Temozolomide versus standard 6-week radiotherapy versus hypofractionated radiotherapy in patients older than 60 years with glioblastoma: the Nordic randomised, phase 3 trial.

BACKGROUND: Most patients with glioblastoma are older than 60 years, but treatment guidelines are based on trials in patients aged only up to 70 years. We did a randomised trial to assess the optimum palliative treatment in patients aged 60 years and older with glioblastoma. METHODS: Patients with newly diagnosed glioblastoma were recruited from Austria, Denmark, France, Norway, Sweden, Switzerland, and Turkey. They were assigned by a computer-generated randomisation schedule, stratified by centre, to receive temozolomide (200 mg/m(2) on days 1-5 of every 28 days for up to six cycles), hypofractionated radiotherapy (34·0 Gy administered in 3·4 Gy fractions over 2 weeks), or standard radiotherapy (60·0 Gy administered in 2·0 Gy fractions over 6 weeks). Patients and study staff were aware of treatment assignment. The primary endpoint was overall survival. Analyses were done by intention to treat. This trial is registered, number ISRCTN81470623. FINDINGS: 342 patients were enrolled, of whom 291 were randomised across three treatment groups (temozolomide n=93, hypofractionated radiotherapy n=98, standard radiotherapy n=100) and 51 of whom were randomised across only two groups (temozolomide n=26, hypofractionated radiotherapy n=25). In the three-group randomisation, in comparison with standard radiotherapy, median overall survival was significantly longer with temozolomide (8·3 months [95% CI 7·1-9·5; n=93] vs 6·0 months [95% CI 5·1-6·8; n=100], hazard ratio [HR] 0·70; 95% CI 0·52-0·93, p=0·01), but not with hypofractionated radiotherapy (7·5 months [6·5-8·6; n=98], HR 0·85 [0·64-1·12], p=0·24). For all patients who received temozolomide or hypofractionated radiotherapy (n=242) overall survival was similar (8·4 months [7·3-9·4; n=119] vs 7·4 months [6·4-8·4; n=123]; HR 0·82, 95% CI 0·63-1·06; p=0·12). For age older than 70 years, survival was better with temozolomide and with hypofractionated radiotherapy than with standard radiotherapy (HR for temozolomide vs standard radiotherapy 0·35 [0·21-0·56], p<0·0001; HR for hypofractionated vs standard radiotherapy 0·59 [95% CI 0·37-0·93], p=0·02). Patients treated with temozolomide who had tumour MGMT promoter methylation had significantly longer survival than those without MGMT promoter methylation (9·7 months [95% CI 8·0-11·4] vs 6·8 months [5·9-7·7]; HR 0·56 [95% CI 0·34-0·93], p=0·02), but no difference was noted between those with methylated and unmethylated MGMT promoter treated with radiotherapy (HR 0·97 [95% CI 0·69-1·38]; p=0·81). As expected, the most common grade 3-4 adverse events in the temozolomide group were neutropenia (n=12) and thrombocytopenia (n=18). Grade 3-5 infections in all randomisation groups were reported in 18 patients. Two patients had fatal infections (one in the temozolomide group and one in the standard radiotherapy group) and one in the temozolomide group with grade 2 thrombocytopenia died from complications after surgery for a gastrointestinal bleed. INTERPRETATION: Standard radiotherapy was associated with poor outcomes, especially in patients older than 70 years. Both temozolomide and hypofractionated radiotherapy should be considered as standard treatment options in elderly patients with glioblastoma. MGMT promoter methylation status might be a useful predictive marker for benefit from temozolomide. FUNDING: Merck, Lion's Cancer Research Foundation, University of Umeå, and the Swedish Cancer Society.

Malignant gastroduodenal obstruction: palliation with self-expanding metallic stents.

PURPOSE: To evaluate the feasibility, efficacy, and tolerance of self-expanding metallic stent insertion under fluoroscopic guidance for palliation of symptoms related to malignant gastroduodenal obstruction. MATERIALS AND METHODS: Seventy-two patients (38 men, 34 women) aged 25-98 years (mean, 62 years) with duodenal (n = 43), antropyloric (n = 13), surgical gastrojejunostomy (n = 10), or pyloroduodenal (n = 6) malignant obstruction were referred for insertion of self-expanding metallic stents over a 6-year period. Stent insertion was performed with use of a peroral or transgastric approach when necessary (n = 11). RESULTS: Stents were successfully inserted in 70 of the 72 patients (97%) and provided symptom relief in 65 patients (90%). Inserted stents were mainly uncovered vascular (n = 55) or enteral (n = 10) Wallstents. One hundred eight stents were initially inserted: one, two, three, or four stents were indicated in 43, 17, nine, and one patient, respectively. Mean follow-up was 119 days (range, 4-513 days). Mean stent patency was 113 days (range, 4-513 days). Mean survival of patients was 120 days. During follow-up, stent obstruction occurred in seven patients as a result of tumoral overgrowth (n = 5) or ingrowth (n = 2). Complications occurred in 12 of the 72 patients (17%), including stent migration (n = 8), stent fracture (n = 1), duodenal perforation (n = 1), and death related to general anesthesia (n = 1). CONCLUSION: Despite a significant complication rate, self-expanding metallic stent insertion under fluoroscopic guidance appears to be a feasible and useful technique in the palliative management of malignant gastroduodenal obstruction.

