Body mass index as independent predictor of overall survival in patients with advanced renal cell carcinoma at start of systemic treatment-Analyses from the German clinical RCC-Registry.

OBJECTIVES: A high body mass index (BMI) is associated with an increased risk for developing renal cell carcinoma (RCC), a higher complication rate after surgery, and a postoperative decline in renal function after nephrectomy. In contrast, a high preoperative BMI has been associated with increased survival in patients with localized RCC. We examined the prognostic impact of the BMI in patients treated for metastatic RCC (mRCC) in daily routine practice in Germany. PATIENTS AND METHODS: The ongoing prospective, multicenter German clinical cohort study on mRCC (RCC-Registry) has recruited patients from more than 110 oncology/urology outpatient centers and hospitals at initiation of systemic first-line treatment. Data on patients' demographics, treatment, and outcome in routine practice, so called "real world data", have been collected. For this analysis, 606 patients were stratified into a low (BMI < 24), medium (24 < BMI < 28), and high (BMI > 28) BMI group. The influence of the BMI on the overall survival (OS) was analyzed using a multivariate Cox proportional hazards model. RESULTS: Median OS was 24.5 (95% confidence interval [CI], 19.3-28.5), 17.9 (95% CI, 15.3-20.8) and 10.9 (95% CI, 7.3-13.4) months in the high, medium, and low BMI patient group, respectively. A significant correlation of BMI with OS, independent of other factors, was found (low vs. high BMI: hazard ratio (HR): 1.94, 95% CI, 1.48-2.54; medium vs. high BMI: HR: 1.40, 95% CI, 1.10-1.78). Memorial Sloan Kettering Cancer Center risk factors were independently correlated with shorter OS. CONCLUSIONS: Our analysis showed a significant and independent correlation of a high BMI with longer OS in a prospective German cohort of mRCC routine patients starting first-line systemic treatment.

A brief instrument to measure health-related quality-of-life in patients with bone metastasis: validation of the German version of Bone Metastases Quality-of-Life-10 (BOMET-QoL-10).

AIMS: This prospective, epidemiologic study was designed to translate the original Spanish Bone Metastases Quality-of-Life-10 (BOMET-QoL-10) questionnaire and undertake a validation of the translated German version of BOMET-QoL-10 in Germany to assess health-related quality-of-life (HRQoL) in patients with bone metastases (BM). METHODS: The translation process included forward and backward translations, and a linguistic validation. Patients aged ≥18 years with histological confirmation of cancer, diagnosed with BM, life expectancy ≥6 months, and fluency in German were eligible for this study (enrolled consecutively in 33 outpatient centers in Germany). Patients were given the German version of BOMET-QoL-10, together with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30 and EORTC QLQ-BM22 questionnaires at inclusion, 6 weeks, 3 months, and 6 months after inclusion. A debriefing questionnaire was administered at inclusion to determine patient acceptability and understanding. RESULTS: Data include 364 patients with BM (median age = 68 years; females = 71.7%). The BOMET-QoL-10 is brief and clear (median completion time = 5 minutes; >90% of patients completed the questionnaire without assistance). The BOMET-QoL-10 forms only one overall scale. All 10 items showed a substantial correlation with the first factor (factor loading, range = 0.58-0.86). BOMET-QoL-10 exhibits high internal consistency and reproducibility (Cronbach's alpha = 0.91; intra-class correlation coefficient = 0.76). BOMET-QoL-10 showed significant correlations (range = 0.69-0.79) both with EORTC QLQ-C30 and EORTC QLQ-BM22 within the functioning (physical, social, interference) and symptom (fatigue, pain) scales, displayed significant sensitivity to change in EORTC QLQ-BM22 scores, and proved the potential ability to detect change in HRQoL in patients with different disease status. LIMITATIONS: There was a high proportion of females in this study, which might represent a limitation. CONCLUSIONS: The German version of BOMET-QoL-10 is a valid, reliable, brief, and clear instrument able to measure HRQoL in patients with BM.

Palliative systemic therapy and overall survival of 1,395 patients with advanced breast cancer - Results from the prospective German TMK cohort study.

