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Efficacy and safety of anlotinib in advanced leiomyosarcoma: Subgroup analysis of a phase IIB trial (ALTER0203)
abstracts
Annals of Oncology
Table: 1693P
Efficacy and safety of anlotinib in advanced leiomyosarcoma: Subgroup analysis of a phase IIB trial (ALTER0203)
Alotinib (n ¼ 27)
Placebo (n ¼ 14)
P-value
mPFS (mos) HR(95%CI) ORR, n(%) DCR, n(%) The most common AEs, n(%) Hypertension TSH elevation Hypertriglyceridaemia Grade3 AEs, n(%) Hypertension Gamma glutamyl transferase elevation Hyponatremia
5.83 2.85-8.81 0(0%) 16(59.26%)
1.43 < 0.0001 1.41-1.45 0(0%) N/A 2(14.29%) 0.01
20(74.07%) 19(70.37%) 13(48.15%)
1(7.14%) < 0.0001 0(0%) < 0.0001 4(28.57%) 0.32
5(18.52%) 2(7.41%) 2(7.41%)
0(0%) 1(7.14%) 0(0%)
< 0.0001 1.0 0.54
Conclusions: Anlotinib not only improves PFS and DCR significantly, but also presents good safety in patients with LMS, which suggests that anlotinib could be an option for LMS patients. Clinical trial identification: NCT02449343. 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.
Y. Chi1, Y. Yao2, Z. Fang3, S. Wang4, G. Huang5, Q. Cai6, G. Shang7, G. Wang8, G. Qu9, Q. Wu10, Y. Jiang11, J. Song12, J. Chen13, X. Zhu14, Z. Cai15, C. Bai16, Y. Lu17, Z. Yu18, J. Shen19, J. Cai20 1 Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China, 2Medical Oncology, Affiliated Sixth People’s Hospital, Shanghai Jiaotong University, Shanghai, China, 3 Orthopedics & Soft Tissue Department, Peking University Cancer Hospital, Beijing, China, 4Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China, 5 Orthopedics & Soft Tissue Department, Hunan Cancer Hospital, Changsha, China, 6 Department of Bone and Soft Tissue, Henan Cancer Hospital, Zhengzhou, China, 7 Orthopedics & Soft Tissue Department, Liaoning Cancer Hospital and Institute, Shenyang, China, 8Orthopedics & Soft Tissue Department, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China, 9Orthopedic Surgery, Harbin Medical University Cancer Hospital, Harbin, China, 10Medical Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China, 11Department of Medical Oncology, Cancer Center, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, Sichuan, China, 12Orthopedics & Soft Tissue Department, Gansu Provincial Cancer Hospital, Lanzhou, China, 13Cancer Center, Wuhan Union Hospital, Wuhan, China, 14Department of Orthopedics, Arthrosis & Sports Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China, 15Department of Orthopedics, The First People’s Hospital Affiliated to Shanghai Jiaotong University, Shanghai, China, 16Medical Oncology, Peking Union Medical College Hospital/ Chinese Academy of Medical Sciences, Beijing, China, 17Department of Breast and Bone Soft Tissue Tumors, Guangxi Medical University Affiliated Tumor Hospital, Nanning, China, 18 Orthopedics Department, Jiangxi Cancer Hospital, Nanchang, China, 19Department of Bone Tumor, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China, 20Department of Hepatobiliary Surgery, Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China Background: Leiomyosarcoma (LMS) is one of the most common pathologic subtypes of soft tissue sarcoma (STS) with limited treatment options. An earlier analysis in ALTER0203 showed efficacy and safety of anlotinib in overall subtype of STS. Here we report subgroup analysis of the patients with Leiomyosarcoma in ALTER0203. Methods: Key inclusion criteria: aged from 18 to 70, confirmed histological diagnosis of advanced LMS, angiogenesis inhibitor naive, progressing after anthracycline-contained chemotherapy, measurable disease (RECIST 1.1), ECOG performance status (PS) 1-2. Anlotinib 12 mg per day 2 weeks on and 1 week off or placebo was given after 2:1 randomization. Primary endpoint: progression-free survival (PFS). Secondary endpoints: overall response rate (ORR), disease control rate (DCR) and so on. Results: 41 eligible LMS patients, 9 males (21.95%), median age 49 (range 28-66), received either anlotinib (n ¼ 27) or placebo (n ¼ 14). The median PFS was 1.43 months for placebo and 5.83 months for anlotinib (P<0.0001). CR or PR was not observed for both placebo and anlotinib. SD was 2/14 for placebo versus 16/27 for anlotinib (P ¼ 0.01). The most common adverse events (AEs) were hypertension, elevated TSH, hypertriglyceridaemia. The most common grade 3 or higher AEs were hypertension, gamma glutamyl transferase elevation, hyponatremia.
