Phase II trial of docetaxel, cisplatin and fluorouracil followed by carboplatin and radiotherapy in locally advanced oesophageal cancer

This study was performed to assess the efficacy and safety of docetaxel, cisplatin and fluorouracil combination in patients with unresectable locally advanced oesophageal squamous cell carcinoma. Treatment consisted of docetaxel 60 mg m−2, cisplatin 75 mg m−2 on day 1 and fluorouracil 750 mg m−2 day−1 on days 2–5, repeated every 3 weeks for three cycles, followed by carboplatin 100 mg m−2 week−1 for 5 weeks and concurrent radiotherapy (45 Gy in 25 fractions, 5 days week−1). After radiotherapy, eligible patients either underwent an oesophagectomy or received high dose rate endoluminal brachytherapy (HDR-EBT). Thirty-one out of 37 enrolled patients completed the planned chemotherapy and 30 completed chemoradiation. After completion of chemotherapy, 49% (95% CI: 32.2–66.2) had a clinical response. Twelve patients (32%) underwent a resection, which was radical in 60% (postoperative mortality: 0%). A pathological complete response was documented in four patients (11% of enrolled, 30% of resected). The median survival was 10.8 months (95% CI: 8.1–12.4), and the 1- and 2-year survival rates were 35.1 and 18.9%, respectively. Grade 3–4 toxicities were neutropoenia 32%, anaemia 11%, non-neutropoenic infections 18%, diarrhoea 6% and oesophagitis 5%. Nine patients (24%) developed a tracheo-oesophageal fistula during treatment. Even if the addition of docetaxel to cisplatin and 5-fluorouracil (5-FU) seems to be more active than the cisplatin and 5-FU combination, an incremental improvement in survival is not seen, and the toxicity observed in this study population is of concern. In order to improve the prognosis of these patients, new drugs, combinations and strategies with a better therapeutic index need to be identified

"Delirium Day": A nationwide point prevalence study of delirium in older hospitalized patients using an easy standardized diagnostic tool

Background: To date, delirium prevalence in adult acute hospital populations has been estimated generally from pooled findings of single-center studies and/or among specific patient populations. Furthermore, the number of participants in these studies has not exceeded a few hundred. To overcome these limitations, we have determined, in a multicenter study, the prevalence of delirium over a single day among a large population of patients admitted to acute and rehabilitation hospital wards in Italy. Methods: This is a point prevalence study (called "Delirium Day") including 1867 older patients (aged 65 years or more) across 108 acute and 12 rehabilitation wards in Italian hospitals. Delirium was assessed on the same day in all patients using the 4AT, a validated and briefly administered tool which does not require training. We also collected data regarding motoric subtypes of delirium, functional and nutritional status, dementia, comorbidity, medications, feeding tubes, peripheral venous and urinary catheters, and physical restraints. Results: The mean sample age was 82.0 \ub1 7.5 years (58 % female). Overall, 429 patients (22.9 %) had delirium. Hypoactive was the commonest subtype (132/344 patients, 38.5 %), followed by mixed, hyperactive, and nonmotoric delirium. The prevalence was highest in Neurology (28.5 %) and Geriatrics (24.7 %), lowest in Rehabilitation (14.0 %), and intermediate in Orthopedic (20.6 %) and Internal Medicine wards (21.4 %). In a multivariable logistic regression, age (odds ratio [OR] 1.03, 95 % confidence interval [CI] 1.01-1.05), Activities of Daily Living dependence (OR 1.19, 95 % CI 1.12-1.27), dementia (OR 3.25, 95 % CI 2.41-4.38), malnutrition (OR 2.01, 95 % CI 1.29-3.14), and use of antipsychotics (OR 2.03, 95 % CI 1.45-2.82), feeding tubes (OR 2.51, 95 % CI 1.11-5.66), peripheral venous catheters (OR 1.41, 95 % CI 1.06-1.87), urinary catheters (OR 1.73, 95 % CI 1.30-2.29), and physical restraints (OR 1.84, 95 % CI 1.40-2.40) were associated with delirium. Admission to Neurology wards was also associated with delirium (OR 2.00, 95 % CI 1.29-3.14), while admission to other settings was not. Conclusions: Delirium occurred in more than one out of five patients in acute and rehabilitation hospital wards. Prevalence was highest in Neurology and lowest in Rehabilitation divisions. The "Delirium Day" project might become a useful method to assess delirium across hospital settings and a benchmarking platform for future surveys

Preoperative concomitant chemo-radiotherapy in superior sulcus tumour: A mono-institutional experience

Superior sulcus tumour (SST) is an uncommon neoplasia whose optimal treatment remains controversial. Usually resected after induction RT or treated with definitive chemo-radiotherapy, it has recently aroused more interest because of preoperative chemo-radiotherapy. Treatment consisted of a platinum-based chemotherapy: carboplatin AUC 5 on days 1 and 22, combined with mitomycin-C 8 mg/m(2) on days 1 and 22, and vinblastine 4 mg/m(2) on days 1, 8, 22 and 29 (MVC) from 1994 to 1999, or combined with navelbine 25mg/m(2) on days 1, 8, 22 and 29 (NC), from 2000 to 2007. Radiotherapy was administered 5 days/week, 30 Gy in 10 fractions on days 22-35 (from 1994 to 1996), or 44 Gy in 22 fractions on days 22-52 (from 1997 to 2007). Surgery was planned after 2-3 weeks since the completion of radiotherapy. Since 1994, 37 pts were treated with induction chemo-radiotherapy, 1 with induction radiotherapy only. Induction chemotherapy: 16 pts had MVC (43%) and 21 NC (57%); induction radiotherapy: 7 patients treated with MVC had 30 Gy/10F, 9 had 44 Gy/22F; all the patients treated with NC had 44 Gy/22F, but 2 of them did not complete radiotherapy because of early death (after 16 Gy/8F) and toxicity (after 38 Gy/19F). Grade 3-4 haematological toxicity of induction chemo-radiotherapy was found in 13 patients (35%); the most frequent non-haematological toxicities were constipation and oesophagitis. One complete, 18 partial and 8 minimal responses/stable disease were observed. Moreover, 1 progression disease and 1 early death occurred. Surgery: 30 upper lobectomies (17 right, 13 left) and 4 segmentectomies, with chest wall resections, were performed (89% resection rate); 4 pts were not operated. Radical resections were achieved in 74% of the patients, with 5 pathologic complete remissions at resection. Twenty-seven patients (71%) had improvement of shoulder/arm pain. Median progression-free survival was 64 weeks and median survival was 148 weeks. The 5-year overall and progression-free survivals were 40% and 29%, respectively. In the multimodality treatment of SST, concurrent carboplatin-based chemotherapy plus radiotherapy were active and feasible without major toxicities. This resulted in high resectability rate and favourable progression-free and overall survival rates