Determinants of the effect of existential behavioral therapy for bereaved partners: a qualitative study.

BACKGROUND: Informal caregivers of palliative patients took part in existential behavioral therapy (EBT), a group intervention comprising mindfulness exercises to reduce psychological distress and improve quality of life. OBJECTIVES: This study examined what the participants perceived as helpful to cope with their loss during the first year of bereavement, particularly with regard to the EBT intervention. DESIGN: Sixteen problem-centered, semi-structured interviews were evaluated with content analysis. RESULTS: Two main categories were found: social support and self-regulation. Social support includes sense of belonging as well as emotional, cognitive, and practical help experienced from others. Mindfulness and acceptance, a clear focus on the positive, and orientation toward the future were helpful strategies of self-regulation; these were also part of the EBT intervention. Mindfulness was understood as permitting emotions and acceptance of one's inner processes, even if they were not pleasant, and was found to be helpful to stop ruminative thinking. CONCLUSIONS: The categories considered as being helpful parallel core elements of EBT and recent grief theories. The intervention was found to be supportive and met the needs of the participants. The interviewees appreciated the continuity of EBT support from palliative care into bereavement.

Offer and use of complementary and alternative medicine in hospitals of the French-speaking part of Switzerland.

Background: In 2004, complementary and alternative medicine (CAM) was offered by physicians in one third of Swiss hospitals. Since then, CAM health policy has considerably changed. This study aims at describing the present supply and use of CAM in hospitals of the French-speaking part of Switzerland, and qualitatively explores the characteristics of this supply. Methods: Between June 2011 and March 2012, a short questionnaire was sent to the medical directors of hospitals (N=46), asking them whether a CAM was offered, where and by whom. Then, a semi-directive interview was conducted with 10 CAM therapists. Results: Among 37 responses (return rate 80%), 19 medical directors indicated that their hospital offered at least one CAM and 18 reported that they did not. Acupuncture was the most frequently proposed CAM, followed by manual therapies, osteopathy and aromatherapy. The disciplines that offered CAM most frequently were rehabilitation, gynaecology- obstetrics, palliative care, psychiatry and anaesthesiology. In eight out of ten interviews, it appeared that the procedures for introducing a CAM in the hospital were not tightly supervised by the hospital but were mainly based on the goodwill of the therapists, rather than clinical/scientific evidence. Conclusion: Hospitals offering CAM in the French-speaking part of Switzerland seems to have risen since 2004. The selection of CAM to be offered in a hospital should be based on the same procedure of evaluation and validation as conventional care, and if their safety and efficiency is evidence-based, they should receive the same structural resources.

Meaning in life and perceived quality of life in Switzerland: results of a representative survey in the German, French and Italian regions.

BACKGROUND: The concept of meaning in life (MIL) has become a central one in recent years, particularly in psycho-oncology and palliative care. The Schedule for Meaning in Life Evaluation (SMILE) has been developed to allow individuals to choose the life areas that they consider to be important for their own MIL. This approach relates to the "World Health Organisation" definition of quality of life (QOL) as an individual's perception of his own position. The aims of this study were (i) to assess MIL in a representative sample of the Swiss population according to the three linguistic regions and (ii) to evaluate whether MIL constitutes a significant determinant of the perceived QOL. METHODS: A telephone survey of the Swiss population, performed by a professional survey company, was conducted between November and December 2013. The interview included the SMILE, perceived QOL (0-10) and health status (1-5), and various sociodemographic variables. In the SMILE, an index of weighting (IOW, 20-100), an index of satisfaction (IOS, 0-100), and a total SMILE index (IOWS, 0-100) are calculated from the areas mentioned by the participants as providing MIL. RESULTS: Among the 6671 telephonic contacts realized, 1015 (15 %) participants completed the survey: 405 French, 400 German and 210 Italian participants. "Family" (80.2 %), "occupation/work" (51 %), and "social relations" (43.3 %) were the most cited MIL-relevant categories. Italian participants listed "health" more frequently than German and French participants (50.4 % vs 31.5 % and 24.8 % respectively, χ(2) = 12.229, p = .002). Age, gender, education, employment, and marital status significantly influenced either the MIL scores or the MIL-relevant categories. Linear regression analyses indicate that 24.3 % of the QOL variance (p = .000) is explained by health status (B = .609, IC = .490-.728, p = .000), MIL (B = .034, IC = .028-.041, p = .000) and socioeconomic status (F = 11.01, p = .000). CONCLUSION: The major finding of our analysis highlights the positive and significant influence of MIL on the perceived QOL in a representative sample of a general, multilingual and multicultural population. This result indicates that the existential dimension is not only determinant for QOL in some critical life events, as shown e.g. in psycho-oncology and palliative care, but also in everyday life.