v694 | Sarcoma
Volume 30 | Supplement 5 | October 2019
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz283.026/5577168 by guest on 24 October 2019
1693P
Efficacy
Annals of Oncology
Table: 1693P
Efficacy and safety of anlotinib in advanced leiomyosarcoma: Subgroup analysis of a phase IIB trial (ALTER0203)
Alotinib (n ¼ 27)
Placebo (n ¼ 14)
P-value
mPFS (mos) HR(95%CI) ORR, n(%) DCR, n(%) The most common AEs, n(%) Hypertension TSH elevation Hypertriglyceridaemia Grade3 AEs, n(%) Hypertension Gamma glutamyl transferase elevation Hyponatremia
5.83 2.85-8.81 0(0%) 16(59.26%)
1.43 < 0.0001 1.41-1.45 0(0%) N/A 2(14.29%) 0.01
20(74.07%) 19(70.37%) 13(48.15%)
1(7.14%) < 0.0001 0(0%) < 0.0001 4(28.57%) 0.32
5(18.52%) 2(7.41%) 2(7.41%)
0(0%) 1(7.14%) 0(0%)
< 0.0001 1.0 0.54
Conclusions: Anlotinib not only improves PFS and DCR significantly, but also presents good safety in patients with LMS, which suggests that anlotinib could be an option for LMS patients. Clinical trial identification: NCT02449343. 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.
Y. Chi1, Y. Yao2, Z. Fang3, S. Wang4, G. Huang5, Q. Cai6, G. Shang7, G. Wang8, G. Qu9, Q. Wu10, Y. Jiang11, J. Song12, J. Chen13, X. Zhu14, Z. Cai15, C. Bai16, Y. Lu17, Z. Yu18, J. Shen19, J. Cai20 1 Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China, 2Medical Oncology, Affiliated Sixth People’s Hospital, Shanghai Jiaotong University, Shanghai, China, 3 Orthopedics & Soft Tissue Department, Peking University Cancer Hospital, Beijing, China, 4Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China, 5 Orthopedics & Soft Tissue Department, Hunan Cancer Hospital, Changsha, China, 6 Department of Bone and Soft Tissue, Henan Cancer Hospital, Zhengzhou, China, 7 Orthopedics & Soft Tissue Department, Liaoning Cancer Hospital and Institute, Shenyang, China, 8Orthopedics & Soft Tissue Department, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China, 9Orthopedic Surgery, Harbin Medical University Cancer Hospital, Harbin, China, 10Medical Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China, 11Department of Medical Oncology, Cancer Center, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, Sichuan, China, 12Orthopedics & Soft Tissue Department, Gansu Provincial Cancer Hospital, Lanzhou, China, 13Cancer Center, Wuhan Union Hospital, Wuhan, China, 14Department of Orthopedics, Arthrosis & Sports Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China, 15Department of Orthopedics, The First People’s Hospital Affiliated to Shanghai Jiaotong University, Shanghai, China, 16Medical Oncology, Peking Union Medical College Hospital/ Chinese Academy of Medical Sciences, Beijing, China, 17Department of Breast and Bone Soft Tissue Tumors, Guangxi Medical University Affiliated Tumor Hospital, Nanning, China, 18 Orthopedics Department, Jiangxi Cancer Hospital, Nanchang, China, 19Department of Bone Tumor, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China, 20Department of Hepatobiliary Surgery, Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China Background: Leiomyosarcoma (LMS) is one of the most common pathologic subtypes of soft tissue sarcoma (STS) with limited treatment options. An earlier analysis in ALTER0203 showed efficacy and safety of anlotinib in overall subtype of STS. Here we report subgroup analysis of the patients with Leiomyosarcoma in ALTER0203. Methods: Key inclusion criteria: aged from 18 to 70, confirmed histological diagnosis of advanced LMS, angiogenesis inhibitor naive, progressing after anthracycline-contained chemotherapy, measurable disease (RECIST 1.1), ECOG performance status (PS) 1-2. Anlotinib 12 mg per day 2 weeks on and 1 week off or placebo was given after 2:1 randomization. Primary endpoint: progression-free survival (PFS). Secondary endpoints: overall response rate (ORR), disease control rate (DCR) and so on. Results: 41 eligible LMS patients, 9 males (21.95%), median age 49 (range 28-66), received either anlotinib (n ¼ 27) or placebo (n ¼ 14). The median PFS was 1.43 months for placebo and 5.83 months for anlotinib (P<0.0001). CR or PR was not observed for both placebo and anlotinib. SD was 2/14 for placebo versus 16/27 for anlotinib (P ¼ 0.01). The most common adverse events (AEs) were hypertension, elevated TSH, hypertriglyceridaemia. The most common grade 3 or higher AEs were hypertension, gamma glutamyl transferase elevation, hyponatremia.
v694 | Sarcoma
Volume 30 | Supplement 5 | October 2019
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz283.026/5577168 by guest on 24 October 2019
1693P
Efficacy