Evaluation of safety and efficacy of gefitinib ('iressa', zd1839) as monotherapy in a series of Chinese patients with advanced non-small-cell lung cancer: experience from a compassionate-use programme

BACKGROUND: The gefitinib compassionate-use programme has enabled >39,000 patients worldwide to receive gefitinib ('Iressa', ZD1839) treatment. This paper reports the outcome of gefitinib treatment in Chinese patients who enrolled into the 'Iressa' Expanded Access Programme (EAP) at the Peking Union Medical College Hospital. METHODS: Thirty-one patients with advanced or metastatic non-small-cell lung cancer (NSCLC) that had progressed after prior systemic chemotherapy were eligible to receive oral gefitinib 250 mg/day as part of the EAP. Treatment was continued until disease progression or unacceptable toxicity occurred. The impact of treatment on disease-related symptoms and quality of life (QoL) was evaluated with the Chinese versions of European Organization for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ-C30 and QLQ-LC13). RESULTS: Gefitinib was well tolerated. Adverse events (AEs) were generally mild (grade1 and 2) and reversible. The most frequent AEs were acneform rash and diarrhoea. Only one patient withdrew from the study due to a drug-related AE. The objective tumour response rate was 35.5% (95% confidence interval [CI]: 18.6–52.3); median progression-free survival was 5.5 months (95% CI, 1.6 to 9.4); median overall survival was 11.5 months (95% CI, 5.6 to 17.3). The QoL response rates for five functioning scales and global QoL varied from 56–88%. The main symptom response rates varied from 44–84%. QoL and symptom response were correlated with objective tumour response. CONCLUSION: Gefitinib demonstrated safety and efficacy as monotherapy in this series of Chinese patients with advanced NSCLC and was also associated with remarkable symptom relief and improvement in QoL. Although clinical trials are needed to confirm these positive findings, the data suggest that treatment with gefitinib may be beneficial for some Chinese patients who do not respond to chemotherapy and have poor prognosis

Stem Cell Research Funding Policies and Dynamic Innovation: A Survey of Open Access and Commercialization Requirements

# The Author(s) 2014. This article is published with open access at Springerlink.com Abstract This article compares and contrasts the pressures of both open access data sharing and commercialization policies in the context of publicly funded embryonic stem cell research (SCR). First, normative guidelines of international SCR orga-nizations were examined. We then examined SCR funding guidelines and the project evaluation criteria of major funding organizations in the EU, the United Kingdom (UK), Spain, Canada and the United States. Our survey of policies revealed subtle pressures to commercialize research that include: in-creased funding availability for commercialization opportuni-ties, assistance for obtaining intellectual property rights (IPRs) and legislation mandating commercialization. In lieu of open access models, funders are increasingly opting for limited sharing models or “protected commons ” models that make the research available to researchers within the same region or those receiving the same funding. Meanwhile, there still is need for funding agencies to clarify and standardize terms such as “non-profit organizations ” and “for-profit research,” as more universities are pursuing for-profit or commercial opportunities. Keywords Stemcell research(SCR).Humanembryonicstem cells (hESC). Induced pluripotent stem cells (iPSC). Open access. Data sharing. Commercialization Abbreviations hESC human embryonic stem cells iPSC induced pluripotent stem cells IPRs intellectual property rights MTA material transfer agreement SCR stem cell research SLA simple letter agreement TTO technology transfer offic

Avoiding Twisted Pixels: Ethical Guidelines for the Appropriate Use and Manipulation of Scientific Digital Images

Digital imaging has provided scientists with new opportunities to acquire and manipulate data using techniques that were difficult or impossible to employ in the past. Because digital images are easier to manipulate than film images, new problems have emerged. One growing concern in the scientific community is that digital images are not being handled with sufficient care. The problem is twofold: (1) the very small, yet troubling, number of intentional falsifications that have been identified, and (2) the more common unintentional, inappropriate manipulation of images for publication. Journals and professional societies have begun to address the issue with specific digital imaging guidelines. Unfortunately, the guidelines provided often do not come with instructions to explain their importance. Thus they deal with what should or should not be done, but not the associated ‘why’ that is required for understanding the rules. This article proposes 12 guidelines for scientific digital image manipulation and discusses the technical reasons behind these guidelines. These guidelines can be incorporated into lab meetings and graduate student training in order to provoke discussion and begin to bring an end to the culture of “data beautification”