ADVERTISEMENT
Reinforcing clinical outcomes with patient-reported QoL outcomes in patients with mCRC receiving FTD/TPI: Pooled analysis of PRECONNECT and TALLISUR studies
Background
Trifluridine/tipiracil (FTD/TPI) is approved for use in patients with metastatic colorectal cancer (mCRC) who have progressed on, or who cannot tolerate, standard therapies. PRECONNECT was an international, multicentre, open-label, phase IIIb trial, and TALLISUR was a prospective, multicentre, open-label phase IV trial; both assessed efficacy, safety and quality of life (QoL) in patients with mCRC receiving FTD/TPI. Here, we present the pooled QoL results from PRECONNECT and TALLISUR and explore whether there is an association between QoL and Eastern Cooperative Oncology Group performance status (ECOG PS) changes.
Methods
In both studies, patients with mCRC received FTD/TPI (35 mg/m2 twice-daily) on days 1–5 and 8–12 of each 28-day cycle, between 2016 and 2020. Patients completed the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (Version 3.0) questionnaire during each treatment cycle. QLQ-C30 analysis was conducted on all patients who answered the questionnaire at baseline and at least once post baseline. Clinically relevant deterioration in QoL was defined as >10-point change in QLQ-C30 score from baseline or death. ECOG PS was evaluated at baseline and during each cycle, and the time of ECOG PS deterioration to ≥2 or death was analysed. The association between changes in ECOG PS and QLQ-C30 Global Health Status (GHS) over time was evaluated.
Results
There were 1100 patients treated in the pooled population (PRECONNECT: N=914; TALLISUR N=186), with baseline ECOG PS scores of 0 (n=506), 1 (n=545), 2 (n=20) or not reported (n=29). For the population as a whole, the mean QLQ-C30 GHS score did not deviate from baseline by >10 points at any time point up to cycle 7. However, 450/975 (46.2%) patients had clinically meaningful deteriorations in QLQ-C30 GHS at some point over the study period (median time to deterioration 3.9 months [95%CI: 3.6, 4.5]). ECOG PS was improved or maintained from baseline in 63.0% of patients at the end of the study period. Better ECOG PS at baseline was associated with better QLQ-C30 GHS at baseline (baseline mean QLQ-C30 GHS score was 67.8, 58.9 and 52.6 in patients with ECOG PS or 0, 1 and 2, respectively). Furthermore, better ECOG PS at baseline resulted in slower deterioration of QLQ-C30 GHS (median 4.2 months [95% CI: 3.7, 5.3] and 3.5 months [95% CI: 2.9, 4.3] with ECOG PS 0 and 1, respectively). At last post-baseline evaluation, patients whose ECOG PS improved from baseline had no deterioration in QLQ-C30 GHS scores (n=45; mean change +0.74), patients whose ECOG PS stayed unchanged (n=544) or deteriorated (n=340) had decreased QLQ-C30 GHS scores (mean change -2.84 and -8.88, respectively). In a Cox regression analysis, the association between time to ECOG PS deterioration and change in QLQ-C30 GHS score over time (change of ≥10 versus < 10) was significant (HR 1.707 [95% CI: 1.4, 2.2]; p < 0.0001).
Conclusions
In this pooled analysis, QoL and ECOG PS were maintained in most patients with mCRC receiving treatment with FTD/TPI. These data also show an association between time to ECOG PS deterioration and change in QLQ-C30 GHS score over time.
Clinical trial identification
PRECONNECT: NCT03306394 TALLISUR: EudraCT: 2017-000292-83.
Editorial acknowledgement
The authors thank Martin Gilmour, PhD, CMPP and Elisabeth Meredith, PhD, of Empowering Strategic Performance (ESP) Ltd, Crowthorne, UK, for providing medical writing support, which was sponsored by SERVIER, in accordance with Good Publication Practice guidelines.
Legal entity responsible for the study
The author.
Funding
Servier.
Disclosures
T. Price: Honoraria (self): Servier, Merck. J. Bachet: Honoraria (self): Servier, Amgen, Merck Serono, Sanofi, Roche, Pierre Fabre, Viatris, Bayer, Astra Zeneca; Advisory / Consultancy: Servier, Amgen, Merck Serono, Pierre Fabre; Travel / Accommodation / Expenses: Servier, Amgen, Merck Serono, Sanofi, Roche. M. Karthaus: Honoraria (self): Servier; Advisory / Consultancy: Servier; Travel / Accommodation / Expenses: Servier. L. Vidot: Full / Part-time employment: Institut de Recherches Internationales Servier. B. Chevallier: Full / Part-time employment: servier, servier, servier. T. Reisländer: Full / Part-time employment: Servier Deutschland GmbH. V. Heinemann: Honoraria (self): Merck, Amgen, Roche, Sanofi, SIRTEX, Servier, Pfizer, Pierre-Fabre, Astra-Zeneca; Advisory / Consultancy: Merck, Amgen, Roche, Sanofi, SIRTEX, BMS; MSD, Novartis, Boehringer Ingelheim, Servier, Pierre-Fabre, Celgene, Terumo; Research grant / Funding (institution): Merck, Amgen, Roche, Sanofi, Pfizer, Boehringer-Ingelheim, Sirtex, Bayer, Servier; Travel / Accommodation / Expenses: Merck, Roche, Amgen, SIRTEX, Bayer, Servier. All other authors have declared no conflicts of interest.
