Aim: To assess the association between tumor response and health-related quality of life (HRQoL) in patients with metastatic Merkel cell carcinoma treated with the anti-PD-L1 avelumab. Materials & methods: Phase II single-arm trial (NCT02155647) data of 88 patients were analyzed. Correlations between percentage reduction in tumor size and change from baseline in Functional Assessment of Cancer Therapy – General (FACT-G), FACT – Melanoma (FACT-M) and EuroQol-5 Dimension scores were calculated. HRQoL and utility by tumor response (per the Response Evaluation Criteria In Solid Tumors version 1.1) was estimated. Results: Tumor shrinkage correlated positively with patients’ change from baseline in the FACT-M total (0.364 [95% CI: 0.050; 0.607]) and subscale scores. Differences in HRQoL and utility between nonprogressive disease and progressive disease were clinically relevant. Conclusion: In patients with metastatic Merkel cell carcinoma, nonprogression during treatment with avelumab correlated with gains in HRQoL.
Merkel cell carcinoma (MCC) is a rare, very aggressive primary cutaneous carcinoma of the skin . In Europe, a crude incidence rate of 0.19 per 100,000 between 2000 and 2007 was reported . In the USA, the incidence rate reported in the most recent analysis of Surveillance, Epidemiology, and End Results data was 0.79 per 100,000 in 2011 . The disease-associated mortality of MCC is estimated to be between 33 and 46%, reflecting the aggressiveness of the tumor [4,5].
Standard of care across all treatment guidelines is surgery in stages I–III of the disease. MCC is considered to be a chemotherapy-sensitive tumor, and chemotherapy is indicated for the treatment of stage IV MCC . However, the effectiveness of chemotherapy in terms of survival benefit is difficult to assess from the literature .
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In this interview discover further details of the JAVELIN Merkel 200 that led to the approval of the first immunotherapy treatment indicated in the EU and the first US FDA-approved systemic therapy for merkel cell carcinoma.