Determination of an optimal response cut-off able to predict progression-free survival in patients with well-differentiated advanced pancreatic neuroendocrine tumours treated with sunitinib: an alternative to the current RECIST-defined response.

BACKGROUND: Sunitinib prolongs progression-free survival (PFS) in patients with advanced pancreatic neuroendocrine tumours (pNET). Response Evaluation Criteria in Solid Tumors (RECIST)-defined partial responses (PR; classically defined as ⩾30% size decrease from baseline) are infrequent. METHODS: Individual data of pNET patients from the phase II [NCT00056693] and pivotal phase III [NCT00428597] trials of sunitinib were analysed in this investigator-initiated, post hoc study. The primary objective was to determine the optimal RECIST (v.1.0) response cut-off value to identify patients who were progression-free at 11 months (median PFS in phase III trial); and the most informative time-point (highest area under the curve (AUC) by receiver operating characteristic (ROC) analysis and logistic regression) for prediction of benefit (PFS) from sunitinib. RESULTS: Data for 237 patients (85 placebo; 152 sunitinib (n=66.50 mg \u274-weeks on/2-weeks off\u27 schedule; n=86 \u2737.5 mg continuous daily dosing (CDD)\u27)) and 788 scans were analysed. The median PFS for sunitinib and placebo were 9.3 months (95% CI 7.6-12.2) and 5.4 months (95% CI 3.5-6.01), respectively (hazard ratio (HR) 0.43 (95% CI 0.29-0.62); P CONCLUSIONS: A 10% reduction within marker lesions identifies pNET patients benefiting from sunitinib treatment with implications for maintenance of dose intensity and future trial design

Predictive factors for severe toxicity of sunitinib in unselected patients with advanced renal cell cancer

Sunitinib has been registered for the treatment of advanced renal cell cancer (RCC). As patient inclusion was highly selective in previous studies, experience with sunitinib in general oncological practice remains to be reported. We determined the efficacy and safety of sunitinib in patients with advanced RCC included in an expanded access programme. ECOG performance status >1, histology other than clear cell and presence of brain metastases were no exclusion criteria. Eighty-two patients were treated: 23% reached a partial response, 50% had stable disease, 20% progressed and six patients were not evaluable. Median progression-free survival (PFS) was 9 months and median overall survival (OS) was 15 months. Importantly, 47 patients (57%) needed a dose reduction, 35 (43%) because of treatment-related adverse events, 10 (12%) because of continuous dosing, and two because of both. Stomatitis, fatigue, hand–foot syndrome and a combination of grade 1–2 adverse events were the most frequent reasons for dose reduction. In 40 patients (49%), there was severe toxicity, defined as dose reduction or permanent discontinuation, which was highly correlated with low body surface area, high age and female gender. On the basis of age and gender, a model was developed that could predict the probability of severe toxicity

Optically written waveguide in an atomic vapor

We present the first demonstration of an optically written waveguide in an atomic vapor. By strongly pumping one rubidium transition, we are able to waveguide a weak probe beam at a different rubidium transition. These effects can be understood with reference to a model of the refractive index for a V system. [S0031-9007(99)08495-1]

Scalability, test–retest reliability and validity of the Brief INSPIRE-O measure of personal recovery in psychiatric services

Introduction: Mental health services have transitioned from treating symptoms to emphasizing personal recovery. Despite its importance, integrating personal recovery into clinical practice remains work in progress. This study evaluates the psychometric qualities of the Brief INSPIRE-O, a five-item patient-reported outcome measure assessing personal recovery.Method: The study collected data from 2018 to 2020 at the Mental Health Services, Capital Region of Denmark, using an internet-based system examining 8,192 non-psychotic patients – receiving outpatient treatment.Materials: This study evaluated the Brief INSPIRE-O and used measures of symptomatology (SCL-10), well-being (WHO-5), and social functioning (modified SDS).Results: The study population comprised 76.8% females with a mean age of 32.9 years, and diagnoses included anxiety (28%), depression (34%), and personality disorder (19%). The mean Brief INSPIRE-O score (39.9) was lower than the general population norm (71.1). The Brief INSPIRE-O showed acceptable test–retest reliability (0.75), scalability (0.39), and internal consistency (0.73). Correlations with other mental health criteria were in the expected direction for symptomatology (−0.46), well-being (0.60), and social functioning (−0.43) and remained consistent across diagnoses.Discussion: The Brief INSPIRE-O demonstrated strong psychometric qualities and could be recommended as a measure of personal recovery for use in both research and clinical practice. Its strong theoretical basis and short completion time make it suitable for use for research. Incorporating Brief INSPIRE-O into clinical assessment will further support the process of mental health systems re-orientating towards personal recovery

Collaboration of community hospital endosonographers improves diagnostic yield of endoscopic ultrasonography guided tissue acquisition of solid pancreatic lesions

Background and study aims Endoscopic ultrasound (EUS)-guided tissue acquisition (TA) is the method of choice for establishing a pathological diagnosis of solid pancreatic lesions. Data on quality and yield of EUS-guided TA performed in community hospitals are lacking. A study was performed to determine and improve the diagnostic yield of EUS-guided TA in a group of community hospitals. Methods Following analysis of the last 20 EUS-guided TA procedures of solid pancreatic lesions performed in each of four community hospitals, a collaborative EUS interest group was formed

Myelosuppression by sunitinib is flt-3 genotype dependent

Personalised Therapeutic