Researchers in cancer care have made great strides in recent years. Contributing to these advancements is the new ability to sequence tumors from cancer patients in order to determine specific gene mutations acquired by tumor cells that underlie tumor growth, termed “driver” mutations. Identifying driver mutations has allowed researchers to develop targeted therapies around a given tumor type; multiple FDA-approved targeted therapies are now available as well as accompanying diagnostic tests to identify specific gene mutations. Tumor profiling means expanded treatment options for patients who may fail first-line therapies or who have rare or aggressive cancers.
However, routine tumor genome sequencing at the DNA or genetic level is often not performed for many patients treated at regional or community cancer centers, as testing is expensive and infrequently covered by insurance. Thus, patients with advanced cancer are usually unaware of the molecular features of their disease. In addition, a lack of widespread testing means that pharmaceutical companies struggle to find patients for trials of new precision drugs targeting specific defects or mutations in DNA code.2
To expand access to routine, next-generation tumor profiling to more patients with advanced or rare cancers, Christiana Care’s Helen F. Graham Cancer Center & Research Institute (Newark, DE) is collaborating with the Strata Precision Oncology Network in order to provide profiling at no cost to these patients. In addition, eligible patients will subsequently by matched to the best available clinical trials or the most innovative therapy. With this partnership, Christiana Care—who has Delaware’s largest and most technologically advanced cancer program—joins other health systems throughout the United States who have also partnered with Strata. By collaborating with other health systems within the Strata Network like Christiana Care, Strata aims to be able to provide genome sequencing to 100,000 patients within the next 3 years. Christiana Care’s partnership activities began on February 1, 2018.2
To gain more insight into this partnership and the future of tumor profiling in cancer treatment, Journal of Clinical Pathways spoke with Nicholas J Petrelli, MD, FACS, Bank of America-endowed medical director of Christiana Care’s Helen F. Graham Cancer Center & Research Institute. Under Dr Petrelli’s leadership, the Graham Cancer Center was selected as a Nation Cancer Institute Community Oncology Research Program and it became one of the original 16 NCI Community Cancer Centers Programs. He provided details on how this new partnership will affect patients with cancer in Delaware as well as how collaborations like this will impact the future of precision oncology.
Can you briefly describe Christiana Care’s project to collaborate with Strata Precision Oncology Network? How will tumor profiling services be offered without added cost?
This is relationship largely due to the contractual arrangements we have with Strata Precision Oncology, in view of our track record here in the state of Delaware, and with our cancer control program and our clinical trials accrual. Strata approached us as a possible site as they put together this program for next-generation sequencing to collect 100,000 patients over the next 3 years. Strata will not be charging the patients for the next-generation sequencing. All advanced disease patients will be candidates for this program. A special form will be completed by the medical/hematologic oncologist, which will be sent to pathology, where the tissue will be processed and sent to Strata. The oncologists will obtain the results and also will know whether their patients may be candidates for in-house trials which are also in partnership with Strata through a central Institutional Review Board. Strata will give us the ability to enter some of these patients into clinical trials based on the results of their next-generation sequencing.
How is tumor profiling and DNA sequencing changing the cancer treatment landscape altogether?
If you look at what the history of cancer treatment has been over the decades—taking colon cancer or rectal cancer, for example—many cancer types were treated similarly. In other words, previously, if you had 2 patients with the same colon cancer and they had advanced disease, they would be treated with the same chemotherapeutic agents.
Now, we have entered into an era where we can look at the gene profiling of the tumor, look at the genetic mutations in the tumor itself, and (we know from The Cancer Genome Atlas project)3 if you have those same 2 patients—although their histology would look the same under the microscope—their gene profiling would be different. The idea is to treat those patients differently based on their gene profiling. This is the era that we have entered into called precision medicine, or personalized medicine, and it is based on the genetic profiling of the tumor of the individual patient.
What does the future look like for DNA sequencing in precision oncology? What are the next advances in precision oncology that you see on the horizon?
I am very optimistic for the future with this new era of cancer treatment, but we must keep in mind that just because we target a certain genetic profile with certain agents does not necessarily mean that those agents are going to be effective. I believe that is one of the important things about our relationship with Strata—this collaboration will allow us to enroll some of our patients in clinical trials so that we will know whether the treatment we are giving them is effective for the specific genomic profiling that they have.
