Highlights
- •Intermittent sunitinib is used in platinum-refractory thymic epithelial tumours.
- •Continuous daily dose (CDD) sunitinib is used other cancers; no data exist in thymic epithelial tumours.
- •We retrospectively analysed data from patients receiving off-label CDD sunitinib.
- •CDD sunitinib schedule showed clinical efficacy and a favourable toxicity profile.
Abstract
Background
Thymic epithelial tumors (TETs) are rare diseases, with diverse clinical behaviour
and prognosis. Intermittent dosing sunitinib represents the gold-standard systemic
treatment following platinum-based chemotherapy. To ensure more homogeneous drug exposure,
continuous daily dosing (CDD) sunitinib is utilised in other malignancies; however,
no data exist in patients with TETs.
Methods
We retrospectively examined data from patients with platinum-resistant TETs receiving
CDD sunitinib 37.5 mg between 1 May 2017 and 31 May 2022 within the Italian collaborative
group for ThYmic MalignanciEs. Primary end-points were median progression-free survival,
overall response rate (ORR), median duration of response and major treatment-related
adverse events.
Results
A total of 20 consecutive patients (12 thymic carcinoma [TC], 6 B3, and 2 B2 thymoma)
were evaluated. Among the 19 patients evaluable for response, ORR was 31.6% (95% CI,
12.5%–56.5%). Among patients with TC, one complete response, four partial responses,
and four stable diseases were observed (ORR 41%).The overall median progression-free
survival was 7.3 months (95% CI, 4.5–10.3): 7.3 months (95% CI, 4.4–NA) within patients
with thymoma and 6.8 months (95% CI, 2.8–10.3) in patients with TC; median duration
of response was 10.3 months (95% CI, 2.8–NA). CDD was associated with a manageable
toxicity profile. Six patients (30%) experienced >G2 toxicity, nine required dose
reduction and three discontinued treatment due to adverse events.
Conclusions
CDD sunitinib showed a relevant antitumor activity and confirmed a good toxicity profile.
Similar effectiveness and a better toxicity profile as compared with intermittent
dosing historical data suggest that this schedule should be considered.
Keywords
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Article info
Publication history
Published online: August 12, 2022
Accepted:
July 8,
2022
Received in revised form:
July 6,
2022
Received:
June 17,
2022
Identification
Copyright
© 2022 Published by Elsevier Ltd.