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Apatinib for Advanced Osteosarcoma after Failure of Standard Multimodal Therapy: An Open Label Phase II Clinical
1Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, People's Republic of China.
Background:
Antiangiogenesis tyrosine kinase inhibitors (TKIs) have been shown to prolong progression-free survival (PFS) in advanced osteosarcoma. Methylsulfonic apatinib is a TKI that specifically inhibits vascular endothelial growth factor receptor-2. We aim to assess apatinib in patients with advanced high-grade osteosarcoma progressing upon chemotherapy.
Materials And Methods:
This phase II trial was conducted at Peking University People's Hospital. We enrolled participants (≥16 years of age) with progressive relapsed or unresectable osteosarcoma. Participants received 750 mg or 500 mg of apatinib according to body surface area once daily until disease progression or unacceptable toxicity. The primary endpoint was objective response rate and PFS at 4 months.
Results:
A total of 37 participants were finally included into the analysis. Until final follow-up, the objective response rate (complete response + partial response) was 43.24% (16/37). The 4-month PFS rate was 56.76% (95% confidence interval [CI], 39.43%-70.84%). Median PFS and overall survival were 4.50 (95% CI, 3.47-6.27) and 9.87 (95% CI 7.97-18.93) months, respectively. Toxic effects led to dose reductions or interruptions in a total of 25 of 37 (67.57%) patients. The most common grade 3-4 adverse events were pneumothorax in six (16.22%) patients, wound dehiscence in four (10.81%), proteinuria in three (8.11%), diarrhea in three (8.11%), and palmar-plantar erythrodysesthesia syndrome in three (8.11%). No other serious adverse events were reported during the trial. There were no treatment-related deaths.
Conclusion:
Apatinib is a sensitive drug for advanced osteosarcoma with a high response rate after failure of chemotherapy, with similar duration of response compared to other TKIs.
Implications For Practice:
For advanced osteosarcoma progressing upon chemotherapy, antiangiogenesis tyrosine kinase inhibitors (TKIs) have been proved to be effective in prolonging the progression-free survival in previous multicenter trials and have been included into new National Comprehensive Cancer Network guidelines as second-line therapy. Apatinib is a TKI that specifically inhibits vascular endothelial growth factor receptor-2, which is domestically made in China. This phase II trial supports the use of apatinib in patients with advanced osteosarcoma progressing after chemotherapy.
Insights
Apatinib shows promise for advanced osteosarcoma, achieving a 43.24% objective response rate in patients progressing after chemotherapy. This tyrosine kinase inhibitor (TKI) offers a viable treatment option with manageable side effects.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Advanced osteosarcoma often progresses despite chemotherapy.
- Antiangiogenesis tyrosine kinase inhibitors (TKIs) demonstrate efficacy in prolonging progression-free survival (PFS).
- Apatinib, a TKI targeting vascular endothelial growth factor receptor-2, is a domestically produced option in China.
Purpose of the Study:
- To evaluate the efficacy and safety of apatinib in patients with advanced high-grade osteosarcoma who have progressed after chemotherapy.
- To determine the objective response rate (ORR) and 4-month progression-free survival (PFS) rate.
Main Methods:
- A phase II, single-center trial enrolled 37 participants (≥16 years) with progressive, relapsed, or unresectable osteosarcoma.
- Patients received daily oral apatinib (750 mg or 500 mg based on body surface area) until disease progression or toxicity.
- Primary endpoints were ORR and 4-month PFS; secondary endpoints included median PFS and overall survival.
Main Results:
- The objective response rate was 43.24% (16/37) and the 4-month PFS rate was 56.76%.
- Median PFS was 4.50 months and median overall survival was 9.87 months.
- Dose reductions/interruptions occurred in 67.57% of patients due to toxic effects, with common grade 3-4 adverse events including pneumothorax, wound dehiscence, proteinuria, diarrhea, and palmar-plantar erythrodysesthesia syndrome.
Conclusions:
- Apatinib demonstrates significant efficacy in advanced osteosarcoma patients who have failed prior chemotherapy.
- The drug exhibits a high response rate and comparable duration of response to other TKIs.
- Apatinib supports the use as a second-line therapy for advanced osteosarcoma, though careful toxicity monitoring is necessary.
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