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Objective: Temsirolimus (TEM) has recently shown activity (NCIC CTG phase II trial) in endometrial cancer (EC). Despite EC having a high rate of PTEN mutation, in this trial activity was independent of PTEN and other molecular markers. We explored whether treatment related toxicity occurring in cycle one was predictive of outcomes., Methods: Patients were those enrolled on two sequential phase II studies of the NCIC CTG that evaluated single agent TEM in women with recurrent or metastatic chemotherapy naïve or treated EC. An exploratory landmark analysis examined the relationship between early treatment related toxicities as well as prior chemotherapy and efficacy outcomes (response, progression, and tumor size shrinkage) in univariate and multivariate analyses. The relationship between molecular markers and outcomes was also reexamined in patients., Results: Mucositis, diarrhea, decreased absolute neutrophil count, as well as elevated glucose, or cholesterol were not independent predictors of response or progression. Highest fasting triglyceride predicted for a 3.5% tumor shrinkage from baseline. Women previously treated with chemotherapy were at 7.37 times greater risk of progression and experienced 20.9% increased tumor growth compared to chemotherapy naïve women. Molecular markers were not predictors of response or progression., Conclusions: Except for elevation in fasting triglyceride being associated with minimal tumor shrinkage, no other relationship between efficacy and TEM induced adverse events was found. mTOR inhibition activity in EC seems greatest in chemo-naïve patients. Future studies of mTOR inhibitors in EC should focus on women without prior chemotherapy while continuing to explore molecular mechanisms of benefit., (© 2013.)

Using sequencing information to guide clinical decision-making requires coordination of a diverse set of people and activities. In clinical genomics, the process typically includes sample acquisition, template preparation, genome data generation, analysis to identify and confirm variant alleles, interpretation of clinical significance, and reporting to clinicians. We describe a software application developed within a clinical genomics study, to support this entire process. The software application tracks patients, samples, genomic results, decisions and reports across the cohort, monitors progress and sends reminders, and works alongside an electronic data capture system for the trial's clinical and genomic data. It incorporates systems to read, store, analyze and consolidate sequencing results from multiple technologies, and provides a curated knowledge base of tumor mutation frequency (from the COSMIC database) annotated with clinical significance and drug sensitivity to generate reports for clinicians. By supporting the entire process, the application provides deep support for clinical decision making, enabling the generation of relevant guidance in reports for verification by an expert panel prior to forwarding to the treating physician., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Objectives: Studies show that women with cancer want more information about and participation in all aspects of their healthcare including decision-making. However, most studies have been done on women with breast cancer, which often runs a lengthy course and has strong patient-advocacy groups. Little is known about the preferences of women with ovarian cancer, the fifth leading cause of cancer death in women, which often has a more rapidly fatal course., Methods: This study of women with ovarian cancer investigates what information is most vital for women with ovarian cancer, their preferred role in decision-making, and the influence of sociodemographic, disease-related, and psychological factors., Results: Questionnaires were completed by 105 women with ovarian cancer in two Canadian university hospital oncology clinics. Their mean age was 55.8 +/- 14. 9 years. Most were married, well-educated, and considered their health status to be excellent or good, even though over 60% had metastatic disease. Over 80% of these women wanted detailed information about ovarian cancer during the diagnosis, treatment, and posttreatment stages of their disease. In particular, they wanted information pertaining to the disease, treatment, and self-care issues. Approximately 60% of women preferred to share decision-making with their doctors at every stage of the illness. Psychological variables and disease severity were found to influence information needs and decisional preferences. In general, the more psychologically distressed the women, the more information they wanted about coping strategies and the more serious the illness, the more shared decision-making was desired., Conclusion: These results present a challenge to health care providers in more adequately meeting the individual information needs of women with ovarian cancer and involving them to the extent that they wish in the decision-making process., (Copyright 2000 Academic Press.)