335MO - Intervention combining nurse navigators (NNs) and a mobile application vs standard of care (SOC) in neuro-oncology patients (pts) treated with oral anticancer agents (OAA): A subgroup analysis of CAPRI, a single-center, randomized phase III trial

Background

Oral treatments are standards in neuro-oncology (e.g. temozolomide-based). Adherence issues are particularly relevant in this setting due to possible concomitant cognitive impairment and discontinuous treatment schedules. In this context, efforts to better manage oral anticancer agents (OAA) are needed.

Methods

We did a randomized phase III trial comparing an intervention combining nurse navigators (NNs) and a mobile application vs. standard-of-care (SOC) in adult cancer pts treated with OAA in our tertiary cancer center. Patients (pts) initiating OAA (all cancers, PS < 3, life expectancy > 6 months) were randomized in a 1:1 basis. NNs provided regular phone follow-ups to manage symptoms and assess toxicities, adherence and supportive care needs. Pts had access to a mobile application to record tracking data and contact NNs via secure messaging or a dedicated phone line. The intervention lasted 6 months. The primary endpoint was the Relative Dose Intensity (RDI). Secondary endpoints included adherence, toxicity, response and survival, quality of life, pt experience (PACIC Score), end-of-life support, and economic estimation of the use of healthcare resources. We herein present a subgroup analysis of the neuro- oncology population.

Results

From October 2016 to May 2019, 51 patients (63% high-grade glioblastoma) were included (26 were randomized in the intervention arm) and 98% received temozolomide. RDI was significantly higher in the intervention arm (105%±0.12 vs 97.6% ±0.13, p = 0.04). The intervention also significantly decreased visits to the emergency room and subsequent hospitalizations, and improved pt experience and use of supportive care resources (all p-values < 0.05). No difference was seen in treatment-related toxicity in both arms.

Conclusions

Compared to SOC, the CAPRI intervention improved RDI, pt experience and emergency admissions. This intervention became a standard in our institution for neuro-oncology pts and deserves larger-scale investigations in neuro-oncology pts.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

French National Research Agency, Philanthropia Lombard Odier Foundation, Novartis and AstraZeneca. The funding bodies were not involved in the study design.

Disclosure

F. Lemare: Full/Part-time employment: AstraZeneca. O. Mir: Advisory/Consultancy: Amgen; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Bayer; Advisory/Consultancy: BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony: Eli-Lilly; Advisory/Consultancy, Shareholder/Stockholder/Stock options: Ipsen; Advisory/Consultancy: MSD; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: Servier; Shareholder/Stockholder/Stock options: Transgene; Advisory/Consultancy: Servier. All other authors have declared no conflicts of interest.