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Unlabelled: Fillion et al. (2012) recently designed a conceptual framework for professional cancer navigators describing key functions of professional cancer navigation., Purpose: Building on this framework, this study defines the core areas of practice and associated competencies for professional cancer navigators., Methods: The methods used in this study included: literature review, mapping of navigation functions against practice standards and competencies, and validation of this mapping process with professional navigators, their managers and nursing experts and comparison of roles in similar navigation programs., Findings: Associated competencies were linked to the three identified core areas of practice, which are: 1) providing information and education, 2) providing emotional and supportive care, and 3) facilitating coordination and continuity of care., Conclusion: Cancer navigators are in a key position to improve patient and family empowerment and continuity of care., Implications: This is an important step for advancing the role of oncology nurses in navigator positions and identifying areas for further research.

For many cancer control programs, cancer navigation has emerged as a specific strategy to improve access to supportive care and the patients' experience of cancer care. This study contributes to a better understanding of professional navigation by comparing two Canadian models: Quebec's Pivot Nurse in Oncology (PNO) and Nova Scotia's Cancer Patient Navigator (CPN). Qualitative interviews were conducted with professional navigators, patients and family members, front-line staff, physicians and health administrators (interviews: n = 49; focus groups: n = 10). The two models were analyzed using the professional navigation framework (Fillion et al., 2012). Although the models are different, results show that professional navigators in both programs perform similar functions and face similar challenges. This study highlights the complexity and the value of cancer navigation and recommends relevant actions to optimize its management within the health care system.

Aim: To evaluate potential drug interactions with antiretroviral therapies or supportive therapies for use in conjunction with the once daily, next generation non-nucleoside reverse transcriptase inhibitor GSK2248761 in patients with HIV-1 infection., Methods: A series of phase I drug interaction studies was conducted., Results: GSK2248761 was shown to be a weak CYP3A4 and CYP2D6 inhibitor in a clinical study with a probe cocktail. Mean plasma concentration-time profiles for atazanavir, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), darunavir (DRV, administered with ritonavir [RTV]), and drospirenone/ethinylestradiol were similar following co-administration of GSK2248761. Plasma raltegravir AUC(0,τ) and C(max) increased by 18% with no change in Cτ when raltegravir was co-administered with GSK2248761. Lopinavir (LPV) plasma AUC(0,τ), C(max) and Cτ decreased by 23%, 14% and 40%, respectively, following administration of lopinavir/ritonavir with GSK2248761. Atorvastatin, rosuvastatin and simvastatin AUC(0,∞) and C(max) increased following co-administration with GSK2248761, with the largest changes observed for simvastatin (3.7-fold and 4.3-fold). Changes in maximum and extent of GSK2248761 exposure were marginal after co-administration with atazanavir, TDF/FTC and raltegravir compared with GSK2248761 administered alone. Co-administration of GSK2248761 with DRV/RTV and LPV/RTV increased plasma GSK2248761 exposures by 1.25- to ≤2-fold compared with GSK2248761 administered alone, and increases in GSK2248761 exposure were higher following single dose co-administration of DRV/RTV or LPV/RTV compared with multiple doses. There were few drug-related AEs, and no treatment-related trends in blood chemistry, haematology, urinalysis, vital signs or ECG findings., Conclusions: These studies indicate that GSK2248761 was safe and well tolerated in healthy adults treated in these studies at the doses and duration of therapy evaluated., (© 2012 ViiV Healthcare. British Journal of Clinical Pharmacology © 2012 The British Pharmacological Society.)

Implementing oncology nurse navigators or IPOs (which stands for "infirmière pivot en oncologie") is a key element of the Québec Cancer Control Program in order to improve the continuity of care. This qualitative study describes the process of implementing IPOs in teams working both in hospitals and in the community. Several groups of stakeholders (IPOs, physicians, nurses, various health workers, administrators, people with cancer and their families) described how they perceive the functions and effects related to this implementation. After putting results into perspective, we recommend developing measures promoting the dissemination of the role and integration of IPOs in formally defined health teams. We strongly advocate for the continuation of joint efforts in order to define and clarify this complex role.

