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There has been considerable debate whether heterogenous germ cell tumors, in particular extragonadal teratomas, could originate from midline somatic stem cells. This debate has been based mostly on the experimental statement that teratoma-like tumors might develop at the injection web site of cultured embryonal stem cells. The stem-cell factor is expressed with an increasing gradient from yolk sac to the gonadal ridge, guiding germ cells to the gonadal ridge. The affiliation of c-kit mutations with bilateral or familial germ cell tumors underlies the significance of this gene during germ cell development. Extragonadal germ cell tumors are presumed to arise from germ cells which have migrated aberrantly. Primordial germ cells populate these intercourse cords and then bear mitotic arrest and remain in that state till puberty. Instead, primordial germ cells populate the primitive gonad while persevering with to divide and proliferate. The entry into meiosis of primordial germ cells is a gradual course of that continues until birth; proliferation continues prior to entry into meiosis. The cells of the intercourse cords may hardly ever become stromal tumors, corresponding to testicular Sertoli or Leydig cell tumors, ovarian granulosa cell tumors, or mixtures of those elements. These tumors might typically show morphologic features which might be discrepant from the intercourse of the patient, thus illustrating the bisexual differential potential of the gonadal stroma. Last, coelomic epithelium covering the ovary may evolve into epithelial neoplasms, discovered most often in adults. Genetics And Molecular Biology Genetic contributions to the pathogenesis of pediatric germ cell tumors embody constitutional genetic changes resulting in increased susceptibility and tumor-specific genetic modifications. Little is thought relating to the previous, particularly with regard to childish germ cell tumors. The affiliation between sex-chromosomal abnormalities and the development of germ cell tumors is well established. Approximately 50% of adolescents with mediastinal germ cell tumors have cytogenetic modifications consistent with Klinefelter syndrome. As we investigate molecular variations in germ cell tumors in youngsters and adolescents, it should be emphasized that few pediatric germ cell tumors have been analyzed to date and variations is most likely not absolute. Four biologically distinct subcategories are distinguished within the pediatric population: tumors of the adolescent testis, tumors of the adolescent ovary, extragonadal tumors of adolescents, and tumors of infancy. Genetic Characteristics of Testicular Tumors in Adolescents and Adults Adolescent testicular germ cell tumors mostly turn into clinically evident several years after puberty, suggesting that a crucial genetic event happens with, or is unmasked at, puberty. However, as a end result of these tumors have been proven to arise in premeiotic germ cells with erased genomic imprinting, some observers consider that the critical occasion occurs within the embryonic gonad. This layer is lost in testicular improvement, thus low frequency of epithelial tumors in testes. Germ cell tumors come up inside the primordial germ cells that migrate from yolk sac to gonad early in development. Isochromosome unfavorable adolescent germ cell tumors almost invariably show acquire of chromosomal materials of 12p, generally presenting as excessive degree amplification at 12p11�12 (from the same parental origin). This finding provides further evidence that this genetic alteration happens early in germ cell tumor pathogenesis. Balanced chromosomal regions lay throughout the reference interval, and regions with chromosomal positive aspects or losses are shown as deviation to the proper or left, respectively. Genetic Characteristics of Ovarian Tumors in Adolescents and Adults the genetic biology of ovarian germ cell tumors is more complex than that of testicular germ cell tumors and is considered individually for mature teratomas, immature teratomas, and malignant ovarian germ cell tumors. Teratomas Cytogenetic assessment of more than 325 ovarian mature teratomas demonstrates that 95% are karyotypically balanced, with solely 5% displaying positive aspects of single entire chromosomes, the identification of which differs from case to case. Some present evidence of a meiotic stem-cell origin, and others show mitotic origins, suggesting the failure of early meiotic arrest. The frequency of chromosomal abnormalities in immature teratoma is greater than in mature teratoma. Most sufferers with cytogenetically irregular immature teratomas reported to date have skilled multiple recurrences. In contrast, patients with karyotypically regular immature teratomas have remained disease free. They are aneuploid: approximately 75% include i(12p); 42% and 32% have gains of chromosomes 21 and 1q, respectively; 25% and 42% have lack of chromosomes thirteen and 8, respectively. Immature teratomas might develop genetic adjustments which would possibly be accompanied by histologic malignant transformations. Genetic Characteristics of Extragonadal Germ Cell Tumors of Older Children Aberrant or incomplete migration of primordial germ cells is one clarification for the origin of extragonadal germ cell tumors. Another speculation is that these tumors come up from totipotent embryonal cells which have escaped the affect of embryonic organizers controlling normal differentiation. These demonstrate that each gonadal and nongonadal germ cell tumors present the absence of methylation of most imprinted genes, strongly supporting a germ cell origin for all germ cell tumors. More refined changes in the methylation sample recommend that early childhood germ cell tumors may come up from a unique stage of germ cell improvement compared with those in adolescents and adults. Cytogenetic analyses of central nervous system teratoma have shown a excessive frequency of sex-chromosomal abnormalities, mostly elevated copies of the X chromosome. The malignant hematopoietic clone generally demonstrates i(12p), unlike hematopoietic malignancies that arise secondary to therapy. Most teratomas in this age group are diploid, have regular karyotypes and, if utterly resected, behave in a benign fashion regardless of diploma of immaturity and web site of origin. Pediatric yolk sac tumors had been enriched for genes related to differentiation and seminomas with genes for proliferation. The histologic options of every subtype are impartial of presenting medical characteristics; tumor biology and scientific behavior differ with site of origin, stage, and age of the affected person. Abundant immature tissue Teratoma with associated malignant germ cell tumor element Teratoma with associated malignant somatic element (squamous carcinoma, glioblastoma, peripheral neuroectodermal tumor, and so forth. Teratomas can additionally be categorized in accordance with their histologic composition: mature, containing well-differentiated tissues; immature, containing various levels of immature fetal tissue, most frequently neuroectodermal; or malignant, containing a minimum of one of many malignant germ cell parts. The mature teratoma is composed of mature representative tissues from all three germ cell layers: ectoderm, mesoderm, and endoderm. Although any tissue sort may be seen, the commonest are skin and skin appendages, adipose tissue, mature brain, intestinal epithelium, and cystic structures lined by squamous, cuboidal, or flattened epithelium. Hematopoietic, pancreatic, or pituitary tissue regularly is found in mediastinal tumors and barely in teratoma at different websites. Unique to these tumors is the presence of varied immature tissues, normally neuroepithelium, although immature ectodermal, mesodermal, and endodermal parts can also be observed. A number of grading techniques have been established for immature teratoma, all of which are variations of the system initially devised by Thurlbeck and Scully. The grading of immature components in childhood immature teratoma has not demonstrated prognostic significance. However, the risk of native recurrence is greater in immature teratomas, especially in the sacrococcygeal region, largely due to the next proportion of incomplete resections.

