Highlights
- •Surufatinib showed a comparable effect on HRQoL to placebo for patients with NETs.
- •Surufatinib increased risk of deterioration in diarrhea versus placebo.
- •Surufatinib decreased risk of deterioration in dyspnea versus placebo.
- •Surufatinib is a promising treatment option for advanced NETs.
Abstract
Aim
To investigate the health-related quality of life (HRQoL) of patients who had neuroendocrine
tumors (NETs) from SANET trials.
Methods
Eligible patients were randomized in a 2:1 ratio to receive surufatinib or placebo.
HRQoL questionnaires, including the European Organization for Research and Treatment
of Cancer QLQ-C30 and QLQ-G.I.NET21, were collected. The prespecified HRQoL outcome
was the mean change of scores from baseline to the last available visit for each domain.
Time until definitive deterioration (TUDD) was defined as the time from randomization
to deterioration of ≥10 points from baseline in domain score, disease progression,
or death.
Results
370 patients were enrolled and randomly assigned to surufatinib (n = 242) or placebo
(n = 128). No significant difference in mean scores change from baseline to the last
available visit was observed for QLQ-C30 and QLQ- G.I.NET21 domains, with the exception
of diarrhea. The mean score of diarrhea increased 11.7 points from baseline in the
surufatinib arm and decreased 1.2 points in the placebo arm, and the between-group
difference was 12.9 points. Compared with placebo, surufatinib treated patients had
a significantly longer TUDD for dyspnea (hazard ratio [HR] 0.58; 95% confidence interval
[CI], 0.39–0.86; P = 0.0058) and a significantly shorter TUDD for diarrhea (HR 2.91;
95% CI, 1.66–5.10; P < 0.0001). There were no significant differences in TUDD for
the remaining domains of QLQ-C30 and G.I.NET-21.
Conclusions
HRQoL was similar in patients treated with surufatinib and placebo except for diarrhea.
The preservation of HRQoL supports surufatinib as a treatment option for NETs.
Clinical trial information
ClinicalTrials.gov: NCT02589821, NCT02588170.
Keywords
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Article info
Publication history
Published online: April 28, 2022
Accepted:
March 18,
2022
Received in revised form:
March 8,
2022
Received:
November 22,
2021
Identification
Copyright
© 2022 Elsevier Ltd. All rights reserved.
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- Corrigendum to ‘Health-related quality of life in patients with advanced well-differentiated pancreatic and extrapancreatic neuroendocrine tumors treated with surufatinib versus placebo: Results from two randomized, double-blind, phase III trials (SANET-p and SANET-ep)’ [European Journal of Cancer 169 (2022) 1–9]European Journal of CancerVol. 178
- PreviewThe authors regret there were mistakes in two figures for the wrong direction of functional scales. High scores for functional scales represent high or healthy level of functioning, but the original direction is opposite. These mistakes were found in Figure 2A, Figure 2C, Figure 3A, Figure 3C, and their figure legends. The outcome results are not affected.
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