Scientific Dialogue at Spring Group Meeting Spans Therapeutic and Diagnostic Imaging Disciplines  

Physicians and researchers met in various committee sessions at the ECOG-ACRIN Cancer Research Group spring 2014 group meeting in Chicago, IL from May 8-10, to continue the development of new scientific concepts for each of ECOG-ACRIN's three scientific programs: Cancer Control and Outcomes, Therapeutic Studies, and Biomarker Sciences. This article provides highlights from the sessions.

  

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Over 700 Attend Spring 2014 Group Meeting  

More than 700 individuals from a wide range of therapeutic and diagnostic imaging disciplines attended the ECOG-ACRIN spring group meeting. Twelve companies provided financial support to make the meeting possible. Sponsors, the top level contributors, were Lilly, Millennium Pharmaceuticals, Inc., and Pharmacyclics, Inc. Amgen, Inc. contributed as a Supporter, the second contribution level. 

 

Nearly 60 sessions were held this spring, addressing the ongoing work of the scientific committees, translational science teams, research support committees, governance committees, and education/training programs for clinical trial professionals. The Audit and Quality Control Committee and the Publications and Research Dissemination Committee did not meet. PrECOG, LLC held its second "meet-and-greet" session for investigators and industry sponsors.

  

General Session Highlights: Robert L. Comis, MD, and Mitchell D. Schnall, MD, PhD, gave the State-of-the-Group presentation. The recipients of the 2014 Young Investigator Award and Paul Carbone, MD Fellowship Award were announced (see stories below) and an overview of the PrECOG scientific portfolio was presented. PrECOG is a not-for-profit company under the ECOG Research and Education Foundation that partners with ECOG-ACRIN and industry to develop and conduct clinical trials in all areas of oncology. 

  

Two keynote speakers presented final results data for studies E5103 (breast) and E1308 (head and neck), two ECOG-ACRIN studies that were orally presented at the May 30-June 3, 2014, American Society of Clinical Oncology (ASCO) annual meeting. An embargo waiver was approved by ASCO to allow authors to share information at our meeting.

  

Kathy D. Miller, MD, presented final results of trial E5103: A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer. A negative study, E5103 demonstrated that Avastin® (bevacizumab) does not improve disease-free survival in the adjuvant setting.

  

Anthony J. Cmelak, MD, presented final results of trial E1308: A Phase II Trial of Induction Chemotherapy followed by Cetuximab (Erbitux®) with Low Dose vs. Standard Dose IMRT in Patients with HPV-Associated Resectable Squamous Cell Carcinoma of the Oropharynx. E1308 is a proof-of-concept study demonstrating that lower-dose radiation therapy is safe for certain patients with lower-risk HPV-positive head and neck cancer. Read the ASCO press release.

  

The meeting offered three education sessions. The Pathology Coordinating Office and Reference Library and the Translational Science Team from the Boston Operations Office conducted a pathology workshop for clinical research associates (CRAs), nurses, and investigators. Co-chairs of the Pharmacy Committee hosted an education symposium for pharmacists, oncology nurses, and CRAs/data managers. On Saturday morning, ECOG-ACRIN data management staff hosted a four-hour general education session for clinical trial professionals.

  

Attendees learned about two new U10 grants for cooperative clinical research recently awarded to ECOG-ACRIN by the NCI on February 25: The ECOG-ACRIN Integrated Leukemia Translational Research Center located at the Montefiore Medical Center (E. Paietta, PhD, Principal Investigator; A. Melnick, MD, and R. Levine, MD, Co-Principal Investigators) and the ECOG-ACRIN Thoracic Translational Science Center at located at Emory University (S. Ramalingam, MD, Principal Investigator). 

  

The Leukemia Laboratory Symposium, open to all attendees, was held to promote ECOG-ACRIN leukemia research. This recurring symposium covers projects that have been completed using ECOG-ACRIN leukemia specimens, investigators presenting ideas for which they will need specimens, and physicians presenting new trials to stimulate ideas among investigators for future use of the those specimens. 