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The age of the patient, location of the tumor, presence or absence of pathologic fracture, and the wishes of the affected person and family must be thought of rigorously. Accordingly, aggressive reconstruction with vascular and/or nerve grafting as needed must be done to save even limited hand and wrist operate. In the decrease extremity, exterior hemipelvectomy results in a particularly poor useful outcome. A hip disarticulation no much less than permits improved sitting although prosthetic use stays poor. For tumors above the proximal tibia, limb salvage with one of the above methods is preferable to amputation and may potentially give equally practical outcomes. Patients present process above the knee amputation have increased energy expenditure compared with those undergoing endoprosthetic reconstruction. Ifosfamide (I) with444 or without261,445 etoposide (E) have proven promising exercise, although their position in improving outcome has not been adequately evaluated. Although early nonrandomized trials advised that the addition of chemotherapy improved the finish result for sufferers with osteosarcoma,433,434,435,436,437 some investigators were involved that the reported improved end result was associated to affected person selection, stage migration (related to the introduction of computed tomography), or improved surgical techniques. The outcomes of that trial advised that the natural historical past of osteosarcoma had indeed modified. Two subsequent controlled randomized trials confirmed the importance of chemotherapy administration for patients with osteosarcoma. In an effort to increase the variety of sufferers able to endure limb-sparing procedures, investigators at Memorial Sloan Kettering Cancer Center began using preoperative chemotherapy. The administration of chemotherapy allowed additional time for building of prosthetic gadgets and in addition had the theoretical benefit of treating presumed micrometastatic disease. Histological response to preoperative chemotherapy turned an essential predictor of end result. However, a Pediatric Oncology Group research revealed equal consequence for sufferers randomly assigned to treatment with adjuvant or neoadjuvant therapy. The concept of altering therapy primarily based on histological response in an effort to enhance outcome was initially proposed by Rosen, who reported that altering therapy following surgical resection for sufferers with a poor histological response resulted in outcome just like that of patients with a great histological response. Although this strategy will increase the number of good responders, in this setting histological response loses its predictive worth. Current Treatment Results North America Since osteosarcoma is a rare malignancy representing only about 3% of childhood most cancers,10,459 only a few single establishments look after sufficient sufferers to carry out single establishment controlled medical trials. This has led to the event of managed medical trials by cooperative groups underneath the auspices of the National Cancer Institute. It is conjugated to phosphatidyl ethanolamine and encapsulated in liposomes to improve delivery to the reticuloendothelial system. Although systemic chemotherapy has dramatically improved the result of osteosarcoma sufferers,7,8,9 we appeared to have reached a plateau in outcome. Detection of additional improvements will likely require an understanding of the pathogenesis of osteosarcoma to be able to develop treatment strategies that focus on these pathways. Alternatively, randomized controlled trials might want to contain accrual of a lot of patients. This will present for the requisite variety of events that can permit us to detect clinically relevant differences in survival amongst treatment arms. One of the strategies to enroll large numbers of patients comparatively quickly is via international collaboration. The aim of this tumor financial institution is to make samples obtainable to investigators interested in evaluating the mechanisms of osteosarcoma improvement. This effort has resulted within the development of the most important osteosarcoma tumor financial institution, an out there useful resource to interested investigators. Since then, worldwide, chemotherapy for osteosarcoma consists of regimens combining a number of cytostatic brokers. Over the past many years, on the basis of the work of Rosen and coinvestigators,450,455,486 most protocols from Europe and elsewhere have included preoperative (neoadjuvant) chemotherapy, adopted by surgery of the primary tumor and postoperative (adjuvant) chemotherapy476 (see Table 34. Most teams have confirmed the connection between histological response to preoperative chemotherapy and the chance of recurrent, metastatic disease8,451,457,477,480,481,482,487 utilizing numerous grading strategies. Even patients with more than 50% viable tumor cells seemed to have a greater prognosis than patients without any response. The response price obtained with the three-drug combination was superior to that of the two-drug arm, 56% versus 39%. As poor responders to preoperative chemotherapy had been scheduled to receive postoperative chemotherapy with different medication (see Table 34. As anticipated, the response rate obtained within the experimental arm was lower than within the typical arm, but the expectation that the outlook for poor responders would be improved by the postoperative addition of two very lively agents was met with failure. Taken collectively, their outcomes argue against an impact of increasing dose intensity above that usually encountered in fashionable protocols. While progressionfree survival was lower for sufferers who received less than all six scheduled cycles, there was no statistically significant correlation between either preoperative dose intensity and histological response or general received dose depth and overall or progression-free survival. Thus, adding one cycle preoperatively, the response rate was certainly elevated and the delivered dose intensity was larger within the experimental arm. There was, however, no proof of a distinction in general or progression-free survival. In this context, it must be famous that attempts to improve the prognosis of sufferers with recurrent osteosarcoma by high-dose chemotherapy with blood stem cell rescue have been met with failure. Around the world, prospective research have generally centered on younger sufferers with localized extremity osteosarcomas, and their results have to be interpreted preserving this in thoughts, as different patients typically have a lot poorer outcomes. For occasion, sufferers with main metastases had event-free survival expectations of no extra than 30% in sequence from Italy,510 France,511 and the German-speaking international locations. In abstract, utilizing the identical general approaches worldwide, survival expectancies achieved in Europe476,512 and for example by selected South American484,513 and Asian487,514 teams are principally equivalent to those reported from North America. However, treatment outdoors of established infrastructures in economically advanced nations poses nice challenges. Many sufferers worldwide nonetheless have a really restricted likelihood to survive their illness, as evidenced by a 5-year survival rate of 7. Within such a program, related results were obtained for 22 sufferers handled in a single heart in Santiago, Chile, and 48 sufferers handled at St. Treatment of Relapse the therapy of patients with recurrent osteosarcoma stays difficult. The most typical website of illness recurrence remains the lung and about 20% to 30% of patients are reported to be cured by exploration and complete surgical resection of all lung metastases. The collection also advised that for patients unable to bear resection the utilization of chemotherapy may need a marginal effect, but that its position in the remedy of recurrence remained to be outlined. The variety of sufferers with recurrent disease obtainable for evaluation precludes the performance of managed randomized trials, which might be the only way to evaluate the position of postsurgical remedy in end result. Many scientific trials have added promising brokers to postsurgical therapy for sufferers with recurrent disease.

