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Poster Display session 1

3710 - The effect of treatment line on the efficacy of Anlotinib hydrochloride in advanced alveolar soft part sarcoma patients

Date

28 Sep 2019

Session

Poster Display session 1

Presenters

Zhiwei Fang

Citation

Annals of Oncology (2019) 30 (suppl_5): v683-v709. 10.1093/annonc/mdz283

Authors

Z. Fang1, Y. Yao2, J. Cai3, Y. Chi4, S. Wang5, G. Huang6, Q. Cai7, G. Shang8, G. Wang9, G. Qu10, Q. Wu11, Y. Jiang12, J. Song13, J. Chen14, Z. Cai15, X. Zhu16, C. Bai17, Y. Lu18, Z. Yu19, J. Shen20

Author affiliations

  • 1 Orthopedics & Soft Tissue Department, Peking University Cancer Hospital, 10042 - Beijing/CN
  • 2 Medical Oncology, Affiliated Sixth People’s Hospital, Shanghai Jiaotong University, shanghai/CN
  • 3 Department Of Hepatobiliary Surgery, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 100021 - Beijing/CN
  • 4 Medical Department, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 100021 - Beijing/CN
  • 5 Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou/CN
  • 6 Orthopedics & Soft Tissue Department, Hunan Cancer Hospital, Changsha, China, changsha/CN
  • 7 Department Of Bone And Soft Tissue, Henan Cancer Hospital, zhengzhou/CN
  • 8 Orthopedics & Soft Tumor Department, Liaoning Cancer Hospital and Institute, shenyang/CN
  • 9 Orthopedics & Soft Tissue Department, Tianjin Medical University Cancer Institute & Hospital, Tianjin/CN
  • 10 Orthopedic Surgery, Harbin Medical University Cancer Hospital, Harbin/CN
  • 11 Medical Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu/CN
  • 12 Department Of Medical Oncology, Cancer Center, State Key Laboratory Of Biotherapy, West China Hospital, Sichuan University, 610041 - Chengdu/CN
  • 13 Orthopedics & Soft Tissue Department, Gansu Provincial Cancer Hospital, Lanzhou/CN
  • 14 Cancer Center, Wuhan Union Hospital, Wuhan/CN
  • 15 Department Of Orthopaedics, Shanghai General Hospital, Shanghai/CN
  • 16 Department Of Orthopedics, Arthrosis & Sports Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou/CN
  • 17 Department Of Medical Oncology, Peking Union Medical College Hospital, 100730 - Beijing/CN
  • 18 Department Of Breast And Bone Soft Tissue Tumors, Guangxi Medical University Affiliated Tumor Hospital, Nanning/CN
  • 19 Orthopedics Department, Jiangxi Cancer Hospital, Nanchang/CN
  • 20 Department Of Bone Tumor, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou/CN
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Resources

Abstract 3710

Background

In the ALTER0203 trial (NCT02449343), anlotinib hydrochloride was used as subsequence therapy for adult advanced soft tissue sacorma (STS) pts who progressed after prior systemic therapies. It has demonstrated that anlotinib significantly prolonged PFS in advanced STS with multiple pathological subgroups. There’s rare treatment method for alveolar soft part sarcoma (ASPS) due to chemotherapy insensitive. Here we report the efficacy of anlotinib on ASPS in 1st line or ≥ 2nd line.

Methods

233 pts were randomised in a 2:1 ratio to receive anlotinib (12 mg QD from day 1 to 14 of a 21-day cycle) or placebo till progression or intolerable toxicity. ASPS pts could be treated at 1st line without prior systemic therapies. Primary endpoint is progression-free survival (PFS). Data cutoff by 2017.4.30, follow-up is still ongoing.

Results

Median PFS of ASPS (n = 56) was significantly improved in the anlotinib arm (n = 38) compared with placebo arm (n = 18) (18.23 vs. 3.00 months, p < 0.0001), and the most common grade ≥3 treatment-related AEs were hypertension, γ-glutamyltransferase increased, hand-foot syndrome and hypertriglyceridemia. Furthermore, remarkable advantages in PFS were observed in the anlotinib arm as well regardless of the treatment line. Meanwhile, the DCR in anlotinib arm was also significantly increased compared to the placebo arm. (Data presented in the table)Table:

1694P Efficacy (date is immature)

1st line≥2nd line
Anlotinib (n = 18)Placebo (n = 10)HRp-vauleAnlotinib (n = 20)Placebo (n = 8)HRP-vaule
Events/ Censored (n/n)6/125/55/156/2
mPFS (mos)15.43.000.240.0073NR1.500.14<0.0001
ORR(%)22.220.000.265225.000.000.2808
DCR(%)83.3340.000.034690.0037.500.0095

Conclusions

In the ALTER0203 trial, a significant improvement in PFS was found in anlotinib treated ASPS from both subgroups (1st line or ≥ 2nd line treatment). This is indicating that anlotinib could be an appropriate option for ASPS pts regardless of the treatment line.

Clinical trial identification

NCT02449343.

Editorial acknowledgement

Legal entity responsible for the study

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Funding

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.

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