In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 6095-6095
Abstract:
6095 Background: In the multicenter, double-blind, randomized, phase 3 REALITY study, apatinib significantly improved clinical benefits in terms of progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) compared to placebo with a tolerable safety profile in patients with progressive locally advanced or metastatic radioactive iodine-refractory, differentiated thyroid cancer (RAIR-DTC). Here, we investigate the association between baseline characteristics and survival endpoints. Methods: Post-hoc analyses of PFS and OS were done in patients treated with apatinib according to the following subgroups: ECOG performance status (PS) (0 vs 1-2), thyroglobulin (Tg) ( 〈 223 vs ≥ 223 ng/mL), and tumor target lesions diameter ( 〈 33.2 vs ≥ 33.2 cm). Results: Among 92 patients with RAIR-DTC included in the study, 46 patients received apatinib. As of December 3, 2021, median PFS was 25.77 (95% CI 11.14-not reached [NR]) vs 11.08 months (95% CI 7.17-NR) for ECOG PS 0 / 1-2, though no statistical significance (HR 0.454, 95% CI 0.161-1.285, p = 0.1373). The median OS was significant prolonged in patients with ECOG PS of 0 compared with those ECOG 1-2 (not reached vs 29.42 months, 95% CI 18.87-NR; HR 0.199, 95% CI 0.054-0.733, p = 0.0152). In subgroups by Tg, median PFS was 25.77 (95% CI 9.11-NR) vs 11.08 (95% CI 5.65-NR) months for Tg 〈 223 / ≥ 223 ng/mL. A trend towards improved PFS was observed (HR 0.444, 95% CI 0.145-1.361, p = 0.1556). The median OS was significantly improved in patients with Tg 〈 223 in contrast to those Tg ≥ 223 ng/mL (NR vs 25.87 months, 95% CI 13.58-NR; HR 0.151, 95% CI 0.033-0.689, p = 0. 0147). The median PFS for tumor target lesions diameter 〈 33.2 cm was significantly improved relative to those ≥33.2 cm (25.77, 95% CI 11.14-NR vs 9.11 months, 95% CI 5.65-NR) with a significant difference (HR 0.289, 95% CI 0.097- 0.859, p = 0.0255); OS data in two subgroups were not mature (NR, 95% CI 29.42-NR vs NR, 95% CI 17.95-NR; HR 0.364, 95% CI 0.112-1.184, p = 0.0932). Conclusions: Post-hoc analysis indicated that among patients receiving apatinib, longer OS benefits were associated with better ECOG PS, lower Tg levels; longer PFS benefits were associated with smaller tumor diameter. These results suggest a better prognosis for early initiation of apatinib treatment in patients with RAIR-DTC. Clinical trial information: NCT03048877.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2022.40.16_suppl.6095
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2022
detail.hit.zdb_id:
2005181-5
detail.hit.zdb_id:
604914-X
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