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An extra advantage of screening can be the sooner detection and therapy of congenital and infantile cataracts. Whether routine screening could be sensible is controversial as a end result of diseases such as retinoblastoma and congenital cataracts are rare (congenital cataracts have an effect on approximately 1 in 2,000 live births) and since pediatricians will not be adequately educated to recognize these conditions. Neovascularization of the anterior chamber and partial closure of the anterior angle (*) are also current. B: Histologic image of rubeosis iridis showing neovascularization (arrows) of the anterior portion of the iris (i) and focally on the endothelial floor of the cornea (arrow). Contraction of the neovascular membrane produces closure of the anterior chamber angle (*). C: Histologic image of the anterior phase of an eye with retinoblastoma seeds on the floor of the iris (i) with focal rosette formation (insert). For sufferers who current with small tumors, cautious scleral depressed examination in the office and later beneath anesthesia as properly as workplace ultrasonography is critical to make the analysis. Because of the rarity of distant metastases in patients with retinoblastoma, a bone marrow examination or bone scan is normally not warranted until the physician has suspicions of systemic involvement. Differential Diagnosis A number of benign circumstances (pseudoretinoblastomas) can clinically simulate retinoblastoma and generally create considerable diagnostic issue for the ophthalmologist. Clinical definition is mandatory as a outcome of the management of these entities differs considerably from the radical treatment of P. Early reviews of the frequency of enucleations carried out for suspected retinoblastomas when an alternative last pathological prognosis is made varied from 30% to 16% based on the degree of oncologic expertise of, and the kind of referrals received by, the group reporting the collection. Contrastenhanced coronal T1-weighted image showing parasellar and left middle fossa unfold of retinoblastoma (T) with extension alongside the sylvian fissure. Other conditions that might be confused clinically additionally produce or simulate a mass within the vitreous or the retina. With the exception of medulloepithelioma, these lesions have in common quite lots of histopathologic features distinct from retinoblastoma that create a tough differential analysis for the pathologist. Toxocara canis endophthalmitis is brought on by the larvae of the nematode Toxocara canis and presents nearly always in youngsters, although by no means at birth. Dead larvae elicit the formation of a localized eosinophilic abscess surrounding the microorganism. Condensed vitreous with gliosis and fibrosis could also be present on the web site of infection. Because these organisms are very small and degenerate, histological confirmation is very tough. A posterior subcapsular cataract varieties if the posterior capsule of the lens is ruptured by the traction of the vessels and fibrous membrane. These irregular vessels leak and create an exudative retinal detachment rich in lipids with subretinal foamy macrophages and ldl cholesterol clefts. The medical presentation and the ancillary radiologic and ultrasonic findings are typical for retinoblastoma in the majority of patients. The resistance to biopsy confirmation of the tumor arises from the dramatic difference between survivals for sufferers with contained intraocular tumors versus those with extraocular seeding of the tumor. The bias towards biopsy can be aggravated by stories of instances where the tumor was misdiagnosed as uveitis or obscured by cataract, and patients developed orbital extensions of retinoblastoma after vitrectomy. The cytological findings are small- to medium-size basophilic cells with scanty cytoplasm that are inclined to group together (rosette-like). The technique avoids vascularized conjunctiva of the limbus and the orbit, sclera and pars plana preventing possible spreading of tumor cells through the needle tract. B: Cytologic preparation of a retinoblastoma displaying cohesive teams of neoplastic cells with high nuclear: cytoplasmic ratio, increased mitotic exercise (dotted arrow) and focal rosette formation (solid arrow). C: Cytologic preparation of cerebrospinal fluid in a affected person with retinoblastoma metastatic to the mind. Notice the cohesive teams of neoplastic cells with excessive nuclear: cytoplasmic ratio. Sections of the eye should embody the structures to evaluate (choroid, tumor, all ranges of the optic nerve, and anterior chamber structures). Any of those techniques must be carried out immediately after enucleation, with consciousness of the anatomic orientation and taking care to avoid collapsing the eye or excessively contaminating P. Before opening the eye, a cross-section of the optic nerve must be obtained and submitted for histopathologic examination to avoid contamination by the tumor. The eye is then placed in 10% formalin and, after adequate fixation, the attention is grossed to obtain a central part including the optic nerve, tumor, and pupil (P. The calottes must be further sectioned into anterior and posterior segments, and submitted on edge for histopathologic examination of the choroid. A: Preferably underneath a stereoscopic microscope the eye is examined to choose the area by which many of the tumor is current. This is achieved by retroillumination to establish the realm of the tumor by the denser shadow. Before sectioning the eye one should get hold of the cross-section of the optic nerve margin for histologic examination. The scleral window should be created perpendicular to this site to obtained tumor at the edge of the bigger mass. B: the opening of the attention is made with a sharp blade or by using a corneal trephine (not proven here), to get hold of a scleral window. C: Under the microscope, select the areas of least necrosis and calcification with out disturbing intraocular constructions corresponding to retina and optic nerve head. Retrieve tumor and placed in cryoresistant tubes to immediately freeze and retailer until needed for genetic research or research. D: Place the eye in 10% formalin gently reforming the round form of the eye and repair for no much less than 24 hours. Gross Features Primary retinoblastomas originate within the sensory retina and occupy the retina and vitreous cavity. Retinoblastoma tumors are often white-gray with a chalky appearance and a delicate, friable consistency. Bright white speckles similar to calcifications are present all through the tumor. These tumors are inclined to completely fill the cavity and produce floating tumor spheres referred to as vitreous seeds. From there, the tumor can permeate the lymphatic vessels and metastasize to regional lymph nodes. A: After adequate fixation take away the calotte where the window to get hold of fresh tumor was created by cutting nearer to the optic nerve (without transecting it) and to avoid the opened space of the sclera. B: Cut and remove the opposite calotte to get hold of the central pupil optic nerve part (P.

