Viktor Grünwald1, Diana Chirovsky2, Winson Y Cheung3, Federica Bertolini4, Myung-Ju Ahn5, Muh-Hwa Yang6, Gilberto Castro7, Alfonso Berrocal8, Katrin Sjoquist9, Hélène Kuyas10, Valérie Auclair11, Xavier Guillaume12, Seongjung Joo13, Roshani Shah14, Kevin Harrington15. 1. Clinic for Internal Medicine (Tumour Research) and Clinic for Urology, University Hospital Essen, Hufelandtsr. 55, 45147 Essen, Germany; Medizinische Hochschule Hannover, Carl-Neuberg-Straße 1, 30625 Hannover, Germany. Electronic address: viktor.gruenwald@uk-essen.de. 2. Merck & Co., Inc., Center for Observational and Real World Evidence, 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA. Electronic address: diana.chirovsky@merck.com. 3. University of Calgary, Tom Baker Cancer Centre, Department of Oncology, 2500 University Dr. NW, Calgary, Alberta T2N 1N4, Canada; Cross Cancer Institute, Medical Oncology, Alberta Cancer Foundation, 11560 University Avenue, Edmonton, Alberta T6G 1Z2, Canada. Electronic address: winson.cheung@ahs.ca. 4. AOU Policlinico di Modena, Day Hospital Oncologico, Azienda Ospedaliero-Universitaria di Modena, Via del Pozzo, 71, 41124 Modena, Italy. Electronic address: bertolini.federica@policlinico.mo.it. 5. Samsung Medical Center, Sungkyunkwan University School of Medicine Section of Hematology-Oncology, Department of Medicine, 135-710 Seoul, South Korea. Electronic address: silkahn@skku.edu. 6. Taipei Veterans General Hospital, No. 201, Section 2, Shipai Road, Beitou District, Taipei City 11217, Taiwan, Republic of China. Electronic address: mhyang2@vghtpe.gov.tw. 7. Instituto de Cancer do Estado de São Paulo, Faculdade de Medicina da USP - Disciplina de Oncologia, Av Dr Arnaldo 251 - 5o andar, São Paulo, SP 01246-000, Brazil. Electronic address: gilberto.cjunior@hsl.org.br. 8. Hospital General Universitario de Valencia, Servicio de Oncologia Medica, Avda Tres Cruces S, N, 46006 Valencia, Spain. Electronic address: berrocal_alf@gva.es. 9. St George Hospital, Cancer Care Centre, 1 Short Street, Kogarah, NSW 2217, Australia; NHMRC Clinical Trials Centre, University of Sydney, ABN 15 211 513 464, Locked Bag 77, Camperdown, NSW 1450, Australia. Electronic address: katrin.sjoquist@ctc.usyd.edu.au. 10. Kantar Health, 3 Avenue Pierre Masse, 75014 Paris, France. Electronic address: helene.kuyas@kantarhealth.com. 11. Kantar Health, 3 Avenue Pierre Masse, 75014 Paris, France. Electronic address: valerie.auclair@kantarhealth.com. 12. Kantar Health, 3 Avenue Pierre Masse, 75014 Paris, France. Electronic address: xavier.guillaume@kantarhealth.com. 13. Merck & Co., Inc., Center for Observational and Real World Evidence, 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA. Electronic address: seongjung.joo@merck.com. 14. Merck & Co., Inc., Center for Observational and Real World Evidence, 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA. Electronic address: roshani1130@gmail.com. 15. The Royal Marsden/Institute of Cancer Research NIHR Biomedical Research Centre, 237 Fulham Road, London SW3 6JB, United Kingdom. Electronic address: Kevin.Harrington@icr.ac.uk.
Abstract
OBJECTIVES: Given a lack of universally-accepted standard-of-care treatment for patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC), study objectives were to assess treatment utilization and survival outcomes for R/M HNSCC in the real-world setting. MATERIALS AND METHODS: A multi-site retrospective chart review was conducted in Europe (Germany, United Kingdom, Italy, Spain), Asia Pacific (Australia, South Korea, Taiwan), and Latin/North America (Brazil and Canada) to identify patients who initiated first-line systemic therapy for R/M HNSCC between January 2011 and December 2013. Patients were followed through December 2015 to collect clinical characteristics, treatment and survival data. RESULTS: Among 733 R/M HNSCC patients across 71 sites, median age was 60 years (inter-quartile range 54-67), 84% male, and 70% Eastern Cooperative Oncology Group performance status 0-1; 32% had oral cavity and 30% oropharyngeal cancers. The most common first-line regimen across all countries consisted of platinum-based combinations (73%), including platinum + 5-fluorouracil (5-FU) (26%), cetuximab + platinum ± 5-FU (22%), or taxane + platinum ± 5-FU (16%). However, use of different platinum-based combinations varied substantially; administration of cetuximab + platinum ± 5-FU was frequent in Italy (81%), Germany (46%) and Spain (38%), whereas use in other countries was limited. Median follow-up was 22.6 months (95% confidence interval [CI]: 21.5-24.6 months). Median real-world overall survival was only 8.0 months (95% CI: 7.0-8.0), with one-year survival reaching only 30.9% (95% CI: 27.5-34.3). CONCLUSION: Systemic therapies used in clinical practice for patients with R/M HNSCC vary substantially across countries. Prognosis remains poor in this patient population, highlighting the need for newer, more efficacious treatments.
OBJECTIVES: Given a lack of universally-accepted standard-of-care treatment for patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC), study objectives were to assess treatment utilization and survival outcomes for R/M HNSCC in the real-world setting. MATERIALS AND METHODS: A multi-site retrospective chart review was conducted in Europe (Germany, United Kingdom, Italy, Spain), Asia Pacific (Australia, South Korea, Taiwan), and Latin/North America (Brazil and Canada) to identify patients who initiated first-line systemic therapy for R/M HNSCC between January 2011 and December 2013. Patients were followed through December 2015 to collect clinical characteristics, treatment and survival data. RESULTS: Among 733 R/M HNSCC patients across 71 sites, median age was 60 years (inter-quartile range 54-67), 84% male, and 70% Eastern Cooperative Oncology Group performance status 0-1; 32% had oral cavity and 30% oropharyngeal cancers. The most common first-line regimen across all countries consisted of platinum-based combinations (73%), including platinum + 5-fluorouracil (5-FU) (26%), cetuximab + platinum ± 5-FU (22%), or taxane + platinum ± 5-FU (16%). However, use of different platinum-based combinations varied substantially; administration of cetuximab + platinum ± 5-FU was frequent in Italy (81%), Germany (46%) and Spain (38%), whereas use in other countries was limited. Median follow-up was 22.6 months (95% confidence interval [CI]: 21.5-24.6 months). Median real-world overall survival was only 8.0 months (95% CI: 7.0-8.0), with one-year survival reaching only 30.9% (95% CI: 27.5-34.3). CONCLUSION: Systemic therapies used in clinical practice for patients with R/M HNSCC vary substantially across countries. Prognosis remains poor in this patient population, highlighting the need for newer, more efficacious treatments.
Keywords:
Cetuximab; Chemotherapy; Clinical practice patterns; Head and neck cancer; Head and neck squamous cell carcinoma; Metastasis; Oral cancer; Real-world evidence; Recurrence; Survival analysis
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