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Published on: September 8, 2021
Efficacy and Safety of Apatinib in Patients with Recurrent or Refractory Melanoma
Shumin Yuan1, Qiang Fu2, Lingdi Zhao1
1Department of Immunotherapy, Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, People's Republic of China.
Background:
The prognosis of patients with metastatic malignant melanoma is very poor and partly due to 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 had received at least one first-line therapy for advanced melanoma and experienced recurrence. Apatinib (500 mg) was orally administered daily.
Results:
Fifteen patients (V660E BRAF status: 2 mutation, 2 unknown, 11 wild type) were included in the analysis. The median PFS was 4.0 months. There were two major objective responses, for a 13.3% response rate. Eleven patients had stable disease, with a DCR of 86.7%. The median OS was 12.0 months. The most common treatment-related adverse events of any grade were hypertension (80.0%), mucositis oral (33.3%), hand-foot skin reaction (26.7%), and liver function abnormalities, hemorrhage, diarrhea (each 20%). The only grade ≥3 treatment-related adverse effects that occurred in 2 patients was hypertension (6.7%) and mucositis (6.7%). No treatment-related deaths occurred.
Conclusion:
Apatinib showed antitumor activity as a second- or above-line therapy in patients with malignant melanoma. The toxicity was manageable.
Clinicaltrials.Gov Identifier:
NCT03383237.
Insights
Apatinib demonstrated antitumor activity in advanced melanoma patients, showing a 13.3% response rate and manageable toxicity. This oral anti-angiogenesis inhibitor offers a new option for patients with recurrent malignant melanoma.
Area of Science:
- Oncology
- Pharmacology
Background:
- Metastatic malignant melanoma carries a poor prognosis, often linked to resistance to conventional chemotherapy.
- Recurrent advanced melanoma necessitates novel therapeutic strategies beyond standard treatments.
Purpose of the Study:
- To evaluate the efficacy and safety of apatinib, an oral anti-angiogenesis inhibitor.
- To assess apatinib's activity in patients with recurrent advanced melanoma who have undergone prior therapies.
Main Methods:
- A single-arm, single-center phase II clinical trial.
- Inclusion criteria: patients with advanced melanoma and recurrence after at least one first-line therapy.
- Primary endpoint: progression-free survival (PFS); Secondary endpoints: objective response rate (ORR), disease control rate (DCR), overall survival (OS). Apatinib 500 mg daily was administered orally.
Main Results:
- Fifteen patients were analyzed; median PFS was 4.0 months.
- Objective response rate (ORR) was 13.3% (2 major responses), with a disease control rate (DCR) of 86.7% (11 patients with stable disease).
- Median overall survival (OS) was 12.0 months. Common adverse events included hypertension (80.0%) and oral mucositis (33.3%). Grade ≥3 hypertension and mucositis occurred in 6.7% of patients. No treatment-related deaths.
Conclusions:
- Apatinib exhibits antitumor activity in patients with malignant melanoma receiving second- or higher-line therapy.
- The toxicity profile of apatinib in this patient population is manageable.
