Avelumab as neoadjuvant therapy in patients with urothelial non-metastatic muscle invasive bladder cancer: a multicenter, randomized, non-comparative, phase II study (Oncodistinct 004 - AURA trial).

INTRODUCTION: Cisplatin-based neoadjuvant chemotherapy (NAC) followed by surgery is the standard treatment for patients with non-metastatic muscle invasive bladder cancer (MIBC). Unfortunately, many patients are not candidates to receive cisplatin due to renal impairment. Additionally, no predictive biomarkers for pathological complete response (pCR) are currently validated in clinical practice. Studies evaluating immune checkpoint inhibitors in the peri-operative setting are emerging with promising results. Clinical trials are clearly required in the neoadjuvant setting in order to improve therapeutic strategies. METHODS AND ANALYSIS: Oncodistinct 004 - AURA is an ongoing multicenter phase II randomized trial assessing the efficacy and safety of avelumab single-agent or combined to different NAC regimens in patients with non-metastatic MIBC. Patients are enrolled in two distinct cohorts according to their eligibility to receive cisplatin-based NAC. In the cisplatin eligible cohort, patients are randomized in a 1:1 fashion to receive avelumab combined with cisplatin-gemcitabine or with dose-dense methotrexate-vinblastine-doxorubicin-cisplatin. In the cisplatin ineligible cohort, patients are randomized at a 1:1 ratio to paclitaxel-gemcitabine associated to avelumab or avelumab alone. Primary endpoint is pCR. Secondary endpoints are pathological response and safety. ETHICS AND DISSEMINATION: The study is approved by ethics committee from all participating centers. All participants provide informed consent prior inclusion to the study. Once completed, results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT03674424).

Multidisciplinary management of testicular cancer complicated by thrombosis of the inferior vena cava: a case report.

INTRODUCTION: Testicular cancer is a rare disease, most commonly seen in young adults. It represents 1% of solid cancers in men. Inferior vena cava (IVC) thrombosis remains a rare complication of testicular cancer and is often associated with a high risk of pulmonary embolism (PE). CASE REPORT: The authors report a case of a 26-year-old man presenting with advanced testicular cancer, left-sided retroperitoneal metastasis and parietal infiltration of the IVC complicated with thrombosis of the left iliac vein and the IVC, both responsible for PE. DISCUSSION: A multidisciplinary management which included curative excision of the lesions, placement of a temporary IVC filter and adjuvant chemotherapy permitted an optimal approach. No complications occurred and the post-operative healing was uneventful. No recurrences were observed on the long-term follow-up. CONCLUSIONS: IVC Thrombosis is a rare complication that should be taken into consideration when diagnosing testicular cancer. Prompt diagnosis is crucial to minimize the risk of PE which can be life-threatening.