The NSABP has randomized more than 100,000 patients with diagnoses of breast or colorectal cancers into clinical trials during the past 50 years. Based on incremental benefit achieved through multiple evolutionary steps of treatment modalities tested in those trials, significant improvement in patient outcomes has been achieved overall. However, this approach also means that there has been significant over-treatment of some patients who did not benefit from the various interventions, which now have become part of legacy treatments to which newer agents are added. Development of reliable prognostic and predictive tests is required to deliver the goal of more personalized treatment. Since, for ethical reasons, trials cannot be conducted again once the efficacy of newer regimens is demonstrated, archived tumor tissue blocks from historical trials conducted by the NSABP provide an essential resource to investigators who are trying to develop such tests. The NSABP Biospecimen Bank at the NSABP Division of Pathology Tissue Bank houses tumor-tissue specimens from more than 87,000 patients and serves as an open resource to the scientific community to provide tissues for development and clinical validation of new prognostic or predictive tests. Tissue specimens are provided to investigators from both academia and the private sector on the basis of scientific merit. A multi-gene expression based prognostic test (OncotypeDx) developed in a collaboration between the private sector and the bank has become a standard in clinical management of hormone receptor positive node negative breast cancer in the United States. In-house development and/or optimization of methods for whole-genome gene-expression analyses and mutation profiling of formalin-fixed, paraffin-embedded blocks further enhances the value of the NSABP Biospecimen Bank.
Since clinical trials cannot be conducted again purely for biomarker discovery or validation, archived tissue blocks from completed trials provide an essential resource for biomarker development. Using NSABP Biospecimen Bank resources, the OncotypeDx assay for prognostication of breast cancer was developed and provided a benchmark for clinical prognostic assay development and validation.
|Pogue-Geile, Kay; Yothers, Greg; Taniyama, Yusuke et al. (2013) Defective mismatch repair and benefit from bevacizumab for colon cancer: findings from NSABP C-08. J Natl Cancer Inst 105:989-92|
|Ingle, James N (2013) Pharmacogenomics of endocrine therapy in breast cancer. J Hum Genet 58:306-12|
|Schroen, Anneke T; Petroni, Gina R; Wang, Hongkun et al. (2012) Achieving sufficient accrual to address the primary endpoint in phase III clinical trials from U.S. Cooperative Oncology Groups. Clin Cancer Res 18:256-62|
|Tang, Gong; Shak, Steven; Paik, Soonmyung et al. (2011) Comparison of the prognostic and predictive utilities of the 21-gene Recurrence Score assay and Adjuvant! for women with node-negative, ER-positive breast cancer: results from NSABP B-14 and NSABP B-20. Breast Cancer Res Treat 127:133-42|
|Conlon, Anna S C; Taylor, Jeremy M G; Sargent, Daniel J et al. (2011) Using cure models and multiple imputation to utilize recurrence as an auxiliary variable for overall survival. Clin Trials 8:581-90|
|Goetz, Matthew P; Schaid, Daniel J; Wickerham, D Lawrence et al. (2011) Evaluation of CYP2D6 and efficacy of tamoxifen and raloxifene in women treated for breast cancer chemoprevention: results from the NSABP P1 and P2 clinical trials. Clin Cancer Res 17:6944-51|
|Schroen, Anneke T; Petroni, Gina R; Wang, Hongkun et al. (2011) Challenges to accrual predictions to phase III cancer clinical trials: a survey of study chairs and lead statisticians of 248 NCI-sponsored trials. Clin Trials 8:591-600|
|Kim, Chungyeul; Tang, Gong; Pogue-Geile, Katherine L et al. (2011) Estrogen receptor (ESR1) mRNA expression and benefit from tamoxifen in the treatment and prevention of estrogen receptor-positive breast cancer. J Clin Oncol 29:4160-7|
|Yothers, Greg; Sargent, Daniel J; Wolmark, Norman et al. (2011) Outcomes among black patients with stage II and III colon cancer receiving chemotherapy: an analysis of ACCENT adjuvant trials. J Natl Cancer Inst 103:1498-506|
|Roh, Mark S; Colangelo, Linda H; O'Connell, Michael J et al. (2009) Preoperative multimodality therapy improves disease-free survival in patients with carcinoma of the rectum: NSABP R-03. J Clin Oncol 27:5124-30|
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