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Anorexia, Hypertension, Pneumothorax, and Hypothyroidism: Potential Signs of Improved Clinical Outcome Following
1Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, People's Republic of China.
Aim:
Apatinib, a specific tyrosine kinase inhibitor (TKI) that targets mainly vascular endothelial growth factor receptor-2 (VEGFR-2) as well as Ret, c-Kit and c-Src, has been assessed in patients with advanced osteosarcoma (phase II), the primary report of which has been published in PMID 30559126. This sub-study explored the potential signs of Adverse Events (AEs) for apatinib-treated osteosarcoma.
Methods:
Participants with advanced osteosarcoma progressing upon chemotherapy received apatinib until disease progression or unacceptable toxicity. Toxicities, progression-free survival (PFS), and clinical benefit rate (CBR) following treatment were evaluated.
Results:
Of the 41 patients recruited to the study, 37 received treatment and constituted the safety population. At data cut-off (December 30, 2017), median follow-up for safety was 7.37 (IQR, 6.33-11.07) months. The most common grade 3-4 AEs were pneumothorax (16.22%), wound dehiscence (10.81%), proteinuria (8.11%), diarrhea (8.11%), and skin reaction (8.11%). Only hypertension was an independent predictive factor for both PFS (hazard ratio [HR], 0.44; P = 0.07) and CBR (P = 0.07). Anorexia was also significantly related to a longer PFS in a Cox regression model (HR, 0.35; P =0.01). For CBR, pneumothorax and hypothyroidism showed more clinical benefit (P = 0.07 and 0.00, respectively).
Conclusion:
The results of this study suggest that anorexia, hypertension, pneumothorax, and hypothyroidism might be markers for a favorable clinical outcome following apatinib-treated refractory osteosarcoma.
Insights
Apatinib treatment for advanced osteosarcoma showed that certain adverse events like anorexia and hypertension may indicate a better clinical outcome. These findings help predict treatment response in refractory osteosarcoma patients.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Apatinib is a tyrosine kinase inhibitor (TKI) targeting VEGFR-2, Ret, c-Kit, and c-Src.
- Previous studies have assessed apatinib in advanced osteosarcoma, with this sub-study focusing on adverse events.
Purpose of the Study:
- To explore potential adverse event (AE) markers associated with favorable clinical outcomes in patients with advanced osteosarcoma treated with apatinib.
- To evaluate the safety and efficacy of apatinib in refractory osteosarcoma.
Main Methods:
- A phase II sub-study involving patients with advanced osteosarcoma progressing on chemotherapy.
- Patients received apatinib until disease progression or unacceptable toxicity, with toxicities, progression-free survival (PFS), and clinical benefit rate (CBR) evaluated.
Main Results:
- The most common grade 3-4 adverse events included pneumothorax (16.22%), wound dehiscence (10.81%), proteinuria (8.11%), diarrhea (8.11%), and skin reaction (8.11%).
- Hypertension was an independent predictive factor for both PFS and CBR.
- Anorexia was significantly related to longer PFS, and pneumothorax and hypothyroidism were associated with greater clinical benefit for CBR.
Conclusions:
- Anorexia, hypertension, pneumothorax, and hypothyroidism may serve as predictive markers for favorable clinical outcomes in apatinib-treated refractory osteosarcoma.
- These findings can aid in predicting treatment response and managing patients with advanced osteosarcoma.
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