Search

Purpose: To determine the feasibility of incorporating bevacizumab consolidation into hypo‐fractionated concurrent chemoradiotherapy (hypo‐CCRT) for patients with unresectable locally advanced non‐squamous non‐small‐cell lung cancer (LA‐NS‐NSCLC). Patients and Methods: Eligible patients were treated with hypo‐RT (40Gy in 10 fractions) followed by hypo‐boost (24‐28Gy in 6–7 fractions), along with concurrent weekly chemotherapy. Patients who completed the hypo‐CCRT without experiencing ≥G2 toxicities received consolidation bevacizumab every 3 weeks for up to 1 year, until disease progression or unacceptable treatment‐related toxicities. The primary endpoint was the risk of G4 or higher hemorrhage. Secondary endpoints included progression‐free survival (PFS), overall survival (OS), locoregional failure‐free survival (LRFS), distant metastasis‐free survival (DMFS), and objective response rate (ORR). All time‐to‐event endpoints (OS, PFS, LRFS, and DMFS) were measured from the start of radiotherapy. Results: Between December 2017 and July 2020, a total of 27 patients were included in the analysis, with a median follow‐up duration of 28.0 months. One patient (3.7%) developed G5 hemorrhage during bevacizumab consolidation. Additionally, seven patients (25.9%) had G3 cough and three patients (11.1%) experienced G3 pneumonitis. The ORR for the entire cohort was 92.6%. The median OS was 37.0 months (95% confidence interval, 8.9–65.1 months), the median PFS was 16.0 months (95% confidence interval, 14.0–18.0 months), the median LRFS was not reached, and the median DMFS was 18.0 months. Conclusions: This pilot study met its goal of demonstrating the tolerability of consolidation bevacizumab after hypo‐CCRT. Further investigation of antiangiogenic and immunotherapy combinations in LA‐NSCLC is warranted, while the potential for grade 3 respiratory toxicities should be taken into consideration. [ABSTRACT FROM AUTHOR]

Background: We launched a single‐arm phase II study to determine the efficacy and cost‐effectiveness of percutaneous endoscopic gastrostomy (PEG) before concurrent chemoradiotherapy (CCRT) in patients with esophageal squamous cell carcinoma (ESCC). Methods: Eligible patients received pretreatment PEG and enteral nutrition during CCRT. The primary outcome was the change of weight during CCRT. The secondary outcome included nutrition status, loco‐regional objective response rate (ORR), loco‐regional progression‐free survival (LRFS), overall survival (OS), and toxicities. A 3‐state Markov model was applied for cost‐effectiveness analysis. Eligible patients were matched and compared with those who had nasogastric tube feeding (NTF) or oral nutritional supplements (ONS). Results: Sixty‐three eligible patients received pretreatment PEG‐based CCRT. The mean change of weight during CCRT was −1.4% (standard deviation, 4.4%), and after CCRT, 28.6% of patients gained weight and 98.4% had normal albumin levels. The loco‐regional ORR and 1‐year LRFS were 98.4% and 88.3%. The incidence of grade ≥3 esophagitis was 14.3%. After matching, another 63 patients were included in the NTF group and 63 in the ONS group. More patients gained weight after CCRT in the PEG group (p = 0.001). The PEG group showed higher loco‐regional ORR (p = 0.036) and longer 1‐year LRFS (p = 0.030). In cost analysis, the PEG group showed an incremental cost‐effectiveness ratio of $3457.65 per quality‐adjusted life‐years (QALY) compared with the ONS group with a probability of cost‐effectiveness of 77.7% at the $10,000 per QALY willingness‐to‐pay threshold. Conclusion: Pretreatment PEG is associated with better nutritional status and treatment outcome in ESCC patients treated with CCRT compared with ONS and NTF. Pretreatment of PEG can be cost‐effective because of its significant clinical benefits. [ABSTRACT FROM AUTHOR]

Researchers make hundreds of decisions about data collection, preparation, and analysis in their research. We use a many‐analysts approach to measure the extent and impact of these decisions. Two published causal empirical results are replicated by seven replicators each. We find large differences in data preparation and analysis decisions, many of which would not likely be reported in a publication. No two replicators reported the same sample size. Statistical significance varied across replications, and for one of the studies the effect's sign varied as well. The standard deviation of estimates across replications was 3–4 times the mean reported standard error. [ABSTRACT FROM AUTHOR]