Centralised RECIST Assessment and Clinical Outcomes with Lenvatinib Monotherapy in Recurrent and Metastatic Adenoid Cystic Carcinoma

SIMPLE SUMMARY: Adenoid cystic carcinoma (ACC) is a rare cancer of the head and neck. Initial treatment may involve surgery and/or radiotherapy with the aim of removing the cancer and preventing spread to other parts of the body. In patients in whom ACC has recurred or spread, systemic therapies such as chemotherapy or immunotherapy have been shown to have minimal benefit and there are currently no recommended standard systemic treatment options. More recently, the targeted therapy lenvatinib has shown promising results in treating ACC patients. We aimed to summarise the real-world experience of lenvatinib use in ACC patients in the UK and found that although some patients obtained clinical benefit, there were no significant responses on radiological imaging by centralized assessment. ABSTRACT: Adenoid cystic carcinoma (ACC) is a rare cancer of secretory glands. Recurrent or metastatic (R/M) ACC is generally considered resistant to cytotoxic chemotherapy. Recent phase II studies have reported improved objective response rates (ORR) with the use of the multi-kinase inhibitor lenvatinib. We sought to evaluate real-world experience of R/M ACC patients treated with lenvatinib monotherapy within the UK National Health Service (NHS) to determine the response rates by Response Evaluation Criteria of Solid Tumour (RECIST) and clinical outcomes. Twenty-three R/M ACC patients from eleven cancer centres were included. All treatment assessments for clinical decision making related to drug therapy were undertaken at the local oncology centre. Central radiology review was performed by an independent clinical trial radiologist and blinded to the clinical decision making. In contrast to previously reported ORR of 12–15%, complete or partial response was not observed in any patients. Eleven patients (52.4%) had stable disease and 5 patients (23.8%) had progression of disease as the best overall response. The median time on treatment was 4 months and the median survival from discontinuation was 1 month. The median PFS and OS from treatment initiation were 4.5 months and 12 months respectively. Multicentre collaborative studies such as this are required to evaluate rare cancers with no recommended standard of care therapy and variable disease courses.