Biosimilar granulocyte-colony-stimulating factor for healthy donor stem cell mobilization: need we be afraid?

Biosimilars are approved biologics with comparable quality, safety, and efficacy to a reference product. Unlike generics, which are chemically manufactured copies of small-molecule drugs with relatively simple chemical structures, the biosimilar designation is applied to drugs that are produced by living organisms, implying much more difficult to control manufacturing and purification procedures. To account for these complexities, the European Medicines Agency (EMA), the US Food and Drug Administration, the Australian Therapeutic Goods Administration, and other regulatory authorities have devised and implemented specific, markedly more demanding pathways for the evaluation and approval of biosimilars.

Pediatric Polytrauma Management.

Caring for pediatric trauma patients requires an understanding of the distinct anatomy and pathophysiology of the pediatric population compared to adult trauma patients. Initial evaluation, management, and resuscitation are performed as a multidisciplinary approach including pediatric physicians, trauma surgeons, and pediatric intensive care physicians. Head injury severity is the principle determinant of outcome and mortality in polytraumatized children.

Sonic hedgehog acts as a negative regulator of {beta}-catenin signaling in the adult tongue epithelium.

Wnt/beta-catenin signaling has been implicated in taste papilla development; however, its role in epithelial maintenance and tumor progression in the adult tongue remains elusive. We show Wnt/beta-catenin pathway activation in reporter mice and by nuclear beta-catenin staining in the epithelium and taste papilla of adult mouse and human tongues. beta-Catenin activation in APC(min/+) mice, which carry a mutation in adenomatous poliposis coli (APC), up-regulates Sonic hedgehog (Shh) and Jagged-2 (JAG2) in the tongue epithelium without formation of squamous cell carcinoma (SCC).

Growth of the orbit after frontoorbital advancement using nonrigid suture vs rigid plate fixation technique.

Purpose: To demonstrate whether a measurable difference occurs on the growth of the orbit when using 2 forms of stabilization of the supra-orbital rim after upper orbital osteotomy in children with craniosynostosis. The 2 methods of fixation include sutures providing nonrigid fixation and titanium or resorbable osteosynthesis plates.

Patients And Methods: In this prospective randomized study, the influence of the mentioned fixation materials was analyzed in a tertiary care center (university hospital).

Positive sentinel lymph nodes are a negative prognostic factor for survival in T1-2 oral/oropharyngeal cancer-a long-term study on 103 patients.

Background: To evaluate prognostic value of sentinel node biopsy (SNB) in oral/oropharyngeal squamous cell cancer (OOSCC) concerning overall/disease-free survival.

Methods: One hundred three consecutive patients with T1-2N0 OOSCC were consecutively recruited for SNB as single invasive staging method for the neck. Two hundred seventy-three sentinel nodes (SNs) were removed (mean, 2.

Er:YAG laser osteotomy for intraoral bone grafting procedures: a case series with a fiber-optic delivery system.

Background: With a wavelength of 2.94 mum, the erbium-doped:yttrium, aluminum, and garnet (Er:YAG) laser is suitable for cutting vital osseous tissue. To analyze the benefit of laser osteotomy in implant dentistry, a fiber-guided Er:YAG laser was used for harvesting intraoral bone grafts.

A CT-free, intra-operative planning and navigation system for minimally invasive anterior spinal surgery - an accuracy study.

Objective: A comprehensive study was performed to evaluate the accuracy of a newly developed CT-free, intra-operative planning and navigation system for anterior spine surgery.

Materials And Methods: Instruments and an image intensifier were tracked using the SurgiGATE navigation system. A laboratory study was performed on 27 plastic vertebrae.

Er:YAG laser osteotomy based on refined computer-assisted presurgical planning: first clinical experience in oral surgery.

Objective: This case report was aimed at primary clinical experience concerning surgical extraction of a displaced tooth with the help of the Er:YAG laser based on refined computer-assisted presurgical planning.

