Real-world outcomes of systemic therapy in locally advanced, recurrent or metastatic cutaneous squamous cell carcinoma

Abstract

Aim: Real-world treatment patterns and clinical outcomes in advanced cutaneous squamous cell carcinoma were evaluated. Methods: Adults receiving their first systemic therapy for unresectable, locally advanced or recurrent/metastatic cutaneous squamous cell carcinoma from 4 September 2014 to 30 June 2017, were evaluated. The primary end point was real-world overall response rate per Response Evaluation Criteria in Solid Tumors or physician assessment. Time-to-event outcomes were assessed using the Kaplan–Meier method. Results: Of 51 eligible patients, the median age was 76 years, 80% were male and 65% had an Eastern Cooperative Oncology Group score of 0–1. The most common regimens were cetuximab (51%) and carboplatin + paclitaxel (22%). Median real-world overall response rate ranged from 9.8% per Response Evaluation Criteria in Solid Tumors to 43.1% when supplemented by physician assessment. Median overall survival was 10.7 months, and median time to next treatment was 7.5 months. Conclusion: Survival in advanced cutaneous squamous cell carcinoma was short. Real-world overall response rate was lower with Response Evaluation Criteria in Solid Tumors than physician assessment.

Plain language summary

This study looked at chemotherapy treatments and responses in patients receiving treatment for advanced cutaneous squamous cell carcinoma, a type of skin cancer. Patients had advanced and metastatic cancer that could not be cured by radiation or surgery. Most of the patients were white males, and their median age was 76 years. About two-thirds of the patients in the study had their original cancer in the head and neck, and in most patients (approximately 80%), the cancer had spread, mostly to the lungs or lymph nodes. Half of the patients in the study were treated with cetuximab, and about a quarter received platinum chemotherapy or other cetuximab-based treatment. The study examined how response to treatment may be measured in clinical care and clinical trials. Response to treatment and length of survival were short: patients responded to treatment for a median of 9 months and survived for a median of 10.7 months.

Keywords::

• cSCC
• cutaneous squamous cell carcinoma
• metastatic
• outcomes
• real-world
• response

Author contributions

TT Vo, JL Espirito, M Boyd, B Gumuscu, D Chirovsky, NJ Robert, RF Swaby, W Zhou and CL Cowey substantially contributed to the conception, design or planning of the study. TT Vo, JL Espirito, M Boyd, B Gumuscu, NJ Robert, RF Swaby and CL Cowey analyzed the data. M Boyd and CL Cowey acquired the data. JL Espirito, M Boyd, B Gumuscu, D Chirovsky, RF Swaby, W Zhou and CL Cowey interpreted the results. TT Vo, JL Espirito, B Gumuscu and CL Cowey drafted the manuscript. JL Espirito, M Boyd, D Chirovsky, NJ Robert, RF Swaby, W Zhou and CL Cowey critically reviewed or revised the manuscript for important intellectual content.

Financial & competing interests disclosure

This study was sponsored by Merck Sharp and Dohme Corp., a subsidiary of Merck and Co., Inc. (NJ, USA). JL Espirito is an employee of McKesson. M Boyd was an employee of McKesson at the time of the study. D Chirovsky, B Gumuscu, TT Vo and W Zhou are employees of Merck, Inc. D Chirovsky and W Zhou own stock in Merck, Inc. CL Cowey received research funding from and is also a consultant for Merck, Inc. RF Swaby was an employee of Merck, Inc., at the time of the study. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

Institutional review board and compliance/privacy approval was obtained prior to initiation of the retrospective research. Since this project involved the analysis of existing data and records, study information was analyzed in such a manner that research participants could not be directly identified. Because of the nature of the study design, patient informed consent was not required. Thus, exemption status and a waiver of informed consent were approved by The US Oncology Network Institutional Review Board. Data were handled in compliance with the Health Insurance Portability and Accountability Act of 1996 and Health Information Technology for Economic and Clinical Health Act.

Additional information

Funding

This study was sponsored by Merck Sharp and Dohme Corp., a subsidiary of Merck and Co., Inc. (NJ, USA). JL Espirito is an employee of McKesson. M Boyd was an employee of McKesson at the time of the study. D Chirovsky, B Gumuscu, TT Vo and W Zhou are employees of Merck, Inc. D Chirovsky and W Zhou own stock in Merck, Inc. CL Cowey received research funding from and is also a consultant for Merck, Inc. RF Swaby was an employee of Merck, Inc., at the time of the study. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.