La metodologia d'intervenció dels treballadors socials en el sistema de les cures pal·liatives

L’atenció a l’etapa final de la vida de les persones és un dels pilars fonamentals de les cures pal·liatives i és des de la professió del treball social que es pot promoure aquesta atenció en concepte de qualitat, tranquil·litat i preservació dels valors de les persones en situació terminal. És per aquesta raó que s’ha elaborat el present document d’investigació, el qual compta inicialment amb un recull bibliogràfic que abraçarà la metodologia d’intervenció dels treballadors socials en el sistema de les cures pal·liatives de l’Estat espanyol i del Regne Unit, país pioner en la creació de les unitats de cures pal·liatives. En aquest recull s’emmarcaran detalladament les diferències existents en termes d’intervenció i de desenvolupament d’aquest àmbit en els dos territoris. La descripció detallada dels dos models d’intervenció pretén donar la resposta a l’interrogant sobre quina és la metodologia d’intervenció que realitzen els treballadors socials en el sistema de cures pal·liatives. Per assolir aquesta resposta, s’adrecen qüestions com els objectius que lideren el treball d’aquests professionals, les funcions que realitzen en la seva pràctica professional diària i les habilitats de les que han de disposar per tal d’aconseguir que la seva intervenció sigui òptima, tant per als mateixos professionals com per a les persones amb les quals intervenen. Posteriorment a la revisió bibliogràfica, es realitzaran tres entrevistes exploratòries a tres treballadors socials de diferents nivells sanitaris que promoguin les cures pal·liatives a Catalunya. S’analitzaran les qüestions treballades en el recull bibliogràfic (objectius, funcions i habilitats dels treballadors socials), les quals permetran comparar la perspectiva teòrica cercada amb la informació primària obtinguda. Finalment, es planteja una proposta de projecte que permetrà aprofundir en la intervenció dels treballadors socials de Catalunya i del Regne Unit, realitzant una comparació entre els dos models a través de la realització de quaranta-vuit entrevistes repartides homogèniament per els dos territoris. D’aquesta manera, s’especificaran totes aquelles accions que es puguin millorar i les intervencions que siguin més òptimes per la tipologia d’atenció que es requereix en els sistemes de les cures pal·liatives d’avui en dia.

Comunicación Terapéutica : Requisitos fundamentales para acompañar emocionalmente al paciente paliativo y su familia.

La comunicación entre los enfermeros y los pacientes oncológicos es fundamental en la construcción de la relación profesional y terapéutica y esencial para administrar unos cuidados realmente enfocados en la persona como ser holístico y no como entidad patológica. Diferentes estudios han demostrado la influencia positiva de la comunicación en la satisfacción del paciente e incluso se ha encontrado relación entre una comunicación efectiva y una mayor adherencia al tratamiento, mejor control del dolor y estado psicológico. La comunicación, como herramienta para establecer una relación terapéutica eficaz, a su vez básica para el cuidado de cualquier paciente, es entonces “la herramienta” y prerrequisito indispensable para cuidar estos pacientes desde una perspectiva holística. Pese a la centralidad en el cuidado enfermero, la comunicación no se emplea en modo correcto en muchos casos. Objetivos: Este trabajo tiene como objetivo individuar las principales habilidades (skills) para lograr una comunicación terapéutica eficaz y cómo emplearlas en la construcción y mantenimiento de la relación terapéutica con el paciente y su familia. Método: búsqueda bibliográfica con las siguientes palabras clave: comunicación, paliativos, enfermería. Se han incluido en la revisión 27 artículos de 17 revistas distintas. Resultados: Las habilidades y factores encontrados en la literatura han sido clasificados en: a. barreras a la comunicación terapéutica b. condiciones y habilidades facilitadoras de la comunicaciónvi c. habilidades de relación d. habilidades para solicitar información e. estrategias y modelos de comunicación Conclusiones: La comunicación es la herramienta principal del cuidado enfermero en cuidados paliativos, difiere de la comunicación social y tiene como objetivo aumentar la calidad de vida del paciente. La habilidad en comunicación no es un don innato sino que es el resultado de un proceso de aprendizaje continuo. Entre las habilidades más citadas y efectivas hay que recordar la escucha activa (entendida como conjunto de técnicas), el tacto terapéutico, el contacto visual, la empatía y la importancia fundamental de la comunicación no verbal. El modelo de comunicación COMFORT es el único centrado en el paciente y a la vez en su familia. Palabras clave: Habilidades comunicación, paliativos, enfermería