Updated Results of TBCRC026: Phase II Trial Correlating Standardized Uptake Value With Pathological Complete Response to Pertuzumab and Trastuzumab in Breast Cancer

PURPOSE: Predictive biomarkers to identify patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer who may benefit from targeted therapy alone are required. We hypothesized that early measurements of tumor maximum standardized uptake value corrected for lean body mass (SULmax) on 18F-labeled fluorodeoxyglucose positron emission tomography-computed tomography (PET-CT) would predict pathologic complete response (pCR) to pertuzumab and trastuzumab (PT). PATIENTS AND METHODS: Patients with stage II or III, estrogen receptor-negative, HER2-positive breast cancer received four cycles of neoadjuvant PT. 18F-labeled fluorodeoxyglucose positron emission tomography-computed tomography was performed at baseline and 15 days after PT initiation (C1D15). Eighty evaluable patients were required to test the null hypothesis that the area under the curve of percent change in SULmax by C1D15 predicting pCR is ≤ 0.65, with a one-sided type I error rate of 10%. RESULTS: Eighty-eight women were enrolled (83 evaluable), and 85% (75 of 88) completed all four cycles of PT. pCR after PT alone was 22%. Receiver operator characteristic analysis of percent change in SULmax by C1D15 yielded an area under the curve of 0.72 (80% CI, 0.64 to 0.80; one-sided P = .12), which did not reject the null hypothesis. However, between patients who obtained pCR and who did not, a significant difference in median percent reduction in SULmax by C1D15 was observed (63.8% v 41.8%; P = .004) and SULmax reduction ≥ 40% was more prevalent (83% v 52%; P = .03; positive predictive value, 31%). Participants not obtaining a 40% reduction in SULmax by C1D15 were unlikely to obtain pCR (negative predictive value, 91%). CONCLUSION: Although the primary objective was not met, early changes in SULmax predict response to PT in estrogen receptor-negative and HER2-positive breast cancer. Once optimized, this quantitative imaging strategy may facilitate tailoring of therapy in this setting

Phase II trial correlating standardized uptake value with pathologic complete response to pertuzumab and trastuzumab in breast cancer

PURPOSE Predictive biomarkers to identify patients with human epidermal growth factor receptor 2 (HER2)–positive breast cancer who may benefit from targeted therapy alone are required. We hypothesized that early measurements of tumor maximum standardized uptake values corrected for lean body mass (SULmax) on [ 18 F] fluorodeoxyglucose positron emission tomography/computed tomography would predict pathologic complete response (pCR) to neoadjuvant pertuzumab and trastuzumab (PT). PATIENTS AND METHODS Patients with stage II/III, estrogen receptor–negative, HER2-positive breast cancer received four cycles of neoadjuvant PT. [ 18 F]Fluorodeoxyglucose positron emission tomography/computed tomography was performed at baseline and 15 days after PT initiation (C1D15). Eighty evaluable patients were required to test the null hypothesis that the area under the curve of percentage of change in SULmax by C1D15 predicting pCR is less than or equal to 0.65, with a one-sided type I error rate of 10%. RESULTS Eighty-eight women were enrolled (83 evaluable), and 85% (75 of 88) completed all four cycles of PT. pCR after PT alone was 34%. Receiver operating characteristic analysis yielded an area under the curve of 0.76 (90% CI, 0.67 to 0.85), which rejected the null hypothesis. Between patients who obtained pCR versus not, a significant difference in median percent reduction in SULmax by C1D15 was observed (63.8% v 33.5%; P, .001), an SULmax reduction greater than or equal to 40% was more prevalent (86% v 46%; P, .001; negative predictive value, 88%; positive predictive value, 49%), and a significant difference in median C1D15 SULmax (1.6 v 3.9; P, .001) and higher proportion of C1D15 SULmax less than or equal to 3 (93% v 38%; P, .001; negative predictive value, 94%; positive predictive value, 55%) were observed. CONCLUSION Early changes in SULmax predict response to four cycles of PT in estrogen receptor–negative, HER2-positive breast cancer. Once optimized, this quantitative imaging strategy may facilitate a more tailored approach to therapy in this setting

The role of excitations statistic and nonlinearity in energy harvesting from random impulsive excitations

Design of an efficient energy harvester is now feasible as technology develops and a viable approach to solve this need is to exploit the concept and application of a nonlinear design. In this letter, we conducted a comparative analysis of linear and nonlinear piezoelectric energy harvesting from random impulsive excitations modelled by white Poisson noise. It is shown that the harvester performance depends on both nonlinearity and properties of ambient energy, and nonlinearity should be optimized for a given type of ambient vibration in order to achieve efficient harvesting

Impact of Birth Preparedness and Complication Readiness Interventions on Birth with a Skilled Attendant: A Systematic Review.

