Final analysis of patient-reported-outcomes (PRO) and early intervention to toxicities as tools for improving compliance of patients with metastatic colorectal cancer (mCRC) treated with aflibercept + FOLFIRI (A-FOLFIRI) under real-world-conditions in Germany

Background

Therapies with A-FOLFIRI in mCRC showed in up to a quarter of patients toxicity-related or patient-triggered discontinuations. The rationale of this study was to describe effects on treatment duration and compliance by using continious recordings of PRO and defined toxicities under the real-world-conditions of oncological practices in Germany.

Methods

Patients with mCRC were assigned and analysed in 2 cohorts: cohort 1 with standardized requests for PRO (visual analog scale and QoL) and defined toxicities (diarrhea, hypertension, fatigue, infections) and cohort 2 without these requests. The patients were treated with a standard protocol of A-FOLFIRI in several therapy lines. The assignments for one of the cohorts were based on decisions of the oncologists.

Results

Data of n = 112 patients (44% women, 56% men, mean age 71,8 years) were sampled between Jan 2014 and Feb 2016 in 18 oncological practices. In cohort 1 n = 37 patients got requests for QoL before start of every cycle and a diary for recording performance by VAS and specific toxicities. In cohort 2 n = 75 patients were guided based on standard oncologist's practice. QoL and VAS data were available in 81% and 67% and showed over all lines a mean of maximal uptake of 9,3 and 7,3 points, respectively. Over all lines A-FOLFIRI was administered for 8,3 cycles (16,8 weeks) in cohort 1 and 7,3 cycles (13,7 weeks) in cohort 2. An appearance of toxicities (≥ 3° CTC 4.0) was transmitted to the oncologist in a mean of 3,2 days. The rates of early discontinuations due to toxicities or patient's wishes could be declined by 5,2% (13,1% cohort 1 vs. 18,3% cohort 2) and dose reductions by 3,5% (17,3% cohort 1 vs. 20,8% cohort 2).

Conclusions

In this cohort study requests for PRO and early intervention to toxicities showed in patients with mCRC under A-FOLFIRI a prolongation of the therapy and a reduction of discontinuations. Recording of PRO and early intervention to toxicities may be a good opportunity to improve patient's compliance and should be tested in a randomised trial with innovative telematic systems.

Clinical trial identification

not applicable

Legal entity responsible for the study

GermanOncology GmbH (Managing Director: Dr. Rainer Lipp)

Funding

GermanOncology GmbH

Disclosure

R. Lipp: Financial support of research project by Sanofi. All other authors have declared no conflicts of interest.