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Reese and Ellsworth superior its use as a main modality for intraocular illness. The grouping that bears their name was developed to predict response and salvage to exterior radiation. From the Nineteen Sixties to the 1980s, bilateral retinoblastoma was treated with enucleation of the superior eye and external radiation of the contralateral eye. Orbital malformation, cataract and dry eye were some of the immediate toxicities that had been reported. At the identical time Stallard, a British ocular oncologist, expanded the role of episcleral brachytherapy with cobalt for select patients. Although solely applicable to certain circumstances with single isolated tumor foci, this method lacked lots of the toxicities related to exterior beam. The entire eye and lens sparing techniques used at present have been proven to enhance the eye preservation price as in comparability with reported older strategies. The fee of ocular salvage depends on the Reese-Ellsworth stage of the disease on the time of treatment as nicely as on the supply of focal therapy for limited recurrences. Radiation harm to the retina, optic nerve, and lens could be challenging to manage. External beam radiotherapy could induce a second cancer in the area of irradiation. This modality, restricted to a handful of facilities world broad, has been demonstrated to administer radiation plans with the least exposure to close by structures. In concept, more focused radiation should be related to decrease charges of radiation-induced tumor, however this has yet to be demonstrated. The ideal dose for adjuvant and salvage radiation remedy following primary chemotherapy is under investigation with centers using doses ranging from 20 Gy to forty five Gy. The long-term secondary tumor risk related to exterior beam radiation was a significant component in promoting systemic chemotherapy as a main modality. This improvement during the Nineteen Nineties led many clinicians to make the most of exterior radiation in one of two strategies. Some administered it as a salvage method for those failing primary chemotherapy. With this approach, external radiation could be delayed and administered at an older age, when the danger of radiationinduced tumors was thought to be lower (particularly after 12 months). While now not a primary modality, the sensitivity of retinoblastoma to radiation makes it an essential therapy choice for resistant and challenging cases; it should remain a critical possibility for any middle managing patients with retinoblastoma. Plaque Radiotherapy Plaque radiotherapy is a form of brachytherapy by which a radioactive implant is placed on the sclera over the bottom of a retinoblastoma with the intent of irradiating the tumor transsclerally. The use of plaque radiotherapy is proscribed to tumors 16 mm in base and 8 mm in thickness. Effective remedy requires an average of 2 to 4 days of remedy time to deliver the entire dose of 4,000 cGy to the apex of the tumor. The visible consequence for the patient varies with tumor measurement and site as properly as related radiation toxicity, which can embody retinopathy or papillopathy. Positive visible outcomes have been reported in 62% of patients; the measured vision was 20/20 to 20/30 in over half the instances. In an effort to keep away from these problems with chemotherapy-treated patients, the tumor apex dose has been decreased to three,500 cGy and radiation plaque therapy is delayed for at least 1 month after the kid has discontinued chemotherapy. Innovations with customized design of plaques, particularly those for small tumor recurrences, have also assisted in avoiding radiation retinopathy. Because of using focal, shielded radiation fields, plaque radiotherapy has not yet been found to be related to induction of second cancers. Advances in episcleral brachytherapy have additionally improved outcomes for children with retinoblastoma. Combined Radiotherapy and Chemotherapy In three separate research, patients presenting with Reese-Ellsworth eye group V retinoblastoma treated with radiotherapy alone have had 10%, 29%, and 66% of their eyes salvaged. Taken together these information suggest that, for patients with retinoblastoma group V disease, the mixture of chemotherapy with external beam radiotherapy might result in a superior salvage fee than with radiotherapy alone. Chemotherapy regimens previously included carboplatin, etoposide, and vincristine. Cyclosporine has been used with the above regimen in an attempt to enhance outcomes by reversing multidrug resistance. The use of etoposide, an epipodophyllotoxin, has been related to second malignancies in patients with leukemia and non-Hodgkin lymphoma. However, the schedule and the cumulative dose of etoposide used in many of the treatment regimens for retinoblastoma are different from those implicated within the reported incidence of second malignancies. Treatment of Systemic Retinoblastoma Treatment of extraocular retinoblastoma requires a mixed therapeutic strategy utilizing both chemotherapy and radiotherapy. Scleral involvement, orbital or bony involvement, involvement beyond the cut finish of the optic nerve, metastatic disease involving brain or different sites, and trilateral retinoblastoma-all these require an aggressive mixed therapeutic method. One regimen is the three-drug regimen together with vincristine, carboplatin, and etoposide, just like the chemoreduction routine mentioned above however with a much longer course of 6 to 18 months relying on the medical response. In different international locations, sufferers might present with more advanced retinoblastoma, including orbital involvement. For these patients, exenteration, chemotherapy, and exterior beam radiotherapy are essential for survival. Use of more advanced exenteration methods, such because the eyelid-sparing exenteration, allows for rapid healing of the wound. The illness is very fatal regardless of aggressive therapy with chemotherapy, radiation therapy, and gamma knife therapy. Longer survival has been correlated with earlier tumor diagnosis in asymptomatic patients. Trilateral retinoblastoma is a serious reason for mortality in children inside 5 years of diagnosis of bilateral retinoblastoma. Clinically, three kinds of regression patterns have been described in tumors which have undergone remedy: type 1 (cottage cheese), type 2 (fish flesh), or sort 3 (combined). In one research, 5 sufferers with sporadic bilateral retinoblastoma underwent deliberate enucleation of their functionally blind eye after two, three (in two patients), 4, or six programs of main chemotherapy with carboplatin, etoposide, cyclophosphamide, and vincristine. The eyes have been examined histopathologically using mild microscopy and immunohistochemical evaluation with proliferation markers. One affected person had a sort 1 (cottage cheese) regression and 4 sufferers had either a kind 2 (fish flesh) or a type 3 (combined) regression pattern. The remaining three patients with sort 2 or type three regressions had histological evidence of actively proliferating tumor cells after two, three, or six programs of chemotherapy. This report confirms histopathologically the clinically described efficacy of major chemotherapy within the therapy of retinoblastoma. Patients with retinoblastoma which have undergone chemotherapy and radiotherapy sometimes are left with tumors with massive areas of fossilized cells and calcification, with areas of photoreceptor differentiation much like retinocytoma.

