Anita T. Shaffer
Fabrice Denis, MD, PhD
Patients with lung cancer who participated in a web-based system for reporting and tracking their symptoms achieved dramatic gains in survival compared with individuals who were followed with typical protocols, according to study results presented at the 2016 ASCO Annual Meeting.
The MoovCare system made a difference for patients because it resulted in early detection of dangerous conditions or recurrences, resulting in healthier individuals who were better able to undergo optimal therapy and earlier supportive care that improved quality of life, said lead study author Fabrice Denis, MD, PhD, during an ASCO presscast.
The median overall survival (OS) rate for patients who used the MoovCare system was 19 months compared with 12 months for participants in the control group (HR, 0.325; P
= .0025), after 20 months of follow-up. Additionally, 75% of the patients followed through MoovCare were still alive at 1 year versus 49% with standard procedures.
There also was a 50% reduction in the average number of imaging tests per patient per year with the use of the app, said Denis, a researcher at the Institut Inter-regional de Cancérologie Jean Bernard in Le Mans, France.
These improvements were achieved even though the relapse rates were similar for both groups—49% among those who used the app and 51% among those with typical follow-up, researchers reported.
However, performance scores stayed higher among patients who used MoovCare. As a result, 74% of these patients were able to undergo optimal therapy upon relapse compared with 33% who had not used the app (P
Denis said the need for an app in lung cancer is particularly pressing. “There are no standard follow-ups to detect relapse in patients,” he said. “Relapses are frequent and often symptomatic…Symptomatic patients often wait, leading to health degradation and nonoptimal therapy.”
MoovCare consists of a software application that patients or their caregiver use to report their symptoms. The algorithm analyzes the information for signals of potential relapse or complications and, if necessary, notifies the oncology care provider via email. The app can be accessed on mobile and desktop devices.
Denis and colleagues tested the system in a phase III trial conducted at 5 medical centers in France. Results were reported for 121 patients in the intent-to-treat analysis who were randomized to use either the MoovCare system (n = 60) or routine follow-up (n = 61). The trial was stopped early at the interim analysis because of the positive results.
The study population consisted of patients with nonprogressive non–small cell lung cancer or small cell lung cancer at stages IIA through IV. Participants were required to have a performance score of 0-2 and a symptomatic score <7. All patients underwent chemotherapy before starting the trial and were permitted to continue tyrosine kinase inhibitor therapy or maintenance therapy throughout the study.
Patients in the MoovCare arm were required to self-report weekly for 12 clinical symptoms including asthenia, cough, dyspnea, and anorexia. Those with stage II-IIIA cancers also received CT scans at 6-, 12-, and 24-month intervals while those with stage IIIB-IV cancers were scheduled for scans at 12 months and 24 months.
In the control arm, patients with stage II-IIIA cancers received scans every 6 months, while participants with stage IIIB-IV disease were scheduled for monthly scans starting at 3 months.
Additional CT scans could be performed at the investigator’s discretion for patients in both arms, Denis said.
The primary endpoint for the trial was OS with the boundary for superiority set at P
<.006. Secondary outcomes including performance score evaluation after first relapse, progression-free survival, and quality-of-life score using the standard FACT-L, FACT-G, and TOI questionnaires.
In response to questions about MoovCare’s practicality, Denis said the system is easy to install on a computer and would simply require a doctor or nurse to monitor the emails.
However, Patricia Ganz, MD, an ASCO commentator who served as moderator for the presscast, said drawing benefit from such a system would necessitate changes in US practices. She said that similar experiments in the United States had found that information patients submit electronically does not generate action because of the cost of deploying personnel to monitor the data.
“We’re trying to restructure how we deliver care so that we can be responsive to these kinds of changes and these tools where patients can report their symptoms and how they’re doing on a regular basis,” said Ganz, a professor at the UCLA Fielding School of Public Health/Department of Health Policy and Management. “If there’s staff in the office who can respond [it would] really make a difference in preventing emergency room visits, hospitalizations, and so forth.”
ASCO spokesman Gregory A. Masters, MD, a lung cancer specialist at the Helen F. Graham Cancer Center in Delaware, said the MoovCare system presents “one way to engage patients and allow them to take a more active role in their care.”
He said this is particularly important in lung cancer. “Lung cancer is a unique cancer in some ways because many of these patients have a lot of guilt about their diagnosis,” said Masters. “I think we see that more in lung cancer patients than in many other patients. Some patients don’t want to bother the doctor or the nurse or the health care team with their symptoms or they think [their symptoms] are not important.”
Sivan Innovation, an e-health company headquartered in Jerusalem that developed MoovCare, said the system is the first web application based on telemonitoring. The company said it would seek regulatory approvals for marketing it as a medical device and that a CE mark procedure is underway in Europe.
The company also said it would start rolling out the application in France in 2017, and then elsewhere in Europe, the United States, Israel, and other countries. MoovCare also is in development for approximately 15 other cancer indications, notably lymphoma, in a partnership with Takeda France, the company said.
Denis F, Lethrosne C, Pourel N, et al. Overall survival in patients with lung cancer using a web-application-guided follow-up compared to standard modalities: results of phase III randomized trial. J Clin Oncol. 2016;34(suppl; abstr LBA9006).
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