Treatment Patterns and Clinical Outcomes in First Line Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (1L R/M SCCHN) Patients in Europe
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 304
- Locations
- 1
- Primary Endpoint
- Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Age
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this observational study is to collect real-world data that describes treatment patterns and clinical outcomes in participants with first line recurrent/metastatic squamous cell carcinoma of the head & neck (1L R/M SCCHN).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants are included in Cohort 1 - Augment if they meet the following criteria:
- •Adults18 years or older
- •Diagnosis of histologically confirmed R/M SCCHN, from any of the following primary sites only: oral cavity, oropharynx, hypopharynx, and larynx between 01-Jun-2017 and 31-June-
- •Prescribed 1L treatment for R/M SCCHN
- •Treatment history and response available for medical chart abstraction from date of diagnosis until death or the end of the study in living participants
- •Have available for review one month of follow-up data available post initiation of 1L R/M SCCHN therapy
- •Informed consent form (ICF) signature/collection of living participants, as required by country regulation and local ethics committees
- •Participants are included in Cohort 1 if they meet the following criteria:
- •Adults 18 years or older
- •Diagnosis of histologically confirmed R/M SCCHN, from any of the following primary sites only: oral cavity, oropharynx, hypopharynx and larynx between 01-Jan-2014 and 31-Dec-
Exclusion Criteria
- •Participants were excluded from either cohort if they meet the following criteria:
- •Were enrolled in a cancer treatment-related clinical trial since the diagnosis of R/M SCCHN
- •Recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary site, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histologies (e.g., mucosal melanoma).
Outcomes
Primary Outcomes
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Age
Time Frame: At Baseline
Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head \& Neck (SCCHN)
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Height
Time Frame: At Baseline
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Weight
Time Frame: At Baseline
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Body surface area (BSA)
Time Frame: At Baseline
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Health insurance coverage
Time Frame: At Baseline
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Tobacco use
Time Frame: At Baseline
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Patient comorbidities
Time Frame: At Baseline
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Alcohol use
Time Frame: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Human papillomavirus(HPV) p -16 status
Time Frame: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Date of early stage diagnosis
Time Frame: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Receive a platinum-based agent for early stage diagnosis
Time Frame: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Receive radiation within 6 months prior to early stage diagnosis
Time Frame: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Undergo related surgeries within 6 months prior to early stage diagnosis
Time Frame: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Date of R/M SCCHN diagnosis
Time Frame: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Specialty of diagnosing physician
Time Frame: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Primary site of SCCHN at R/M diagnosis
Time Frame: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Clinical stage at R/M diagnosis
Time Frame: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Primary tumor stage at R/M diagnosis
Time Frame: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Lymph node involvement at R/M diagnosis
Time Frame: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Metastasis at R/M diagnosis
Time Frame: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Histologic tumor grade at R/M diagnosis
Time Frame: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Overall prognosis at R/M diagnosis
Time Frame: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Platinum-based grouping
Time Frame: At Baseline
Distribution of diagnostic procedures of 1L R/M SCCHN participants treated with nivolumab
Time Frame: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: First (second, third+) Line of therapy (LOT)
Time Frame: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Duration of LOT
Time Frame: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Administration form
Time Frame: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose
Time Frame: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose changes
Time Frame: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Frequency of treatment regimen
Time Frame: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Schedule of agent administration
Time Frame: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Number of planned cycles
Time Frame: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Number of completed cycles
Time Frame: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Reasons for prescribing therapy
Time Frame: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Reasons for discontinuing therapy
Time Frame: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose delays
Time Frame: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Radiation performed for R/M disease
Time Frame: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Surgical procedures performed for R/M disease
Time Frame: At Baseline
Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab
Time Frame: At Baseline
Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab: Action taken
Time Frame: At Baseline
Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab: Resolution
Time Frame: At Baseline
Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Response to therapy
Time Frame: At Baseline
Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Duration of response
Time Frame: Up to approximately 36 months
Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Overall survival
Time Frame: Up to approximately 36 months
Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Progression free survival
Time Frame: Up to approximately 36 months
Secondary Outcomes
- Comparison of patient demographics, clinical characteristics, and treatment patterns between the Cohort 1- Augment and Cohort 1(At Baseline)
- Comparison of time to event endpoints of OS, PFS, and DOR between Cohort 1- Augment and Cohort 1(Up to approximately 36 months)