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Tunneled central vascular catheter placement in pediatric oncology patients has been related to a decrease fee of an infection and mechanical problems when carried out by image-guided radiology strategies than by surgery. In some instances, excessive doses can induce skin erythema, desquamation, and epilation. These deterministic results may not current for as a lot as several weeks after the irradiation. Patients receiving greater than three Gy skin entrance dose ought to be recognized and requested to return for a follow-up examination in 30 days to monitor for these results. Pediatric oncology patients endure repeated diagnostic radiology studies during the course of their disease, and interventional radiology procedures are a potential contributor to giant cumulative radiation exposures in these patients. This includes detection of situations requiring emergent or pressing treatment, diagnosis, staging of disease burden and extent for risk stratification, determination of optimal remedy, and evaluation of response to antitumor therapy. Imaging also serves as a method of surveillance for tumor relapse and complications of therapy. Details of the diagnostic imaging of particular tumors are mentioned in other chapters of this text. Some basic guidelines for the diagnostic imaging of kids with malignancies are offered at this juncture. Detection of Conditions Requiring Emergent or Urgent Treatment Although prompt initiation of tumor-specific remedy is a crucial objective in treating pediatric malignancies, particularly tumors that grow rapidly, some sufferers current with situations identified by imaging that require pressing or emergent management before definitive diagnostic workup and tumor-specific remedy. Airway obstruction may end up from pharyngeal, neck, or thoracic tumors, and substantial narrowing of the airway can happen without signs of respiratory compromise throughout respiratory at relaxation. Life-threatening higher airway obstruction during common anesthesia or heavy sedation is a possible complication of a big anterior mediastinal mass, most commonly P. Those at excessive threat could be directed towards much less invasive interventional radiology procedures requiring solely local anesthesia, or steroids may be administered to shrink sure mediastinal plenty prior to common anesthesia or deep sedation. Although not essentially requiring emergent therapy, occlusion or narrowing of the brachiocephalic veins, subclavian veins, or inside jugular veins by an adjacent mass is important to notice on imaging, as a result of this may affect the strategy to placement of a central vascular catheter, which many pediatric oncology sufferers require for treatment. An axial image from a head computed tomography examination obtained without contrast shows hemorrhagic infarction in the proper frontal lobe (arrow) consequent to incomplete sagittal sinus and cortical venous thrombosis. Such an intussusception may be troublesome to treat by way of fluoroscopy-guided pneumatic or hydrostatic discount. Detection of urinary tract obstruction by imaging prior to remedy permits remedial measures corresponding to dialysis or urinary diversion to be instituted. Although not always attainable by imaging, differentiating among the many etiologies of vascular occlusion influences the choice about whether anticoagulation ought to be instituted. Tumor involvement of significant weight-bearing sites, such because the proximal femurs, acetabulae, or vertebrae, or websites uncovered to important distractive forces, such as the proximal humeri, portends a danger of pathologic fracture. The telangiectatic form of osteosarcoma is associated with a very excessive fee of pathologic fracture. Anteroposterior (A) and lateral (B) chest radiographs reveal a big anterior mediastinal mass lesion displacing the guts leftward and compressing and displacing the airway (arrowheads). An axial contrast-enhanced computed tomography picture (C) depicts a blended strong and cystic mass containing fats (asterisk) and calcification (arrow), characteristic of a teratoma. Small intraparenchymal hemorrhages are sometimes the initial manifestation of acute childhood leukemia. Spot image (B) obtained throughout tried hydrostatic reduction with water-soluble distinction reveals a big filling defect in the colon (arrow) representing the intussusceptum within the intussuscipiens. Astrocytomas, ependymomas, and gangliogliomas compose the vast majority of intramedullary tumors. Coronal contrast-enhanced computed tomography image shows marked biliary ductal dilatation (black arrow) as a result of biliary obstruction by a pancreas head mass (white arrows). Extracranial Head and Neck Tumors Most neck lots in children are of a congenital or inflammatory nature quite than neoplastic, and the optimum imaging strategy depends on the most likely etiology of the mass, as determined by scientific analysis. The location of the mass and the character of the mass as solid or cystic are key components in formulating an applicable differential diagnosis. Ultrasound is especially helpful in determining whether a mass is cystic or strong. Branchial cleft cysts and thymopharyngeal duct cysts are more laterally positioned and have characteristic positions in relation to the neck musculature and vasculature. A congenital neck mass with stable and cystic components is most commonly a teratoma. Axial contrast-enhanced computed tomography photographs show a big left renal tumor (asterisk) with plentiful ascites (A), intracaval tumor thrombus (asterisk), and diminished enhancement of the posterior facet of the liver consequent to hepatic venous obstruction (B), as properly as proper atrial tumor thrombus (asterisk) and huge bilateral pleural effusions (C). The two commonest solid malignant tumors in the extracranial head and neck in youngsters are lymphoma and rhabdomyosarcoma. Nasopharyngeal carcinoma is rare in youngsters and tends to be locally superior on the time of clinical presentation. A mass within the anterior or inferior periauricular area can represent a parotid gland tumor. To avoid misdiagnosis of infiltrative parotid tumor, you will need to recognize the progressive fatty infiltration that usually occurs as youngsters age. An accent parotid gland may be confused for a neoplastic mass, but knowledge of its typical location (superficial to the masseter muscle and anterior to the principle parotid gland) may help keep away from this error. Most frequently, this mass represents reactive hyperplasia or lymphadenitis associated to head and neck infections. Fibromatosis colli classically presents as a mass alongside the anterior neck in the course of the first few weeks to months after birth, usually in affiliation with torticollis. Sonographic demonstration of a heterogeneously echoic mass-like swelling along the sternocleidomastoid muscle and a normal appearance of the adjacent soft tissues assist verify the analysis of fibromatosis P. Axial gadolinium-enhanced T1-weighted magnetic resonance picture (A) reveals a soft tissue mass (asterisk) asymmetrically occupying the nasopharynx and invading the skull base. Petroclival sphenoid bone destruction (arrows) is best depicted on an axial computed tomography picture at bone windows (B). Vascular malformations and vascular tumors are a typical explanation for an extracranial head or neck mass. Vascular malformations are classified on the idea of their endothelial traits as arterial, capillary, venous, lymphatic, or combined. The finding of phleboliths within a lesion also helps establish a analysis of venous malformation. Hemangiomas of infancy are vascular tumors that seem during early infancy, endure a proliferative section, and then involute. Most hemangiomas of infancy occur in the cervicofacial area and have an especially excessive incidence in premature infants of low birth weight. Congenital hemangiomas are vascular tumors that come up in utero and postnatally may be quickly involuting or noninvoluting. Kaposiform hemangioendotheliomas are pediatric vascular tumors which would possibly be histologically intermediate between hemangiomas and angiosarcomas and are responsible for most cases of Kasabach-Merritt syndrome with profound thrombocytopenia. Neck irradiation for a childhood malignancy is a threat factor for development of thyroid carcinoma. Tiny cysts inside the thyroid are frequently seen and often characterize benign colloid cysts. Thyroid scintigraphy can be of limited worth in distinguishing benign and malignant thyroid nodules, as a result of not all malignant nodules are "chilly," and solely 20% of chilly nodules in kids are malignant.

