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Background: Despite the well-known negative prognostic value of the V600EBRAF mutation in patients with metastatic colorectal cancer (mCRC), its outcome is quite heterogeneous, and the basis for this prognostic heterogeneity should be better defined. Methods: Two large retrospective series of V600EBRAF-mutated mCRC from 22 institutions served as an exploratory and validation set to develop a prognostic score. The model was internally and externally validated. Results: A total of 395 V600EBRAF-mutated mCRCs were included in the exploratory set. Performance status, CA19.9, lactate dehydrogenase, neutrophil/lymphocyte ratio, grading and liver, lung and nodal involvement emerged as independent prognostic factors for overall survival (OS). Two different scoring systems were built: a ‘complete’ score (0–16) including all significant covariates and a ‘simplified’ score (0–9), based only on clinicopathological covariates, and excluding laboratory values. Adopting the complete score, proportions of patients with a low (0–4), intermediate (5–8) and high (9–16) score were 44.7%, 42.6% and 12.6%, respectively. The median OS was 29.6, 15.5 (hazard ratio [HR] for intermediate vs low risk: 2.16, 95% confidence interval [CI]: 1.44–3.22, p < .001) and 6.6 months (HR for high vs low risk: 4.72, 95% CI: 2.72–8.20, p < .001). Similar results were observed also after adjusting for the type of first-line treatment and adopting the simplified score. The simplified prognostic score derived from the exploratory set was then applied to the validation set for external confirmation. Conclusions: These scoring systems are based on easy-to-collect data and defined specific subgroups with relevant differences in their life expectancy. These tools could be useful in clinical practice, would allow better stratification of patients in clinical trials and may be adopted for proper adjustments in exploratory translational analyses.

Objective: To report the safety and efficacy results of patients enrolled in the Italian Nivolumab Renal Cell Cancer Expanded Access Programme. Patients and Methods: Patients with metastatic renal cell cancer (mRCC) previously treated with agents targeting the vascular endothelial growth factor pathway were eligible to receive nivolumab 3 mg/kg once every 2 weeks. Patients included in the analysis had received ≥1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. Results: A total of 389 patients were enrolled between July 2015 and April 2016, of whom 18% were aged ≥75 years, 6.7% had non-clear cell RCC, 49.6% had bone and 8.2% brain metastases, and 79% had received ≥2 previous lines of therapy. The most common any-grade treatment-related AEs were fatigue (13%) and rash (9%). Twenty-two patients (5.7%) discontinued treatment because of AEs. There were no treatment-related deaths. The objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% confidence interval 3.7–6.2) and the 12-month overall survival rate was 63%. Similar survival rates were reported among patients with non-clear-cell histology, elderly patients, those with bone and/or brain metastases, and those who had received prior first-line sunitinib or pazopanib, or prior everolimus. Conclusion: The safety and efficacy observed were consistent with those reported in the pivotal Checkmate 025 trial. Results in patients with non-clear-cell mRCC who were elderly, pretreated with everolimus, and had bone and/or brain metastases encourage the use of nivolumab in these categories of patients. © 2018 The Authors BJU International

Advanced biliary tract cancers are poor prognosis tumors with limited therapeutic options. The conven-tional treatment consists of combination chemotherapy resulting in overall survival of less than 12 months. Recently, a subgroup of patients characterized by an exceedingly fa-vorable prognosis has been reported in the literature. In our study, we assessed the prevalence and provided a clinico-pathological characterization of this subset of patients in the context of daily practice. In particular, we were able to identify female sex and neutrophil-to-lymphocyte ratio as independent predictors of long-term survival. Based on these premises, we deem it necessary to prompt transla-tional research projects aimed at molecularly characterized long-term survivors, particularly focusing on sex-and im-mune-related determinants.

Myofibroblastoma of the breast is a rare benign stromal tumor that occurs in both sexes with a higher prevalence in male breast of older populations. Furthermore, myofibroblastoma can arise in extra mammary sites, along the milk-line. A variety of morphological variants in addition to the classic type have been identified. The differential diagnosis includes both benign and malignant entities that, through the use of clinical and radiological imaging, is difficult to characterize. Histopathological examination and immunohistochemistry are fundamental in the establishment of appropriate management of the disease and avoidance of overtreatment. The present study focuses on two cases of male mammary myofibroblastoma, with a short literature review.

Background and Aim: REGARD and RAINBOW were global, phase 3, randomized, double-blind trials of second-line ramucirumab for metastatic gastric or gastroesophageal junction adenocarcinoma. Exploratory subgroup analyses were described to assess the efficacy and safety of ramucirumab in REGARD and RAINBOW in young (≤45 and

Background: CTIBL in breast cancer (BC) women is wellknow. It is commonly, but not exclusively, related to aromataseinhibitors. The “Nota 79” by AIFA contemplatesthe primary prevention of fracture risk in BC women inadjuvant hormonal treatment with bisphosphonates or denosumab,at osteoporosis dosage. At the Modena CancerCenter we started a collaboration with oncologists hematologistsand bone specialists in order to offer thebest tailored treatment in high risk fracture patients.Patients and Methods: patients newly diagnosed with BCin hormonal treatment fill-out a form, in order to evaluatethe risk factors for osteoporosis, and based on the resultsand the bone density they are referred to the osteoncologyunit along with serological and urinary markers of boneturn-over.Results: in over 18 months of activity, more than 600patients have been screened by self-completed questionnaire.From the analysis of the first 400 questionnairesemerged that 61% had one or more risk factors, 20%received supplement of vitamin D, and approximately 5%were on bisphosphonates. At baseline, the measurement ofthe height, the evaluation of the spine at the chest X ray orby morphometry highlighted asymptomatic vertebral fracturesin few patients. Several patients presented with secondaryhyperparathyroidism, that required correctionbefore to start any treatment with antiresorptive agents.Cases with hypercalciuria were also corrected along withantiresorptive therapy. Few cases demonstrated high boneturn-over with CTX levels above the limits. The treatmenthas been individualized based on the medical history andcomorbidities, oncological treatment and the bone turnover.All the patients have been informed of the possiblerisk of osteonecrosis of the jaw; dental medical history wascollected for each patient, but orthopanthomography andodontoiatric evaluation was prescribed in selected patients.Vitamin D level was corrected before any therapy andimprovement of the dietary habits and physical activitywas highly recommended. Data analysis is still ongoing.Conclusions: all the patients receiving AIs require the preventionof CTIBL, but the limited resources pushed us toselect, at this time, the patients with special needs to beevaluated in multidisciplinary group. The complexity of thebone health requires attentive evaluation by bone specialistsin selected cases before to start antiresorptive agents.Supplemental data will be presented at the meeting.