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Research article
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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CURRENT STATUS: Under Review
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Posted 05 Oct, 2020
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Review #1 received
Received 04 Jan, 2021
Reviewer #1 agreed
On 14 Dec, 2020
Reviewers invited
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On 14 Sep, 2020
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This preprint is under consideration at BMC Cancer. A preprint is 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.
Learn more about In Review
Research article
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
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 05 Oct, 2020
No community comments so far
Review #1 received
Received 04 Jan, 2021
Reviewer #1 agreed
On 14 Dec, 2020
Reviewers invited
Invitations sent on 28 Oct, 2020
Editor assigned
On 15 Sep, 2020
Submission checks complete
On 14 Sep, 2020
Editor invited
On 14 Sep, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
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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