Effectiveness,safety and quality of life of trifluridine/tipiracil in pretreated patients with metastatic colorectal cancer: Real-world data from the noninterventional TACTIC study in Germany

The prospective, multicenter, noninterventional TACTIC study assessed effectiveness and safety of trifluridine/tipiracil (FTD/TPI) in patients with metastatic colorectal cancer (mCRC) in a real-world setting in Germany, thus evaluating the external validity of the findings from the pivotal RECOURSE trial. Primary endpoint was overall survival (OS). Secondary objectives included progression-free survival (PFS), safety, and quality of life (QoL). Subgroups comprised patients with good (<3 metastatic sites at inclusion, ≥18 months from diagnosis of first metastasis to inclusion) or poor (remaining patients) prognostic characteristics (GPC/PPC). GPC without liver metastases was considered best prognostic characteristics (BPC). In total, 307 eligible patients (pretreated or not suitable for other available therapies) were treated with FTD/TPI. Overall, median [95%-CI] OS was 7.4 months [6.4-8.6], median PFS was 2.9 months [2.8-3.3]. In BPC (n = 65) and GPC (n = 176) compared to PPC (n = 124) subgroup, median OS (13.3 [9.1-17.6] vs 8.9 [7.6-9.8] vs 5.1 [4.4-7.0] months) and median PFS (4.0 [3.3-5.3] vs 3.4 [3.0-3.7] vs 2.6 [2.4-2.8] months) were longer. Patient-reported QoL, assessed by validated questionnaires (EQ-5D-5L, PRO-CTCAE), was stable throughout FTD/TPI treatment. Predominant FTD/TPI-related adverse events of grades 3 or 4 were neutropenia (13.0%), leukopenia (7.5%), and anemia (5.2%). Altogether, palliative FTD/TPI therapy in patients with pretreated mCRC was associated with prolonged survival, delayed progression, maintained health-related QoL, and manageable toxicity. Low metastatic burden and indolent disease were favorable prognostic factors for survival. TACTIC confirms the effectiveness and safety of FTD/TPI, highlighting its value in routine clinical practice.     

Clinical Benefit-Risk Profile of Lenalidomide in Patients With Lower-risk Myelodysplastic Syndromes Without del(5q): Results of a Phase III Trial

BackgroundIn the phase III MDS-005 study of patients with lower-risk, non-del(5q) myelodysplastic syndromes, lenalidomide was associated with a higher rate of ≥ 8 weeks red blood cell transfusion independence (RBC-TI) compared with placebo, but also with a higher risk of hematologic adverse events (AEs).Patients and MethodsThis analysis evaluated the ratio of clinical benefit-risk in patients treated with lenalidomide or placebo, and assessed the effect of lenalidomide dose reductions on response. Clinical benefit was a composite endpoint defined as RBC-TI, transfusion reduction ≥ 4 units packed red blood cells, hemoglobin increase ≥ 1.5 g/dL, or cytogenetic response.ResultsThe rate of clinical benefit was higher with lenalidomide than with placebo (31.9% vs. 3.8%). The ratio of response (RBC-TI and clinical benefit) to risk (hematologic AEs) favored lenalidomide over placebo. Patients who underwent ≥ 1 lenalidomide dose reduction had a longer duration of treatment, received a higher cumulative dose, and were more likely to experience clinical benefit versus patients without dose reductions.ConclusionDespite the occurrence of hematologic AEs, the overall benefit-risk profile supported lenalidomide treatment. Appropriate management of hematologic AEs by dose reductions may help patients with myelodysplastic syndromes to remain on treatment and achieve clinical benefit.     