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Planning a Clinical Trial Objectives the first step in planning a medical trial is to outline the objectives clearly. For instance, the major objective may be "to check the event-free survival of patients with leukemia receiving greatest current remedy with or without New Drug X. The outcomes of the medical trial are based on analyses of the buildup of end level assessments, the criteria which have been predetermined by the investigator. A well-constructed protocol incorporates end factors which might be objective, sensible, and related to the clinical situation beneath study. By defining finish factors, the researcher signifies precisely which measures of end result reliably meet the objectives of the protocol. These objectives help in clarifying what medical and laboratory data need to be obtained in the course of the trial and provide the idea for statistical analysis. Trial Design Cancer clinical trials are conventionally categorized into three varieties. Phase 1 Trials: Specific Designs the objective of a section 1 trial or dose-finding study7 is to select a dose to carry ahead to further evaluation, the so-called beneficial phase 2 dose, which is used here synonymously with the "most tolerated dose". It is generally assumed that both efficacy and toxicity enhance with dose, so the objective is to choose the very best tolerable dose with the concept this can have the very best probability of efficacy. Common definitions and standards are necessary to ensure comparability across studies. Often, a modified Fibonacci scheme is used to determine the degrees for successive cohorts. The diminishing proportion increase reflects increasing caution as one turns into farther faraway from the beginning dose. An alternate version of this scheme is to double the dose till "biologic exercise," such as gentle myelosuppression, is observed, then to institute the diminishing increases of the Fibonacci series. Dose escalation often continues in children past the phase 2 dose established for adults, as a outcome of children usually display greater tolerance to chemotherapy. The algorithmic designs, which embody 3 + 3-like designs and accelerated titration designs, are characterized by prespecified deterministic guidelines that govern dose escalation or deescalation. In children, a modification of the 3 + 3 known as the "rolling 6" 20,21 has been developed to lower trial duration without increasing the chance of toxicity. That is, within the three + three, in essence, only the current dose degree data is considered in determining the next dose level; information from different dose levels which have already been studied are ignored. Either chance or Bayesian methods are used to frequently update the expected chance of toxicity primarily based on the experience noticed up to that point within the research. Phase 1 Trials: Sample Size, Subject Population, and Reporting Sample sizes for section 1 trials typically range from 15 to 40 subjects and are pushed by the number of dose ranges studied and the variety of topics at every stage. Thus, a research with five dose ranges using a 3 + 3 design would enroll at most 30 topics, though it could conceivably be far fewer. It is frequent to perform pharmacokinetic research as part of part 1 trials, and people outcomes ought to be summarized. For agents which have already been properly studied in adults, pediatric phase 1 pharmacokinetic research might have restricted or sparse sampling. Although incessantly omitted, details of the design should be included in stories of phase 1 trials. Phase 2 Trials: Objectives and End Points the primary objective of a "normal" phase 2 trial is to decide whether or not the new agent(s) is(are) sufficiently promising to warrant additional study, often by evaluating the new remedy with a prespecified normal or historic control. More recently, questions addressed by section 2 studies have become significantly extra various with objectives ranging from dose refinement and analysis of early evidence of efficacy to choice of biomarker outlined subgroups to definitive comparison. Although the gold commonplace for analysis of clinical profit in oncology is improvement in total survival, this is hardly ever a feasible outcome in section 2 trials. It takes too long, and research agent results are more likely to be confounded, with effects of subsequent therapies rendering the survival results uninterpretable. More just lately, dissatisfaction with the loss of data due to categorization has resulted within the suggestion to deal with response as a continuous variable,35,36 although this concept continues to be fairly controversial. One disadvantage, nevertheless, is that small early differences in tumor measurement could not replicate clinically significant results, maybe lowering an already low bar for calling a remedy "lively," with the danger that these sorts of section 2 studies will predict part 3 success even much less well than these utilizing the item response price to decide drug exercise. In addition, correct measurement of small adjustments in tumor size is notoriously troublesome, and even small errors might significantly bias results. Other commonly used end factors in phase 2 studies embody time to tumor progression (where deaths not as a result of cancer are censored), progression-free survival (where deaths not due to cancer are events), overall survival, high quality of life, change in molecular biomarkers, and change in useful imaging. Phase 2 Trials: Specific Designs-Single Arm Most part 2 trials use a binary or categorical outcome and include only a single arm or illness cohort. In pediatric studies, several completely different diagnoses may be included, with the agent evaluated individually in every one. The design could be based mostly on attaining a sure confidence interval or a more formal take a look at of speculation, often chosen to have good power however more relaxed one-sided kind I error rates. Acceptably high nontoxicity fee Probability of retaining a toxic drug 10% 10% 10% 10% 10% 30% 5% 30% 5% 30% 5% 30% 5% 30% 5% - - - - 60% - - - - - - - - 80% 10% Probability of retaining a "good" drug Sample sizes and choice guidelines 85% 85% 85% 85% 85% N first stage Responses required to proceed to second stage "Nontoxicities" required to continue to second stage - - 18 3 13 2 eleven 2 19 3 - - - - thirteen N Responses required to conclude in favor of drug "Nontoxicities" required to conclude in favor of drug Expected N when drug is unhealthy (or too toxic) 27 6 27 6 28 6 35 7 forty three 8 - - - - 30 27 20. Sample sizes are sometimes conservatively estimated utilizing a dichotomization method (see earlier), and sample dimension estimation is just like that used for response. There are quite a few variations with numerous optimization schemes,forty,46,47,forty eight consideration of ordinal response,forty nine early illness progression and response,50 or survival as the first outcome. Simon outlined two approaches: minimizing the maximum sample size (minimax) and minimizing the "expected" pattern size when the response rate is poor (optimal). In our instance, the optimal design pattern is about 25% bigger than the minimax, but the first stage is significantly smaller, possibly allowing an early choice with fewer subjects. Bayesian approaches to phase 2 trials have been described that incorporate prior data and frequently replace the estimated probability of response based on the accumulating observations. Finally, toxicity info obtainable after part 1 may be based mostly on very restricted pattern measurement. Although toxicity is at all times monitored in part 2 research and early stopping or pausing might considered on an advert hoc basis, it might be prudent to incorporate extra formal guidelines for early stopping in the face of extreme toxicity. The strategy assumes that toxicity and response are approximately independent and has been proven to have fairly robust efficiency. Because most childhood cancers are treatable at prognosis with better-characterized therapies, however, most early phase trials require that there not be recognized curative therapy obtainable for potential subjects. One technique to improve the generalizability of results of section 2 studies is to perform a brief section 2 examine in sufferers before normal therapy begins. Formal comparability amongst interventions is mostly performed in randomized section 3 trials, mentioned in detail later. Recently, however, the will to examine outcomes earlier has led to growth of randomized part 2 designs. The concept is controversial, with some arguing that multiple randomized arms must be used sparingly,15 while others argue that randomization is needed for better, extra dependable conclusions. Second, randomization to a quantity of experimental remedies or a management has been proposed as a approach to validate the historical management data used to design the trial. In each the first and second case, individual arms are normally designed using single arm approaches.

