Precision Medicine in Oncology

Right now, it's not really used for decision treatment in most centers, but there are a lot of studies that have started this year or starting next year that have MRD as an endpoint so we will see, said Elisabet Manasanch, MD, assistant professor in the Department of Lymphoma/Myeloma and Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center.

Metastatic disease is the leading cause of death in the over 600,000 individuals worldwide who die of breast cancer each year. A new blood-based assay to detect minimal residual disease (MRD) in patients with stage 0 to 3 breast cancer was shown to have 100-fold greater sensitivity compared with digital droplet polymerase chain reaction.

A primary analysis of data from the GeparOcto trial showed no difference in pathologic complete response among patients with early-stage breast cancer enrolled in 2 neoadjuvant treatment arms: sequential intense dose-dense epirubicin, paclitaxel, and cyclophosphamide and weekly paclitaxel and nonpegylated liposomal doxorubicin.

Can we predict which patients are at high risk of hospitalization? How can we reduce this risk? Debra Patt, MD, MPH, MBA, executive vice president of policy and strategy at Texas Oncology, posed these questions during the ACCC 46th Annual Meeting and Cancer Center Business Summit.

The authors said their study is the first to show that targeted treaments for patients with certain molecular alterations could be a possibility in pancreatic cancer.

Some of the best ways to assess minimal residual disease (MRD) are using flow cytometry or using sequencing, said Elisabet Manasanch, MD, assistant professor in the Department of Lymphoma/Myeloma and Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center.

Rebecca Kaul, MBA, vice president and chief innovation officer at The University of Texas MD Anderson Cancer Center, said the best technology improves the patient experience.

Joshua Ofman, MD, MSHS, gave his keynote address during Patient-Centered Oncology Care, the annual multistakeholder gathering presented by The American Journal of Managed Care® in Philadelphia, Pennsylvania.

Education efforts among providers, payer, and patients can help answer the fundamental and important questions raised by the use of real-world data, said Viraj Narayanan, MBA, vice president of Life Sciences at COTA Healthcare.

Health-related quality of life (QOL) improved in 54% of patients 18 years or older with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) after therapy with tisagenlecleucel (Kymriah; Novartis), one of 2 FDA-approved chimeric antigen receptor (CAR) T-cell therapies. The patients’ general health, vitality, physical function, and social function improved the most.

Fragmentation in the US healthcare system hinders implementation of efficient workflows when it comes to real-world data, said Viraj Narayanan, MBA, vice president of Life Sciences at COTA Healthcare.

With patients living longer thanks to new therapies, we need more accurate, sensitive, and standardized tools to guide their therapy.

Opportunities for precision medicine can be lost if clinicians do not perform biomarker testing, and payers may be part of the reason, according to Stuart Goldberg, MD, a hematologist/oncologist and chief of the Division of Outcomes and Value Research at the John Theurer Cancer Center at Hackensack University Medical Center in New Jersey.

Radium-223’s (Ra-223) low levels of alpha particle radiation induce double-strand DNA breaks, which leads to cell apoptosis. Sipuleucel-T (SipT), which is an immunotherapy manufactured from a patient’s peripheral blood mononuclear cells, activates T cells to spur an immune response. Both are used to treat bone-metastatic castration-resistant prostate cancer (CRPC). Study data suggest a synergistic immune effect when Ra-223 is added to treatment with SipT.

Real-world data can help resolve some challenges commonly faced in clinical trails, said Viraj Narayanan, MBA, vice president of Life Sciences at COTA Healthcare.

Flow cytometry (FCM), next-generation sequencing, (NGS), and polymerase chain reaction (PCR) are the 3 most common methods clinicians use to diagnose minimal residual disease (MRD) in patients with acute lymphoblastic leukemia who have undergone chemotherapy, radiotherapy, or immunotherapy. MRD can be found both in bone marrow via aspiration and peripheral blood circulation through a draw.

A testosterone-related genetic variant (HSD3B2[1245C]) is linked to poor outcomes in advanced prostate cancer, according to a recent study published in JAMA Oncology.

Instead of replacing clinical trials, real-world data will be used to supplement traditional clinical trial information, said Viraj Narayanan, MBA, vice president of Life Sciences at COTA Healthcare.

Anti-CD19 chimeric antigen receptor natural killer (CAR NK) cells, derived from donor umbilical cord blood, produced a 73% objective response rate in 11 patients with lymphoid tumors who received just 1 dose of the infused therapy, with no occurrences of cytokine release syndrome or neurotoxicity, in preliminary study results out of MD Anderson. Seven patients had a complete remission.

The integration of real-world data into clinical research may mark a shift away from clinical trial information, said Viraj Narayanan, MBA, vice president of Life Sciences at COTA Healthcare.

This week, top managed care stories included a new plan for Medicaid block grants; federal officials’ response to the novel coronavirus; FDA offers guidance for gene therapies.

Chimeric antigen receptor (CAR) T cells are a patient’s own, harvested and reengineered to attack specific malignant cells. They were initially developed using knowledge gleaned from allogeneic stem cell transplants: that donor mature immune cells can attack healthy cells in the recipient patient.

CMS said it is expanding coverage of next generation sequencing (NGS) for use as a diagnostic for patients with germline breast and ovarian cancer, paving the way for Medicare beneficiaries to receive more personalized medicine. However, an advocate said the wording of CMS' decision could actually limit testing access for some women with breast or ovarian cancer.

We speak with one of the authors of a recent study examining why overall biomarker testing rates remain poor for metastatic colorectal cancer.

Minimal residual disease (MRD), a measure of how many cancer cells remain in a patient during or following chemotherapy or stem cell transplant, is a potent indicator of whether or not a patient is likely to relapse; recent research probed the associations between MRD status and certain prognostic risk factors in childhood B-lymphoblastic leukemia after both induction and consolidation.