Methods: The case refers to the extraction of a displaced maxillary canine in a female patient. For the osteotomy, a pulsed Er:YAG laser was applied with pulse energy of 500 mJ, pulse duration of 250 microsec and pulse frequency of 12 Hz.

Head and neck squamous cell carcinoma: sentinel node or selective neck dissection.

Improved knowledge about the metastatic behavior of mucosal squamous cell cancer of the head and neck made it possible to reduce the extension of elective and even therapeutic neck dissections by sparing selected levels, thereby reducing morbidity. The diagnostic question of when to treat a clinically negative neck to avoid unnecessary overtreatment, even through selective neck dissections, might be answered with sentinel lymph node biopsy. A thorough and sophisticated evaluation of this technique is necessary when defining suited patients.

The diagnostic role of radioactivity in sentinel nodes in oral and oropharyngeal cancer.

Sentinel lymph node biopsy (SNB), using radioactive tracers, is a novel, interesting tool in the staging of patients with oral and oropharyngeal squamous-cell carcinoma (OOSCC), which could lead to a reduced rate of elective neck dissections. The aim of the study was to evaluate the ranking of measured radioactivity in the sentinel lymph nodes (SLNs) and to correlate these findings with histopathological results to assess the number of SLN being sufficient for exact staging of the neck. In 77 consecutive patients with T1-4 OOSCC clinically and positron emission tomography-staged N0, between 15 and 55 MBq of Tc- 99m-labeled albumin-microcolloids were injected peritumorally and 213 SLNs were excised by small skin incisions using a gamma probe 2-3 hours later.

Response to intraarterial induction chemotherapy: a prognostic parameter in oral and oropharyngeal cancer.

Background: Patients with head and neck cancer and good pathologic response to neoadjuvant systemic induction chemotherapy have a better prognosis for survival than do those with stable or progressive disease. Thus, induction chemotherapy could theoretically help in stratifying further treatment, but toxicity is much too high. The prognostic implication of superselective intraarterial high-dose cisplatin administered by a femoral approach, which has much less toxicity, is not yet known.

Maximized combined modality treatment of an unselected population of oral and oropharyngeal cancer patients. Final results of a pilot study compared with a treatment-dependent prognosis index.

Background: In an attempt to raise the survival of an unselected and representative population of oral and oropharyngeal squamous cell cancer patients, a pilot study of an integrated four-modality treatment was conceived. Final endpoints were compliance, loco-regional control, survival (after complete 5-year follow-up), and a concept of trial assessment using the treatment-dependent prognostic index TPI.

Patients: Eighty-seven consecutive patients with histologically proven untreated stages I-IV disease presented in the period between 1997 and 1999 of whom 14 had to be considered uncurable and 73 were fit to be treated with the intention of achieving a cure.

Intra-arterial high-dose chemotherapy with cisplatin as part of a palliative treatment concept in oral cancer.

Background And Purpose: Patients with cancer of the oral cavity often present with advanced tumor stages, distant metastasis, or severe comorbidities, which render radical surgery unfeasible. The purpose of this study was to investigate the response rate, technical feasibility, and safety of intra-arterial (IA) chemotherapy as palliative treatment in this situation.

Methods: From November 1997 to December 2003, 64 patients with histologically proven oral squamous cell carcinoma, classified as inoperable, received IA high-dose chemotherapy with cisplatin as a palliative treatment at our institution.

Sentinel node biopsy as staging tool in a multimodality treatment approach to cancer of the oral cavity and the oropharynx.

Objectives: Feasibility of sentinel lymph node (SLN) biopsy in head and neck cancer as a staging tool embedded in a multimodality regimen including neoadjuvant intraarterial chemotherapy.

Study Design And Setting: 39 patients with oral and anterior oropharyngeal cancer classified N0 by [18 F]FDG-PET underwent SLN scintigraphy. Selective SLN biopsy without elective neck dissection (ND) was performed, immediately followed by radical resection of the primary tumor.

Positron emission tomography in combination with sentinel node biopsy reduces the rate of elective neck dissections in the treatment of oral and oropharyngeal cancer.