  

J. Radich, MD (Fred Hutchinson Cancer Research Center/SWOG), principal investigator of the NCI-sponsored CARDINAL biomarker study, presented preliminary data from this analysis, which was accomplished through specimens supplied by ECOG-ACRIN and other groups. CARDINAL is an acronym for The Genetics of "Non-Response" in Adult AML: The Comprehensive Analysis of Refractory Disease in Acute Leukemia. The rationale for CARDINAL is to define the genetic elements and networks associated with "non-response." This will be accomplished by comparing the genetic signatures of primary non-responders with normal karyotype AML (refractory to initial induction chemotherapy) with those of optimal responders (continued first complete remission > 2 years). For more information, view the clinicaltrials.gov record NCT01421862.

  
ECOG-ACRIN Receives Reduced NCTN Grant Awards; Governance Committees Meet to Assess Impact 

On March 1, 2014, the National Cancer Institute (NCI) officially launched its National Clinical Trials Network (NCTN). This date also marks the beginning of ECOG-ACRIN's participation as a network group in the NCTN through two NCI-funded grants: the Network Operations Center grant (formerly known as the Chair's grant) and the Network Statistics and Data Management Center grant. Unfortunately, ECOG-ACRIN learned that the NCI cut more than $4.7 million per annum across both grants.

 

The leadership of ECOG-ACRIN became aware of the cuts while working with the March preliminary funding estimates. The cuts were later confirmed with the receipt of Notices of Award in late April. The cuts have led to the loss of support for ECOG-ACRIN laboratory programs, researchers, and member institutions. More than 20 FTEs (full-time equivalent staff) were released-experienced research personnel across therapeutic and diagnostic imaging disciplines who had been deemed essential following the merger of ECOG and ACRIN in 2012.

 

ECOG-ACRIN's two governing bodies, the Executive Committee and the Principal Investigator Committee, each devoted a major portion of their regularly scheduled meetings on May 8 to understanding the magnitude of NCTN funding issues and identifying options for advancing its scientific agenda within and outside the NCI system.

 

ECOG-ACRIN's Scientific Planning Committee also discussed the impact of these cuts on the development of new translational science and clinical trials.

 

A summary of these deliberations was shared with attendees at the State-of-the Group presentation. Drs. Comis and Schnall assured attendees that the Group will:

  • Continue to develop and foster the best science from our committees
  • Consider a priori whether to pursue NCI or non-NCI funding
  • Continue to encourage scientific development of large trials (>1,000 patients) by seeking non-NCI funding
  • Ask the NCI for supplemental funds to support new initiatives
  • Cultivate new relationships with non-NCI partners

The ECOG-ACRIN leadership issued a public statement on May 16, following the deliberations at the group meeting. Additional information will be circulated among the membership as it becomes available. Read the public statement.

  
Mayo Clinic's Shaji Kumar Honored as Young Investigator of the Year  

 

This year's Young Investigator Award was presented to Shaji K. Kumar, MD, at the General Session of the ECOG-ACRIN spring group meeting on May 9, 2014. Dr. Kumar is Professor of Medicine at the Mayo Clinic College of Medicine in Rochester, MN. He is currently the Vice Chair of Laboratory Studies of the ECOG-ACRIN Myeloma Committee.

 

This is the 15th anniversary of ECOG-ACRIN's Young Investigator Award and the Group's most prestigious honor. It recognizes a young physician recommended by his or her research mentors as an outstanding leader who has made substantial scientific and administrative contributions to the organization and to the field. Individuals who are younger than 46 years of age and work in an ECOG-ACRIN member institution are eligible for nomination.

 

After concluding his medical schooling, house-staff, and medical oncology training in New Delhi, India, Dr. Kumar completed his internal medicine residency and Fellowship in Hematology-Oncology at the Mayo Clinic Graduate School of Medicine. In 2006 he was appointed Assistant Professor of Medicine and in 2012 Professor of Medicine at the Mayo Clinic College of Medicine.

