Cisplatin-based chemoradiation plus cetuximab in locally advanced head and neck cancer: a phase II clinical study.

BACKGROUND: Intensification of chemoradiation for advanced head and neck squamous cell carcinoma (HNSCC) is unlikely due to toxicity. Cetuximab combined either with radiotherapy or with chemotherapy showed favourable toxic profile with positive results in both combinations. Therefore, cetuximab could intensify chemoradiation without worsening toxicity. We conducted a phase II study of chemoradiation and cetuximab. PATIENTS AND METHODS: Eligible patients had stage III-IV M0 HNSCC. Treatment consisted of three cycles of cisplatin (20 mg/m(2)/day × 5 days) and fluorouracil (200 mg/m(2)/day × 5 days) rapidly alternated to three split courses of radiotherapy up to 70 Gy and concurrent weekly cetuximab. The primary end point of the study was complete response (CR) rate. Secondary end points were toxicity, progression-free survival (PFS) and overall survival (OS). RESULTS: Fourty-five patients were enrolled: median age was 56 years, 38 had stage IV disease and 40 nodal involvement. CR occurred in 32 patients (71%). PFS and OS was 21+ months and 32.6+, respectively. Acute grade 3-4 toxic effects were in the expected range, but grade 3 radiodermatitis occurred in 33 patients. CONCLUSIONS: The combination of cetuximab, cisplatin, fluorouracil and radiotherapy leads to a very high proportion of CR and it is feasible with toxic effects similar to those expected by radiochemotherapy. The only unexpected toxicity was skin toxicity: grade 3 radiodermatitis occurred in 73% of the patients.

[Correlation between job satisfaction and stress factors, burn-out and psychosocial well-being among nurses working in different healthcare settings]. / Correlazione tra soddisfazione lavorativa e fattori di stress, burnout e benessere psicosociale tra infermieri che lavorano in differenti ambiti sanitari.

The aim of this study was to evaluate the prevalence and the causing factors of job dissatisfaction in three subgroups of nurses working in different context: i) hospital wards for acute patients, ii) units for long-term patients, and iii) home care for chronic patients. An anonymous, self report questionnaire was used, composed by socio-demographic, burnout, stress and psychosocial (INRS) standardized variables. A specific summarizing item was also employed to evaluate the perception of job satisfaction. One hundred thirty seven out of 190 delivered questionnaires were returned (72.1%). About 30% of the total sample is unsatisfied, 28% of the sample suffered emotional exhaustion, 20% depersonalization, and 43% declared a low level of personal accomplishment. Stress scores beyond the threshold value of 17 were found for anguish (22.7 +/- 155), anxiety (22.3 +/- 15.8) and gastroenteric symptoms (19.0 +/- 17.8). Psychosocial scores beyond the threshold value of 50 were found for the variables general job load (56.7 +/- 19.8), attention (83.8 +/- 20.9), and social support from the supervisor (51.3 +/- 25.3). The logistic regression analysis suggested that coming from extracommunitarian Countries (OR: 3.76; CI: 1.04-13.65; p < 0.05), working with acute patients (OR: 2.94; CI: 0.85-10.11; p = 0.08), home-care of chronic patients (OR: 73; CI: 11.27-473.0; p < 0.001), assumption of psychodrugs (OR: 5.01; CI: 1.40-17.92 p < 0.01), and anxiety (OR: 3,71; CI: 1.20-11.44; p < 0.05), were factors significantly associated with a low job satisfaction compared to the other subgroups. On the contrary, a high work degree of work involvement (OR: 0.37; CI: 0.14-0.97; p < 0.05) resulted to be a protective factor respect to job disaffection. These findings suggest that changes that have been occurring in the last years in the social conditions and in health organization in Italy can deeply influence the degree of job satisfaction among the nurses. In order to improve the analysis of the welfare state of the health workers, more effective methods of analysis should be used, in addition to the questionnaires.

[Collateral effects of a project of latex rubber removal in a hospital institution]. / Effetti collaterali di un progetto di bonifica dal latice della gomma in un'azienda sanitaria ospedaliera.

Within a stepwise approach to remove natural rubber latex products from the hospital of Cuneo, latex gloves for examination were completely replaced by nitrile powder free gloves. About a month after their introduction in the whole facility, 31 health care workers (HCW) presented with symptoms of dermatitis characterized by erythema, itching, dryness and chapping on the dorsum of the hands. The symptoms typically appeared 1-3 days after the first nitrile gloves employment, 1-3 hours after they were put on. On the basis of both a detailed clinical examination and specific laboratory tests a diagnosis of irritant contact dermatitis was confirmed in all symptomatic HCW. Samples of nitrile gloves were submitted for analysis by a university toxicological laboratory. Evident traces of a powder containing calcium carbonate were found inside of the gloves. Therefore the declaration of the firm that the product was absolutely powder free must be considered wrong. We suppose that frequent and prolonged contacts between the alcaline pH of the powder found in the gloves and the acid pH of the skin of the hands - together with other individual and environmental factors - could have determined the onset of the symptoms in the HCW. In spite of this adverse reaction, a significant reduction (-68%) of the incidence of latex sensitization and latex-related symptoms was observed in 2006 compared to 2005. We conclude that the complete removal of latex gloves from the workplace is a favourable preventive measure and that switching to nitrile powder free devices is a safe and cost-effective alternative to the latex gloves. However, it is always advisable to demand to the producer a formal declaration of compliance to the security standards of the medical devices.

[Consequences of work environment on the ability judgment in a hospital company in Piemonte]. / Conseguenze dell'evoluzione dell'ambiente di lavoro sui giudizi di idoneita in un'Azienda Sanitaria Ospedaliera Piemontese.

The aim of this study is to analyze whether the changes recently occurred in the Italian society and in the occupational context can influence the prevalence of job restrictions among health care workers (HCW) of the Cuneo Hospital, between 1998 and 2006. After subdivision in: nurses, physicians, auxiliary nurses, administrative staff, and technicians, sociodemographic data of HCW were collected. In 2006, the total amount (+176), number of part-time (+274), mean age (+2.6 ys) and seniority (+2.1 ys) of HCW--this latter not for physicians and technicians-- were significantly increased (p < 0.001) compared to 2000. The prevalence of job inability--obtained dividing all the new restrictions expressed for each year between 1998-2000, 2001-2003, and 2004-2006 by the number of HCW working at the end of each period--increased, respectively, from 12.1% to 12.7%, to 16.1% (chi2 = 18.6; p < 0.001). The higher percentage of inability was observed among physicians (+ 183%) and administrative staff (+7/1%). In each period, subjects with job restrictions resulted to be younger than the whole HCW (p < 0.001). In conclusion, the number of job restrictions is rising but it doesn't seem to be associated to the increase of age and seniority among HCW.