ASCO Publishes Recommendations for Genomic Testing in Metastatic Cancer

Patients with metastatic cancer with certain specific genomic alterations should undergo genomic sequencing as a routine part of clinical care, according to a provisional clinical opinion (PCO) from the American Society of Clinical Oncology (ASCO). The report was published in Journal of Clinical Oncology.

An expert panel convened by ASCO provided guidance on the use of genomic sequencing for the purposes of informing treatment selection.

“This PCO seeks to guide clinicians on the appropriate use of tumor genomic testing for patients with metastatic or advanced cancer, defining clinical scenarios where there is established evidence for antitumor efficacy of genomic biomarker–linked therapies as indicated by regulatory approval of agents on the basis of specific genomic alterations,” the authors wrote. “The PCO will also guide clinicians when an alteration suggests the possibility of response to a particular targeted therapy, but there is no approved agent for the specific clinical setting.”

The PCO did not contain a formal systematic review of clinical trial evidence; all recommendations are based on informal consensus.

The report includes recommendations for:

• Decision-making on multigene panel–based genomic sequencing with disease-specific approved markers
• Assessment of mismatch repair deficiency status and/or microsatellite instability–high status and tumor mutational burden
• Testing for gene fusions and exon-skipping variants
• Decision-making on panel tests with no approved disease-specific markers

Interpretation of genomic sequencing data can be difficult, and as such, the PCO strongly recommended against off-label and off-study use of genomic biomarker-linked therapies. “…response in one tumor type does not assure a response in another cancer,” the expert panel wrote.

In addition to recommendations, the report acknowledged the impact of racial and ethnic disparities in cancer care.

“Although ASCO clinical practice guideline products represent expert recommendations on the best practices in disease management to provide the highest level of cancer care, it is essential to note that many patients have limited access to medical care and/or receive fragmented care,” the authors wrote.

The PCO also addressed cost considerations, since patients with cancer pay a large proportion of treatment costs through deductibles and coinsurance with higher out-of-pocket costs representing a barrier to starting and adhering to treatments.

While the experts recommend a multigene panel vs serial testing as a more resource- and time-effective course of action, the PCO did not take into consideration reimbursement of genomic testing; instead, i- focused on discussions around the cost of treatments.

“Discussion of cost is an integral part of shared decision making,” the experts wrote. “Clinicians should discuss with patients the use of less expensive alternatives when it is practical and feasible for treatment of the patient's disease, and there are 2 or more comparable treatment options in terms of benefits and harms.”

Reference

Chakravarty D, Amber Johnson A, Sklar J, et al. Somatic genomic testing in patients with metastatic or advanced cancer: ASCO provisional clinical opinion. J Clin Oncol. Published online February 17, 2022. doi:10.1200/JCO.21.02767