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Fridlyand J.,Genentech | Simon R.M.,U.S. National Cancer Institute | Walrath J.C.,Friends of Cancer Research | Roach N.,Fight Colorectal Cancer | And 6 more authors.
Nature Reviews Drug Discovery | Year: 2013

As diagnostic tests become increasingly important for optimizing the use of drugs to treat cancers, the co-development of a targeted therapy and its companion diagnostic test is becoming more prevalent and necessary. In July 2011, the US Food and Drug Administration released a draft guidance that gave the agency's formal definition of companion diagnostics and introduced a drug-diagnostic co-development process for gaining regulatory approval. Here, we identify areas of drug-diagnostic co-development that were either not covered by the guidance or that would benefit from increased granularity, including how to determine when clinical studies should be limited to biomarker-positive patients, defining the diagnostically selected patient population in which to use a companion diagnostic, and defining and clinically validating a biomarker signature for assays that use more than one biomarker. We propose potential approaches that sponsors could use to deal with these challenges and provide strategies to help guide the future co-development of drugs and diagnostics. © 2013 Macmillan Publishers Limited. All rights reserved. Source


Fleisher L.,Childrens Hospital of Philadelphia | Fleisher L.,Temple University | Ruggieri D.G.,St Josephs University | Miller S.M.,Temple University | And 15 more authors.
Patient Education and Counseling | Year: 2014

Objective: This article describes the rigorous development process and initial feedback of the PRE-ACT (Preparatory Education About Clinical Trials) web-based- intervention designed to improve preparation for decision making in cancer clinical trials. Methods: The multi-step process included stakeholder input, formative research, user testing and feedback. Diverse teams (researchers, advocates and developers) participated including content refinement, identification of actors, and development of video scripts. Patient feedback was provided in the final production period and through a vanguard group ( N= 100) from the randomized trial. Results: Patients/advocates confirmed barriers to cancer clinical trial participation, including lack of awareness and knowledge, fear of side effects, logistical concerns, and mistrust. Patients indicated they liked the tool's user-friendly nature, the organized and comprehensive presentation of the subject matter, and the clarity of the videos. Conclusion: The development process serves as an example of operationalizing best practice approaches and highlights the value of a multi-disciplinary team to develop a theory-based, sophisticated tool that patients found useful in their decision making process.Practice implications Best practice approaches can be addressed and are important to ensure evidence-based tools that are of value to patients and supports the usefulness of a process map in the development of e-health tools. © 2014 Elsevier Ireland Ltd. Source


Grothey A.,Mayo Medical School | Flick E.D.,Genentech | Cohn A.L.,Rocky Mountain Cancer Center | Bekaii-Saab T.S.,Ohio State University | And 6 more authors.
Pharmacoepidemiology and Drug Safety | Year: 2014

Purpose: This analysis from Avastin® Registries: Investigation of Effectiveness and Safety (ARIES) examined the association between exposure to bevacizumab after disease progression (PD) and postprogression survival (PPS) in bevacizumab-exposed metastatic colorectal cancer (mCRC) through the application of time-dependent and time-fixed analytical methods. Methods: Patients with mCRC who were treated with first-line bevacizumab and who survived first PD (PD1) were included. A time-dependent Cox regression model was fitted to assess the effect of cumulative bevacizumab exposure on PPS, while controlling for potential confounders. In addition to support findings from previous studies, a modified intent-to-treat (mITT) analysis compared PPS in patients who received bevacizumab beyond disease progression (BBP) with those who did not (No-BBP). Results: Of 1550 patients, 1199 survived PD1 and had a median PPS of 13.4months. Cumulative bevacizumab exposure was associated with improved PPS (p=0.0040). After adjusting for confounders, the hazard ratios (HRs) for PPS decreased, on average, by 1.2% (range, 1.1-1.3%) with each additional dose of bevacizumab. In the mITT analysis, the median PPS for BBP (n=438) was 14.4months vs 10.6months with for No-BBP (n=667). BBP was found to be independently associated with longer PPS in a multivariable Cox regression analysis (HR, 0.84; 95% confidence interval, 0.73-0.97). Protocol-specified adverse events suspected to be associated with bevacizumab occurred in 13.0% of patients with BBP. Conclusion: This analysis supports the observation that bevacizumab exposure after PD1 is associated with longer PPS in mCRC. © 2014 John Wiley & Sons, Ltd. Source


Stoffel E.M.,University of Michigan | Mangu P.B.,American Society of Clinical Oncology | Gruber S.B.,Fight Colorectal Cancer | Hamilton S.R.,University of Southern California | And 5 more authors.
Journal of Clinical Oncology | Year: 2015

Purpose To provide recommendations on prevention, screening, genetics, treatment, and management for people at risk for hereditary colorectal cancer (CRC) syndromes. The American Society of Clinical Oncology (ASCO) has a policy and set of procedures for endorsing clinical practice guidelines that have been developed by other professional organizations. Methods The Familial Risk-Colorectal Cancer: European Society for Medical Oncology Clinical Practice Guideline published in 2013 on behalf of the European Society for Medical Oncology (ESMO) Guidelines Working Group in Annals of Oncology was reviewed for developmental rigor by methodologists, with content and recommendations reviewed by an ASCO endorsement panel. Results The ASCO endorsement panel determined that the recommendations of the ESMO guidelines are clear, thorough, and based on the most relevant scientific evidence. The ASCO panel endorsed the ESMO guidelines and added a few qualifying statements. Recommendations Approximately 5% to 6% of patient cases of CRC are associated with germline mutations that confer an inherited predisposition for cancer. The possibility of a hereditary cancer syndrome should be assessed for every patient at the time of CRC diagnosis. A diagnosis of Lynch syndrome, familial adenomatous polyposis, or another genetic syndrome can influence clinical management for patients with CRC and their family members. Screening for hereditary cancer syndromes in patients with CRC should include review of personal and family histories and testing of tumors for DNA mismatch repair deficiency and/or microsatellite instability. Formal genetic evaluation is recommended for individuals who meet defined criteria. Copyright © 2015 American Society of Clinical Oncology.© 2014 by American Society of Clinical Oncology. Source


Benson III A.B.,Northwestern University | Bekaii-Saab T.,Ohio State University | Chan E.,Vanderbilt Ingram Cancer Center | Chen Y.-J.,City of Hope Comprehensive Cancer Center | And 25 more authors.
JNCCN Journal of the National Comprehensive Cancer Network | Year: 2013

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Colon Cancer begin with the clinical presentation of the patient to the primary care physician or gastroenterologist and address diagnosis, pathologic staging, surgical management, peri-operative treatment, patient surveillance, management of recurrent and metastatic disease, and survivorship. The NCCN Colon Cancer Panel meets annually to review comments from reviewers within their institutions and to reevaluate and update their recommendations. In addition, the panel has interim conferences as new data necessitate. These NCCN Guidelines Insights summarize the NCCN Colon Cancer Panel's discussions surrounding metastatic colorectal cancer for the 2013 update of the guidelines. Importantly, changes were made to the continuum of care for patients with advanced or metastatic disease, including new drugs and an additional line of therapy. Copyright © 2013 JNCCN-Journal of the National Comprehensive Cancer Network. Source

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