Dr. Ethan M. Basch presents LBA2.
Ethan M. Basch, MD, MSc, FASCO, of The University of North Carolina at Chapel Hill, presented the findings of the study (Abstract LBA2) at the Plenary Session on June 4. “This approach should be considered for inclusion as a part of standard symptom management,” Dr. Basch said. The results of the study were published in the Journal of the American Medical Association simultaneously with the presentation.
Symptoms are common in advanced cancer, and symptom management is a cornerstone of oncology practice to alleviate suffering and avoid downstream complications. However, numerous hurdles inhibit patient reporting of symptoms, and previous research has shown that up to half of symptoms are not reported to clinicians, Dr. Basch said. Research has also shown that systemic symptom monitoring can help close this gap, and that patients are willing and able to self-report, even when they are ill or close to death.
The standard model for reporting symptoms is a reactive approach in which patients must take the initiative to remember and report their symptoms to health professionals, who can then take action to alleviate the symptoms, Dr. Basch noted. In a proactive model, e-reminders can be sent periodically to patients prompting them to report symptoms, which are then conveyed to health professionals through e-alerts.
Investigators at Memorial Sloan Kettering Cancer Center, where Dr. Basch was practicing when the study was conducted, hypothesized that allowing patients to self-report their symptoms through an online portal would prompt physicians to intervene earlier, improving symptom management, and thus improving outcomes. They recruited patients receiving chemotherapy for metastatic breast, lung, genitourinary, or gynecologic cancers.
Patients were randomly assigned to receive either standard symptom monitoring or the intervention in which they could self-report 12 common symptoms before and between visits. Patients received weekly email reminders, and when they reported symptoms, email alerts were sent to nurses. Oncologists received printed reports at visits.
Dr. Monika Krzyzanowska discusses LBA2.
The study enrolled 766 patients between June 2007 and January 2011. OS analysis was conducted in June 2016, after two-thirds of the patients had died, at which time median follow-up was 7 years. Characteristics were well balanced between arms at baseline. Patient age ranged from 26 to 91, and the median age was 62 and 61 in the standard-care and self-reporting arms, respectively.
Patients self-reported symptoms 73% of the time when prompted to do so, even among elderly patients. Nurses took action in response to alerts 77% of the time with interventions including counseling, referrals to emergency services, and chemotherapy dose modifications.
In the primary outcome of QOL at 6 months compared with baseline, 31% more patients in the self-reporting arm experienced benefits compared with the standard-care arm (34% vs. 18%, respectively; p < 0.001).
Median OS was 5 months longer for patients in the self-reporting arm compared with standard care (31.2 vs. 26.0 months; p = 0.03). This translated to a 5-year absolute survival benefit of 8%. The difference remained significant in multivariable analysis (adjusted hazard ratio [HR] 0.832, 95% CI [0.696, 0.995]).
Dr. Basch proposed three possible mechanisms of action for the survival benefit: Proactive monitoring prompts clinicians to intervene early, before symptoms worsen and cause downstream complications; symptom control helps patients stay more functional, which is associated with better survival; and symptom monitoring enhances control of chemotherapy side effects, enabling more intensive and longer duration therapy. In the trial, self-reporting patients received chemotherapy 2 months longer on average than standard-care patients (8.2 vs. 6.3 months; p = 0.002).
Discussant Monika K. Krzyzanowska, MD, MPH, FRCPC, of the Princess Margaret Cancer Center, in Canada, called this a “practice-changing study.”
“Proactive symptom monitoring should be considered the new standard of care,” she said, “and oncology practices should consider the implementation recommendations as we take up this challenge.”
Dr. Krzyzanowska noted that, for the seven drugs approved for treatment of metastatic solid tumors in 2016 that reported OS data, the median survival advantage ranged from approximately 2 months to more than 11 months. Only one of these drugs outperformed the median survival difference reported by Dr. Basch in this study of remote patient monitoring.
“Managing symptoms during treatment is a fundamental aspect of our role as oncology clinicians, and hence this trial is relevant to all of us in the oncology community regardless of what cancers we treat and where we practice,” she said.
–Tim Donald, ELS