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Human erythrocyte thiopurine methyltransferase: radiochemical microassay and biochemical properties. Genetic variation in response to 6-mercaptopurine for childhood acute lymphoblastic leukemia. Thiopurine drugs in the treatment of childhood leukaemia: the influence of inherited thiopurine methyltransferase activity on drug metabolism and cytotoxicity. Pharmacogenetics during standardised initiation of thiopurine remedy in inflammatory bowel disease. Inosine triphosphate pyrophosphatase and thiopurine S-methyltransferase genotypes relationship to azathioprineinduced myelosuppression. Genetic polymorphism of inosine triphosphate pyrophosphatase is a determinant of mercaptopurine metabolism and toxicity during remedy for acute lymphoblastic leukemia. Is maintenance chemotherapy in acute lymphoblastic leukemia being optimally delivered Oral 6-mercaptopurine in childhood leukemia: parent drug pharmacokinetics and energetic metabolite concentrations. Pharmacokinetic determinants of 6-mercaptopurine myelotoxicity and therapeutic failure in youngsters with acute lymphoblastic leukemia. Inhibition of first-pass metabolism in cancer chemotherapy: interplay of 6-mercaptopurine and allopurinol. Childhood leukemia: a relationship between intracellular 6-mercaptopurine metabolism and neutropenia. Variable mercaptopurine metabolism and treatment outcome in childhood lymphoblastic leukemia. Mercaptopurine metabolism and threat of relapse in childhood lymphoblastic leukemia. Is 6-thioguanine extra acceptable than 6-mercaptopurine for youngsters with acute lymphoblastic leukemia Thioguanine versus mercaptopurine for remedy of childhood lymphoblastic leukaemia: a comparability of haematological toxicity and drug metabolite concentrations. Pharmacokinetics and metabolism of thiopurines in kids with acute lymphoblastic leukemia receiving 6-thioguanine versus 6-mercaptopurine. Leucocyte versus erythrocyte thioguanine nucleotide concentrations in children taking thiopurines for acute lymphoblastic leukaemia. Portal hypertension develops in a subset of children with standard danger acute lymphoblastic leukemia handled with oral 6thioguanine during upkeep remedy. Chronic hepatotoxicity following 6-thioguanine therapy for childhood acute lymphoblastic leukaemia. Genetic polymorphism of thiopurine methyltransferase and its scientific relevance for childhood acute lymphoblastic leukemia. Pharmacogenetics of acute azathioprine toxicity: relationship to thiopurine methyltransferase genetic polymorphism. Altered mercaptopurine metabolism, toxic effects, and dosage requirement in a thiopurine methyltransferase-deficient child with acute lymphocytic leukemia. Congenital thiopurine methyltransferase deficiency and 6-mercaptopurine toxicity throughout remedy for acute lymphoblastic leukemia. Thiopurine methyltransferase deficiency in childhood lymphoblastic leukaemia: 6-mercaptopurine dosage methods. Possible carcinogenic effect of 6-mercaptopurine on bone marrow stem cells: relation to thiopurine metabolism. Etoposide and antimetabolite pharmacology in sufferers who develop secondary acute myeloid leukemia. Clinical and experimental pharmacokinetic interplay between 6-mercaptopurine and methotrexate. Pharmacokinetics of 2-F-ara-A (9-beta-D-arabinofuranosyl-2-fluoroadenine) in cancer sufferers during the section I clinical investigation of fludarabine phosphate. Modulation of arabinosylnucleoside metabolism by arabinosylnucleotides in human leukemia cells. Fludarabine infusion potentiates arabinosylcytosine metabolism in lymphocytes of patients with chronic lymphocytic leukemia. Modulation of arabinosylcytosine metabolism by arabinosyl-2-fluoroadenine in lymphocytes from sufferers with chronic lymphocytic leukemia: implications for mixture therapy. Nonmyeloablative allogeneic stem cell transplantation for the treatment of persistent myeloid leukemia in first chronic section. Experience with 2-chlorodeoxyadenosine in beforehand untreated children with newly identified acute myeloid leukemia and myelodysplastic ailments. Treatment of youngsters with Langerhans cell histiocytosis with 2-chlorodeoxyadenosine. Pharmacokinetics of cladribine (2-chlorodeoxyadenosine) in youngsters with acute leukemia. Phase I scientific and pharmacology research of clofarabine in sufferers with stable and hematologic cancers. Pharmacokinetics and pharmacodynamics of plasma clofarabine and cellular clofarabine triphosphate in patients with acute leukemias. Clofarabine, a novel nucleoside analog, is active in pediatric sufferers with superior leukemia. Differential metabolism of 9-beta-D-arabinofuranosylguanine in human leukemic cells. Metabolism and selective cytotoxicity of 9-beta-D-arabinofuranosylguanine in human lymphoblasts. Phase I examine of 506U78 administered on a consecutive 5-day schedule in youngsters and adults with refractory hematologic malignancies. Recruitment of quiescent tumor by humoral stimulatory activity: requirement for successful chemotherapy. Recombinant human granulocyte-macrophage colony-stimulating factor together with standard induction chemotherapy in de novo acute myeloid leukemia. Simultaneous administration of granulocyte-macrophage colony-stimulating issue and cytosine arabinoside for the remedy of relapsed acute myeloid leukemia. Standard and low-dose chemotherapy for the treatment of myelodysplastic syndromes. The pharmacokinetics of cytosine arabinoside in the plasma and cerebrospinal fluid during typical and high-dose therapy. A clinical�pharmacological comparison of hepatic arterial and peripheral vein infusion of cytarabine for liver most cancers [abstract]. Alterations of the pharmacokinetics of high-dose ara-C by its metabolite, excessive ara-U in sufferers with acute leukemia. Continuous infusion high-dose cytosine arabinoside in refractory childhood leukemia.