Purpose: To assess the impact of a diagnostic ladder including [(18)F]fluorodeoxyglucose positron emission tomography (PET) and lymphoscintigraphy guided sentinel node biopsy (LS/SNB) on neck treatment in patients with oral and oropharyngeal squamous cell carcinoma (OOSCC).

Patients And Methods: Prospectively, 62 patients with resectable T1-3 OOSCC underwent computed tomography (CT) and PET. Patients without neck uptake in PET were defined as cN0 and were accrued for LS/SNB.

Intra-arterial induction high-dose chemotherapy with cisplatin for oral and oropharyngeal cancer: long-term results.

Intra-arterial (IA) chemotherapy for curative treatment of head and neck cancer experienced a revival in the last decade. Mainly, it was used in concurrent combination with radiation in organ-preserving settings. The modern method of transfemoral approach for catheterisation, superselective perfusion of the tumour-feeding vessel, and high-dose (150 mg x m(-2)) administration of cisplatin with parallel systemic neutralisation with sodium thiosulphate (9 g x m(-2)) made preoperative usage feasible.

Postoperative chemotherapy with cisplatin and 5-fluorouracil in cancer of the oral cavity and the oropharynx--long-term results.

Adjuvant chemotherapy has not yet been proven to have a survival benefit for patients with head and neck cancer. Studies dealing with this topic have had several faults like mingling tumor localizations and treatment modalities. To re-examine the role of postoperative chemotherapy in oral cavity cancer, a single-center study was conducted with the attempt to have higher homogeneity.

Long-term complete remission of oral cancer after anti-neoplastic chemotherapy as single treatment modality: role of local chemotherapy.

The impact of intra-arterial local chemotherapy on squamous cell carcinomas of the oral cavity is doubtful when considering long-term survival, especially in cases of nodal involvement. But even in patients with strictly local disease it is not possible to determine the effect of intra-arterial chemotherapy because it is mainly used as a neoadjuvant treatment modality. In the present paper, long-term courses of two patients are described who refused any further treatment after one cycle of intra-arterial chemotherapy with cisplatin followed by systemic chemotherapy with 5-fluorouracil and one cycle of intra-arterial chemotherapy with high-dose cisplatin, respectively.

Monocomponent chemoembolization in oral and oropharyngeal cancer using an aqueous crystal suspension of cisplatin.

Intensification of intra-arterial chemotherapy with high-dose cisplatin and concomitant reduction of toxicity under the conditions of the head and neck was aimed at by combination of antineoplastic activity and embolizing effect in the same pharmacon. A cisplatin suspension in normal saline (5 mg in 1 ml) with precipitation of microembolizing cisplatin crystals was prepared. No additional pharmacons.

Minimization of zygomatic complex fracture treatment.

The aims of this non-randomized prospective study were to establish and justify minimized therapy for zygomatic complex fractures. Fifty-two consecutive patients were examined and classified with conventional routine radiographs. Preoperative symptoms were recorded.

Influence of chemotherapy on endosteal implant survival and success in oral cancer patients.

Little is known about the effect of chemotherapy on the osseointegration and survival of endosteal dental implants. In a retrospective study, two groups of patients were compared: one group consisting of 30 oral cancer patients received postsurgical adjuvant chemotherapy with either cis- or carboplatin and 5-fluorouracil in three cycles and were treated subsequently with 106 dental implants placed in the mandible; the other group consisting of 17 patents suffering from oral cancer was prescribed with 54 dental implants placed in the mandible after oncological surgery. No patient was treated with radiotherapy.

Intraarterial chemotherapy as neoadjuvant treatment of oral cancer.

Neoadjuvant chemotherapy in patients with primary squamous cell carcinomas of the oral cavity should lead to high remission rates whilst having low morbidity. Efficacy can also be enhanced by treating small tumour stages. As part of a multi-modality therapy of all stages of primary oral cavity carcinoma, 103 patients were treated with neoadjuvant intraarterial (i.