Grade Myxofibrosarcoma of the Extremities: A Retrospective Analysis.

Oncol Res Treat 2020 18;43(10):531-538. Epub 2020 Aug 18.

IRCCS Azienda Ospedaliera Universitaria Sant'Orsola-Malpighi, Bologna, Italy.

Background: The aim of this retrospective study is to verify whether preoperative systemic inflammatory markers (serum C-reactive protein [CRP] and neutrophil-lymphocyte ratio [NLR]) can help in predicting the disease-specific survival (DSS) and local recurrence (LR) rate in adult patients affected by localized myxofibrosarcoma (MFS) of the extremities.

Methods: We reviewed 126 adult patients with primary, localized MFS of the limbs. We analyzed DSS and LR.

Results: Median age at the time of surgery was 68 years (range 19-92). Median CRP was 0.4 mg/dL and median NLR was 2.8. A worse DSS was found in patients who had preoperative CRP >0.5 mg/dL (p = 0.002) and in those with NLR >3.5 (p < 0.001). In multivariate analysis, tumor size and grade as well as preoperative CRP values and NLR were confirmed to be prognostic factors in terms of DSS. An increased risk of LR was found in multivariate analysis in patients with a tail sign and with high gadolinium enhancement at preoperative MRI.

Conclusions: Patients with high preoperative CRP and NLR levels, as well as large and high-grade tumors, might be considered as candidates for additional, more aggressive treatment approaches or more stringent follow-up schedules.
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http://dx.doi.org/10.1159/000509429DOI Listing
January 2021

Denosumab for Bone Giant Cell Tumor of the Distal Radius.

Orthopedics 2020 Sep 6;43(5):284-291. Epub 2020 Aug 6.

There are conflicting reports regarding the outcome and effect of denosumab for distal radius giant cell tumor of bone (GCTB). The authors performed this study to evaluate the behavior of distal radius GCTB in relation to the type of treatment and the administration of denosumab. The files of 72 patients with distal radius GCTB treated from 1984 to 2018 were reviewed. Fourteen patients were administered denosumab. Surgical treatment consisted of curettage (25 patients) or resection (47 patients) and allograft or vascularized fibular head graft reconstruction. Median follow-up was 63.1 months (interquartile range [IQR], 35.5-107.1 months). The authors evaluated local recurrences, metastasis, function, and complications. The local recurrence rate was 30.6% at a median of 14.0 months (IQR, 10-19 months), with no difference between curettage and resection. The local recurrence rate was significantly higher in the patients who received denosumab. The metastasis rate was 9.7% at a median of 41.0 months (IQR, 15-114 months), with no difference regarding denosumab administration. Function was significantly better in patients after curettage. The complication rate was 25%; vascularized fibular graft reconstruction was associated with fewer complications. This study found that denosumab increases the risk of local recurrence after curettage, function is better after curettage, and vascularized fibular graft is the optimal reconstruction after resection of distal radius GCTB. [Orthopedics. 2020;43(5):284-291.].
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http://dx.doi.org/10.3928/01477447-20200721-03DOI Listing
September 2020

Femoral fracture in primary soft-tissue sarcoma of the thigh treated with radiation therapy: indications for prophylactic intramedullary nail.

Arch Orthop Trauma Surg 2020 Jul 23. Epub 2020 Jul 23.

IRCCS Istituto Ortopedico Rizzoli, via Pupilli 1, 40136, Bologna, Italy.

Introduction: Post-radiation fractures of the femur (PRF) are difficult to treat and are associated with a high risk of delayed union and non-union. We report a series of patients affected by soft tissue sarcoma (STS) of the thigh, treated with limb-sparing surgery and perioperative radiotherapy (RT), to analyse post-radiotherapy femur fracture (FF) rate and its management.

Material And Methods: 547 patients treated with surgery and RT for a deep primary STS of the thigh were included. "Periosteal stripping" and "bone tangential resection" were performed in case of tumor invasion. In the case of complete bone involvement, the patient received its complete resection and econstruction.

