Abstract 1920P
Background
Anlotinib is a multikinase inhibitor that achieved a nearly 2-fold PFS compared with placebo in ALTER01031 (NCT02586350) study for medullary thyroid cancer (MTC). Progressed disease, older age and bone metastasis are generally thought to be negative prognostic factors for thyroid cancer. ALTER01031 study enrolled a large number of pts with these risk factors and this subanalysis explored the outcomes for these pts with or without anlotinib treatment.
Methods
ALTER01031 was a randomized, placebo-controlled phase IIb trial with the major endpoint of progression-free survival (PFS). Pts enrolled in this study who had progressed disease within 1 year before enrollment (confirmed by medical history recorded or radiographic imaging) or had older age (≥ 50) or diagnosed as bone metastasis were selected to conduct subanaysis. The PFS and overall survival (OS) for these pts were estimated and compared between pts received anlotinib and placebo.
Results
91pts enrolled were randomized to receive anlotinib (62) or placebo (29). The median PFS (mPFS) were 20.67 versus 11.07 months (mo) (P = 0.029). The subanalysis results were summarized in the table below. Pts in placebo arm with high prognostic risk showed poor mPFS. The significant PFS benefits were shown across all subgroups received anlotinib compared with their counterparts who received placebo (P < 0.05). The risk of death was also declined but the difference showed no statistically significance, which may cause by the lack of enough follow-up duration and endpoint events. Table: 1920P
| No. of pts with prognostic risk (anlotinib / placebo) | mPFS for anlotinib (mo) | mPFS for placebo (mo) | HR (95% CI) (PFS) | P (PFS) | mOS for anlotinib (mo) | mOS for placebo (mo) | HR (95% CI) (OS) | P (OS) |
| Progression within 1 year before enrollment (46/22) | 20.7 | 9.1 | 0.48 (0.24, 0.95) | 0.032 | NE | NE | 0.74 (0.29, 1.88) | 0.520 |
| Older age (36/15) | 17.5 | 6.8 | 0.31 (0.15, 0.68) | 0.002 | 28.6 | 18.5 | 0.62 (0.27, 1.43) | 0.255 |
| Bone metastasis (29/18) | 20.7 | 7.0 | 0.44 (0.20, 0.94) | 0.029 | NE | NE | 0.75 (0.28, 2.01) | 0.562 |
Conclusions
In ALTER01031, Pts with MTC who has high prognostic risk such as progressed disease, older age or bone metastasis can obtained survival benefits from anlotinib treatment.
Clinical trial identification
NCT02586350.
Editorial acknowledgement
Legal entity responsible for the study
Ming Gao.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.