The other major issue that we are studying today—which many other people are studying also4,5—is that although you may have certain genetic mutations, you do not know which mutations are passenger mutations and which are driver mutations. There is still a lot of research to be done here, but I believe that advancements we have made in this era will continue. I do not think this is something that is just going to be popular for a couple of years. It is already being used in certain tumors today, especially on the leukemic side, as a standard of care in treating those patients. The difference is, in leukemia, only 1 or 2 mutations may be present. In solid tumors, many mutations are likely to be present; finding out what the driver mutations and the passenger mutations are and then targeting those driver mutations is what precision medicine and next-generation sequencing is all about.
Which patients will benefit most from this genetic tumor profiling project and in what ways?
The criteria for this project are advanced disease solid tumors. The common cancers are included in this project: breast cancer, lung cancer, colon cancer, and rectal cancer. Also included are refractory lymphoid malignancies and any stage of pancreatic cancer.
From an economic standpoint, are there certain patients that will benefit more from this no-cost offering?
We do not distinguish between patients that cannot afford next-generation sequencing from those that can. One of the advantages we have here in the state of Delaware, which is extremely unique, is the Delaware Cancer Treatment Program.6 If you are a family of 4 making up to $120,000 a year and you are uninsured, the state will pay for 2 years of your cancer treatment. As a matter of fact, in recent years, because of the expenses associated with the immunotherapy era and the driving costs of immunotherapy, the state will also help with the copay that many of these patients cannot afford. This is a very unique program in the state of Delaware that Washington should take a hard look at. It is a great model for the rest of the country.
At the Graham Center here at Christiana Care, we spent a significant amount of money on the uninsured patients in the last year. Next-generation sequencing can be very expensive—up to $5000 for sequencing. But the Strata initiative, which hopes to collect 100,000 patients from several institutions across the country over the next 3 years, will offer a no-cost option and make serious ground regarding what is effective and what not is effective. And I think that is critical—the progress we have made in cancer care comes from clinical trials. What attracted us to Strata was the ability for some of the patients that are going to receive next-generation sequencing will be candidates for these trials.
What is the ultimate goal for Christiana Care in this alliance? Is it to locate those patients who would be suitable for clinical trials?
Christiana Care sees the majority of the new cancer cases in Delaware to begin with. Our goal here at Christiana Care and the Graham Cancer Center with this project is to help push the clinical efforts forward and get answers through the Strata clinical trials and to also find an answer to the most effective way for next-generation sequencing to make a dent in cancer care.
Are there any other important points you would like to touch on about this program?
It is important to note that 85% of cancer care is provided in community cancer centers here in the United States.7 I think for community cancer centers like ours, which is considered a hybrid academic community cancer center (very similar to Skip Trump’s program at Inova and also similar to Derek Raghavan’s in the Levine Cancer Center),8 are very suitable programs to partner with Strata for this initiative. It is critical for patients to be aware of the centers in which they are receiving their treatment in order to ensure they are receiving the best quality care and to ensure that those centers are staying on the cutting edge of cancer treatment.
References
1. Duke University School of Medicine. Tumor profiling and targeted treatment. Duke Center for Applied Genomic & Precision Medicine website. https://precisionmedicine.duke.edu/education/providers/tumor-profiling-and-targeted-treatment. Accessed January 30, 2018.
2. Milligan C. Helen F Graham Cancer Center to offer no-cost tumor profiling and DNA sequencing. Delaware Business Times. January 4, 2018. https://www.delawarebusinesstimes.com/helen-f-graham-cancer-center-offer-no-cost-tumor-profiling-dna-sequencing/. Accessed January 30, 2018.
3. Cancer Genome Atlas Network. Comprehensive molecular characterization of human colon and rectal cancer. Nature. 2012;487(19):330-337.
4. Accumulation of driver and passenger mutations during tumor progression. Ivana Bozic, Tibor Antal, Hisashi Ohtsuki, Hannah Carter, Dewey Kim, Sining Chen, Rachel Karchin, Kenneth W. Kinzler, Bert Vogelstein, and Martin A. Nowak. Proc Natl Acad Sci USA. 2010;107(43):18545-18550.
5. Greenman C, Stephens P, Smith R. Patterns of somatic mutation in human cancer genomes. Nature. 2007;446(7132):153-158.
6. Delaware State Government. Cancer treatment program provides financial help for uninsured patients. Delaware Health and Social Services website. https://www.dhss.delaware.gov/dhss/dph/dpc/catreatment.html. Accessed January 30, 2018.
7. Petrelli N. A community cancer center program: getting to the next level. J Am Coll Surg. 2010;210(3):261-270.
8. Raghavan D, Petrelli N, Trump DL. Hybrid cancer centers exploring links with NCI-designated institutions. The Cancer Letter. https://cancerletter.com/articles/20180126_5/. Published January 26, 2018. Accessed January 31, 2018.