Results: Twenty-three (4.3%) patients underwent surgical procedures involving periosteum and cortical bone. In 11 (2.0%) patients a bone resection was required because of massive bone involvement. Six out of these 11 (54.5%) patients developed major complications (infection and aseptic loosening). At the time of STS excision, 11 patients (2.0%) underwent prophylactic intramedullary nailing (PIN). PRF occurred in 15 patients (3.0%) at a median follow up of 52 months (range 3-151). Among patients who developed PRF, three were treated with a prosthesis (no complications) and eight nailing (7/8, 87.5% did not heal and developed a non-union).

Conclusions: Given the potentially devastating complication of a PRF, PIN should be considered. We suggest prophylactic IM nail in patients at higher risk the time of STS excision. In other cases, IM nail can be postponed in the following years considering the prognosis.
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http://dx.doi.org/10.1007/s00402-020-03544-xDOI Listing
July 2020

Correction to: Intercalary bone graft of the tibia: case series and review of the literature.

Eur J Orthop Surg Traumatol 2020 Dec;30(8):1429

AOU Sant'Orsola-Malpighi, Via Massarenti 9, Bologna, Italy.

The original version of this article unfortunately contained a mistake. The spelling of the name 'Valerio Bochicchio' was incorrect.
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http://dx.doi.org/10.1007/s00590-020-02732-0DOI Listing
December 2020

Correction to: Silver-coated (PorAg®) endoprosthesis can be protective against reinfection in the treatment of tumor prostheses infection.

Eur J Orthop Surg Traumatol 2020 Dec;30(8):1355

Azienda Ospedaliera Sant'Orsola-Malpighi, Bologna, Italy.

The original version of this article unfortunately contained a mistake. The correct information is given below.
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http://dx.doi.org/10.1007/s00590-020-02725-zDOI Listing
December 2020

Role of (Neo)adjuvant Denosumab for Giant Cell Tumor of Bone.

Curr Treat Options Oncol 2020 07 4;21(8):68. Epub 2020 Jul 4.

Orthopaedic Surgery, UC Davis, Sacramento, USA.

Opinion Statement: Denosumab is a RANK ligand inhibitor approved for the treatment of giant cell tumor of bone. While the role of denosumab in the setting of advanced and unresectable disease is well established, its role in surgically resectable disease is currently under discussion. Several prospective and retrospective series on neoadjuvant therapy in potentially resectable tumor with high morbidity surgery reported a relapse rate of 10-20% after resection and 30-40% after curettage. At the same time, less morbid surgery has obvious clinical advantages for the patient, and several studies have shown the efficacy of denosumab in downgrading of the surgical procedure. Currently, the role of neoadjuvant denosumab in operable GCTB is limited to selected cases in which a diffuse reactive bone formation and peripheral ossification can make an easier surgical procedure, for example, in tumors with a large soft tissue component. A planned resection may become less morbid when preoperative denosumab is administered. Whenever a segmental resection is thought to be indicated at diagnosis, denosumab may be considered in the neoadjuvant setting. A preoperative course of 6 months is considered safe and effective. Two case scenarios are presented and critically discussed. Because of the high recurrence rates after denosumab treatment followed by curettage, we discourage the use of denosumab when curettage is considered feasible. In this setting, a short course of preoperative denosumab (2-6 months) may be considered for highly selected cases, for example in pathological fractures. The role of adjuvant denosumab needs further investigation. Long-term disease control has been reported in case of non-surgical lesions, even after treatment interruption, but there is no consensus on ideal treatment duration and dosage for these scenarios. In all cases, multidisciplinary discussion with oncology, pathologist, radiologist, and surgeons is mandatory. Patient's comorbidities, dental conditions, and preferences, including family planning, should always be taken into account.
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http://dx.doi.org/10.1007/s11864-020-00766-4DOI Listing
July 2020

Angiosarcoma of bone: a retrospective study of the European Musculoskeletal Oncology Society (EMSOS).

Sci Rep 2020 07 2;10(1):10853. Epub 2020 Jul 2.

IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.

