Clinical Research Papers:
Evaluation of real-world treatment outcomes in patients with distant metastatic Merkel cell carcinoma following second-line chemotherapy in Europe
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Jürgen C. Becker1,2,15, Eva Lorenz3,14, Selma Ugurel2, Thomas K. Eigentler4, Felix Kiecker5, Claudia Pföhler6, Ivonne Kellner7, Friedegund Meier8,16, Katharina Kähler9, Peter Mohr10, Carola Berking11, Gabriele Haas2, Christoph Helwig12, Dina Oksen12, Dirk Schadendorf2, Lisa Mahnke13 and Murtuza Bharmal12
1Translational Skin Cancer Research (TSCR), German Cancer Research Center (DFKZ) Partner Site Essen/Düsseldorf, Essen University Hospital, 45147, Essen, Germany
2Department of Dermatology, University Hospital of Essen, 45122 Essen, Germany
3IMS HEALTH GmbH and Co OHG, 60598, Frankfurt am Main, Germany
4Department of Dermatology, University Hospital of Tübingen, 72076 Tübingen, Germany
5Charité Universitätsmedizin Berlin, Department of Dermatology, 10117 Berlin, Germany
6Saarland University Medical School, Department of Dermatology, 66421 Homburg/Saar, Germany
7Helios-Klinik, Department of Dermatology, 99089 Erfurt, Germany
8Skin Cancer Center, University Cancer Centre, and National Center for Tumor Diseases Dresden, 01307 Dresden, Germany
9Universitätsklinikum, Department of Dermatology, 24105 Kiel, Germany
10Elbe-Kliniken, Skin Cancer Center, 21614 Buxtehude, Germany
11University Hospital Munich (LMU), Department of Dermatology and Allergy, 80337 Munich, Germany
12Merck KGaA, 64293 Darmstadt, Germany
13EMD Serono, Inc., Billerica, MA, 01821, USA
14Present address: Institute for Medical Statistics, Epidemiology and Informatics, University Medical Center Mainz, 55131 Mainz, Germany
15Department of Dermatology, University Hospital of Würzburg, 97080, Würzburg, Germany
16Department of Dermatology, University Hospital Carl Gustav Carus at the TU Dresden, 01307 Dresden, Germany
Jürgen C. Becker, email: email@example.com
Keywords: Merkel cell carcinoma, skin cancer, retrospective study, chemotherapy, observational study
Received: April 25, 2017 Accepted: June 27, 2017 Published: July 13, 2017
Background and aims: Merkel cell carcinoma (MCC) is a rare, aggressive skin cancer; few treatments exist for patients with advanced disease. Once tumors metastasize to distant sites, patients generally receive chemotherapy, but response duration and progression-free survival (PFS) are typically short. Few studies have assessed the efficacy of second-line chemotherapy for metastatic MCC. Here, we studied outcomes in patients who received ≥ 2 lines of chemotherapy for metastatic MCC.
Materials and Methods: Patients in an MCC-specific registry diagnosed with stage IV MCC between November 1, 2004, and September 15, 2015, and treated with second-line or later chemotherapy were analyzed retrospectively. Patient records, including baseline characteristics, immunocompetent status, and responses to prior chemotherapy, were evaluated. Patients meeting eligibility criteria were followed through December 31, 2015.
Results: Of 29 patients with metastatic MCC and immunocompetent status who had received ≥ 2 lines of chemotherapy, 3 achieved a partial response, for an objective response rate (ORR) of 10.3% (95% CI, 2.2–27.4). In the overall population including patients with immunocompetent and immunocompromised status (n = 34), the ORR was 8.8% (95% CI, 1.9–23.7). The median duration of response was 1.9 months (range, 1.3–2.1 months; 95% CI, 1.3–2.1). In the immunocompetent population, median PFS and overall survival were 3.0 months (95% CI, 2.5–6.0) and 5.3 months (95% CI, 4.3–6.0), respectively.
Conclusions: The low response rates and limited durability confirm previous reports of the ineffectiveness of second-line or later chemotherapy in patients with metastatic MCC and provide a benchmark for assessing clinical benefit of new treatments.
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