Along with other areas of medicine, the cancer community has embraced the concept of patient-centered care. Patients today are encouraged to take an active role in their care from the moment of diagnosis, and the latest research highlights both challenges and solutions for ensuring every patient receives quality cancer care.
First, 2016 marked important milestones in two key initiatives that hold great promise for people with cancer: CancerLinQ, ASCO’s big-data initiative to rapidly improve the quality of cancer care, and the TAPUR (Targeted Agent and Profiling Utilization Registry) study, which is the first clinical trial conducted by ASCO.
In addition, an advance has been made in preventing nausea and vomiting in patients receiving chemotherapy. Researchers have identified a more powerful medication combination that will help ease these challenging adverse effects of treatment. Not only does this advance improve patients’ quality of life, it also helps more people complete the full dose and course of chemotherapy.
New tools and programs, such as a Web-based tool for self-monitoring symptoms and patient navigation and education programs for underserved populations with lower health literacy, are being developed to improve care and quality of life. Such programs will become increasingly important in the era of precision medicine.
Finally, a major study reported in 2016 provides long-awaited answers about outcomes with three standard approaches for early prostate cancer: active surveillance, surgery, and radiation therapy. The findings will inform physician and patient discussions about treatment.
A Policy Focus: Importance of Data Sharing in Cancer Care and Research
ASCO continues to advance policies that improve the widespread interoperability of electronic health records, which refers to the ability to identify, extract, and use health care data within and among systems. Interoperability is essential for the complex treatment of cancer because multiple health care providers using different information systems need a way to exchange detailed clinical information to coordinate care effectively. Furthermore, interoperability will provide a critical foundation for big-data efforts, including ASCO’s CancerLinQ initiative, which holds great promise in unlocking advances by distilling massive volumes of clinical data from large groups of patients with cancer.
ASCO was a major supporter of the 21st Century Cures Act, and congratulated President Obama, Vice President Biden, and Congress when the legislation was signed into law and funded in December 2016. The law includes provisions to advance interoperability, such as requiring the secure access, transfer, exchange, and use of all electronically accessible health information for authorized purposes, and banning information blocking, which is the practice of knowingly and unreasonably interfering with the exchange or use of electronic health information.
Now that 21st Century Cures Act has been signed into law, ASCO will continue to serve as a resource to policymakers to support implementation.
ASCO Advances Patient Care Through Precision Medicine and Big Data
In early 2016, CancerLinQ—ASCO’s big-data initiative to rapidly improve the quality of care for people with cancer—went live. The number of participating oncology practices grew steadily throughout the year, ranging from small private practices to some of the leading cancer centers in the nation. More than 70 vanguard practices in 40 states and the District of Columbia have signed on to feed patient data into CancerLinQ and use the system in their practices. The rapid-learning system run by CancerLinQ, a wholly owned nonprofit subsidiary of ASCO, is now drawing on more than 1 million patient records from across the United States.
In addition, CancerLinQ has agreements in place with Cancer Informatics for Cancer Centers (CI4CC) and SAP. The collaborative agreement with CI4CC, which represents senior informatics leaders and chief data scientists at NCI-designated cancer centers and other major medical and research institutions across the nation, will bring the nation’s leading clinical, genomic, and biomedical informaticists, academicians, and data scientists together with the oncology community to help improve cancer care through CancerLinQ. The CancerLinQ platform was codeveloped with SAP using the SAP Connected Health platform that runs on SAP HANA, a flexible, in-memory data management and application platform created by SAP.
CancerLinQ is continuing to add new practices and will soon enable the cancer community to begin to gain critical insights from the growing data resources of the system that will improve cancer care and spark new research.
The ASCO TAPUR study (ClinicalTrials.gov identifier: NCT02693535) was also launched in 2016, officially opening patient enrollment on March 14. TAPUR is designed to evaluate molecularly targeted cancer drugs and collect data on clinical outcomes to learn about additional uses of these drugs outside of indications already approved by the FDA. It will offer flexibility, allowing physicians to choose the tumor specimen or blood sample and genomic profiling test; use broad general eligibility criteria; and streamline data collection and reduce the overall amount of data collected.
The precision medicine trial has enjoyed robust expansion in just its first year, continuously adding both patients and participating sites. As of January 2017, seven pharmaceutical companies are participating in TAPUR, providing 17 drugs that yield 15 different targeted therapy options (some of the drugs are used in combination with one another) for participants with advanced solid tumors, multiple myeloma, or B-cell non-Hodgkin lymphoma; additional drugs and companies may be added as the trial continues.
This year, TAPUR is expected to expand enrollment to include pediatric patients by lowering the eligibility age from 18 to 12 years. This will extend the opportunity for participation to adolescent patients with advanced cancer.