Angiosarcoma of bone (B-AS) is a rare malignant tumor of vascular origin. The aim of this retrospective study is to report on treatments and prognosis. Data were collected from the EMSOS website. 80 patients in 9 centers included: 51 male/29 female; median age 54 years (range 17 to 92); 56% with localized disease, 44% metastatic. Primary tumor surgery: 76% (30% amputation, 26% intralesional margins); radiotherapy (RT): 41%; chemotherapy (CT): 47% (56% in metastatic, 41% in localized cases). With a median follow-up of 31 months (range 40 to 309), 5-year overall survival (OS) was 27% (95%CI 16-30): 41% (95%CI 25-56) for localized patients, and 8% (95%CI 0-20) for metastatic (p = 0.002). In metastatic patients, 1 year OS was significantly influenced by chemotherapy response: 67% (95CI% 29-100) for those who responded or had stable disease (n = 7), and 18% (95CI% 0-41) for patients with progressive disease (n = 11), p 0.002. The surgical complete remission (SCR) status was pivotal in localized patients (5-year OS 45% for SCR, 17% no SCR, p = 0.03); also 5-year OS was significantly influenced by age and site of the tumor. After multivariate analysis, the addition of radiotherapy to surgery significantly influenced the disease-free survival (DFS) rate, whereas the use of chemotherapy lost the significance showed at the univariate analysis. Overall, patients with metastatic B-AS have a dismal prognosis, with a prolonged survival in case with a response to chemotherapy. Experimental trials with more active systemic treatment regimens are needed. In patients with localized disease, the patient's age and site of the tumor are prognostic factors and any effort must be made to achieve an SCR status. No definitive conclusions can be drawn from our data on the use of adjuvant chemotherapy, while the use of adjuvant radiotherapy might improve DSF in patients surgically free of disease.
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http://dx.doi.org/10.1038/s41598-020-66579-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7331738PMC
July 2020

Extraskeletal Myxoid Chondrosarcoma with Molecularly Confirmed Diagnosis: A Multicenter Retrospective Study Within the Italian Sarcoma Group.

Ann Surg Oncol 2021 Feb 22;28(2):1142-1150. Epub 2020 Jun 22.

Department of Surgery, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.

Background: Extraskeletal myxoid chondrosarcoma (EMC) is a rare sarcoma of uncertain origin, marked by specific chromosomal translocations involving the NR4A3 gene, and usually characterized by an indolent course. Surgery (with or without radiotherapy) is the treatment of choice in localized disease. The treatment for advanced disease remains uncertain. In order to better evaluate prognostic factors and outcome, a retrospective pooled analysis of patients with EMC treated at three Italian Sarcoma Group (ISG) referral centers was carried out.

Methods: All patients with localized EMC surgically treated from 1989 to 2016 were identified. Diagnosis was centrally reviewed according to WHO 2013. Only patients with NR4A3 rearrangement were included.

Results: Sixty-seven patients were identified: 13 (20%) female, 54 (80%) male. Median age was 56 years (range 18-84). Numbers and type of translocation were: 50 (80%) NR4A3-EWS, 10 (16%) NR4A3-TAF15, 1 (2%) NR4A3-TCF12, and 1 (2%) NR4A3-TFG. Median follow-up was 55 months (range 2-312). Five- and ten-year overall survival rates were 94% (86-100 95%CI) and 84% (69-98 95%CI). Thirty-five (52%) patients relapsed: 9 had local recurrence (LR) and 26 had distant metastasis (5 with concomitant LR). The 5- and 10-year disease-free survival rates (DFS) were 51% (38-65 95%CI) and 20% (7-33 95%CI). Size of the primary tumor was significantly related to distant metastasis-free survival (DMFS) (p = 0.004). Patients carrying the NR4A3-EWS translocation had a trend in favor of better DFS (p = 0.08) and DMFS (p = 0.09) compared with the patients with NR4A3-TAF15.

Conclusions: Prolonged survival can be expected in patients with EMC, in spite of a high rate of recurrence. Size is significantly associated with distant relapse. The type of NR4A3 translocation could influence outcome.
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http://dx.doi.org/10.1245/s10434-020-08737-7DOI Listing
February 2021

Pathological fracture does not affect prognosis in dedifferentiated chondrosarcoma of the limbs.

J Orthop Sci 2020 Jun 18. Epub 2020 Jun 18.

IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.

Background: The aim of this retrospective study is to analyze history and treatment outcomes of pathological fracture (PF) in dedifferentiated chondrosarcoma (DdChS) of the limbs..

Methods: We retrospectively reviewed 175 adult patients with primary DdChS of the limbs.Disease-specific survival (OS) and local recurrence (LR) were analyzed.

