neoadjuvant pegylated liposomal doxorubicin in combination with cisplatin and infusional fluoruracil ccf with and without endocrine therapy in locally advanced primary or recurrent breast cancer

Abstract Purpose To explore the activity of pegylated liposomal doxorubicin (PLD) as neoadjuvant therapy of breast cancer. Methods The combination of PLD with cisplatin and infusional fluorouracil (CCF) for 8 courses was investigated in patients with primary or recurrent T2-T4a-d N0-3 M0 breast cancer. Patients with ER and/or PgR ≥10% tumors also received letrozole (±triptorelin). Results Forty patients entered the study. Four patients had recurrent tumors and 13 had cT4d tumors. Overall, clinical response rate was 77.5% whereas a pathological complete response (pCR) was obtained in 3 patients (7.7%), 4 when considering bilateral tumors. Noticeably 3 pCR were observed among the 10 patients with T4d ER positive tumors (33%). Eleven patients discontinued treatment before completion of the 8 planned courses. Conclusions Our results indicated that CCF yielded an appreciable rate of clinical responses in a series of very locally advanced tumors and an unusually high rate of pCR in T4d ER positive tumors, suggesting an enhanced cutaneous activity of PLD

preoperative therapy with trastuzumab and oral vinorelbine endocrine therapy in patients with her2 positive breast cancer

Abstract Background Combined trastuzumab and intravenous vinorelbine yielded high clinical activity as preoperative treatment in patients (pts) with HER 2/ neu positive breast cancer. Patients and methods We tested a preoperative combination of trastuzumab with oral vinorelbine (oV) in pts with locally advanced (T2-T4 N0-3 M0) HER2-positive breast cancer. Trastuzumab was administered i.v q 3 wks and oV was administered at the dose of 55 mg/sqm on days 1 and 3 q 3 wks, for 8 courses. Pts with ER ≥ 10% tumors received endocrine therapy with letrozole 2.5 mg/day, plus monthly triptorelin if premenopausal. Results Forty-five pts entered the study. The overall response rate (CR + PR) was 76% (95% CI: 60%–87%). pCR was observed in 4 pts (10%). Among ER-positive tumors 21/25 pts obtained a clinical response (84%) and two pts obtained a pCR (8%). Conclusions The combination of trastuzumab and oral vinorelbine demonstrated encouraging activity in patients with HER 2 positive ER-positive tumors. Alternative strategies should be investigated in patients with endocrine non responsive disease

Neurotensin: any clue in pediatric celiac disease?

Background and aims: Neurotensin (NT) is a gut hormone secreted by specific endocrine cells scattered throughout the epithelial layer of the small intestine which has been identified as an important mediator in several gastrointestinal functions and disease conditions. Its potential involvement in celiac disease (CD) has been investigated, but there are conflicting findings. The aim of this study was to evaluate serum NT levels in children with CD at diagnosis comparing to a control group and to investigate if NT correlated in CD patients with symptoms, antibody response and intestinal mucosal damage. Patients and methods: Children who underwent gastrointestinal endoscopy for CD or other clinical reasons were enrolled. Patients with CD diagnosed according to the latest ESPGHAN guidelines without biopsy were also recruited. Fasting serum samples were analyzed for NT levels using ELISA. Mann Whitney, Wilcoxon rank sum and Spearman’s rank tests were used for statistical analysis. Results: 30 children (12M:18F, 1-16 years) were enrolled in this study. Of 25 patients who underwent endoscopy, 9 were CD patients, 13 were controls, 3 were excluded due to unspecific inflammation at duodenal biopsy. CD was diagnosed in 5 patients without biopsy. NT median was higher in CD patients compared to controls (13.25 pg/ml vs 7.8 pg/ml; p = 0.02) (Mann-Whitney and Wilcoxon tests). No statistically significant correlation of NT with clinical, serological or histological data of CD was observed in this cohort. Conclusion: At our knowledge, this is the first Italian study that evaluates NT in pediatric CD. Results show that NT is higher in the serum of CD children at diagnosis compared to controls; however, larger scale studies are required to validate these findings. Whether serum NT levels can be an adjunctive marker for pediatric CD remains currently elusive

Fasting Neurotensin Levels in Pediatric Celiac Disease Compared with a Control Cohort