Voices of Cancer Research: Lori Wallace-Pushinaitis
When Lori received her second breast cancer diagnosis in 2014, the cancer had already spread throughout her body. However, despite having advanced disease, Lori spent more than a year on a clinical trial for lurbinectedin, seeing slow and steady improvement for 14 months until the cancer began to grow again.
Still committed to exploring her options, Lori has moved on to other treatments. She is grateful, however, as she feels clinical trials have given her more time with her son.
Lori is a volunteer with the Bay Area Young Survivors (BAYS), Mets in The City (MITC), Facing Our Risk of Cancer Empowered (FORCE), Young Survival Coalition (YSC), and METAvivor.
Better Way to Prevent Chemotherapy-Triggered Nausea
Nausea and vomiting are among the most common adverse effects of chemotherapy. These symptoms are not only uncomfortable and debilitating, but may also be so severe that they prevent patients from completing the full course of chemotherapy. As a result, such patients may have a higher chance of cancer recurrence and shorter survival.
According to a large clinical trial, a new treatment regimen prevents chemotherapy-related nausea better than standard antinausea treatments (this study was funded in part by a grant from the NCI).78 Patients received olanzapine or placebo, in combination with standard antinausea treatments (aprepitant or fosaprepitant and a 5-hydroxytryptamine type 3-receptor [5HT3] antagonist) on the day of chemotherapy and for several days after chemotherapy. The patients were being treated with cisplatin or cyclophosphamide–doxorubicin, types of chemotherapy that often trigger nausea. In the first 24 hours after chemotherapy, the proportion of patients who were nausea free was much higher in the olanzapine group than in the placebo group (74% v. 45%), and over a 5-day period after chemotherapy (37% v. 22%).
These findings add to evidence from other clinical trials suggesting the benefit of olanzapine in preventing chemotherapy-related nausea and vomiting. Olanzapine is approved by the FDA for treatment of psychosis. The adverse effects typically include mild short-term sedation, weight gain, and increased risk of type 2 diabetes. In this study, patients who received olanzapine had drowsiness on the second day, which subsided in the subsequent days. There were no serious adverse effects related to olanzapine.
Patient Self-Reporting of Symptoms Improves Care
Most patients with advanced cancer will experience symptoms while receiving treatment. Physicians or nurses typically ask patients about their symptoms only during clinic visits, and toxicity data in clinical trials are biased according to selection of patients who enroll in the trials (compared with the average patient in practice who receives the drug) and by the limited nature of gathering the data. As a result, symptoms that are more common in patients who may not be represented in the trials and that appear or change between visits can be missed or simply forgotten and can thus go untreated.
In the past several years, more efficient ways of monitoring symptoms have been proposed. One of these involves collecting symptom information directly from patients through standardized questionnaires, without physician interpretation. This approach is part of a growing recognition of the importance of patient-reported outcomes in medicine and patient-centered health care in general.
A large clinical trial recently showed how one patient-reported outcome tool can have positive effects on the well-being of patients with cancer.79 In the study, patients receiving chemotherapy for advanced breast, genitourinary, gynecologic, or lung cancer were randomly assigned to the self-reporting group or the usual care group.
Self-reporting was conducted via a Web-based questionnaire that covered 12 common symptoms, such as appetite loss, constipation, cough, diarrhea, and fatigue. The tool triggered e-mail alerts to nurses whenever patients reported symptoms worsening. Usual care consisted of discussing and documenting symptoms during patients’ visits with their oncologists.
Over a 6-month period, more patients in the self-reporting group (34%) had an improvement in health-related quality of life (HRQL) than in the usual care group (18%). Conversely, fewer patients in the self-reporting group (38%) had worsening of HRQL than in the usual care group (53%). HRQL measures mobility, self-care, usual activities, pain or discomfort, anxiety, and depression. More studies are needed to determine if symptom self-reporting would have such a large benefit in other care settings, but this and other studies have proven that this technology holds promise in the supportive care of patients receiving cancer treatment.
Patient Navigation Program Improves Compliance With Cancer Therapy
The first patient navigation programs were developed nearly three decades ago to improve access to cancer screening. Since then, a variety of such programs have been launched to help people, particularly those in medically underserved communities, overcome barriers to receiving quality care—from diagnosis through treatment and survivorship.
Patient navigators guide patients through all the complexities of multidisciplinary cancer care. This may include ensuring that patients schedule and attend physician visits, start cancer therapy as soon as possible, and take prescription medicines as directed.
A recent report describes a navigation program designed to reduce the challenges faced by underserved minority patients with cancer.80 Although minority women in the United States are less likely to develop breast cancer, they are more likely to die as a result of breast cancer than white women. The higher breast cancer death rate among minority women results in part from treatment delays and patients not sticking to treatment.