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Primary metastatic osteosarcoma: presentation and consequence of patients treated on neoadjuvant Cooperative Osteosarcoma Study Group protocols. Improved prognosis of kids with osteosarcoma metastatic to the lung(s) on the time of prognosis [published erratum seems in Cancer 1993;71(9):2879]. Metastases detected on the time of prognosis of main pediatric extremity osteosarcoma at prognosis: imaging options. Skip metastases in osteosarcoma: expertise of the cooperative osteosarcoma study group. Prognostic significance of serum alkaline phosphatase in osteosarcoma of the extremity handled with neoadjuvant chemotherapy: latest expertise at Rizzoli Institute. Prognostic significance of serum alkaline phosphatase measurements in patients with osteosarcoma treated with adjuvant or neoadjuvant chemotherapy. Predictive factors of disease-free survival for non-metastatic osteosarcoma of the extremity: an analysis of 300 sufferers treated at the Rizzoli Institute. Radiological appearances of appendicular osteosarcoma: a complete pictorial review. Computed tomography of pulmonary metastases from osteosarcoma: the much less poor method. Midcourse thallium-201 scintigraphy to predict tumor response in bone and soft-tissue tumors. Thallium-201 scintigraphy for the analysis of tumor response to preoperative chemotherapy in patients with osteosarcoma. Dynamic magnetic resonance imaging of regional contrast entry as a further prognostic consider pediatric osteosarcoma. Positron emission tomography for staging of pediatric sarcoma sufferers: outcomes of a prospective multicenter trial. Positron emission tomography/computed tomography with 18fluoro-deoxyglucose within the detection of native recurrence and distant metastases of pediatric sarcoma. Comparison of fantastic needle aspiration cytology and needle core biopsy within the diagnosis of radiologically detected stomach lesions. Tissue dealing with and specimen preparation in surgical pathology: issues in regards to the recovery of nucleic acids from formalin-fixed, paraffin-embedded tissue. Effect of time to resumption of chemotherapy after definitive surgical procedure on prognosis for non-metastatic osteosarcoma. Results of free vascularized fibula grafting for allograft nonunion after limb salvage surgical procedure for malignant bone tumors. Massive allografts within the therapy of osteosarcoma and Ewing sarcoma in kids and adolescents. Limb salvage with osteoarticular allografts after resection of proximal tibia bone tumors. Osteoarticular allografts for reconstruction after resection of a musculoskeletal tumor in the proximal finish of the tibia. Osteoarticular allografts for reconstruction in the proximal a half of the humerus after excision of a musculoskeletal tumor. The outcomes of transplantation of intercalary allografts after resection of tumors. Treatment of tibial defects and nonunions using ipsilateral vascularized fibular transposition. Massive osteoarticular allografts in the reconstruction of extremities following resection of tumors not requiring chemotherapy and radiation. Endoprosthetic reconstruction for the treatment of musculoskeletal tumors of the appendicular skeleton and pelvis. Influence of chemotherapy on perioperative complications in limb salvage surgical procedure for bone tumors. Prosthetic survival and scientific results with use of large-segment replacements in the treatment of high-grade bone sarcomas. Antibiotic prophylaxis and an infection resistance of massive tumor endoprostheses throughout chemotherapy. The bioexpandable prosthesis: a brand new perspective after resection of malignant bone tumors in kids. Expandable endoprosthetic reconstruction of the skeletally immature after malignant bone tumor resection. Non-invasive distal femoral expandable endoprosthesis for limbsalvage surgical procedure in paediatric tumours. Expandable endoprosthesis reconstruction in skeletally immature patients with tumors. Use of extendable complete femoral replacements in youngsters with malignant bone tumors. Extramedullary porous coating to prevent diaphyseal osteolysis and radiolucent lines round proximal tibial replacements. Effect of chemotherapy on preliminary compressive osseointegration of tumor endoprostheses. Massive allograft implantation following radical resection of highgrade tumors requiring adjuvant chemotherapy therapy. Reconstruction for defects of the proximal part of the femur utilizing allograft arthroplasty. An analysis of perform and outcome evaluating allograft and prosthetic reconstructions. Evaluation of the allograft-prosthesis composite method for proximal femoral reconstruction after resection of a primary bone tumour. Function after amputation, arthrodesis, or arthroplasty for tumors concerning the shoulder. Resection-arthrodesis for malignant and potentially malignant lesions concerning the knee using an intramedullary rod and native bone grafts. Reconstruction of the proximal humerus after extensive extraarticular resection for osteosarcoma: a report of two circumstances with clavicula pro humero reconstruction. Reconstruction of the pelvis after resection of malignant bone tumours in youngsters and adolescents. Reconstruction using the saddle prosthesis following excision of major and metastatic periacetabular tumors. Pelvic reconstruction with a structural pelvic allograft after resection of a malignant bone tumor. The use of hemipelvic allografts or autoclaved grafts for reconstruction after wide resections of malignant tumors of the pelvis. Treatment outcome of pelvic sarcomas in younger kids: orthopaedic and oncologic analysis. Functional results and high quality of life after therapy of pelvic sarcomas involving the acetabulum. Hip transposition as a common surgical procedure for periacetabular tumors of the pelvis.

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