 

Dr. Kumar is the Study Chair for trial E1A11 aka ENDURANCE, a randomized phase III study evaluating the combination therapy Velcade® (bortezomib), Revlimid® (lenalidomide), and dexamethasone, to see how well it works compared to the combination of Kyprolis® (carfilzomib), Velcade, and dexamethasone, in treating patients with newly diagnosed multiple myeloma. E1A11 has several secondary research objectives that relate to quality of life. It is currently open and enrolling patients.

 

He is also the Study Chair for trial E2A08, a phase II trial evaluating how well giving bortezomib together with liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide works in treating patients with multiple myeloma that relapsed within 12 months after autologous stem cell transplant. E2A08 has completed patient enrollment and is currently in follow-up.

 

He has led many laboratory studies including one identifying response biomarkers using gene expression profiling and cytogenetics (Blood. 2011 October 20; 118(16): 4359-62; British Journal of Haematology. 2011 November; 155(3): 340-8). He has published more than 250 peer-reviewed publications with more than 60 as first author. In addition, he has had more than 280 abstracts accepted and has made high-profile oral presentations at the American Society of Hematology and the American Society of Clinical Oncology.

 

Dr. Kumar received more letters of recommendation (seven) than anyone in the history of this award. Kenneth C. Anderson, MD, Dana Farber/Brigham and Women's Cancer Research Center; Morie Gertz, MD, MACP, Mayo Clinic; Michael S. Katz, Co-Chair of the ECOG-ACRIN Cancer Research Advocates Committee; Robert A. Kyle, MD, MACP, Mayo Clinic; Gareth Morgan, PhD, FRCP, FRCPath, Centre for Myeloma Research; Antonio Palumbo, MD, University of Torino, Italy; and S. Vincent Rajkumar, MD, Mayo Clinic made the recommendations. He is described as a true 'star' and representing the 'best' we have at ECOG-ACRIN in talent and dedication.

  
New Sessions Added to Spring Meeting
 
Chairs from the breast and genitourinary cancer committees added two new scientific sessions to the spring group meeting agenda to address specific needs. Christopher E. Comstock, MD, Imaging Chair of the Breast Cancer Committee, convened the Abbreviated Breast MRI Protocol Development Working Group, formed after the mini retreat of the Breast Cancer Committee at the fall 2013 group meeting, when the importance of an abbreviated MRI concept was identified.
 
Many states have passed breast density notification laws due to the shortcomings of mammography (sensitivity of 38 percent) in women with dense breasts. This has led to the increased use of screening breast ultrasound simply because it is widely available and relatively cheap despite the fact that it is not the best test. According to Dr. Comstock, MRI is the most sensitive test for breast cancer but has not been used due to its high cost and time. A new application of MRI is being developed that can be performed in less than 10 minutes at a cost similar to ultrasound that may find 150 percent more cancers than mammography and ultrasound.
 
The working group has been developing a trial based on this concept over the last six months, and met in person to address final design changes. The proposed trial will soon be submitted to the ECOG-ACRIN Executive Review Committee. The committee will be seeking industry funding for this trial.
 
Michael A. Carducci, MD, FACP, and Chair of the Genitourinary (GU) Cancer Committee has reinvigorated the GU Early Modality Subcommittee. Since many GU malignancies are diagnosed by urologists, the subcommittee was formed to include the input of urologists in the development of clinical trial concepts relating to treatment of early disease, particularly of the prostate, kidney, bladder, and testis. The subcommittee is also charged with reviewing concepts being developed by medical oncologists for which patient recruitment will require the involvement of clinical sites where patients with early disease are treated. Such studies must be both feasible and of scientific interest to secure the support, input, and buy-in of urologists. 
 
The GU Early Modality Subcommittee is now led by Edouard J. Trabulsi, MD, and Edward M. Schaeffer, MD, PhD, both urologists. Imaging and radiation oncology specialists are also members. ECOG-ACRIN also supports in-person meetings of this group at the annual meetings of the American Urologic Association and ASCO Genitourinary Cancers Symposium, to encourage cross fertilization of scientific dialogue across the NCTN National Clinical Trials Network.
  