Data on treatment and outcome of advanced breast cancer in routine practice are rare, especially concerning recurrent disease, but important to complement the results from clinical trials and to improve the standard of care. We present data on choice of systemic first-line treatment, number of treatment lines, and survival of patients treated by medical oncologists in Germany. 1395 patients recruited by 124 sites at start of first-line therapy into the ongoing, prospective German clinical cohort study TMK (Tumour Registry Breast Cancer) between February 2007 and October 2015 were analysed. The median OS was 33.8 months (95% CI 30.2-40.2) for HR-positive/HER2-negative, 38.2 months (95% CI 31.3-43.0) for HER2-positive and 16.8 months (95% CI 11.5-22.0) for triple negative breast cancer. Patients with triple negative tumours more often died before start of a third-line therapy than patients with HR-positive or HER2-positive tumours (44% vs. 25%). Use of taxane-based chemotherapies has increased since 2007, with 65% of all first-line chemotherapy-treatments containing taxanes in 2013-15 (60% HR-positive/HER2-negative, 75% HER2-positive, 56% triple negative). 52% of the patients with HR-positive/HER2-negative tumours received first-line endocrine therapy in 2013-15; when restricted to patients with only non-visceral metastases this percentage increased to 63%. To our knowledge, this is the first cohort study showing systemic first-line therapy for all subtypes of advanced breast cancer. Overall survival in the TMK is comparable to that reported by clinical trials despite the inclusion of older and comorbid patients.

Dermatux: phase IV trial of Cetuximab plus FOLFIRI in first-line metastatic colorectal cancer receiving a pre-defined skin care.

PURPOSE: Cetuximab-induced skin rash Gd3+ occurs in ≥16% patients (pts) (Heinemann et al., Lancet Oncol 15(10):1065-1075, 2014; Van Cutsem et al. J Clin Oncol 27(19):3117-25; 2009b). Survival, response, and toxicity parameters were re-evaluated under a pre-defined skin prophylaxis consistent of vitamin K1 ointment and oral doxycycline. METHODS: This is a national, multicenter, phase 4, first-line mCRC (K-RAS wt) trial. Pts received irinotecan 180 mg/m² (d1), FA 400 mg/m² (d1), 5-FU 400 mg/m² (d1), 5-FU 2400 mg/m² (d1-2), and cetuximab [400 mg/m² (d1), and then 250 mg/m² qw], prophylactic 0.1% vitamin K1 ointment qd, and oral doxycycline 100 mg bid. PRIMARY OBJECTIVE: 1-year PFS rate; secondary objectives: skin side-effects (grade, onset), objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) time, and overall survival (OS) time and safety. RESULTS: Twenty centers recruited 55 patients. Recruitment started Q1 2011 and ended Q3 2013 due to slow accrual. Characteristics were in line with CRYSTAL trial except for age and colonic location. 1-year PFS rate was 25.9%, mOS 21.8 months (m), and mPFS 8.5 m. ORR was 63.0%, DCR 77.8%. Rash Gd2+ occurred in 42.6% [median onset was 4.0 weeks (w)]; paronychia Gd2+ occurred in 22.2% (median onset 15.4w.); skin fissures Gd2+ occurred in 31.5% (median onset 19.9 weeks) 7% pts abandoned cetuximab treatment due to toxicity. CONCLUSION: Our data reveal encouraging improvements in skin reactions and their time to occurrence due to a pre-defined skin care.

Examining psychokinesis: the interaction of human intention with random number generators--a meta-analysis.

Séance-room and other large-scale psychokinetic phenomena have fascinated humankind for decades. Experimental research has reduced these phenomena to attempts to influence (a) the fall of dice and, later, (b) the output of random number generators (RNGs). The meta-analysis combined 380 studies that assessed whether RNG output correlated with human intention and found a significant but very small overall effect size. The study effect sizes were strongly and inversely related to sample size and were extremely heterogeneous. A Monte Carlo simulation revealed that the small effect size, the relation between sample size and effect size, and the extreme effect size heterogeneity found could in principle be a result of publication bias.