REBECA: a phase I study of bevacizumab and whole-brain radiation therapy for the treatment of brain metastasis from solid tumours.

BACKGROUND: Brain metastases (BMs) are associated with a poor prognosis. Standard treatment comprises whole-brain radiation therapy (WBRT). As neo-angiogenesis is crucial in BM growth, combining angiogenesis inhibitors such as bevacizumab with radiotherapy is of interest. We aimed to identify the optimal regimen of bevacizumab combined with WBRT for BM for phase II evaluation and provide preliminary efficacy data. PATIENTS AND METHODS: In this multicentre single-arm phase I study with a 3 + 3 dose-escalation design, patients with unresectable BM from solid tumours received three cycles of bevacizumab at escalating doses [5, 10 and 15 mg/kg every 2 weeks at dose levels (DL) 0, 1 and 2, respectively] and WBRT (30 Gy/15 fractions/3 weeks) administered from day 15. DL3 consisted of bevacizumab 15 mg/kg with WBRT from day 15 in 30 Gy/10 fractions/2 weeks. Safety was evaluated using NCI-CTCAE version 3. BM response (RECIST 1.1) was assessed by magnetic resonance imaging at 6 weeks and 3 months after WBRT. RESULTS: Nineteen patients were treated, of whom 13 had breast cancer. There were no DLTs. Grade 1-2 in-field and out-field toxicities occurred for five and nine patients across all DLs, respectively, including three and six patients (including one patient with both, so eight patients overall) of nine patients in DL3. One patient experienced BM progression during treatment (DL0). At the 3-month post-treatment assessment, 10 patients showed a BM response: one of three treated at DL0, one of three at DL1, two of three at DL2 and six of seven at DL3, including one complete response. BM progression occurred in five patients, resulting in two deaths. The remaining patient died from extracranial disease progression. CONCLUSION: Bevacizumab combined with WBRT appears to be a tolerable treatment of BM. DL3 warrants further efficacy evaluation based on the favourable safety/efficacy balance. ClinicalTrials.gov Identifier: NCT01332929.

[Obstetric data in a population with postural changes during labor and delivery]. / Données obstétricales dans une population bénéficiant de variations posturales en cours de travail et d'accouchement.

INTRODUCTION: The aim of this study was to describe the potential impact of an active birth on classical obstetrical outcomes, as labor duration, cesarean section rate, couples and team satisfactions. MATERIAL AND METHODS: This observational study was prospective, monocentric and took place between May 2007 and February 2009 at the maternity ward of the University Hospital of Caen, France. An "active birth" was defined as an active latent-phase (having a change in position and/or a bath and/or a walk) followed by at least three changes in position during the active phase. The suggested positions were: lateral or dorsal decubitus, ROSA, on all fours, seated, standing and crouch. A position must have lasted at least 20 minutes to be considered. RESULTS: Out of the 1906 women included, 828 had an active birth (43.4%). Due to our definition of an "active birth", a "non-active birth" was significantly associated with a quicker labor. An "active birth" was associated with a decreased rate of cesarean section (OR=0.71; IC95%=[0.51-0.99]). The parturients satisfaction median was 9 on a scale of 0 to 10, the spouses'one was 10. Midwives were more satisfied when it was an "active birth". CONCLUSION: Significant associations with active births were highlighted, which would require to be validated by a randomised study. This practise plenty satisfied couples and midwives. In fact, no litterature exists to date. A consensus about the definition of an active birth is still necessary in order to lead to guidelines.

[Inferior alveolar nerve block with ropivacaine: effect on nausea and vomiting after mandibular osteotomy]. / Bloc du nerf alvéolaire inférieur par ropivacaïne : effets sur les nausées et vomissements en postopératoires (NVPO) des ostéotomies mandibulaires.

INTRODUCTION: Our objective was to evaluate the contribution of bilateral inferior alveolar nerve block (BIANB) in patients before mandibular sagittal osteotomy for postoperative pain management, consumption of opioids, treatment of nausea and vomiting. MATERIALS AND METHODS: We included 30 patients undergoing mandibular sagittal osteotomy in a prospective, randomized, double blind study. The first group of patients (n=14) underwent a standard procedure (general anesthesia with postoperative morphine treatment). The second group of patients (n=16) underwent BIANB before surgery, in addition to the standard procedure. The postsurgical management was evaluated every four hours for the first 24hours, according to the following criteria: postoperative nausea and vomiting (PONV), visual analogue scale (VAS) assessment of pain, consumption of morphine (cumulative dose) and antiemetic drugs, and need for releasing inter-maxillary blockage. RESULTS: PONV was significantly less frequent in the second group (6.3 % versus 42.9 %, P=0.031). The frequency of releasing inter-maxillary blockage and the consumption of antiemetic drugs were not significantly different in the two groups. The mean VAS pain score was significantly lower in the second group (1.6 versus 0.9 avec P=0.045). There was no significant difference in cumulative morphine requirements between the two groups at 24hours. DISCUSSION: BIANB during mandibular osteotomy increases the patient comfort by decreasing PONV and improving postsurgical analgesia.