No abstract

Our study confirms the association between SPINK5 and AD.

Purpose To quantitatively evaluate the upper extremity and elbow function with the Mayo Elbow Performance Score (MEPS) in children with transphyseal fracture of the distal humerus (TFDH) treated surgically. Methods During the period between 2005 and 2015, a total of 16 patients (ten male, six female) met the inclusion criteria. Mean age at the time of injury was 18 months (11 to 37) and mean follow-up was 42.3 months (6 to 98). Based on a modified version of Delee’s classification (Group A to C), the clinical and radiographic outcome of TFDH in toddlers treated surgically were retrospectively evaluated. Results Mean humeral-ulnar (HU) angle of the injured and non-injured side was 1.2° (-18° to 14°) and 8.8° (2° to 19°), respectively (p = 0.001). Closed and open reduction showed similar HU angle values (p = 0.682). Mean MEPS score of the injured and non-injured side was 85.5 points (70 to 95) and 95 points (90 to 100), respectively (p = 0.002). No significant association was identified between MEPS score and gender, side, age at trauma, direction of displacement, time from trauma to surgery, presence of ossified capitellum, type of surgery and type of fracture. Conclusion Functional outcome was generally good regardless of surgical procedure performed, closed or open and type of fracture according to modified Delee’s classification. However, a residual cubitus varus was commonly observed among toddlers with transphyseal fractures of the distal humerus. Level of evidence: Level IV – Therapeutic study

CP94 has been used either topically in humans or in conjunction with PDT treatment in humans. We would also like to point out that, although not published, a the description of the post-hoc sample size calculation conducted by Mangano et al. to derive the figures published was kindly supplied to us and found to be flawed. They appeared to be using percentage change in their calculations rather than tumour thickness reductions and furthermore performed their calculations to detect a reduction of 300% (Mangano A, Albertin A, La Colla L, personal communication). We do not support this position and would power our future studies to detect a much smaller difference between groups, so that the reduction in tumour thickness being considered would be much more clinically relevant.We therefore conclude that the study design and statistical analysis of our investigation was well considered and appropriate and that we have achieved our primary objective by determining that the addition of CP94 to dermatological PDT appears to be safe and feasible. We observed a significant trend of increasing efficacy with increasing CP94 dose even in this small pilot study and this observation warrants further detailed investigation in a fully randomized controlled trial as stated in the original article. References1 Mangano A, Albertin A, La Colla L. Clinical investigation of the novel iron-chelating agent, CP94, to enhance topical photodynamic therapy of nodular basal cell carcinoma: when statistics make a difference. Br J Dermatol 2008; 161:215-16. 2 Campbell SM, Morton CA, Alyahya R et al. Clinical investigation of the novel iron-chelating agent, CP94, to enhance topical photodynamic therapy of nodular basal cell carcinoma. Br J Dermatol 2008; 159:387-93.

LBA7511 Background: INFORM (a phase III, randomized, multicenter, parallel group study; NCT00770588 ) investigated the efficacy, safety and tolerability of gefitinib (G) vs. placebo (P) as maintenance therapy in pts with locally advanced/metastatic NSCLC following standard first-line platinum based chemotherapy. Methods: Pts (≥18 years, with stage IIIB/IV NSCLC and WHO performance status 0-2) had completed 4 cycles of first-line platinum based doublet chemotherapy without progression/unacceptable toxicity. Pts were randomized 1:1 to G 250mg/day or P on discontinuation of first-line therapy. Progression-free survival (PFS; primary endpoint) was assessed in the intent to treat population (Cox proportional hazards adjusted for histology [adenocarcinoma vs. non-adenocarcinoma], smoking status [never-smoker vs. smoker], EGFR mutation status [positive vs. negative vs. unknown] and best response to first-line chemotherapy [complete response/partial response vs. stable disease]). PFS was considered superior with gefitinib if the G:P hazard ratio (HR) upper confidence interval (CI) was <1.00. Secondary endpoints included overall survival (OS), objective response rate, disease control rate, symptom improvement and tolerability. Results: 296 pts (n=148 G, n=148 P) were randomized (27 centers in china; 26 September 2008-10 August 2009). PFS data cutoff on 24 January 2011. Median duration of follow-up was 16.8 months: 91% pts progressed; 59% deaths. Demography was balanced between treatments; overall, 54.1% pts were never-smokers, 70.6% had adenocarcinoma, and 40.9% were female. For G vs. P, PFS HR=0.42; 95% CI 0.32-0.54; p<0.0001; median PFS 4.8 vs. 2.6 months. Most common AEs (any grade) with G were rash (49.7%), diarrhea (25.2%), and ALT increase (21.1%) which were generally mild/moderate. Overall incidence of serious AEs: G (6.8%); P (3.4%). Other secondary endpoint data (including OS and biomarkers) will be presented. Conclusions: PFS was significantly longer with G compared with P as maintenance therapy in Chinese patients with locally advanced NSCLC.