Rare patients in routine care: Treatment and outcome in advanced papillary renal cell carcinoma in the prospective German clinical RCC-Registry

Non-clear cell renal cell carcinoma is a very rare malignancy that includes several histological subtypes. Each subtype may need to be addressed separately regarding prognosis and treatment; however, no Phase III clinical trial data exist. Thus, treatment recommendations for patients with non-clear cell metastatic RCC (mRCC) remain unclear. We present first prospective data on choice of first- and second-line treatment in routine practice and outcome of patients with papillary mRCC. From the prospective German clinical cohort study (RCC-Registry), 99 patients with papillary mRCC treated with systemic first-line therapy between December 2007 and May 2017 were included. Prospectively enrolled patients who had started first-line treatment until May 15, 2016, were included into the outcome analyses (n = 82). Treatment was similar to therapies used for clear cell mRCC and consisted of tyrosine kinase inhibitors, mechanistic target of rapamycin inhibitors and recently checkpoint inhibitors. Median progression-free survival from start of first-line treatment was 5.4 months (95% confidence interval [CI], 4.1–9.2) and median overall survival was 12.0 months (95% CI, 8.1–20.0). At data cutoff, 73% of the patients died, 6% were still observed, 12% were lost to follow-up, and 9% were alive at the end of the individual 3-year observation period. Despite the lack of prospective Phase III evidence in patients with papillary mRCC, our real-world data reveal effectiveness of systemic clear cell mRCC therapy in papillary mRCC. The prognosis seems to be inferior for papillary compared to clear cell mRCC. Further studies are needed to identify drivers of effectiveness of systemic therapy for papillary mRCC.     

Suizide im deutschen Strafvollzug: Häufigkeit,Risikofaktoren und Prävention

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz - Gefangene haben ein hohes Suizidrisiko und die höchsten Suizidraten sind bei Untersuchungsgefangenen zu verzeichnen. Suizid...     

Merging self-reported with technically sensed data for tracking mobility behavior in a naturalistic intervention study. Insights from the GISMO study

Sound exposure data are central for any intervention study. In the case of utilitarian mobility, where studies cannot be conducted in controlled environments, exposure data are commonly self-reported. For short-term intervention studies, wearable devices with location sensors are increasingly employed. We aimed to combine self-reported and technically sensed mobility data, in order to provide more accurate and reliable exposure data for GISMO, a long-term intervention study. Through spatio-temporal data matching procedures, we are able to determine the amount of mobility for all modes at the best possible accuracy level. Self-reported data deviate ±10% from the corrected reference. Derived modal split statistics prove high compliance to the respective recommendations for the control group (CG) and the two intervention groups (IG-PT, IG-C). About 73.7% of total mileage was travelled by car in CG. This share was 10.3% (IG-PT) and 9.7% (IG-C), respectively, in the intervention groups. Commuting distances were comparable in CG and IG, but annual mean travel times differ between  = 8,458 min (σ = 6,427 min) for IG-PT,  = 8,444 min (σ = 5,961 min) for IG-C, and  = 5,223 min (σ = 5,463 min) for CG. Seasonal variabilities of modal split statistics were observable. However, in IG-PT and IG-C no shift toward the car occurred during winter months. Although no perfect single-method solution for acquiring exposure data in mobility-related, naturalistic intervention studies exists, we achieved substantially improved results by combining two data sources, based on spatio-temporal matching procedures.     

The War on Prevention II: Battle Metaphors Undermine Cancer Treatment and Prevention and Do Not Increase Vigilance

ABSTRACT

Bellicose metaphors for cancer are ubiquitous. But are they good metaphors for health communicators to use? Because metaphors can guide reasoning about abstract concepts, framing cancer with metaphors of battle, war, and enemies leads people to apply attributes of these concepts to cancer. The current research investigates how this affects inferences about cancer treatment, prevention, and monitoring. Battles and war are usually seen as being difficult. Indeed, reading about a person’s “battle” or “fight” against cancer makes cancer treatment seem more difficult (studies 1–4). One way to approach a battle is to surrender and give up control. Consistent with this implication, battle metaphors increase fatalistic beliefs about cancer prevention (e.g. believing that there is little one can do to prevent getting cancer; study 3). Finally, even though battles invoke vigilance and action, Study 4 failed to find that such metaphors motivate people to immediately see their doctor when imagining a cancer scare. These findings suggest that bellicose metaphors for cancer can influence the health beliefs of nonpatients in ways that may make them less willing to enact healthy behaviors