Activity and safety of afatinib in a window preoperative EORTC study in patients with squamous cell carcinoma of the head and neck (SCCHN).

Background: To investigate the activity and safety of afatinib in the preoperative treatment of squamous cell carcinoma of the head and neck (SCCHN). Patients and methods: This study was an open-label, randomized, multicenter, phase II window of opportunity trial. Treatment-naïve SCCHN patients selected for primary curative surgery were randomized (5 : 1 ratio) to receive afatinib during 14 days (day -15 until day -1) before surgery (day 0) or no treatment. Tumor biopsies, 2-[fluorine-18]-fluoro-2-deoxy-d-glucose positron emission tomography (FDG-PET), and magnetic resonance imaging (MRI) were carried out at diagnosis and just before surgery. The primary end point was metabolic FDG-PET response (according to EORTC guidelines). Other end points included response assessment based on the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1, dynamic contrast-enhanced (DCE)-MRI, diffusion weighted (DW)-MRI, safety, and translational research (TR). Results: Thirty patients were randomized: 25 to afatinib and 5 to control arm. Of the 23 eligible patients randomized to afatinib, 16 (70%; 95% CI: 47% to 87%) patients had a partial metabolic FDG-PET response (PMR). Five patients (22%; 95% CI: 8% to 44%) showed a partial response by RECISTv1.1. Responses assessed via DCE-MRI and DWI-MRI did not show a strong association with PMR or RECIST. One patient discontinued afatinib after 11 days for grade 3 diarrhea with subsequent renal failure and 24 days delay in surgery. No grade 4 toxicities or surgical comorbidities related to afatinib were reported. TR results indicated that PMR was more frequent in the tumors with high Cluster3-hypoxia score expression and with TP53 wild type. Conclusion: Afatinib given for 2 weeks to newly diagnosed SCCHN patients induces a high rate of FDG-PET partial metabolic response and partial response according to RECISTv1.1. Afatinib can be safely administered before surgery. Although exploratory, the hypoxic gene signature needs further investigations as a predictive biomarker of afatinib activity. Clinical trial registration: ClinicalTrials.gov: NCT01538381.

Parathyroidectomy in primary hyperparathyroidism: retrospective study of 167 patients, experience in Jules Bordet Institute.

The aim of this study is to compare our surgical results of parathyroidectomies in primary hyperparathyroidism with literature results. From 1985 until 2009, 167 patients were operated for primary hyperparathyroidism by bilateral central neck exploration. The sex ratio (women/men) is 4/1 and the middle age is 57 years old. We record clinical information, laboratory and radiological results of the preoperative period. We count 158 adenomas, 5 parathyroid hyperplasias, two carcinomas and two parathyroid glands reported as normal. The morbidity rate was low (0.6%) and there was no mortality. With a mean follow-up of 6 years, the majority of symptoms and clinical signs improved after surgery, the parathyroid hormone level (PTH) and the calcaemia normalized in all patients except 4/166 (2.41%). Among twenty-four patients who go for a Dual-Energy X-ray Absorptiometry test (DEXA), 16/24 (66.67%) demonstrated a lumbar spine bone mass increase and 15/24 (62.5%) a total hip bone mass increase. There was one recurrence of hyperparathyroidism due to a missed second adenoma in the mediastinum. In conclusion, the parathyroidectomy by bilateral neck exploration under general anesthesia in the treatment of primary hyperparathyroidism is a surgical technique associated with a high recovery rate and a low complications rate. A systematic study of the bone mass before and after parathyroidectomy should allow identification of the factors that are associated with the bone density increase of these patients.

[Selective opacification of the oviduct (author's transl)]. / Salpingographie sélective. Résultats préliminaires.

A new procedure of selective opacification of the oviduct is proposed. This technic is easy fast, safe and not painful. Clear visualisation of the oviduct and salpinx is possible in many cases of failure of hysterosalpingography. Obstruction of the oviduct and hysterosalpinx can be demonstrated without any doubt.