Biomarker assessment of the CBCSG006 trial: a randomized phase III trial of cisplatin plus gemcitabine compared with paclitaxel plus gemcitabine as first-line therapy for patients with metastatic triple-negative breast cancer.

Background: CBCSG006 trial reported the superior efficacy of cisplatin plus gemcitabine (GP) regimen than paclitaxel plus gemcitabine (GT) regimen as first-line treatment of metastatic triple-negative breast cancer (mTNBC). This study focused on the updated survival data and the explorations of potential biomarkers for efficacy. Patients and methods: Germ-line mutations of homologous recombination (HR) panel, BRCA1/2 included, were evaluated in 55.9% (132/236) patients. PD-L1 expression was evaluated in 48.3% (114/236) patients. A nonparametric sliding-window subpopulation treatment effect pattern plot (STEPP) methodology was used to analyze the absolute survival benefits. All statistical tests were two-sided. Results: Median progression-free survival (PFS) was 7.73 [95% confidence interval (CI) 6.46-9.00] months for GP arm and 6.07 (95% CI 5.32-6.83) months for GT arm (P = 0.005). No significant difference in overall survival (OS) was observed. There was significant interaction between HR status and treatment for PFS and status of HR deficient significantly correlated with higher objective response rate (ORR) and longer PFS in GP arm than in GT arm (71.9% versus 38.7%, P = 0.008; 10.37 versus 4.30 months, P = 0.011). There was no significant interaction between germ-line BRCA1/2 (gBRCA1/2) status and treatment for PFS. Patients with gBRCA1/2 mutation had numerically higher ORR and prolonged PFS in GP arm than in GT arm (83.3% versus 37.5%, P = 0.086; 8.90 versus 3.20 months, P = 0.459). There was no significant interaction between PD-L1 status and treatment for PFS, and no significant differences in ORR, PFS or OS between two arms regardless of PD-L1 status. In STEPP analysis, patients with lower composite risks had more absolute benefits in PFS than those with higher composite risks. Conclusions: GP regimen has superior efficacy than GT regimen as first-line chemotherapy for mTNBC patients. Germ-line mutations of BRCA1/2 and HR panel are possible biomarkers for better performance of cisplatin-based regimens. A composite risk model was developed to guide patient selection for GP treatment in TNBC patients. Trial registration: ClinicalTrials.gov, NCT01287624.

Ultrasound assessment of swallowing in malnourished disabled children.

Oral motor dysfunction is common in children with neurological impairment. Nutritional advice depends upon an accurate assessment of feeding potential in these cases. Videofluoroscopic assessment of oral motor function has been the accepted "gold standard" investigation for several years but has significant drawbacks, including the time constraints set by the use of ionizing radiation and the problems posed by the cumbersome equipment needed in mimicking the child's normal feeding situation. Ultrasonography (US) has been suggested as an alternative or additional investigation of oral motor function in children with neurological impairment. We prospectively evaluated a scoring system derived from US assessment of oral motor function in 32 malnourished disabled children with feeding problems by comparing them with a group of matched control children without neurological impairment. US imaging provided useful information with regard to the oral cavity and the soft tissue structures, capturing the salient features of tongue/hyoid/palate activity and bolus transport across the tongue and through the hypopharyngeal area. The mean percentage score obtained by US assessment of oral motor function in children with neurological impairment was 54.3 +/- 23.2 and from children without neurological impairment 91.9 +/- 12.7 (p < 0.0001). Scores for the oral and pharyngeal phases of swallowing were also very significantly lower than that in the control group, both phases being equally impaired in the disabled children. This study has demonstrated that a scoring system based on US assessment of different components of oral motor activity detects statistically significant differences in the feeding capabilities of children with neurological impairment.

Assessment of factors affecting palpability of breast masses using ultrasonography in Chinese women.

Five hundred and twenty-nine women with self-discovered or clinically palpable breast lumps had physical examination followed by high-resolution ultrasonographic examination of the breast. A total of 482 palpable and 146 nonpalpable masses were discovered by ultrasonography. The median values of the breast stromal, premammary, and retromammary fat thickness measurements were 1.3 cm, 0.1 cm, and 0.1 cm, respectively. The median depths of the lesions and the distance of the lesions from the pectoralis muscle were 0.5 cm and 0.2 cm, respectively. The median size of all breast masses was 1.5 cm. These measurements (of the tissue characteristics of the breast, location of the breast mass, and size of the breast lesion) were correlated with palpability or nonpalpability of the breast lesions. Multivariate logistic regression performed for all breast masses showed the only significant factors affecting palpability to be the size (anteroposterior and transverse diameters) and the depth of a breast mass. This is expressed by the following equation: [formula: see text] where z = -0.8759 + 0.9691 (g) + 2.2770 (e)-1.5332 (d), and d represents depth of lesion from the cutaneous surface and e and g represent anteroposterior and transverse diameters of the breast mass, respectively. The nature of the breast tissue (i.e., the premammary fat, retromammary fat, or breast stromal thickness as determined by ultrasonography) does not affect palpability. This study would therefore strongly support the recommendation of breast self-examination, irrespective of breast structure.

Cranial computed tomography in the assessment of neurological complications in critically ill patients with systemic lupus erythematosus.

The cranial computed tomography findings in 22 critically ill patients with systemic lupus erythematosus in the intensive care unit were reviewed to document the spectrum of pathology encountered and to assess the contribution of cranial computed tomography to the diagnosis and management of such patients, many of whom had severe multisystem disease. Thirty-one scans were performed in 22 patients, all of which were abnormal. Premature cerebral atrophy was identified in fifteen patients (68%), cerebral infarction in five (23%), intracranial haemorrhage and cerebral oedema in four each (18%), and hydrocephalus in three (14%). Six patients had multiple pathologies. The cranial computed tomography findings confirmed the clinical diagnosis in 13 of 22 cases (59%) and altered it in nine (41%). The contribution to diagnosis and management justifies transportation and computed tomography scanning. The contribution to patient outcome, however, is uncertain as mortality was 91%.