Background and Aims. Neurotensin (NT) is a gut hormone secreted by specific endocrine cells scattered throughout the epithelial layer of the small intestine, which has been identified as an important mediator in several gastrointestinal functions and disease conditions. Its potential involvement in celiac disease (CD) has been investigated, but there are conflicting findings. The aim of this study was to evaluate serum NT levels in children with CD at diagnosis, compared to a control group, and to investigate whether NT correlated in CD patients with symptoms, antibody response, and intestinal mucosal damage. Materials and Methods. Children (1-16 years old) undergoing gastrointestinal endoscopy for CD or for other clinical reasons were included in this study. Patients with CD diagnosed according to the 2012 European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) guidelines without biopsy were also recruited. Fasting serum samples were analyzed for NT levels using ELISA. Logistic regression, Wilcoxon rank sum, and Spearman’s rank tests were used for statistical analysis. Results. Thirty children (18 females, 2.2-15.9 years old) were enrolled. Of 25 patients who underwent endoscopy, 9 were CD patients, 13 were controls, and 3 were excluded due to nonspecific inflammation at duodenal biopsy. CD was diagnosed in 5 patients without biopsy. NT median was higher in CD patients compared to controls (13.25 (IQR 9.4-17.5) pg/ml vs. 7.8 (IQR 7.6-10) pg/ml; p=0.02). No statistically significant association between NT and clinical, serological, or histological data of CD was observed in this CD cohort. Conclusions. To our knowledge, this is the first study that evaluates NT in CD children from Italy. Results show that NT is higher in the serum of CD children at diagnosis compared to controls. However, larger-scale studies are required to validate these findings. Whether serum NT levels can be an adjunctive marker for pediatric CD remains currently elusive

Cereal consumption among subjects with celiac disease: A snapshot for nutritional considerations

Background: To our knowledge no study has focused on the pattern of cereal-based products (CBP) consumption among people with celiac disease (CD). Our study aimed at evaluating the dietary intake of CBP among patients with CD and comparing it with a control population. Methods: Eighty-two volunteers with CD and 77 non-CD volunteers enrolled throughout Italy were asked to register their consumption of CBP on specific diaries for three days. Results: CD patients’ median three-day intake of biscuits and crackers was higher compared to controls (65.8 g vs. 22.7 g and 44.7 g vs. 10.6 g, p < 0.05 respectively, Mann–Whitney test). A significant difference was observed also comparing the two groups for median three-day bread consumption, with the CD group consuming less bread than controls (109.5 g vs. 150.7 g, p < 0.05, Mann–Whitney test). When assessing regional and gender-related CBP consumption patterns, significantly higher rice consumption was found among CD women from Northern Italy compared to CD women from Central and Southern Italy (p = 0.006 and p = 0.002 respectively, Fisher’s exact test). No other significant differences were observed. Conclusions: Our results provide a snapshot of the overall consumption of CBP among Italian subjects with CD. Altogether, these data show that, despite minor differences, dietary consumption of CBP among CD patients is similar to the general population

Narrow band imaging combined with water immersion technique in the diagnosis of celiac disease

BACKGROUND: The "multiple-biopsy" approach both in duodenum and bulb is the best strategy to confirm the diagnosis of celiac disease; however, this increases the invasiveness of the procedure itself and is time-consuming. AIM: To evaluate the diagnostic yield of a single biopsy guided by narrow-band imaging combined with water immersion technique in paediatric patients. METHODS: Prospective assessment of the diagnostic accuracy of narrow-band imaging/water immersion technique-driven biopsy approach versus standard protocol in suspected celiac disease. RESULTS: The experimental approach correctly diagnosed 35/40 children with celiac disease, with an overall diagnostic sensitivity of 87.5% (95% CI: 77.3-97.7). An altered pattern of narrow-band imaging/water immersion technique endoscopic visualization was significantly associated with villous atrophy at guided biopsy (Spearman Rho 0.637, p<0.001). Concordance of narrow-band imaging/water immersion technique endoscopic assessments was high between two operators (K: 0.884). The experimental protocol was highly timesaving compared to the standard protocol. CONCLUSIONS: An altered narrow-band imaging/water immersion technique pattern coupled with high anti-transglutaminase antibodies could allow a single guided biopsy to diagnose celiac disease. When no altered mucosal pattern is visible even by narrow-band imaging/water immersion technique, multiple bulbar and duodenal biopsies should be obtaine