Purpose: Inflammation indexes and body mass index (BMI) are easily evaluated, predict survival, and are potentially modifiable. We evaluated the potential association of inflammatory indexes and BMI with the clinical outcome of patients with renal cell carcinoma (RCC) undergoing immune checkpoint inhibitor therapy.Experimental Design: A prospective cohort of patients with metastatic RCC treated with nivolumab enrolled in the Italian Expanded Access Program from July 2015 through April 2016 was examined. Reference measures of inflammation were identified for neutrophil-to-lymphocyte ratio (NLR) ! 3, systemic immune inflammation index (SII) ! 1,375, and platelet-tolymphocyte ratio (PLR) ! 232. Patients were classified as high BMI (!25 kg/m 2 ) versus normal BMI (<25 kg/m 2 ).Results: Among 313 evaluable patients, 235 (75.1%) were male, and median age was 65 years (range, 40-84 years), with 105 (33.69%) !70 years. In univariate analysis, age, performance status, BMI, SII, NLR, and PLR were able to predict outcome. In multivariate analyses, SII !1,375, BMI <25 kg/m 2 , and age !70 years independently predicted overall survival [OS; HR ¼ 2.96, 95% confidence interval (CI), 2.05-4.27; HR ¼ 1.59, 95% CI, 1.10-2.30; and HR ¼ 1.65, 95% CI, 1.07-2.55, respectively). A patient with both SII !1,375 and BMI <25 kg/m 2 was estimated to have much worse OS (HR, 3.37; 95% CI, 2.29-4.95; P <0.0001) than a patient with neither or only one risk factor. SII changes at 3 months predicted OS (P <0.0001).Conclusions: Normal BMI combined with inflammation tripled the risk of death, suggesting that these biomarkers are critical prognostic factors for OS in patients with RCC treated with nivolumab.Four groups of SII changes: (i) low-low (baseline SII < 1,375 and follow-up SII < 1,375); (ii) low-high (baseline SII < 1,375 and follow-up SII ! 1,375); (iii) high-low (baseline SII ! 1,375 and follow-up SII < 1,375); and (iv) high-high (baseline SII ! 1,375 and follow-up SII ! 1,375).De Giorgi et al.
Patients with melanoma brain metastases have a poor prognosis and historically have been excluded from clinical trials. The Expanded Access Program (EAP) provided an opportunity to evaluate the feasibility of ipilimumab (3 mg/kg every 3 weeks for four doses) in patients with stage 3 (unresectable) or 4 melanoma and asymptomatic brain metastases, who had failed or did not tolerate previous treatments and had no other therapeutic option available. Tumor assessments were conducted at baseline and week 12 using immune-related response criteria and patients were monitored for adverse events (AEs). Of 855 patients participating in the EAP in Italy, 146 had asymptomatic brain metastases. With a median follow-up of 4 months, the global disease control rate was 27 %, including 4 patients with a complete response and 13 with a partial response. Median progression-free survival and overall survival were 2.8 and 4.3 months, respectively and approximately one-fifth of patients were alive 1 year after starting ipilimumab. In total, 29 % of patients reported a treatment-related AE of any grade, which were grade 3/4 in 6 % of patients. AEs were generally reversible with treatment as per protocol-specific guidelines. Ipilimumab shows durable benefits in some patients with advanced melanoma metastatic to the brain, with safety results consistent with those previously reported in clinical trials.
Although the long experience acquired with the widespread use of dermoscopy has allowed the establishment of criteria for the recognition of benign and malignant skin lesions, very few data are available on cutaneous melanoma metastases. As the characteristic clinical aspects are multiform and even histological evaluation may sometimes be difficult, we have studied and characterized the patterns of cutaneous melanoma metastases in dermoscopy. In this paper, we report dermoscopic data on 130 histologically confirmed metastases observed in 32 patients affected by melanoma, with particular emphasis on dermoscopic features. Nine dermoscopic elements (homogeneous, saccular, amelanotic, polymorphic and vascular patterns, colour, perilesional erythema, pigmentary halo, peripheral grey spots) were studied in 130 cutaneous melanoma metastases and compared with those of 350 melanomas, 150 common naevi, 40 blue naevi, 40 haemangiomas and 50 basal cell carcinomas. The saccular and vascular patterns (especially polymorphic atypical vessels and winding vessels), as well as pigmentary halo and peripheral grey spots, seem to be the most significant elements suggestive of cutaneous melanoma metastases. The interest in and importance of the dermoscopic aspects of cutaneous melanoma metastases cannot be neglected if the American Joint Committee has determined that microsatellitosis and micrometastases are fundamental in the new TNM staging classification for cutaneous melanoma.
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