IntroductionBortezomib, a novel proteasome inhibitor, is approved for the treatment of relapsed multiple myeloma (MM). Efficacy and safety of bortezomib is well known; however, it was necessary to validate the data in patients with different ethnic backgrounds. The efficacy and safety of bortezomib was assessed in patients from China with relapsed/refractory MM in a real-world scenario.MethodsThis prospective, non-interventional, observational study enrolled both male and female Chinese patients, aged ≥18 years and diagnosed with relapsed or refractory MM. Administration of intravenous bortezomib at 1.3 mg/m2 was recommended twice a week for 2 weeks (days 1, 4, 8 and 11), followed by a 10-day rest period (maximum of 8 cycles) and a follow-up every 12 weeks for 3 years. Efficacy assessments included best response, objective response rate (ORR), time to response, duration of response, and overall survival. Safety was also assessed.ResultsA total of 517 patients were enrolled with a median age of 58.7 years. Patients predominantly had immunoglobulin G type (46.2%) and stage III (47.8%) myeloma. Overall, 202 (42.3%) patients had partial response as best response, ORR was 88.9% and the proportion of patients exhibiting complete response was 24.7%. The median time to response observed was 27 (21–40) days. Median time to progression was 415 days and median overall survival was 475 days. Thrombocytopenia (14.4%) was the most common adverse event.ConclusionBortezomib demonstrated clinical response in majority of patients and was well tolerated in this observational study in Chinese patients with relapsed/refractory MM.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-014-0159-z) contains supplementary material, which is available to authorized users.

Background: Inversion deformities caused by insufficient medial support are especially common when the PHILOS locking plate is used to treat proximal humeral fractures. Using finite element analysis, the present study aimed to compare the biomechanical properties of a PHILOS locking plate (PLP) and a PHILOS plate combined with a lateral intertubercular sulcus plate (PLP-LSP) in the fixation of proximal humeral fractures with loss of the medial column. We also present representative results for a 69-year-old female patient with a comminuted fracture of the proximal right humerus (Neer type four-part fracture) who underwent successful surgical treatment with a PHILOS plate combined with an auxiliary lateral intertubercular sulcus plate. Methods: After creating a three-dimensional finite element model of proximal humeral fracture with loss of the medial column, three implant models were established. A full-screw PHILOS plate (PLP) was used in Group A, while a PHILOS plate lacking medial screw support and an auxiliary plate were used in Group B (MPLP-LSP). A full-screw PHILOS plate and auxiliary plate were used in Group C (PLP-LSP). The three fixation models were applied to the proximal humerus fracture model, following which horizontal, compressive, and rotational loads were applied to the humerus model. We evaluated the structural stiffness and stress distribution of the implant and compared displacement and angle changes among the three models. Results: Displacement and angle changes were smallest in Group C (PLP-LSP). The implant model used in Group C also had the highest structural rigidity, endured less von Misses stress than the other two models , and had the strongest stability. In our clinical case, X-ray and computed tomography images obtained 3 months after the operation indicated that the fracture had healed, with good positioning of internal fixation and good functional recovery.Conclusion: A lateral intertubercular sulcus plate placed at the internodal grove not only aids in anatomical reduction but also provides effective lateral and medial support, thereby reducing stress on the PHILOS plate and providing better stability in patients with proximal humeral fractures.