HNSCC, Hypopharynx Cancer, Larynx Cancer, Oral Cavity Cancer, Oropharynx Cancer
Conditions
Keywords
Elderly, Radiotherapy, Chemotherapy, Chemoradiotherapy, Cisplatin, Cetuximab, Real-world data
Brief summary
The number of elderly head-and-neck squamous cell carcinoma (HNSCC) patients is increasing; however, the evidence regarding the ideal treatment for this often vulnerable and frail patient cohort is limited. Although the benefit of concomitant chemotherapy has been reported to decrease in elderly HNSCC patients based on the MACH-NC meta-analysis, it remains unknown whether state-of-the art radiotherapy techniques such as intensity-modulated radiotherapy (IMRT), modern supportive treatments and alternative chemotherapy fractionation (e.g., cisplatin weekly) may have altered this observation. The objective of this retrospective multinational multicenter study is to determine the oncological outcomes of elderly patients (≥65 years) with locally advanced HNSCCs undergoing definitive (chemo-)radiation and to investigate the influence of concomitant chemotherapy on overall survival and progression-free survival after adjusting for potential confounder variables such as age, performance status and comorbidity burden.
Interventions
None listed
Sponsors
Charite University, Berlin, Germany
Johann Wolfgang Goethe University Hospital
University Hospital, Zürich
Wuerzburg University Hospital
University Hospital Schleswig-Holstein
Johannes Gutenberg University Mainz
University Hospital Munich
Friedrich-Alexander-Universität Erlangen-Nürnberg
Case Western Reserve University
Icahn School of Medicine at Mount Sinai
Ohio State University
German Oncology Center, Cyprus
University of Leipzig
Johns Hopkins University
Martin-Luther-Universität Halle-Wittenberg
University of Giessen
Brno University Hospital
Jena University Hospital
University Hospital Freiburg
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* definitive (chemo-)radiotherapy of locoregionally advanced (cT3-4 and/or cN+) head-and-neck squamous cell carcinomas (HNSCC) of the oral cavity, oropharynx, hypopharynx or larynx * primary treatment since 2005 * age ≥65 years at the time of (chemo-)radiotherapy
Exclusion criteria
* adjuvant (chemo-)radiotherapy * history of previous head-and-neck cancers or radiotherapy in the head-and-neck region * distant metastases at (chemo-)radiotherapy initiation (cM1) * HNSCCs of the nasopharynx, salivary glands, skin or with unknown primary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Up to 5 years | Time from radiotherapy start until death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Up to 5 years | Time from radiotherapy start until death from any cause, local progression, locoregional progression or distant progression (whichever occurs first) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patterns of chemotherapy administration | during radiotherapy | Type of concomitant chemotherapy |
| Cumulative cisplatin dose | during radiotherapy | Dose of concomitant cisplatin in mg/m2 body surface area |
| Radiotherapy compliance | during treatment | Radiotherapy completion rate |
| Chemotherapy compliance | during treatment | Chemotherapy completion rate |
Countries
Cyprus, Czechia, Germany, Switzerland, United States
Contacts
Primary ContactAlexander Rühle, MD, MHBA
Outcome results
None listed