Anlotinib Monotherapy for Refractory Metastatic Colorectal Cancer: A Double-Blinded, Placebo-Controlled, Randomized Phase III Trial (ALTER0703)

Chi, Yihebali; Shu, Yongqian; Ba, Yi; Bai, Yuxian; Qin, Baoli; Wang, Xiuwen; Xiong, Jianping; Xu, Nong; Zhang, Helong; Zhou, Jianfeng; Xu, Jianming; Cheng, Ying; Feng, Jifeng; Hu, Chunhong; Chen, Yigui; Chen, Zhendong; Wang, Jufeng; Dang, Chengxue; Wang, Jianhong; Wan, Yiye; Tang, Yong; Wang, Donglin; Liu, Jiang; Wu, Minhui; Deng, Yanhong; Li, Xingwen; Li, Yongqiang; Dong, Jian; Jiang, Da; Li, Guisheng; Wu, Qiong; Jin, Li; Qi, Yujuan; Sun, Yongkun; Cai, Jianqiang

doi:10.1002/onco.13857

Cited by 42 publications

(42 citation statements)

References 25 publications

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“…In the present study, most of the adverse events in patients received anlotinib therapy were grade 1-2 in severity. The incidence of secondary hypertension, hand-foot syndrome, and proteinuria was consistent with previous relevant clinical trials ( 36 ). Antiangiogenic drugs may increase the risk of bleeding.…”

Section: Discussionsupporting

confidence: 88%

A real-world study of anlotinib as third-line or above therapy in patients with her-2 negative metastatic breast cancer

Shao

Luo²,

Yu³

et al. 2022

Front. Oncol.

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BackgroundAntiangiogenic agents provides an optional treatment strategy for patients with metastatic breast cancer. The present study was conducted to evaluate the efficacy and safety of anlotinib as third-line or above therapy for patients with HER-2 negative metastatic breast cancer.MethodsPatients with HER-2 negative metastatic breast cancer who have failed from prior therapy and treated with anlotinib monotherapy or combined with chemotherapy or immunotherapy from June 2018 to December 2020 were retrospectively analyzed based on real-world clinical practice. The primary end point was progression free survival (PFS). Secondary end points included objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety.Results47 patients with HER-2 negative metastatic breast cancer received anlotinib monotherapy or combination therapy as third-line or above therapy. In the general population, 10 patients achieved PR, 25 patients had SD and 12 patients had PD. The overall ORR and DCR were 21.3% and 74.5%, respectively. Subgroup analysis suggested that there were no statistically significant differences in ORR and DCR with respect to HR status (positive vs. negative), treatment programs (monotherapy vs. combination) and treatment type in combination group (chemotherapy vs. immunotherapy). The patients who did not received previously anti-angiogenesis therapy had superior DCR (84.8% vs. 50.0%, P=0.012). Median PFS and OS were 5.0 months (95% CI=4.3-5.7) and 21.0 (95% CI=14.9-27.1) months, respectively. The PFS (6.5m vs. 3.5m, P=0.042)and OS (28.2m vs. 12.6m, P=0.040) were better in HR positive patients than HR negative patients. And simultaneously, patients who received anlotinib combination therapy obtained better PFS (5.5m vs. 3.0m, P=0.045). The incidence of Grade 3-4 adverse events(AEs) was 31.9%.ConclusionsAnlotinib monotherapy or combination therapy provide a viable third-line or above therapeutic strategy in patients with HER-2 negative metastatic breast cancer, a median PFS of 5.0 months was obtained with well tolerated toxicity.

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Section: Discussionsupporting

confidence: 88%

A real-world study of anlotinib as third-line or above therapy in patients with her-2 negative metastatic breast cancer

Shao

Luo²,

Yu³

et al. 2022

Front. Oncol.

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“…Grade 3-4 adverse reactions occurred in 15 (34.9%) patients. Anlotinib related AEs were consistent with the known safety profiles of anti-angiogenesis therapy, including secondary hypertension, hand-foot syndrome and proteinuria (27)(28)(29). Most AEs mainly come from chemotherapy and immunotherapy.…”

Section: Discussionsupporting

confidence: 68%

Clinical Study of Anlotinib as Third-Line or Above Therapy in Patients With Advanced or Metastatic Gastric Cancer: A Multicenter Retrospective Study

Nie

He²,

Lv³

et al. 2022

Front. Oncol.

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BackgroundThe present study was conducted to evaluate the efficacy and safety of anlotinib as third-line or above therapy for patients with advanced or metastatic gastric cancer.MethodsPatients with advanced or metastatic gastric cancer who have failed from second-line treatment and treated with anlotinib monotherapy or combined with chemotherapy or immunotherapy from June 2019 to January 2021 in 3 institutions across China were retrospectively analyzed. The primary end point was progression free survival (PFS). Secondary end points included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety.Results43 patients with advanced or metastatic gastric cancer who have failed prior treatment received anlotinib monotherapy or combination therapy as third-line or above therapy. In the general population, 4 patients achieved PR, 21 patients had SD and 18 patients had PD. The overall ORR and DCR were 9.3% (4/43) and 58.1% (25/43), respectively. Median PFS and OS were 3.0 months (95% CI=2.5-3.5) and 6.0 months (95% CI=4.4-7.6), respectively. The incidence of Grade 3-4 adverse events(AEs) was 34.9%. Subgroup analysis suggested that the ORR of anlotinib combination therapy was superior than anlotinib monotherapy, but with similar PFS and OS. The clinical benefit of anlotinib was not associated with previously anti-angiogenesis therapy with apatinib.ConclusionsAnlotinib monotherapy or combination therapy provide a feasible third-line or above therapeutic strategy in patients with advanced or metastatic gastric cancer a median PFS of 3.0 months and median OS of 6.0 months was obtained with well tolerated toxicity.

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“…In lung cancer, third-line monotherapy (37) or second-line chemotherapy (38,39) combined with immunotherapy (40) has been effectively applied. Studies have achieved effective results not only in NSCLC and SCLC (10), but also in liver cancer (19,41) or refractory metastatic colorectal cancer (42). There are currently more (15) revealed that anlotinib had a profound inhibitory effect on ribosomes, and regulated the cell cycle, RNA metabolism, and lysosomes as determined by transcriptomics, proteomics, and phosphor proteomics profiling.…”

Section: Discussionmentioning

confidence: 99%

Anlotinib plus nab-paclitaxel/gemcitabine as first-line treatment prolongs survival in patients with unresectable or metastatic pancreatic adenocarcinoma: a retrospective cohort

Wu¹,

Huang²,

Zhao³

et al. 2022

Ann Transl Med

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Anlotinib Monotherapy for Refractory Metastatic Colorectal Cancer: A Double-Blinded, Placebo-Controlled, Randomized Phase III Trial (ALTER0703)

Abstract: Background. Treatment options for refractory metastatic colorectal cancer (mCRC) were limited. Anlotinib is a novel multitarget tyrosine kinase inhibitor. ALTER0703 study was conducted to assess efficacy and safety of anlotinib for refractory mCRC patients.

Cited by 42 publications

References 25 publications

A real-world study of anlotinib as third-line or above therapy in patients with her-2 negative metastatic breast cancer

A real-world study of anlotinib as third-line or above therapy in patients with her-2 negative metastatic breast cancer

Clinical Study of Anlotinib as Third-Line or Above Therapy in Patients With Advanced or Metastatic Gastric Cancer: A Multicenter Retrospective Study

Anlotinib plus nab-paclitaxel/gemcitabine as first-line treatment prolongs survival in patients with unresectable or metastatic pancreatic adenocarcinoma: a retrospective cohort

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