Abstract
Purpose Anti-PD-1 antibody improves the survival of patients with advanced melanoma. However, the efficacy and safety of anti-programmed death protein 1 (PD-1) antibody have not been fully elucidated in Chinese melanoma patients, who show high frequency of mucosal and acral melanoma subtypes; besides, the factors influencing the efficacy of anti-PD-1 antibody have not been evaluated broadly. Patients and Methods Patients with advanced melanoma treated with regimens containing anti-PD-1 antibody from June 2016 to January 2019 were evaluated. Baseline characteristics and blood parameters were assessed, and outcome and adverse events were evaluated according to different regimens. The Cox proportional hazards regression model was used for univariate and multivariate analyses. Results A total of 51 patients with advanced melanoma were included in this study. The overall objective response rate (ORR) was 17.6%, the disease control rate was 58.5%, and the median time to progression was 5.2 months. The ORR of patients with PD-1 blockade-based combination therapy, without liver metastases and higher level of C-reactive protein (CRP) before PD-1 blockade, is higher than that of those not. Univariate analysis based on clinical features showed that ECOG scores, liver metastasis, elevated lactate dehydrogenase (LDH), and CRP levels were the factors affecting time to progression (TTP). Multivariate analysis showed that elevated CRP before PD-1 blockade was an independent predictive factor for ORR of PD-1 blockade therapy (P=0.009), while only Eastern Cooperative Oncology Group (ECOG) score was an independent predictor for TTP (P=0.032). The treatment was well tolerated in these cohort patients, and there was no treatment-related death. Conclusion Anti-PD-1 antibody-containing regimen was safe and effective in Chinese patients with advanced melanoma, and elevated CRP and ECOG score were independent factors predicting the efficacy of anti-PD-1 therapy.
Highlights
With an annual growth rate of 3–5%, melanoma has become one of the fastest growing tumors of all malignant tumors [1]
Some clinical trials were conducted in Chinese patients with advanced melanoma, the objective response rate (ORR) was about 18–20% when antiPD-1 was used as monotherapy and the ORR could be improved to 50% when anti-progressive disease (PD)-1 was combined with axitinib [14,15,16]
(31.4%) were acral melanomas that arose from the soles, palms, and subungual sites, (34.3%) were mucosal melanomas, and (34.3%) were chronic sun-damaged (CSD) or non-CSD melanomas that arose in the skin other than in the acral sites. irty-eight patients received PD-1 blockade alone, and 13 patients received PD-1 blockadebased combination therapy
Summary
With an annual growth rate of 3–5%, melanoma has become one of the fastest growing tumors of all malignant tumors [1]. In 2018, 287,723 new cases of cutaneous melanoma occurred with 60,712 deaths worldwide [2]. In the United States, most melanoma cases occur on sites of sun-irradiated skin. Long-term chronic sun-irradiated injury may lead to increased mutations, and the tumor mutation burden is relatively high [3]. Before the emergence of immunecheckpoint inhibitors, the main therapeutic modality for metastatic melanoma was chemotherapy; the ORR was about 10%, and the median survival time was about 10 months [4]. E emergence of immune-checkpoint inhibitors such as anti-cytotoxic T lymphocyte antigen-4 (CTLA-4) and anti-PD-1 antibodies has changed the therapeutic modality for metastatic melanoma greatly, increasing the possibility of long-term survival for some patients. Before the emergence of immunecheckpoint inhibitors, the main therapeutic modality for metastatic melanoma was chemotherapy; the ORR was about 10%, and the median survival time was about 10 months [4]. e emergence of immune-checkpoint inhibitors such as anti-cytotoxic T lymphocyte antigen-4 (CTLA-4) and anti-PD-1 antibodies has changed the therapeutic modality for metastatic melanoma greatly, increasing the possibility of long-term survival for some patients. e ORR of anti-PD-1 antibodies alone is about 30% [5, 6]; in combination with anti-CTLA-4 antibodies, it could be as high as 57.6% [7]
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