In the study, patients diagnosed with breast cancer were paired with a patient navigator, while a second group of patients received usual care (i.e., without the help of patient navigators). Most of the patients were either African American (45%) or Hispanic (38%), and 72% were enrolled in a program. The navigators met with patients at all radiology and oncology medical appointments, as well as on the day of surgery. They also provided financial consultations and helped negotiate payments, as needed.
Patients who received help from patient navigators began cancer treatment sooner than those who received usual care and had better compliance with treatment after surgery. On average, women in the patient navigation group started chemotherapy approximately 30 days earlier and hormone therapy approximately 95 days earlier than those in the usual care group. Patient compliance with either chemotherapy or hormone therapy was 100% among women in the navigation program. In contrast, among women who received usual care, only 57% were compliant with chemotherapy and 69% with hormone therapy. These findings affirm that use of navigators within cancer centers is vital to improving cancer care, especially in medically underserved and vulnerable populations.
Addressing Health Literacy in the Era of Precision Medicine
Genomics-based targeted cancer therapies have had a major, positive effect on modern cancer therapy. However, the ability to offer truly personalized cancer care to most patients will require lower costs for genomic testing and faster sample processing times. Not all communities and individuals have equal access to genomic testing, and such testing may not even be clinically informative for many patients. Another challenge is that precision medicine and its associated terminology are complex.
Recent research suggests that the public may not fully understand the current possibilities and limitations of genetic or genomic information, including results of genetic testing. One reason may involve the health literacy level of consumers, meaning how much people do or don’t understand health and medical information. For instance, one study shows that understanding health information is an important factor in how people perceive the importance of genetic testing (this study was funded in part by a grant from the NIH).81 Those with high health literacy scores tended to understand the importance and implications of genetic testing better than those who had low or limited health literacy scores. These findings are relevant whenever genetic testing is used to inform patient care, regardless of disease.
In the study, researchers surveyed more than 600 patients at a primary health clinic of a large hospital, which serves a diverse patient population in the St Louis, Missouri, area. Participants were asked to complete a written questionnaire followed by a set of verbally administered questions to measure their level of health literacy. The written questionnaire covered knowledge of genetics, participants’ confidence in their ability to use genetic information, and perceived importance of genetic information and family history. Most participants were aware of the importance of family health history and were sure they could talk about it with family members; however, approximately half of participants (47%) were found to have limited health literacy.
People with limited health literacy had lower genetics-related knowledge and lower awareness of the value of knowing family health history. Those with limited health literacy were more likely to think that learning about their genetic information was important, compared with those with adequate health literacy; however, they were less likely to think that family health history information was important. Interestingly, people with limited health literacy were more likely to discuss family health history with their physicians than those with adequate health literacy.
These findings underscore the need for education programs to improve health literacy, particularly with regard to genetics. An informed patient is able to make better decisions regarding genetic testing and screening and how these tools may be used to inform his or her health care.
Excellent 10-Year Survival for Patients With Early Prostate Cancer, Regardless of Treatment
One in eight men will be diagnosed with prostate cancer at some point during his lifetime. In 2016 alone, an estimated 181,000 men received a prostate cancer diagnosis.82 In recent decades, widespread prostate-specific antigen (PSA) testing has increased prostate cancer diagnoses and treatment.
However, because prostate cancer often grows slowly, many men who are diagnosed with early cancer die as a result of other causes before they succumb to prostate cancer. This means that treatment of early prostate cancer is not always necessary. Prostate cancer treatment may also cause complications, such as sexual, urinary, and bowel problems.
In addition, the choice of treatment for men with prostate cancer that is detected on the basis of PSA testing is controversial. A recent clinical trial provided answers to a long-standing question in prostate cancer care: which approach is best in treating localized, early-stage prostate cancer: surgery, radiation therapy, or active surveillance?83
The trial randomly assigned 1,643 men diagnosed with localized prostate cancer to either active surveillance, surgery (radical prostatectomy), or radiation therapy with short-course hormone therapy. PSA levels were regularly measured in men assigned to active surveillance, and those with rising PSA levels had the option of continuing surveillance or receiving curative therapy, including surgery and radiation therapy.
After a median follow-up period of 10 years, there were no significant differences among the three groups in rate of prostate cancer-related deaths (approximately 1%). Similarly, there were no differences in the number of deaths resulting from any cause. However, cancer had worsened in more men in the active surveillance group (20%) than in men who received either surgery (8%) or radiation therapy plus hormone therapy (8%). Likewise, the rate of metastasis was higher in the active surveillance group (6%) than in either the surgery (2%) or radiation therapy plus hormone therapy group (3%).
This trial addresses the important question of clinical effectiveness regarding these three approaches to treating early, localized prostate cancer. Although the findings suggest that immediate active treatment is more effective than active surveillance to avoid disease worsening, longer follow-up may be needed to see if there are differences in death rates across the three approaches. Meanwhile, the insights from this study will inform treatment discussions between physicians and patients.
For additional notable advances in patient care, please see Appendix Table A1.