A profile of the role and functions of an oncology patient-navigator nurse (OPN) and the preliminary phases to implementing this role within a team specializing in oncology are first presented. This is followed by a qualitative study that provides a descriptive assessment for implementing an initial OPN in the head and neck oncology area of a university hospital centre (UHC) with a supraregional model for oncology. Three groups of stakeholders (individuals with cancer and families, caregivers, network partners) were interviewed on three occasions: before, during and after implementation. The results show that this new role can be integrated within a team specializing in oncology. The beneficial effects of this role on the process of adaptation to illness, interdisciplinary work and continuity of care are described. Several recommendations are formulated, one being the importance of situating the implementation process from an organizational change perspective.

GW395058, a PEGylated peptide agonist of the thrombopoietin receptor, stimulates megakaryocytopoiesis and has previously been shown to increase platelet counts in vivo. The pharmacokinetics and pharmacodynamics of GW395058 were characterized using a randomized, crossover study in a large-animal model (dog) of chemotherapy-induced thrombocytopenia. Nine beagle dogs received i.v. carboplatin (350 mg/m(2)) on day 0 and day 28. GW395058 (1.31 mg/kg) (n = 6) or vehicle control (n = 3) was administered on day 1 and day 29 either as an i.v. bolus or s.c. injection. After i.v. administration, peak concentrations of GW395058 occurred rapidly, while the half-life averaged approximately 56 h. Bioavailability (+/- standard deviation) of GW395058 given s.c. was 78.2% (20.9%). GW395058 (i.v. and s.c.) ameliorated the platelet nadir (p = 0.0086) and resulted in a shorter time to recovery compared to the control group. The mean nadir platelet counts following carboplatin administration were 197,000 cells/microl (80,000) for the i.v. GW395058-dose group, 183,000 cells/microl (72,000) for the s.c.-dose group and 71,000 cells/microl (38,000) for the vehicle-alone group. GW395058 reduced the thrombocytopenic effects of carboplatin in dogs. No GW395058-related adverse side effects were observed.

GW395058, a potent PEGylated peptide human thrombopoietin receptor (HuTPOr) agonist in vitro, is being evaluated for the treatment of thrombocytopenia. GW395058 shares no sequence homology with TPO. In this report the pharmacokinetics and hematological effects of GW395058 in rats and monkeys are described. Doses eliciting thrombocytosis in rodents (2 or 10 microg/kg s.c.) produced insufficient plasma concentration data for pharmacokinetic parameter estimate calculations. At higher i.v. doses in rats (500, 1,000 or 2,000 microg/kg) serum t1/2 (half-life) values were >20 h, and the area under the concentration time curve increased proportionally with dose. In cynomolgus monkeys GW395058 plasma t1/2 values ranged from 37 to 68 h after s.c. or i.v. dosing, and similar values were observed in rhesus monkeys following s.c. dosing. Rat platelet counts increased following 2 (1.6-fold) or 10 microg/kg (fourfold) s.c. doses. Cynomolgus and rhesus monkey platelet counts did not change significantly at comparable s.c. doses, but did increase slightly (

Administration of exogenous proteins and peptides as therapeutics carries with it the potential for immune system recognition and the development of neutralizing antibodies to endogenous regulatory proteins. PEGylation of proteins typically reduces their immunogenicity in vivo. GW395058 is a PEGylated peptide thrombopoietin receptor (TPOr) agonist being evaluated for the treatment of chemotherapy-induced thrombocytopenia. Although GW395058 shares no homology with TPO, it does compete with TPO for binding to a common receptor, and a similarity in local structure could result in shared epitopes. Thus GW395058 could elicit TPO-neutralizing antibodies. In this study, we evaluated the immunogenicity of GW395058 in mice, the potential of rabbit antibodies elicited by immunizations with the non-PEGylated parent peptide AF15705 to cross-react with recombinant human (rHu) TPO, and the potential of mouse anti-rHuTPO antibodies elicited by repeated dosing with rHuTPO to cross-react with AF15705. GW395058-dosed mice failed to produce antibodies to AF15705 or rHuTPO. Mouse anti-rHuTPO did not cross-react with AF15705 and rabbit anti-AF15705 antibodies failed to cross-react with rHuTPO. GW395058 caused no immune-mediated lesions in mice, but rHuTPO suppressed megakaryocytopoiesis and caused B-lymphocyte hyperplasia in lymphoid tissues consistent with antigenic stimulation. These data suggest that the potential for an immune response to GW395058 in man would be low.