ASCO Publishes First Guideline on Use of Molecular Biomarkers in Localized Prostate Cancer

The clinical course of prostate cancer is highly variable, reflecting the heterogeneity of the disease. Although most men diagnosed with prostate cancer have low-risk, favorable disease characteristics, some may harbor aggressive features and experience disease progression despite conventional therapy. Therefore, initial risk stratification is vitally important for determining effective treatment strategies and improving clinical outcomes.

An increased molecular understanding of localized prostate cancer and advancements in proteomic and genomic technologies have led to the development of a vast array of diagnostic and prognostic tests, including tissue-based assays. Although the development of these assays has created new opportunities for improving prostate cancer diagnosis, prognosis, and treatment, clinicians and reimbursing agencies are faced with unique challenges in terms of prioritizing, selecting, and incorporating these assays into the continuum of patient care.1

To address some of these challenges, the American Society of Clinical Oncology (ASCO), in partnership with members of the European Association of Urology, the American Urological Association, and the College of American Pathologists, recently published a set of recommendations in the Journal of Clinical Oncology that offers further guidance to urologists, medical oncologists, radiation oncologists, and other healthcare practitioners as they navigate prostate cancer management decisions.2

The expert panel was comprised of 12 members with expertise in urology, oncology, pathology and laboratory medicine, and research methodology, as well as 1 patient representative. The guideline development process began with a PubMed search that identified 555 studies of localized prostate cancer biomarkers published between January 2013 and January 2019. The recommendations were developed based on 77 of those articles as well as 32 additional references. The references described results for 4 commercially available tissue-based biomarker tests: Oncotype DX Prostate, Prolaris, Decipher, and ProMark.

The guideline was developed to consider the potential role of commercially available molecular biomarkers in the following areas: identifying patients who are likely to derive benefit from active surveillance; diagnosing clinically significant prostate cancer (ie, cancer with the potential to metastasize or ultimately cause symptoms); and guiding the decision between postprostatectomy adjuvant versus salvage radiation therapy. The guideline also evaluated the relative strengths and weaknesses of genomics testing and magnetic resonance imaging for identifying clinically significant prostate cancer.

“There are numerous factors that go into treatment decision-making for newly diagnosed patients with prostate cancer. The committee came together to review the data available to date on how tissue-based molecular biomarkers may help inform these decisions. We found that there are a few biomarker tests that have undergone extensive clinical testing, and these tests may provide additional information in some (but not all) patients for risk stratification—particularly in cases where clinical variables are less certain,” said Himisha Beltran, MD, Associate Professor of Medicine in the Lank Center for Genitourinary Oncology and the Division of Molecular and Cellular Oncology at Dana-Farber Cancer Institute, Boston, MA, who served on the panel.

The committee asserted that although several commercially available molecular biomarkers have been developed to improve risk stratification and disease management, the value and cost-effectiveness of biomarker assays for detecting clinically significant prostate cancer or stratifying patients who would most benefit from prostate biopsy have not been clearly established. Therefore, routine ordering of molecular biomarkers is not recommended. Instead, the panel recommended that providers consider the use of these biomarkers when the assay result, considered along with routine clinical factors, is likely to affect management, for example, in select patients with high-volume, low-risk or favorable, intermediate-risk prostate cancer who are considering active surveillance, or in patients with high-risk features being considered for treatment intensification.

Regarding the question of relative value of the genomic tests compared with magnetic resonance imaging, the panel acknowledged that there was a lack of sufficient data to support a consensus statement. They asserted that both modalities may provide clinically relevant information about the likelihood of upgrading on subsequent biopsy or at prostatectomy, and may each provide independent and actionable information for specific patients.

The expert panel did not endorse any specific biomarker assays over others, noting the absence of sufficient, rigorously designed, head-to-head clinical trials comparing cost- effectiveness and clinical benefit of these tests.


References

  1. Cucchiara V, Coopersberg MR, Dall’Era M, et al. Genomic markers in prostate cancer decision making. Eur Urol. 2018;73:572-582.
  2. Eggener SE, Rumble RB, Armstrong AJ, et al. Molecular biomarkers in localized prostate cancer: ASCO Guideline. J Clin Oncol. 2019 Dec 12. Epub ahead of print.

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