Biorepositories for NCI-Sponsored Cancer Clinical Trials

Scientific Impact

In 2000-2007 the CGBs had collected 807,767 solid tumor specimens, 143,047 serum specimens and 49,491 leukemia specimens.  During the same time period the banks distributed 720,172 solid tumor specimens, 38,663 serum specimens and 28,728 leukemia specimens to approximately 2,000 investigators.  Over 1,350 peer-reviewed scientific publications and 36 patents have resulted from the use of CGB specimens and data in 2000-2008.  Three hundred fifty two of the publications appeared in journals with an impact factor >10 and contained scientific discoveries by the investigators who utilized CGB specimens. We've highlighted selected publications that came from research with CGB specimens.

While the list of important scientific contribution is too large to detail here, a few examples illustrate the usefulness of the CGBs.

NSABP bank specimens were used to develop the OncotypeDx™ test (Paik S et al, NEJM 2004, Sparano JA et al, JCO 2008), a 21-gene multi-gene assay that predicts the likelihood of recurrence in women with early stage invasive breast cancer and assists patient and physician with the decision whether to use chemotherapy in addition to endocrine adjuvant therapy.  Formerly, at least 90% of stage I breast cancer patients would have received chemotherapy, many of them unnecessarily. The test is now covered by most insurance companies in the U.S., and tens of thousands of tests have been performed.  An NCI supported trial designed to confirm the clinical utility of OncotypeDx™ , Trial Assigning Individualized Options for Treatment (TAILORx) recently completed accrual.  A SWOG trial is planned to test whether Oncotype can determine the need for chemotherapy in women with node positive breast cancer.

Colon cancer specimens from several CGBs were used to test for K-ras mutation status which predicted benefit from treatment with anti-epidermal growth factor receptor (anti-EGFR) antibodies in advanced colorectal cancer (Karapetis CS et al, NEJM 2008).  As a result, K-ras mutational status is now assessed before treatment with these agents in clinical practice. 

CALGB specimens helped to identify a microRNA signature associated with event-free survival in acute myeloid leukemia (Marcucci et al, NEJM 2008).  SWOG specimens contributed to better predicting disease severity in early stage multiple myeloma (Barlogie et al. Blood 2008).  Molecular markers have been incorporated into prospective clinical trials to develop novel myeloma treatment approaches (Trials S0120 and S0777). NSABP specimens were used to demonstrate inconsistencies in HER2 testing in community laboratories, leading to the ASCO/CAP guideline for HER2 testing in breast cancer (Hammond et al, JCO 2010).

Several CGBs have contributed specimens to support important trans-NCI initiatives.  The COG bank provided specimens for the Therapeutically Applicable Research to Generate Effective Treatments (TARGET) (ALL and neuroblastoma) and Strategic Partnering to Evaluate Cancer Signatures (SPECS) (ALL and soft tissue sarcoma). The GOG bank supplied cancer specimens and normal DNA to The Cancer Genome Atlas Project (TCGA) to facilitate genome analysis and large-scale sequencing in ovarian tumors.  CGB specimens were successfully used by group, intergroup, R01 and R21 investigators in validation marker studies as well as by pharmacogenomic researchers to explore clinical, epidemiologic, and genomic markers related to treatment response and/or adverse events in NCI-sponsored clinical trials.