Long-Term Toxicity and Health-Related Quality of Life After Adjuvant Chemoradiation Therapy or Radiation Therapy Alone for High-Risk Endometrial Cancer in the Randomized PORTEC-3 Trial

PURPOSE: The survival results of the PORTEC-3 trial showed a significant improvement in both overall and failure-free survival with chemoradiation therapy versus pelvic radiation therapy alone. The present analysis was performed to compare long-term adverse events (AE) and health-related quality of life (HRQOL). METHODS AND MATERIALS: In the study, 660 women with high-risk endometrial cancer were randomly assigned to receive chemoradiation therapy (2 concurrent cycles of cisplatin followed by 4 cycles of carboplatin/paclitaxel) or radiation therapy alone. Toxicity was graded using Common Terminology Criteria for Adverse Events, version 3.0. HRQOL was measured using EORTC QLQ-C30 and CX24/OV28 subscales and compared with normative data. An as-treated analysis was performed. RESULTS: Median follow-up was 74.6 months; 574 (87%) patients were evaluable for HRQOL. At 5 years, grade ≥2 AE were scored for 78 (38%) patients who had received chemoradiation therapy versus 46 (24%) who had received radiation therapy alone (P = .008). Grade 3 AE did not differ significantly between the groups (8% vs 5%, P = .18) at 5 years, and only one new late grade 4 toxicity had been reported. At 3 and 5 years, sensory neuropathy toxicity grade ≥2 persisted after chemoradiation therapy in 6% (vs 0% after radiation therapy, P < .001) and more patients reported significant tingling or numbness at HRQOL (27% vs 8%, P < .001 at 3 years; 24% vs 9%, P = .002 at 5 years). Up to 3 years, more patients who had chemoradiation therapy reported limb weakness (21% vs 5%, P < .001) and lower physical (79 vs 87, P < .001) and role functioning (78 vs 88, P < .001) scores. Both treatment groups reported similar long-term global health/quality of life scores, which were better than those of the normative population. CONCLUSIONS: This study shows a long-lasting, clinically relevant, negative impact of chemoradiation therapy on toxicity and HRQOL, most importantly persistent peripheral sensory neuropathy. Physical and role functioning impairments were seen until 3 years. These long-term data are essential for patient information and shared decision-making regarding adjuvant chemotherapy for high-risk endometrial cancer

Home-based palliative approach for people with severe multiple sclerosis and their carers: Study protocol for a randomized controlled trial

Background: Preliminary evidence suggests that palliative care may be useful for people with severe multiple sclerosis (MS). The aim of this study is to determine the effectiveness of a home-based palliative approach (HPA) for people with severe MS and their carers. Methods/design: This is a single-blind randomized controlled trial with a nested qualitative study. Seventy-five severe MS-carer dyads are being randomized (at three centers, one in each area of Italy) to HPA or usual care (UC) in a 2:1 ratio. Each center has a specially trained team consisting of four professionals (physician, nurse, psychologist, social worker). The team makes a comprehensive assessment of the needs of the dyads. HPA content is then agreed on, discussed with the patient's caring physician, and delivered over six months. The intervention is not intended to replace existing services. At later visits, the team checks the HPA delivery and reviews/modifies it as necessary. Discussion: The results of our study will show whether the HPA is feasible and beneficial to people with severe MS and their carers living in the three Italian geographic areas. The nested qualitative study will add to the understanding of the strengths and limitations of the intervention

Knowledge and information networks in an Italian wine cluster

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Gatekeepers of Knowledge within Industrial Districts: Who They Are, How They Interact

Morrison A. Gatekeepers of knowledge within industrial districts: who they are, how they interact, Regional Studies. Studies on industrial districts suggest that their innovative performance is strictly linked to their ability to absorb external knowledge. Yet, the existing literature provides few insights into the functioning of this process. This paper, focusing on leader firms located in a successful Italian furniture district, investigates whether they feed the district with knowledge absorbed from external sources, thereby behaving as 'gatekeepers of knowledge'. Findings show that leader firms are well connected with knowledge sources; yet, linkages with districts firms are far more limited as are informal exchanges that, when they do occur, are mostly restricted to generic information. [image omitted] Morrison A. Les gardiens du savoir dans les regions industrielles: qui sont-ils, comment interagissent-ils?, Regional Studies. De recentes etudes sur les regions industrielles suggerent que leurs performances en matiere d'innovation sont strictement liees a leur capacite a absorber le savoir exterieur. Neanmoins, la litterature existante fournit peu d'eclaircissements quant au fonctionnement de ce processus. Cet article, axe sur des societes leaders situees dans une region d'Italie ou l'industrie de l'ameublement est prospere, examine si ces societes alimentent la region en savoir assimile aupres de sources exterieures, se comportant ce faisant en gardiens du savoir. Les resultats montrent que ces societes leaders sont bien connectees aux sources de savoir; neanmoins, les liens avec les entreprises de la region sont beaucoup plus limites que ne le sont les echanges informels qui, lorsqu'ils interviennent effectivement, se limitent pour l'essentiel a des informations generiques. Flux de savoir Regions industrielles Societes leaders Communaute de techniciens Industrie de l'ameublement Region de Murge Morrison A. Wissensregulatoren in Industriebezirken: Wer sie sind und in welcher Wechselwirkung sie zueinander stehen, Regional Studies. Aus den neuesten Studien uber Industriebezirke geht hervor, dass die innovative Leistung dieser Bezirke stark von ihrer Fahigkeit abhangt, externes Wissen zu absorbieren. Die Funktionsweise dieses Prozesses wurde in der Literatur hingegen bisher nur selten untersucht. In diesem Beitrag konzentrieren wir uns auf fuhrende Firmen in einem erfolgreichen italienischen Mobelindustriebezirk und untersuchen, ob diese Firmen den Bezirk mit Wissen aus externen Quellen anreichern und somit als Wissensregulatoren auftreten. Die Ergebnisse lassen darauf schliessen, dass fuhrende Firmen gut mit Wissensquellen verknupft sind. Die Verknupfungen zu den Firmen des Bezirks sind jedoch weitaus starker eingeschrankt; dasselbe gilt fur den informellen Austausch, der - wenn er uberhaupt auftritt - sich meist auf generelle Informationen beschrankt. Wissensstrome Industriebezirke Fuhrende Firmen Gemeinschaft der Fachleute Mobelindustrie Region Murge Morrison A. Guardianes del conocimiento en comarcas industriales: quienes son y como interactuan, Regional Studies. En recientes estudios se ha observado que el rendimiento innovador de las comarcas industriales esta estrictamente vinculado a su capacidad de absorber conocimiento externo. Sin embargo, la literatura presente ofrece pocas perspectivas en cuanto al funcionamiento de este proceso. En este ensayo me centro en empresas lideres ubicadas en una comarca italiana conocida por su exitosa industria del mueble e investigo si estas empresas proporcionan a la comarca conocimientos absorbidos de fuentes externas y si entonces se comportan como guardianes del conocimiento. Los resultados indican que si bien las empresas lideres estan bien conectadas con fuentes de conocimiento, los enlaces con empresas de la comarca estan mucho mas limitados que los intercambios informales que, aunque ocurren, estan principalmente restringidos a informacion generica. Flujos de conocimiento Comarcas industriales Empresas lideres Comunidad de tecnicos Industria del mueble Region de MurgeKnowledge flows, Industrial districts, Leader firms, Community of technicians, Furniture industry, Murge region,