Emory University's Olatunji Alese Given Carbone Fellowship Award  

This year's Paul Carbone, MD Fellowship Award was presented to Olatunji B. Alese, MD, FWACS, at the ECOG-ACRIN spring 2014 group meeting in Chicago, IL. Dr. Alese is a research fellow in the Hematology/Medical Oncology Fellowship Program at Emory University's Winship Cancer Institute in Atlanta, GA.

The Paul Carbone, MD Fellowship Award is a professional mentoring award that aims to develop and promote excellence in clinical trials leading to improvements in cancer care. The award is named in honor of Paul P. Carbone, MD, who served as Group Chair of the Eastern Cooperative Oncology Group (ECOG) from 1970-1990. Each year, ECOG-ACRIN gives an award to one outstanding senior oncology or hematology research fellow pursuing an ongoing cancer clinical research project at an ECOG-ACRIN member institution.

Dr. Alese graduated from the College of Medicine at the University of Ibadan, Nigeria, where he was ranked in the top five of his class. After his initial residency, he went to the Charite University of Medicine in Berlin, Germany, for surgical oncology training as a German Academic Service Scholar. He finished his residency program at the New York Medical College at the Metropolitan Hospital Center in New York, NY. Dr. Alese is the recipient of numerous grants and scholarships including the 2007 American Society of Clinical Oncology International Development and Education Award as a promising future oncologist.

Dr. Alese's proposed study, Comparative Analysis of Molecular Characteristics of Colorectal Cancer; Case Controlled Cohort Study of Africans, African-Americans, and Caucasians, is a retrospective study to describe the comparative analyses of the molecular characteristics of colorectal cancer in a high risk population. All consecutive cases of colorectal cancer treated between 2004 and 2013 (10 years) at the University College Hospital, Ibadan, Nigeria, will be enrolled. The methodology will use case identification and archival tumor tissue retrieval, estimating that 95 percent of the archival samples will be suitable for inclusion. Criteria for inclusion include confirmed pathological diagnosis and adequate tissue samples.

Now in its 10th year, the program has provided professional recognition and an associated monetary award to the recipient's institution to support the proposed clinical research project. The amount of the award is currently $25,000 plus funding for Dr. Alese to attend and accept the award at the ECOG-ACRIN group meeting.

Visit the website to read more about the history and previous recipients of the Paul Carbone, MD Fellowship Award. 
  
Launch of New TRIAD™ Website: The Latest in a Series of Moves to Support Researchers' Integration with NCTN Core IT Systems  

The American College of Radiology (ACR) recently launched a dedicated website for users of TRIAD ACR Image and Information Exchange, an application built by the ACR and now integrated with the National Cancer Institute (NCI) National Clinical Trials Network (NCTN) core information technology systems. TRIAD, an acronym that stands for "Transfer of Images and Data," is a cloud-based software application used in many clinical trials across the NCTN. The new website, triadhelp.acr.org, is a centralized resource for information about TRIAD use in clinical trials, ACR accreditation of images, and imaging registries.

 

For users across the NCTN, the "Clinical Trials" section of the website, trialhelp.acr.org/clinicaltrials, contains a wealth of information, including user guides and FAQs for clinical users at NCTN research sites, and quality control reviewers.

 

Clinical institutions with imaging and radiation therapy (RT) facilities onsite, or partnering with a stand-alone imaging/RT facility, use TRIAD for studies (as noted in the protocol document) to upload images and manage data associated with those images. In addition, quality control reviewers access those images in TRIAD for review and respond to the clinical sites by entering comments into standardized case report forms in the Medidata Rave® clinical data management system.

 

Technical teams from the ACR and NCI Cancer Trials Support Unit (CTSU) have worked together to build a seamless integration between the CTSU's Regulatory Support System (RSS), TRIAD, and Medidata Rave. Now, users have integrated access to all three applications through the NCI Cancer Therapy and Evaluation Program's Identity and Access Management (CTEP-IAM) application.

 

User rights are controlled through the assignment of person-level roles in RSS. Access to TRIAD for clinical institution personnel and quality control reviewers will be managed via the CTSU roster. Personnel at NCTN research sites or their associated imaging/RT centers who are responsible for the uploading of images to TRIAD will need a CTEP-IAM account and the appropriate TRIAD role on their CTSU roster listing.

