Study Underscores Value of PROs in Improving Lung Cancer Survival

A presentation by oncologist Ethan Basch, MD, from Memorial Sloan Kettering Cancer Center, during the plenary session at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting, created a big splash. A patient self-reporting tool developed by his team, which allows patients to monitor and self-report their symptoms during routine treatment, helped improve overall survival among patients with solid tumors, compared with those patients who received usual care and routine monitoring.

At the 2018 ASCO Annual Meeting, a study conducted in France revealed the impact of electronic patient-reported outcomes (PROs) on survival among patients being treated for lung cancer. The study was presented by Fabrice Denis, MD, PhD, radiation oncologist at Institut Inter-regional de Cancérologie Jean Bernard, Le Mans, France.

Web-based monitoring of patients undergoing treatment for lung cancer is dual-pronged: not only is there evidence on improved survival, data also suggest improved resource utilization. For their current trial, patients with advanced-stage lung cancer without evidence of disease progression after initial treatment were randomly assigned to either:

• An experimental arm of web-mediated follow-up based on weekly self-scoring of 13 common patient symptoms, or
• A control arm of routine follow-up with 3-6 months repeated computed tomography (CT) scans.

The recruitment period was between June 2014 and January 2016; 133 patients were enrolled in the study, 121 of whom were in the intent-to-treat analysis. The majority of patients had stage III or IV disease.

When patients in the experimental arm self-scored their symptoms, the oncologist received an email alert if those symptoms matched predefined criteria. The primary outcome was overall survival (OS).

An interim analysis, the results of which were published late last year, found a 7-month median OS benefit associated with web-based monitoring to detect recurrence after initial treatment, compared with the scheduled imaging.¹ The median OS was 19.0 months (95% CI, 12.5 to noncalculable) in the experimental arm and 12.0 months (95% CI, 8.6-16.4) in the control arm (P = .001) (hazard ratio [HR], 0.32; 95% CI, 0.15-0.67; P = .002).

“Based on the results of our interim analysis, we hypothesized that benefit was due to earlier detection of symptoms and relapses, prompting earlier treatment and supportive care,” Denis said. At the ASCO meeting, he presented final results from a 2-year follow-up of the patients.

The software used to assemble patient input, MoovCare, has been developed using the same rigorous standards as an implantable medical device, according to the software’s developer, SIVAN innovation. MoovCare is the “first real personalized follow-up in lung cancer,” Denis said.

“Via the web-mediated follow-up, the patient or caregiver provides a 12-symptom weekly report,” said Denis, which was prospectively assessed. So, the primary requirement is for the patient or caregiver to have internet access.

Of the 34 patients alive in the control arm, 10 were eligible to cross over following the interim analysis. With 2 years of follow-up, and 70 deaths, the median OS was 23.0 months in the experimental arm and 14.8 months without adjustment for crossover in the control arm (HR, 0.62; 95% CI, 0.39-0.995; P = .048). Minus the crossover patients, the HR decreased further to 0.53 (95% CI, 0.33-0.85; P = .009), the authors found.

Following the longer follow-up, and despite the crossover of patients in the control arm into the experimental arm, the OS remained significantly larger with the web-mediated follow-up based on PROs than with routine disease follow-up by CT alone, Denis concluded.

He informed the audience of their team’s plan to conduct similar, larger trials in other cancers.

References

1. Denis F, Lethrosne C, Pourel N, et al. Randomized trial comparing a web-mediated follow-up with routine surveillance in lung cancer patients. J Natl Cancer Inst. 2017;109(9). doi: 10.1093/jnci/djx029.
2. Denis F, Basch EM, Lethrosne C, et al. Randomized trial comparing a web-mediated follow-up via patient-reported outcomes (PRO) vs. routine surveillance in lung cancer patients: Final results. J Clin Oncol. 2018;36,(suppl; abstract 6500).