Dataset Information

Quality of Life during Treatment with Lenvatinib for Thyroid Cancer: The Patients' Perspective beyond the Medical Evaluation.

ABSTRACT:

Background

Lenvatinib (LEN) has shown great efficacy but important toxicity in patients with advanced radioactive iodine-refractory (RAI-R) thyroid cancer (TC); a focused evaluation of its impact on patients' quality of life (QoL) is still lacking. Our prospective study investigated the impact of this drug on QoL in a group of RAI-R TC patients treated at our centre.

Methods

All patients filled in two questionnaires before and during treatment: (1) the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events adapted questionnaire, assessing prevalence, severity, and/or interference on daily activities of the most frequent symptomatic adverse events (AEs) reported in previous clinical trials during therapy with LEN, and (2) the European Quality of Life 5 Dimensions 3 Levels (EQ-5D-3L) questionnaire, providing the EQ-5D index and the EQ visual analogue scale (EQ-VAS). Data from baseline questionnaires were compared with those obtained 3, 6, and 12 months after the start of treatment.

Results

In our population (n = 20), an overall increased perception of symptomatic AEs emerged during treatment (statistically significant for abdominal pain, asthenia/fatigue, decreased appetite, and xerostomia). The median EQ-5D index and EQ-VAS scores after 3 months of treatment were lower than at baseline, almost returning to initial values after 12 months.

Conclusion

RAI-R TC patients reported a general increase in prevalence and interference on daily activities of symptomatic AEs during therapy with LEN. Self-perceived QoL initially decreased during therapy. However, our data suggest that QoL could be restored after 12 months; this trend might partly reflect the impact of therapy optimisation.

SUBMITTER: Nervo A

PROVIDER: S-EPMC7983562 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundIn the phase 3 SELECT study, lenvatinib significantly improved prognostic outcomes vs. placebo in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC). However, toxicity of lenvatinib is sometimes considerable and requires frequent dose interruptions and modifications. Recently, planned drug holidays have been proposed as a means of avoiding severe adverse events (AEs).MethodsWe retrospectively reviewed medical records to compare the efficacy and safety of lenvatinib in RR-DTC patients who underwent planned drug holidays (planned holiday group) vs. those who received conventional daily oral administration (daily group).ResultsThe subjects were 25 patients in the planned holiday group and 21 in the daily group. Median age was 73 years (range 43-84) and 62 years (range 42-75), and histologic subtype of papillary/follicular was 21/4 cases and 15/6 cases, respectively. Time to treatment failure (TTF) and overall survival (OS) were significantly longer in the planned holiday group than the daily group (not reached [NR] vs. 14.9 months, hazard ratio [HR] 0.25, 95% confidence interval [Cl] 0.11-0.58, p<0.001; NR vs. 26.6 months, HR 0.20, 95% CI 0.073-0.58, p=0.001, respectively). Median progression-free survival (PFS) was NR in the planned holiday group vs. 15.1 months in the daily group (HR 0.31, 95% CI 0.14-0.68, p=0.002). Duration of the period with lenvatinib dose ≥10 mg was significantly longer in the planned holiday group (NR vs. 6.5 months, HR 0.22, 95% CI 0.10-0.49, p<0.001), and the frequency of drug interruption due to intolerable AEs was lower (68.0% vs. 95.2%, p=0.027).ConclusionPlanned drug holidays for lenvatinib demonstrated significantly longer PFS, TTF, and OS than daily oral administration, and less intolerable toxicity leading to further unplanned treatment interruption. These benefits were apparently associated with a more extended period of lenvatinib administration at ≥10 mg. These findings might contribute to a favorable patient prognosis and safer toxicity profile.