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NCORP Updates from Mike Thompson

News about the National Cancer Institute’s Community Oncology Research Program.

Wednesday, November 26, 2014

ECOG-ACRIN Annual Meeting of the National Clinical Trials Network

Overview 

The Eastern Cooperative Oncology Group & American College of Radiology Imaging Network (ECOG-ACRIN) Cancer Research Group Fall meeting was held in Orlando, FL on November 13 to 15, 2014. Within the context of this NCI National Clinical Trials Network (NCTN) cooperative group meeting the NCI Community Oncology Research Program (NCORP) was discussed and principal investigators (PIs) for the NCORP sites met to discuss current and future protocols. Major themes of the meeting included molecularly guided “precision” medicine as well as value in health care including Cancer Care Delivery Research (CCDR).

 

Precision Medicine

Much of what you get out of a meeting like ECOG-ACRIN depends on what tumor-specific meetings you attend. However, one overarching theme included precision medicine. The concept of molecularly driven “precision” (precise or accurate?) medicine has been an increasing theme in oncology and within the NCTN.  The ECOG-ACRIN Young Investigator Award went to Shaji Kumar, MD (@MyelomaMD), and he discussed the topic of “Multiple Myeloma: Matching Therapy to Patient” at the general session.

 

Studies include “Basket” trials (e.g., MATCH - different cancers, separate study arms, single drug, single mutation) as well as “Umbrella” master protocols (Lung-MAP & ALCHEMIST, single cancer, different drugs, different mutations), and the Exceptional Responders Pilot Study (“pharmacomics” in exceptional responding patients). Molecular studies will pay for screening biopsies, and in some cases more granular detail was given on this at the meeting.

 

Current NCTN Activated Studies:

1.  ALCHEMIST - Adjuvant Lung Cancer enricHmEnt Marker Identification and Sequencing Trials

This was discussed by Dr. Comis.

 

The three trials of ALCHEMIST are:
ALCHEMIST - Screening component (A151216)
Coordinated by the Alliance | Principal Investigators: Pasi A. Jänne, MD, PhD and Geoffrey Oxnard, MD, Dana-Farber Cancer Institute, Boston.
http://www.cancer.gov/clinicaltrials/NCT02194738


ALCHEMIST - EGF Treatment component (A081105)
Coordinated by the Alliance | Principal Investigator: Ramaswamy Govindan, MD, Washington University, St. Louis.
http://www.cancer.gov/clinicaltrials/NCT02193282
 
ALCHEMIST - ALK Treatment component (E4512)
Coordinated by ECOG-ACRIN | Principal Investigator: David Gerber, MD, University of Texas Southwestern Medical Center at Dallas.

http://www.cancer.gov/clinicaltrials/NCT02201992

 

2.   LungMAP

Dr. Ramalingam (@RamalingamMD) discussed that SWOG (#SWOGOnc) S1400 study Lung MAP includes MAP = shortened “Master Protocol.” Lung MAP has its own Twitter handle -- @LungMAP and website – www.lung-map.org.

 

3.   NCI Exceptional Responders Pilot Study: Molecular Profiling of Tumors From Cancer Patients Who Are Exceptional Responders (NCT02243592)

 

Pending Activation 2/2015

EAY131 - NCI MATCH - Molecular Analysis for Therapy CHoice

Peter O'Dwyer, MD, updated the group, noting that over 40 drugs are pledged to MATCH, with approximately nine set to start on study activation. He noted that using the NCI central IRB is critical. He characterized the study as a bunch of parallel n=31 phase 2 clinical trials with response rate the primary endpoint (5% vs 25%).

ECOG-ACRIN NCORP Research Base Key Aims

Lynne Wagner, PhD Co-Principal Investigator, EA NCORP Research Base reviewed the aims:

 

     Coalesce an integrated, multi-disciplinary national scientific community dedicated to clinical trials across the continuum of care from prevention, early detection, diagnosis, and surveillance to cancer control and survivorship with dedicated expertise in cost-effectiveness, patient-reported outcomes, health equity and disparities research, and CCDR

     Advance a robust clinical trials program that contributes to improved patient outcomes throughout the cancer care continuum:

     Biomarker-driven chemoprevention trials

     Advance precision strategies for cancer detection and post-treatment surveillance focusing on reducing over diagnosis and overtreatment

     Advance understanding of impact of cancer prevention, screening, and treatment through hypothesis-driven patient-reported outcome (PRO) research

    Study the biology of cancer and treatment-related morbidity and fashion targeted interventions that mitigate their impact

 

Dr. Wagner noted that with the merging with ACRIN, that additional imaging capabilities will be incorporated in clinical trials. Additionally, centralization of resources such as e-PRO and telegenetics is in development.

 

The potential for collaborating with NCI-funded programs to provide a centralized telegenetics resource was discussed. Ruth Carlos, MD (@RuthCarlosMD) also highlighted potential collaborations with groups such as Patient-Centered Outcomes Research Institute (PCORI).  

 

 

Recently Activated ECOG-ACRIN Trials

No current CCDR studies.

 

Cancer Control

    Engendering Reproductive Health within Oncologic Survivorship (EROS; E1Q11)

       Not CCDR because approved before 8/1/14

     Phase II Study of MRI and Multiparameter Gene Expression Assay in DCIS (E4112/EA1124)

     Genetic Predictors for Aromatase Inhibitor MusculoSkeletal Symptoms (AIMSS) (E1Z11)

 

PRO endpoints

    14 Active NCTN protocols with PRO endpoints

       Brain tumor working group, Breast, GU, Head & neck, Leukemia, Lymphoma, Melanoma, Myeloma, Thoracic

 

Other non-NCORP concepts included:

    The FoRtitude trial: Targeted eHealth intervention to reduce fear of recurrence among breast cancer survivors (1R21 CA173193) -- “FoR” is acronym for “fear of recurrence,” and FoRtitude = strength and resilience in the face of uncertainty.”

 

Conclusions

The ECOG-ACRIN NCORP Research Base has a robust development program to contribute across CCDR, cancer control, and cancer prevention studies. Cross-disciplinary collaboration including the ACRIN specialization in imaging will be part of future clinical trials.

 

More terse notes and links are included in my #NCORP tagged tweets at the meeting. I also started using #CCDR as a Twitter hashtag. And others were using #EAOnc as well.