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Research
Zibing Wang
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Corresponding Author
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Background
Prognosis of patients with metastatic malignant melanoma is very poor and partly due to high resistance to conventional chemotherapies. The study’s objectives were to assess the activity and tolerability of apatinib, an oral small molecule anti-angiogenesis inhibitor, in patients with recurrent advanced melanoma.
Methods
This was a single-arm, single-center phase II trial. The primary endpoint was progression-free survival (PFS) and the secondary endpoints were objective response rate (ORR), disease control rate (DCR), and overall survival (OS). Eligible patients received at least one first-line therapy for advanced melanoma and experienced recurrence. Apatinib (500 mg) was orally administered daily. Trail registration: Clinical Trials, ID: NCT03383237. Registered on 24 December 2017. URL of trail registry record: https://register.clinicaltrials.gov.
Results
Fifteen patients were included in the analysis. The median PFS was 4.0 months. There were two major objective responses, for a 13.33% response rate. Eleven patients had stable disease, with a DCR of 86.67%.The median OS was 12.0 months. The most common clinically significant grade 3 or 4 toxicities included hypertension and canker sore. No treatment-related deaths occurred.
Conclusions
Apatinib showed antitumor activity as a second or first-line therapy in patients with malignant melanoma. The toxicity was manageable.
Keywords
Melanoma, Targeted therapy, Apatinib, PFS, OS
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A new preprint design is coming!
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This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Research
Zibing Wang
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
History
CURRENT STATUS: Posted
Version 1
Posted 20 Aug, 2020
No community comments so far
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Cancer Biology
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Prognosis of patients with metastatic malignant melanoma is very poor and partly due to high resistance to conventional chemotherapies. The study’s objectives were to assess the activity and tolerability of apatinib, an oral small molecule anti-angiogenesis inhibitor, in patients with recurrent advanced melanoma.
Methods
This was a single-arm, single-center phase II trial. The primary endpoint was progression-free survival (PFS) and the secondary endpoints were objective response rate (ORR), disease control rate (DCR), and overall survival (OS). Eligible patients received at least one first-line therapy for advanced melanoma and experienced recurrence. Apatinib (500 mg) was orally administered daily. Trail registration: Clinical Trials, ID: NCT03383237. Registered on 24 December 2017. URL of trail registry record: https://register.clinicaltrials.gov.
Results
Fifteen patients were included in the analysis. The median PFS was 4.0 months. There were two major objective responses, for a 13.33% response rate. Eleven patients had stable disease, with a DCR of 86.67%.The median OS was 12.0 months. The most common clinically significant grade 3 or 4 toxicities included hypertension and canker sore. No treatment-related deaths occurred.
Conclusions
Apatinib showed antitumor activity as a second or first-line therapy in patients with malignant melanoma. The toxicity was manageable.
Figure 1
Figure 2
Figure 3
This is a list of supplementary files associated with this preprint. Click to download.
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