Results: Median age was 66 years (range, 29-91). Most DdChS (121, 69.1%) were localized in the femur. Forty-nine (28.0%) had metastasis at diagnosis; thirty-nine DdChS (22.3%) had a PF.OS rate was lower in patients with metastasis at diagnosis (8.6% Vs 41.0% at 10 years, p < 0.001). A similar OS was observed among patients with localized disease, whether with/without PF (p = 0.638), with/without chemotherapy (p = 0.543) and independently from the type of surgery (resection/amputation) (p = 0.877). Amputation reduces the risk of LR (80.0% vs 63.1% at 5 years, p = 0.039), particularly in the PF group..

Conclusion: Patients with metastases have a particularly poor prognosis in DdChS, but pathological fracture does not influence prognosis in terms of survival and local control. Initial curative resection is essential in order to reduce the chance of recurrences. Amputation might be an option in patients with localized disease and a PF to reduce the risk of LR..
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http://dx.doi.org/10.1016/j.jos.2020.04.013DOI Listing
June 2020

Intercalary bone graft of the tibia: case series and review of the literature.

Eur J Orthop Surg Traumatol 2020 Dec 19;30(8):1421-1427. Epub 2020 Jun 19.

AOU Sant'Orsola-Malpighi, Via Massarenti 9, Bologna, Italy.

Aims: We report a series of patients treated with intercalary bone graft (IBG) of the tibia diaphysis (TD) after resection of primary bone tumors. The purpose of this study was to evaluate the mid- and long-term survival of TD IBG reconstruction in children and adults, characterizing patterns of success and failure.

Methods: A total of 35 patients were included in this retrospective study. Median age was 22 years (range, 8-57). This series included 19 patients (54.3%) treated with homologous bone graft alone and 16 patients (45.7%) treated combining intercalary allograft with fibular autograft. Complications were recorded according to Henderson classification.

Results: Median follow-up was 36 months (range, 1-165). Local recurrence occurred in 2 patients (5.7%) after 12 and 60 months, respectively. Major complications included graft fracture (9 cases), non-union (5 cases) and infection (4 cases). Other complications were axial deformity (2 cases), superficial infection (2 cases), compartmental syndrome (1 case).

Conclusion: Intercalary bone grafts of TD have been recommended as a reliable solution with long-term success rates and good functional outcome in more than 80% of patients. However, approximately half of the patients may require further surgeries to treat major complications (deep infection, delayed or non-union and graft fracture). Additional vascularized fibula graft may ameliorate final result.
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http://dx.doi.org/10.1007/s00590-020-02718-yDOI Listing
December 2020

Expandable distal femur megaprosthesis: A European Musculoskeletal Oncology Society study on 299 cases.

J Surg Oncol 2020 Jun 7. Epub 2020 Jun 7.

Orthopedic Surgery, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.

Background And Objectives: Expandable distal femur prostheses have become more popular over the last decades, but scientific data is limited.

Methods: A retrospective study was performed, including cases treated between 1986 and 2019 in 15 European referral centers for bone sarcomas.

Results: A total of 299 cases were included. Average follow-up was 80 months (range, 8-287 months). Mean patient age was 10 years. Most (80%) of the implants were noninvasive growers and a fixed hinge knee was used more often (64%) than a rotating hinge. Most prosthetic designs showed good (>80%) implant survival at 10 years, but repeat surgery was required for 63% of the patients. The most frequent reason for revision procedure was the completion of lengthening potential. Noninvasive expandable implants showed less risk of infection compared to invasive growers (11.8% vs 22.9% at 10 years). No difference in aseptic loosening was found between cemented and uncemented stems.

Conclusions: This study shows the increasing popularity of expandable distal femur prostheses, with overall good results for function and implant survival. However, repeat surgery is frequently required, especially in patients under the age of 10 years old. Infection is less frequent in noninvasive growers compared to implants that require invasive lengthening procedures.
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http://dx.doi.org/10.1002/jso.26060DOI Listing
June 2020

The Biology of Myxofibrosarcoma: State of the Art and Future Perspectives.

Oncol Res Treat 2020 25;43(6):314-322. Epub 2020 May 25.

IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.

Background: Myxofibrosarcoma (MFS) is among the most highly complex sarcoma types. Molecular cytogenetic studies have identified a high level of genomic complexity.

