A Cost-Effectiveness Analysis of Nivolumab versus Docetaxel for Advanced Nonsquamous NSCLC Including PD-L1 Testing.

INTRODUCTION: Nivolumab (NIV) was recently approved in several countries for patients with pretreated advanced NSCLC. NIV is not cost-effective compared with docetaxel (DOC) for the treatment of squamous NSCLC. However, its cost-effectiveness for nonsquamous NSCLC and the consequences of programmed death ligand 1 (PD-L1) testing are unknown. METHODS: This literature-based health economic study used CheckMate-057 trial data to model the incremental cost-effectiveness ratio (ICER) of NIV versus DOC in the Swiss health care setting. The effect of PD-L1 positivity for patient selection was assessed. RESULTS: In the base case model, NIV (mean cost CHF66,208; mean effect 0.69 quality-adjusted life-years [QALYs]) compared with DOC (mean cost CHF37,618; mean effect 0.53 QALYs) resulted in an ICER of CHF177,478/QALY gained. Treating only patients with PD-L1-positive tumors (threshold ≥10%) with NIV compared with treating all patients with DOC produced a base case ICER of CHF124,891/QALY gained. Reduced drug price, dose, or treatment duration decreased the ICER partly below a willingness-to-pay threshold of CHF100,000/QALY. Health state utilities strongly influenced cost-effectiveness. CONCLUSIONS: Compared with DOC, NIV is not cost-effective for the treatment of nonsquamous NSCLC at current prices in the Swiss health care setting. Price reduction or PD-L1 testing and selection of patients for NIV on the basis of test positivity improves cost-effectiveness compared with DOC.

Assessment of prostate cancer with dynamic contrast-enhanced computed tomography using an en bloc approach.

OBJECTIVES: The aim of this study was to assess the performance of dynamic contrast-enhanced computed tomography of the prostate in patients with biopsy-proven prostate cancer. MATERIAL AND METHODS: A total of 46 male patients (median age, 65 years; range, 49-73 years) with biopsy-proven prostate cancer underwent an en bloc computed tomography perfusion (CTP) scan of the prostate before surgery. The perfusion parameters mean transit time (MTT), blood flow (BF), and blood volume (BV), as well as the microvessel density (MVD) of surgical specimens were determined. Differences in CTP parameters and MVD among postsurgical Gleason score (sGS) and postsurgical combined Gleason grade (sGG) groups were analyzed. Spearman correlation coefficients were determined between CTP parameters and presurgical biopsy-derived Gleason score (bGS), presurgical biopsy-derived combined Gleason grade (bGG), sGS, sGG, MVD, and pathological tumor stage. A linear regression analysis was carried out for exogenous variables BF, BV, MTT, bGS, and presurgical biopsy-derived combined Gleason grade and endogenous variables sGS, sGG, MVD, and T stage. A receiver operating characteristics analysis was performed to analyze the discriminating performance of CTP parameters and bGS between intermediate- and high-grade tumors. RESULTS: The mean perfusion parameters within the prostate tissue were as follows: BF, 39.1 ± 13.4 mL/100 mL min; BV, 4.9 ± 2.4 mL/100 mL; and MTT, 8.9 ± 3.7 seconds. The mean MVD of the tumor tissue was 144.3 ± 55.6/mm. Computed tomography perfusion parameters and MVD were significantly higher in patients with high-grade tumors compared with those with intermediate-grade tumors (P < 0.01 for BF, BV, and MVD). Only BV and MVD were significantly different among sGS and sGG groups. Moderate correlations were found between BF and sGS (0.38) and between BV and sGS (0.43). Linear relations of BV to sGS and to sGG were found. Blood volume (area under the curve, 0.86) was superior to bGS (area under the curve, 0.75) in discriminating high-grade from intermediate-grade tumors. CONCLUSION: Computed tomography perfusion parameters derived by en bloc perfusion of the prostate are higher in high-grade tumors compared with intermediate-grade tumors. Blood flow and BV correlate with the definitive Gleason score. Blood volume predicts high-grade tumors better than does the Gleason score of biopsy specimens. Further studies are needed to determine a potential role for CTP in prostate cancer patients.

A multicenter assessment of liver toxicity by MRI and biopsy in IBD patients on 6-thioguanine.

BACKGROUND/AIMS: Although 6-thioguanine (6-TG) has been suggested as an effective treatment option for patients with inflammatory bowel disease (IBD), the recent description of its hepatotoxicity has led to the recommendation not to consider this drug. We initiated a multicenter safety study in IBD-patients treated with 6-TG to investigate hepatic changes by liver biopsy and magnetic resonance imaging (MRI). METHODS: Forty-five patients from three European centers treated with 6-TG (40-80 mg/d) at least for 8 weeks were enrolled. In all patients liver biopsy and MRI were performed. Slides and MR images were independently read by two pathologists and radiologists, respectively, and interpreted according to predefined criteria by consent. RESULTS: In 8 patients nodular regenerative hyperplasia (NRH) was diagnosed by liver biopsy, in 8 additional patients NRH could not be excluded due to equivocal pathological findings. MRI demonstrated a sensitivity of 77% and a specificity of 72% in the detection of pathohistological findings consistent with and/or possibly related to NRH. CONCLUSIONS: Our study suggests that 6-TG therapy in IBD patients is associated with NRH of the liver. Based on a special MRI protocol, non-invasive diagnosis of NRH with promising sensitivity and specificity was demonstrated.