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Publication Number
US-10501807-B2
Publication Date
2019-12-10
Expiration Date
Abstract
Biomarkers and methods using the biomarkers for the prediction of the recurrence risk of cancer in a patient are provided.
Core Innovation
The invention provides methods and compositions for cancer diagnosis and prognosis using cell-cycle genes (CCGs), including gene panels whose expression tracks cell-cycle progression. A sample comprising cancer tumor tissue from a patient is obtained, and the expression of CCGs is determined in the sample. The measured gene expression is compared with expected expression from a reference population, using abnormal or elevated versus reference or threshold expression to infer prognosis-related status, including prognosis of recurrence and progression risk.
The approach further incorporates gene status information and can include PTEN status combined with CCG expression and/or clinical parameters to improve recurrence prediction. The disclosed cancer prognosis can be applied across cancers, with example support including multi-cancer prognostic utility. The methods also describe integrating CCG signatures with clinical nomograms to provide predictive value synergistically.
In a prostate cancer context, the invention specifies prognosis using a panel that includes NUSAP1 and UBE2C or NUSAPI and UBE2C, where prognosis is determined as having a decreased or increased likelihood of progression based on whether the expression in the patient sample is lower or higher than expected expression from a reference population. Treatment decisions are then made by administering active surveillance when the prognosis indicates decreased likelihood of progression until symptoms develop or signs indicate accelerated growth, and administering active treatment when symptoms develop or growth accelerates, including one or more of hormonal therapy, chemotherapy, radiation therapy, and surgery.
Claims Coverage
The provided independent claims cover two alternative prostate cancer treatment frameworks that use gene panel expression comparison to a reference population, with NUSAP1 and UBE2C or NUSAPI and UBE2C, to determine prognosis and guide selection of active surveillance versus active treatment.
Gene-panel expression-based decreased-progression prognosis guiding active surveillance to active treatment
Determining the expression of a panel of genes comprising NUSAP1 and UBE2C in a sample comprising prostate cancer tumor tissue; prognosing the patient as having a decreased likelihood of prostate cancer progression when the expression of NUSAP1 and UBE2C is lower than the expected expression from a reference population; administering active surveillance based on the prognosis until symptoms develop or there are signs that cancer growth is accelerating; and administering active treatment based on developed symptoms or accelerated growth, wherein the active treatment is one or more of hormonal therapy, chemotherapy, radiation therapy and surgery.
Gene-panel expression-based increased-progression prognosis selecting active treatment
Determining the expression of a panel of genes comprising NUSAPI and UBE2C in a sample comprising prostate cancer tumor tissue; prognosing the patient as having an increased likelihood of prostate cancer progression when the expression of NUSAPI and UBE2C is higher than the expected expression from a reference population; and administering one or more of hormonal therapy, chemotherapy, radiation therapy and surgery based on the prognosis.
Across the independent claims, the main inventive coverage centers on prognosing prostate cancer progression likelihood by comparing measured expression of specific cell-cycle gene panel members to expected expression from a reference population, then using that prognosis to guide either active surveillance-to-treatment switching or selection of active treatment.
Stated Advantages
Provides prognosis of prostate cancer progression likelihood based on comparison of gene-panel expression to expected expression from a reference population.
Enables treatment selection, including administering active surveillance until symptoms develop or growth accelerates and administering active treatment accordingly.
Supports recurrence and progression risk prediction using CCG signatures, including improved recurrence prediction when PTEN is combined with CCG and/or clinical parameters.
Documented Applications
Treating prostate cancer in a patient by obtaining a prostate cancer tumor tissue sample, determining expression of gene panels comprising NUSAP1 and UBE2C or NUSAPI and UBE2C, prognosing progression likelihood relative to a reference population, and administering active surveillance and/or active treatment.
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