Anlotinib for Recurrent or Metastatic Primary Malignant Bone Tumor: A Multicenter, Single-Arm Trial
Lina Tang1, Xiaohui Niu2, Zhen Wang3
1Shanghai 6th People's Hospital, Shanghai Jiao Tong University, Shanghai, China.
Objective:
Anlotinib, a novel multitarget kinase inhibitor of VEGFR, FGFR, PDGFR and c-Kit, has proven to be effective and safe for refractory soft tissue sarcoma patients, but has not been examined in recurrent or metastatic primary malignant bone tumors in a clinical trial setting.
Methods:
This is a multicenter single-arm trial. Patients with pathologically proven recurrent or metastatic primary malignant bone tumors were eligible. Anlotinib was administered orally at 12 mg per day. Each cycle consisted of 2 weeks of treatment followed by 1-week off-treatment. The primary endpoint was progression-free survival (PFS), as assessed in the intention-to-treat (ITT) population. Secondary endpoints included objective response rate (ORR), disease control rate (DCR) and overall survival (OS). Adverse events (AEs) were assessed per NCI CTCAE version 4.03.
Results:
A total of 42 patients were enrolled. Median PFS was 5.3 months (95% CI 3.5-8.4 months) in the overall analysis, 4.8 months (95%CI 3.5-7.1 months) in osteosarcoma patients and 2.8 months [95%CI 1.3 months to not reached (NR)] in chondrosarcoma patients. The median OS was 11.4 months (95% CI 10.1 months to NR) in the overall analysis, not reached (95% CI, NR, NR) in osteosarcoma patients and 11.4 months (95% CI 1.8 to 21.1 months) in chondrosarcoma patients. The ORR was 9.52% and DCR was 78.57%. Grade 3 or above AEs occurred in 54.76% of the patients, and included hypertension (19.05%), hypertriglyceridemia (9.52%) and pustulosis palmaris et plantaris (7.14%). No treatment-related death was reported.
Conclusion:
Anlotinib demonstrated promising antitumor activities in recurrent or metastatic primary malignant bone tumors with manageable AEs.
Insights
Anlotinib shows promise for recurrent or metastatic bone tumors, offering antitumor activity with manageable side effects in a clinical trial. This study evaluated its efficacy and safety in patients with advanced bone cancers.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Anlotinib, a multi-targeted kinase inhibitor, is effective for refractory soft tissue sarcoma.
- Its efficacy in recurrent or metastatic primary malignant bone tumors remains unexamined in clinical trials.
Purpose of the Study:
- To evaluate the antitumor activity and safety of anlotinib in patients with recurrent or metastatic primary malignant bone tumors.
- To determine progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and overall survival (OS).
Main Methods:
- A multicenter, single-arm trial involving 42 patients with pathologically proven recurrent or metastatic primary malignant bone tumors.
- Anlotinib administered orally at 12 mg daily (2 weeks on, 1 week off).
- Primary endpoint: PFS. Secondary endpoints: ORR, DCR, OS. Adverse events (AEs) assessed using NCI CTCAE v4.03.
Main Results:
- Median PFS was 5.3 months overall, 4.8 months in osteosarcoma, and 2.8 months in chondrosarcoma.
- Median OS was 11.4 months overall.
- Objective response rate (ORR) was 9.52%, and disease control rate (DCR) was 78.57%.
- Grade 3+ AEs occurred in 54.76%, most commonly hypertension (19.05%). No treatment-related deaths.
Conclusions:
- Anlotinib exhibits promising antitumor activity in recurrent or metastatic primary malignant bone tumors.
- The drug demonstrates a manageable safety profile with notable AEs like hypertension.
- Anlotinib represents a potential therapeutic option for this patient population.
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