Polyetheretherketone Rods in Lumbar Spine Degenerative Disease: Mid-term Results in a Patient Series Involving Radiological and Clinical Assessment.

AIM: To evaluate the satisfaction of patients operated due to degenerative lumbar spinal diseases with dynamic stabilization placing polyetheretherketone (PEEK) rods and to share their radiological and clinical results (mid-term) with visual analogue scale (VAS) and Oswestry disability index (ODI) scores. MATERIAL AND METHODS: The preoperative and postoperative low back pain, leg pain VAS and ODI scores of 172 patients who were operated for degenerative spinal diseases, were evaluated. Preoperative and postoperative lumbar lordosis were compared. The patients included to the study were evaluated postoperatively around the 2nd year with lumbar MRI by means of adjacent segment disease (ASD) and additional problems. RESULTS: A statistically but not radiologically-by means of sagittal profile reconstruction-significant increase in lumbar lordosis angle was achieved. Significant improvement was observed in the comparison of preoperative and postoperative period in the analysis of patients’ preoperative low back pain (p < 0.0001), and decompression-related leg pain VAS scores (p < 0.0001). Significant improvement was also observed in the ODI scores of the patients (p < 0.0001). Among 172 patients with dynamic stabilization, there were 10 patients who underwent reoperation (5.8%). CONCLUSION: Although it is statistically significant, it can be seen that the lumbar lordosis can not be corrected at significant degrees radiographically in the operations performed with the PEEK rod. Dynamic stabilization with PEEK rod is insufficient for sagittal correction, but the mid-term results reached satisfactory reoperation rates clinically outcomes. Rate of ASD is quite low in stabilization with PEEK rod.

The European medicines agency review of eribulin for the treatment of patients with locally advanced or metastatic breast cancer: summary of the scientific assessment of the committee for medicinal products for human use.

The European Commission issued on March 17, 2011, a marketing authorization valid throughout the European Union (EU) for eribulin (Halaven; Eisai Limited). The decision was based on the favorable opinion of the Committee for Medicinal Products for Human Use recommending a marketing authorization for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least 2 chemotherapeutic regimens for advanced disease. Eribulin mesylate is a structurally simplified synthetic analogue of halichondrin B, which is a natural product isolated from the marine sponge Halichondria okadai (ATC code L01XX41). Eribulin is a nontaxane, microtubule dynamics inhibitor belonging to the halichondrin class of antineoplastic agents. Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates leading to G(2)-M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic blockage. The recommended dose of eribulin is 1.23 mg/m(2) (equivalent to 1.4 mg/m(2) eribulin mesylate) to be administered intravenously over 2 to 5 min on days 1 and 8 of a 3-week cycle. In the pivotal trial, eribulin was associated with increased overall survival in patients with locally advanced or metastatic breast cancer who received at least 2 prior chemotherapy lines for advanced disease (median overall survival was 13.2 months in the eribulin arm vs. 10.6 months in the control arm; HR = 0.805; 95% confidence interval, 0.677-0.958; P = 0.014). The most common side effects are asthenia or fatigue and neutropenia. The objective of this article is to summarize the scientific review of the application leading to approval in the EU. The detailed scientific assessment report and product information, including the summary report and product information, including product characteristics, are available on the European Medicines Agency website.

Eribulin mesylate (Halaven) for breast cancer.

Eribulin mesylate (Halaven-Eisai) has been approved by the FDA for treatment of patients with metastatic breast cancer who have previously received at least 2 chemotherapy regimens for metastatic cancer. Prior therapy should have included an anthracycline and a taxane in either an adjuvant or metastatic setting. Other drugs used to treat anthracycline- and taxane-refractory metastatic breast cancer include capecitabine (Xeloda), gemcitabine (Gemzar, and others) and vinorelbine (Navelbine, and others).