CLINICAL RESULTS MOOVCARETM
PRODUCT

Results of the Phase III Randomized Trial to confirm the overall survival benefit of MoovcareTM in Lung Cancer Patients

New publication

Results of the Phase III Randomized Trial to confirm the overall survival benefit of MoovcareTM in Lung Cancer Patients are published in the JNCI

(Journal of the National Cancer Institute)


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Improved Overall Survival in Lung Cancer Patients using a Web-application-mediated Follow-up compared to Standard Modalities: Results of a Phase III Randomized Trial

According to Fabrice DENIS MD, PhD (Le Mans, France) LBA9006, Abstract Oral Session Annual Meeting of Clinical Oncology 2016 (Chicago)

Introduction and Rationale

The rational of this study is that most of relapses are symptomatic in lung cancer (80-90%) and symptomatic patients often wait many weeks before visit. More and more patients are connected and patient-reported outcome by web-application may be useful to optimize communication of symptoms between patient and physician. It may also improve survival.

Method

It has been developed a web-mediated follow-up in which patients report 12 symptoms weekly using smartphone or PC. Patients can also use a free text window. An algorithm analyses dynamic of symptoms and triggers email alerts to oncologist if relapse or dangerous medical conditions are detected. If an alert is confirmed by a phone call from oncologist, an anticipated visit and, if needed imaging is performed as well as early supportive care.

Previous phase II results

previous results validation of algorithm previous results survival

Design of the randomized phase III study

In the experimental arm, scheduled imaging were strongly reduced but when a phone call confirmed a web-application alert, an anticipated visit and unscheduled imaging were then performed. Primary outcome was overall survival.

phase 3 multi-centric randomized study

Phase III results

In web app arm, the first alert after randomization was associated with a relapse in 71% of patients, a dangerous medical condition in 20% and supportive care alone in 9%. Relapse detection rate between planned visit was 74% in web-app arm vs 33% in standard arm (p<0.001) confirming that relapse is often detectable between planned visit!

Survival results

Median follow-up was 9-months.

Median overall survival was 19 months in web-app arm and 12 in standard arm. 9-months absolute benefit was 20% and one year benefit was 26%. HR for death = 0.3, (IC 95%: 0.157-0.672), p=0.0025. This planned analysis led to early stop the trial and to switch all patients in the web-app followup.

Relapse results

PS 0-1: 77% of patients (Web-app arm) vs 33% (Standard arm): p<0,001

Treatment of Relapse: 74% « Optimal » (Web-app arm) vs 33% (Standard arm): p<0,001

An optimal treatment was defined as a treatment with maximal number of drugs at full dose.

Pre-specified subgroups analysis

Although the population was rather heterogeneous, it improved overall survival EVEN in the main pre-planned subgroups.

Pre-specified patient subgroups analysis of overall survival favored web-application in small and non small cell carcinoma and in stage IIIA or IIIB/4.

This planned analysis led the independent committee to early stop the trial and to progressively switch patients in the web-application followup.

pre-specified subgroups analysis

Quality of Life results

quality of life mean score at 6 months

6-month quality of life was significantly higher in Webapp arm for all FACT questionnaires.

Progression free survival

does high QoL improve PFS

Progression-free survival and relapse rates were not significantly different between groups. Relapse rates: 51% (standard arm) vs 49% (Web-app arm), p=0.1346

One explanation of the lack of overall PFS differences between arms may be that web application follow-up allowed earlier relapse detection but, conversely, it may contribute to delay relapse by allowing high QoL level (using earlier supportive care). It may be interesting to confirm this hypothesis… because it may contribute to explain why earlier supportive care improves survival.

Compliance-
Management

The compliance of the patients for filling weekly their form was high (84%) and was similar as previously reported in our pilot study (82%).
Observance of scheduled visits and imaging was assessed and showed no substandard attention provided to patients in the control arm. The mean weekly duration spent by the oncologist to manage alerts was 15 minutes for the 60 patients who used the web-application. We also noted a strong reduction of inopportune patients phone calls in experimental arm.
Moreover, the number of imaging was reduced by 50% per patient per year in experimental arm.

Cost-effectiveness
of follow-up

cost-effectiveness of follow-up

Here are comparisons of survival benefit and incremental cost- effectiveness ratio of 4 different follow-up.
ICER QALY of our web-application is estimated less than 10 000$ in our study as compared with follow-up of some cancers.

Other « intensive »
clinical follow-up

other intensive clinical follow-up studies

They all showed high benefit in 1-year survival. However this phase III randomized study conducted by F Denis is the first assessing survival as primary outcome, in a specific cancer population AND in a multi-centric trial.

Conclusion

This benefit was probably subsequent to a frequent high PS at relapse leading to optimal therapy in most of relapsing patients, to the early detection and treatment of dangerous medical conditions (such as sepsis, pulmonary embolisms…) and to an improvement in quality of life subsequently to the early use of supportive care that seemed to also improve PFS.

conclusion

It was assessed in 3 prospective trials in almost 300 patients and in the first phase 3 multicentric trial assessing overall survival as primary outcome.
This lead to the highest evidence level of efficacy of a web-mediated follow-up in lung cancer that had never been reported before.
This Web application led to perform less imaging but at the right time and allowed a personalized follow-up. This 2.0 follow-up results led us to initiate randomized studies in others cancers.It was assessed in 3 prospective trials in almost 300 patients and in the first phase 3 multicentric trial assessing overall survival as primary outcome. This lead to the highest evidence level of efficacy of a web-mediated follow-up in lung cancer that had never been reported before.
This Web application led to perform less imaging but at the right time and allowed a personalized follow-up. This 2.0 follow-up results led us to initiate randomized studies in others cancers.