Summary: This review provides an update of the current research related to MFS, with particular emphasis on emerging mechanisms of tumorigenesis and their potential therapeutic impact. Many novel possible molecular markers have been identified, not only for prognostication in MFS, but also to serve as possible therapeutic targets, and thereby improve clinical outcomes. However, the molecular pathogenesis of MFS remains incompletely understood. Key Messages: Patients suffering from advanced MFS might benefit from expanded molecular evaluation in order to detect specific expression profiles and identify drug-able targets. Moreover, immunotherapy represents an intriguingly perspective due to the presence of "T-cell inflamed" tumor microenvironment.
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http://dx.doi.org/10.1159/000507334DOI Listing
September 2020

Silver-coated (PorAg) endoprosthesis can be protective against reinfection in the treatment of tumor prostheses infection.

Eur J Orthop Surg Traumatol 2020 Dec 24;30(8):1345-1353. Epub 2020 May 24.

Azienda Ospedaliera Sant'Orsola-Malpighi, Bologna, Italy.

Introduction: We aim to evaluate the use of silver (PorAg) coated compared to uncoated prosthesis in two-stage revision for prosthetic joint infection (PJI) of distal femur and proximal tibia megaprosthesis in oncological patients.

Materials And Methods: In total, 68 patients were retrospectively evaluated. Median age was 30 years (range 14-83). In total, 29 patients were re-implanted with PorAg prosthesis and 39 with uncoated prosthesis (Megasystem C, Waldemar Link GmbH & Co. KG, Hamburg, Germany). All patients had PJI confirmed according to Musculoskeletal Infection Society (MSIS) criteria. In 10 cases, no microorganism was identified at the time of first-stage revision, but all had a sinus communicating with the prosthesis. Successful eradication of the infection was defined by the absence of clinical/serologic evidence of infection at 6 months after the second stage or at latest follow-up. Infection was again defined according to the MSIS criteria.

Results: At 3-year follow-up, estimated reinfection rate in the silver group was slightly lower than in uncoated EPR (10.3% vs. 17.5%, p = 0.104). Among reinfected patients, only one out of three patients (33%) in the silver group required an amputation compared to 80% in the nonsilver group (p = 0.047).

Conclusions: Our results show the efficacy of PorAg coating in the two-stage revision of knee EPR. PorAg-coated EPR may have possible advantages over this traditional strategy, in particular when applied to patients with a higher risk of reinfection.
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http://dx.doi.org/10.1007/s00590-020-02705-3DOI Listing
December 2020

Neoadjuvant Chemotherapy in High-Risk Soft Tissue Sarcomas: Final Results of a Randomized Trial From Italian (ISG), Spanish (GEIS), French (FSG), and Polish (PSG) Sarcoma Groups.

J Clin Oncol 2020 07 18;38(19):2178-2186. Epub 2020 May 18.

Department of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.

Purpose: To determine whether the administration of histology-tailored neoadjuvant chemotherapy (HT) was superior to the administration of standard anthracycline plus ifosfamide neoadjuvant chemotherapy (A+I) in high-risk soft tissue sarcoma (STS) of an extremity or the trunk wall.

Patients And Methods: This was a randomized, open-label, phase III trial. Patients had localized high-risk STS (grade 3; size, ≥ 5 cm) of an extremity or trunk wall, belonging to one of the following five histologic subtypes: high-grade myxoid liposarcoma (HG-MLPS); leiomyosarcoma (LMS), synovial sarcoma (SS), malignant peripheral nerve sheath tumor (MPNST), and undifferentiated pleomorphic sarcoma (UPS). Patients were randomly assigned in a 1:1 ratio to receive three cycles of A+I or HT. The HT regimens were as follows: trabectedin in HG-MLPS; gemcitabine plus dacarbazine in LMS; high-dose prolonged-infusion ifosfamide in SS; etoposide plus ifosfamide in MPNST; and gemcitabine plus docetaxel in UPS. Primary and secondary end points were disease-free survival (DFS) and overall survival (OS), estimated using the Kaplan-Meier method and compared using Cox models adjusted for treatment and stratification factors. The study is registered at ClinicalTrials.gov (identifier NCT01710176).

