According to Shumin Yuan and colleagues from the Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital in Zhengzhou, China, metastatic malignant melanoma is associated with very poor prognosis, partly due to resistance against conventional chemotherapies. The researchers conducted a phase II trial to assess the safety and efficacy of apatinib, an oral anti-angiogenesis inhibitor, in patients with recurrent advanced melanoma. According to their article, published in The Oncologist, reported that “apatinib showed antitumor activity as a second- or above-line therapy in patients with malignant melanoma,” with manageable toxicity.
The single-arm trial enrolled 15 patients with melanoma from one center to receive apatinib 500 mg daily. Patients had received at least one first-line therapy for advanced melanoma and subsequently recurred. The primary measure of the study was progression-free survival, while secondary endpoints included objective response rate (ORR), disease control rate (DCR), and overall survival (OS).
Among the 15 patients treated with apatinib, the median PFS was 4.0 months. According to the study’s authors, there were two major objective responses (13.3%), and eleven patients had stable disease with a DCR of 86.7%. The cohort had a median OS of 12.0 months. Additionally, the most common treatment-related adverse events (TRAE) of any grade were hypertension (80.0%), mucositis oral (33.3%), hand-foot skin reaction (26.7%), liver function abnormalities (20.0%), hemorrhage (20.0%), and diarrhea (20.0%). The only grade III or higher TRAE was hypertension and mucositis in two patients. No treatment-related deaths were recorded.
Overall, the study’s authors judged apatinib to have a manageable toxicity profile and clinical antitumor activity in patients with recurrent or refractory melanoma, potentially representing a much needed second-line treatment for patients who fail conventional platinum-based chemotherapy.