Background: Increased preparedness for birth and complications is an essential part of antenatal care and has the potential to increase birth with a skilled attendant. We conducted a systematic review of studies to assess the effect of birth preparedness and complication readiness interventions on increasing birth with a skilled attendant. Methods: PubMed, Embase, CINAHL and grey literature were searched for studies from 2000 to 2012 using a broad range of search terms. Studies were included with diverse designs and intervention strategies that contained an element of birth preparedness and complication readiness. Data extracted included population, setting, study design, outcomes, intervention description, type of intervention strategy and funding sources. Quality of the studies was assessed. The studies varied in BP/CR interventions, design, use of control groups, data collection methods, and outcome measures. We therefore deemed meta-analysis was not appropriate and conducted a narrative synthesis of the findings. Results: Thirty-three references encompassing 20 different intervention programmes were included, of which one programmatic element was birth preparedness and complication readiness. Implementation strategies were diverse and included facility-, community-, or home-based services. Thirteen studies resulted in an increase in birth with a skilled attendant or facility birth. The majority of authors reported an increase in knowledge on birth preparedness and complication readiness. Conclusions: Birth Preparedness and Complication Readiness interventions can increase knowledge of preparations for birth and complications; however this does not always correspond to an increase in the use of a skilled attendant at birth

Opportunities for male involvement during pregnancy in Magu district, rural Tanzania

Male involvement during antenatal care is promoted to be an important intervention to increase positive maternal and new born health outcomes. Despite active promotion to stimulate male involvement during antenatal care, few men in Tanzania accompany women to their antenatal care visits. This study aims to understand perceptions, attitudes and behaviour of men regarding their role and involvement during pregnancy and antenatal care visits in a rural district in Tanzania. Data collection took place in Magu District between September 2013 and March 2014, using a mixed method approach. This included observations at six government health facilities, nine focus group discussions (with a total of 76 participants) and 26 semi-structured interviews of participants, included through convenience- and snowball sampling. Additionally, a questionnaire was distributed among 156 women attending antenatal care, regarding their partners' involvement in their pregnancy. Qualitative analysis was done through coding of themes based on the Three Delays Framework. Descriptive analysis was used for quantitative data. Male involvement in pregnancy and antenatal care in Magu district is low. Although men perceived antenatal care as important for pregnant women, most husbands had a passive attitude concerning their own involvement. Barriers for male involvement included: traditional gender roles, lack of knowledge, perceived low accessibility to join antenatal care visits and previous negative experiences in health facilities. Although several barriers impede male involvement during antenatal care, men's internal motivation and attitudes towards their role during pregnancy was generally positive. Increasing community awareness and knowledge about the importance of male involvement and increasing accessibility of antenatal clinics can reduce some of the barriers

Additional file 1: of Opportunities for male involvement during pregnancy in Magu district, rural Tanzania

Semi-structured Interview guide. (DOCX 31 kb

Piflufolastat F-18 (18F-DCFPyL) for PSMA PET imaging in prostate cancer

Introduction: Accurate imaging is essential for staging prostate cancer and guiding management decisions. Conventional imaging modalities are hampered by a limited sensitivity for metastatic disease. Nearly all prostate cancers express prostate-specific membrane antigen (PSMA) and 18F-DCFPyL (piflufolastat F 18) is a new FDA-approved positron emission tomography (PET) agent that targets PSMA for improved staging of prostate cancer. Areas covered: This article provides an overview of PSMA, the mechanism of action of 18F-DCFPyL, and compares the performance of 18F-DCFPyL to conventional prostate imaging modalities. Current prostate cancer imaging guidelines are reviewed, as well as what changes can be expected in the future with increased access to PSMA-PET. Expert opinion: The OSPREY and CONDOR clinical trials have demonstrated the superiority of 18F-DCFPyL over conventional imaging modalities for the staging and restaging of prostate cancer. The remarkable diagnostic accuracy of PSMA-PET is reshaping prostate cancer imaging and the modularity of these agents hint at exciting new diagnostic and therapeutic opportunities that have the potential to improve the care of patients with prostate cancer as a whole.