Results: Between May 2011 and May 2016, 287 patients (UPS: n = 97 [33.8%]; HG-MLPS: n = 65 [22.6%]; SS: n = 70 [24.4%]; MPNST: n = 27 [9.4%]; and LMS: n = 28 [9.8%]) were randomly assigned to either A+I or HT. At the final analysis, with a median follow-up of 52 months, the projected DFS and OS probabilities were 0.55 and 0.47 (log-rank = .323) and 0.76 and 0.66 (log-rank = .018) at 60 months in the A+I arm and HT arm, respectively. No treatment-related deaths were observed.

Conclusion: In a population of patients with localized high-risk STS, HT was not associated with a better DFS or OS, suggesting that A+I should remain the regimen to choose whenever neoadjuvant chemotherapy is used in patients with high-risk STS.
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http://dx.doi.org/10.1200/JCO.19.03289DOI Listing
July 2020

Wrist Arthrodesis and Osteoarticular Reconstruction in Giant Cell Tumor of the Distal Radius.

J Hand Surg Am 2020 Sep 17;45(9):882.e1-882.e6. Epub 2020 Apr 17.

Istituto Di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Ortopedico Rizzoli, Bologna, Italy; Università degli Studi di Bologna, Bologna, Italy.

Purpose: The aim of this multi-institutional retrospective study was to compare osteoarticular graft reconstruction (OA) and wrist arthrodesis (WA) after distal radius resection for giant cell tumor.

Material And Methods: Sixty-seven patients affected by giant cell tumor of the distal radius underwent resection and reconstruction with OA (47 patients) or WA (20 patients). The mean age was 40 years (range, 13-74 years). Grafts included fresh-frozen allograft or nonvascularized fibular autograft. Complications requiring surgical revision were recorded. Clinical outcome was assessed with the Musculoskeletal Tumour Society Score (MSTS) and Disabilities of the Arm, Shoulder, and Hand (DASH) score.

Results: Fifteen patients developed a local recurrence after a median of 12 months (range, 6-137 months). Sixteen patients required revision surgery for complications. Of these, 10 were graft-related complications (7 in the OA group and 3 in the WA group). Among OA, 2 patients with painful instabilities and 4 with severe arthritis required conversion into WA after a mean of 26 months (range, 13-38 months) At a median follow-up of 105 months (range, 12-395 months), similar functional outcome (MSTS and DASH score) was observed between OA and WA.

Conclusions: Our results did not show any advantage of OA or WA over the other technique. A patient-by-patient decision should be taken both regarding the type of reconstruction (OA or WA) and the type of graft (allograft or autograft). The reconstructive choice should also consider the patient's functional expectations.

Type Of Study/level Of Evidence: Therapeutic IV.
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http://dx.doi.org/10.1016/j.jhsa.2020.03.005DOI Listing
September 2020

Pexidartinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor: safety and efficacy.

Expert Rev Anticancer Ther 2020 06 22;20(6):441-445. Epub 2020 Apr 22.

Orthopedic Oncology, IRCCS Istituto Ortopedico Rizzoli , Bologna, Italy.

Introduction: Tenosynovial giant cell tumor (TGCT) is a benign clonal neoplastic proliferation arising from the synovium often causing pain, swelling, joint stiffness, and reduced quality of life. The optimal treatment strategy in patients with diffuse-type TGCT (dt-TGCT) is evolving. Surgery is the main treatment, with a high recurrence rate and surgery-related morbidity. Radiotherapy is associated with important side effects. TGCT cells overexpress colony-stimulating factor 1 (CSF1). Pexidartinib (Turalio™) is a selective CSF1 R inhibitor, which was recently approved by the FDA for the treatment of TGCT.

Areas Covered: This article reviews the pharmacological properties, clinical efficacy, and safety of pexidartinib.

Expert Opinion: Pexidartinib was effective with an acceptable safety profile for advanced TGCT in phase I-III studies. The phase III trial (ENLIVEN) in unresectable TGCT met its primary endpoints of overall response rate. These results led to FDA approval for this TGCT population. Mixed or cholestatic hepatotoxicity was observed in rare cases. For this reason, pexidartinib is currently available only through a Risk Evaluation and Mitigation Strategy (REMS) Program in the USA. TGCT significantly impairs patients' quality of life. The approval of pexidartinib has changed the therapeutic armamentarium for this condition. However, strict monitoring of liver function is warranted.
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http://dx.doi.org/10.1080/14737140.2020.1757441DOI Listing
June 2020