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Background: Medullary thyroid carcinoma MTC is a rare disease ith no standard therapies available in China for unresectable, advanced or relapsed MTC patients. Anlotinib is a multi-target RTK inhibitor, ith inhibition activities to VEGFR123, FGFR123, PDGFRx3B1;x3B2;, c-Kit, Ret etc in nanomole level. Recommended dose in phase I study is 12mg daily, 2 eeks onone eek off. We conducted a single-arm, multi-center phase 2 study NCT01874873 to assess efficacy and safety of anlotinib in advanced MTC patients. Methods: Pathology-confirmed advanced or relapsed MTC patients, ho cannot receive radical surgery and have measurable indicators RECIST1.1 , ere treated ith anlotinib. Assess efficacy every 6 eeks. The primary endpoint is PFS. This study used Simonx0027;s To-Stage design, assuming DCR of anlotinib can achieve 70 percent. Results: From Sept. 2013, e recruited 58 patients in 8 centers in China, including 34 male patients and 24 female patients. Average age is 48 22-71 . One patient dropped after one cycle treatment, 2 patients ithout measurable lesions, 55 patients are assessable for efficacy. As of May 2015, average PFS is 12.8 months and median PFS is still not reached. 7 patients achieved PR at second treatment cycle, and 31 patients achieved PR over time 28 patients confirmed , overall ORR is 48.28 percent FAS . DCR is 92.16 percent at eek 24, and 84.53 percent at eek 48. 58 patients are assessable for safety. Common grade IIIIV AEs are: hand-foot-skin reaction n=5 , hypertension n=3 , mucositis n=2 , stomachache n=1 , diarrhea n=1 , fatigue n=1 , cholesterol increase n=2 , triglyceride increase n=2 , amylase increase n=2 , lipase increase n=2 , ALT increase n=1 , and proteinuria n=1 . 12 patients 20.7 percent have dose adjustment during treatment, reducing to 10mg daily, 2 eeks on 1 eek off. Conclusions: Anlotinib has a high ORR 48.28 percent for treatment of MTC, average PFS is 12.8 months and median PFS is still not reached. The disease can be controlled for long term DCR is 92.16 percent at eek 24 . The primary endpoint of this study has been met. Meanhile, anlotinib is ell tolerated. The randomized, controlled clinical trial is ongoing. Sun Yongkun and Yihebali Chi contributed equally to this ork. Clinical trial information: lta href=http:clinicaltrials.govshoNCT01874873 NCT01874873,J Clin Oncol 34, 2016 suppl; abstr 6015 ,NCT01874873,00:00.0,Head and Neck Cancer
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