  
Presence at ASCO 2014   

 

The upcoming newsletter will highlight ECOG-ACRIN and PrECOG presence at the ASCO annual meeting.

 

In the meantime, follow the link below to view the listing of all presentations, posters, and publications associated with the ASCO meeting. 

asco 2014 guide
  
 
June 2014
In This Issue
Spring Meeting Scientific Recap
Over 700 Attend Spring Meeting
NCTN Budget Reductions
Young Investigator of the Year
New Sessions at Spring Meeting
Carbone Fellowship Award
New TRIAD Website
Presence at ASCO 2014
Latest Group Meeting Info
Roster Update Form
Spring Meeting Survey
Recognitions and Distinctions
Young Investigator Symposium
New Principal Investigators
In Case You Missed it...


Latest Group Meeting Information
 
The fall 2014 ECOG-ACRIN group meeting will take place from Thursday morning, November 13 through Saturday evening, November 15, 2014, in Orlando, FL at the JW Marriott and The Ritz-Carlton Orlando Grande Lakes.

Online registration for the upcoming meeting will open in early fall. 

 

Attendees: Please remember the Thursday to Saturday format when making travel plans.

 

Future Dates and Locations

The group meeting dates and locations are set through 2015. 
 
Visit the Group Meetings section of the ECOG-ACRIN website for details. 
Now Posted: Revised ECOG-ACRIN Roster Update Form

The ECOG-ACRIN roster update form has been modified. Please use the modified form to submit requests for listings of new research personnel or to update existing listings.

The form now features an interactive "Submit via Email" button for your convenience.

  
Extended through June 16: Spring 2014 Group Meeting Survey

We would still like to hear from meeting attendees who have not yet had a chance to respond to the spring group meeting survey. 
 
As we strive to accommodate the increase in the number of sessions required to address ECOG-ACRIN's broad scientific portfolio, your input will help with the planning of future meetings.

 

To gauge your level of satisfaction with the meeting content and format, we have prepared a brief survey. It will should take less than four minutes to complete. Please take a moment to...


Thank you for your time!
  
Recognitions and Distinctions...
 
michael-katz Congratulations to Michael S. Katz, MBA, Co-Chair of the ECOG-ACRIN Cancer Research Advocates Committee and member of the ECOG-ACRIN Executive Committee, for receiving the 2014 Partners in Progress Award from the American Society of Clinical Oncology. 

The award recognizes a person involved in patient advocacy activities that impact public awareness about cancer, its causes, cures, or treatment; or activities that result in additional support either legislatively or fiscally for cancer research, treatment, prevention, or care. 


  

Young Investigator Symposium 2014

Annual Call for Abstracts

 

ECOG-ACRIN will be accepting applications from June 1 through September 30, 2014, from young investigators interested in presenting their research at the fall 2014 group meeting.

 

View application instructions and download the abstract submission form... 

PI Committee Approves New Representatives 

At its spring 2014 meeting, the Principal Investigator (PI) Committee approved four roster changes.

At Johns Hopkins University, Julie R. Brahmer, MD, replaces Arlene A. Forastiere, MD, as PI.

At the University of New Mexico, MBCCOP, Martin J. Edelman, MD, PhD, replaces Mohammad Houman Fekrazad, MD, as PI.

At Dartmouth Hitchcock Medical Center, Marc S. Ernstoff, MD, replaces William C. Black, MD, as PI.

At Case Western Reserve University, Hillard M. Lazarus, MD, replaces Bruce J. Averbook, MD, as PI.

  
In Case You Missed It... 
Recent press releases announcing trial activations
 
E2112, evaluating the addition of entinostat to endocrine therapy in patients with advanced breast cancer

E1912, investigating whether a targeted nonchemotherapy-based regimen (ibrutinib-rituximab) can replace chemotherapy-based treatment as initial therapy for patients with CLL or SLL

E1910, evaluating a new immune therapy (blinatumomab) in patients with newly diagnosed ALL

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