THASSOS-INTL: Real-world Treatment Patterns and Associated Outcomes in Patients With Resectable Early-stage Non-small Cell Lung Cancer
Study Details
Study Description
Brief Summary
This is a non-interventional, multi-country, multicentre, retrospective study designed to determine the treatment patterns and associated survival rate in patients with primary stage IA to IIIB resectable NSCLC diagnosed between 01 January 2013 and 31 December 2017 and followed until at least 31 December 2020 The main objective of this study is to describe the treatment patterns and determine their associated 3-year survival rate according to clinical and pathologic staging in patients with resectable early-stage (IA to IIIB as per AJCC seventh edition) NSCLC.
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Detailed Description
This is a non-interventional, multi-country, multicentre, retrospective study designed to determine the treatment patterns and associated survival rate in patients with primary stage IA to IIIB resectable NSCLC diagnosed between 01 January 2013 and 31 December 2017 and followed until at least 31 December 2020. This study will also determine the prevalence of EGFR mutations and PD-L1 expression, and the clinical outcomes as per the treatment patterns and clinico-pathological staging. Data will be collected retrospectively from the patients' medical records from the date of initial diagnosis of early-stage NSCLC (index date) to the end of follow up ie, until death, the last medical record entry, or date of data extraction, whichever is the earliest. The data on treatment modalities, sociodemographic, clinico-pathological characteristics, and exposure and outcome variables (ie, medical and treatment history, disease staging, biomarker assessments, radiological findings, concomitant medications, survival), factor(s) for prescribing neo-adjuvant and/or adjuvant treatment and reason(s) for discontinuation will be extracted from patients' medical records.
Study Design
Outcome Measures
Primary Outcome Measures
- Proportion of patients per treatment modalities [3 Years]
Proportion of patients, overall and as per clinical and pathologic staging (seventh edition of the tumour, nodes, metastases [TNM] classification for lung cancer [AJCC]) who underwent treatment Surgery only, Neo-adjuvant therapy (chemo+/-radiotherapy) only, Adjuvant therapy (chemo+/-radiotherapy) only or Neo-adjuvant and adjuvant therapies modalities
- Duration of treatment [3 years]
Duration of treatment for each treatment regimen in neo-adjuvant and adjuvant treatment settings, dose of each agent, and reason(s) for stopping treatment in each setting
- Survival rate [3 Years]
Survival rate (overall, and as per clinical and pathologic staging) defined as percentage of patients, confirmed to be alive at 3 years from the index date.
Secondary Outcome Measures
- Demographic characteristics [3 Years]
Demographic overall and as per treatment modalities ; underwent treatment Surgery only, Neo-adjuvant therapy (chemo+/-radiotherapy) only, Adjuvant therapy (chemo+/-radiotherapy) only or Neo-adjuvant and adjuvant therapies modalities): age, gender, ethnicity, body mass index, smoking status, geographical location
- Eastern Cooperative Oncology performance status Group characteristics [3 Years]
Proportion and classification of Eastern Cooperative Oncology Group (ECOG) performance status Clinical-pathological characteristics overall and as per treatment modalities ; underwent treatment Surgery only, Neo-adjuvant therapy (chemo+/-radiotherapy) only, Adjuvant therapy (chemo+/-radiotherapy) only or Neo-adjuvant and adjuvant therapies modalities
- Histological type [3 Yewars]
Proportion of Histological type (adenocarcinoma, adenosquamous carcinoma, bronchioalveolar carcinoma, large-cell carcinoma, and NSCLC not otherwise specified)
- Clinical-pathological Tumor stage [3 Years]
Tumor Staging as per seventh edition AJCC (IA, IB, IIA, IIB, IIIA, IIIB) with lymph node metastasis status (N0, N1, and N2)
- TNM staging at index diagnosis [1 Month]
TNM staging at index diagnosis
- Genetic alterations [3 Years]
Other genetic alterations(anaplastic lymphoma kinase [ALK], Kirsten rat sarcoma viral oncogene [KRAS], B-Raf proto-oncogene [BRAF], rearranged during transfection [RET], mesenchymal-to-epithelial transition factor [MET], human epidermal growth factor receptor 2 [HER2], ROS proto-oncogene 1 receptor tyrosine kinase [ROS1], and tumour protein 53 [TP53]
- Survival rates at pre-defined landmark timepoints (other than 3-year) [1 Years]
Survival rates at pre-defined landmark timepoints (other than 3-year) for each of the treatment modality; ho underwent treatment Surgery only, Neo-adjuvant therapy (chemo+/-radiotherapy) only, Adjuvant therapy (chemo+/-radiotherapy) only or Neo-adjuvant and adjuvant therapies
- Prevalence of EGFR mutations [3 Years]
Proportion of patients with EGFR mutation-positive status
- Prevalence of PD-L1 expression [3 Years]
Proportion of patients with PD-L1 positivity at various cut-off points (<1%, ≥1% to <25%, ≥25% to <50%, and ≥50%)
Other Outcome Measures
- Effectiveness outcomes rwDFS defined as time from the date of surgery to recurrence or death [3 Years]
Effectiveness outcomes will be determined for each treatment modality as; rwDFS defined as time from the date of surgery to recurrence or death due to any cause; rwDFS rate at predefined landmark timepoints (overall, per clinical, and pathologic staging) for evaluation of primary treatment
- Effectiveness outcomes rwEFS rate at predefined landmark timepoints [3 Years]
Effectiveness outcomes will be determined for each treatment modality as; rwEFS rate at predefined landmark timepoints (overall, per clinical and pathologic staging) for evaluation of primary treatment
- Effectiveness outcomes rwPFS defined as time from local or distant relapse to disease progression or death [3 Years]
Effectiveness outcomes will be determined for each treatment modality as; rwPFS defined as time from local or distant relapse to disease progression or death due to any cause for evaluation of subsequent treatment ie, first, second, and third LOTsa
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult female and male patients aged ≥18 years or 'adults' according to age of majority as defined by the local regulations on index date
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Patient or next of kin/legal representative (for deceased patients at study entry, unless a waiver is granted) willing and able to provide written or electronic informed consent according to the local regulations, where applicable
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Patients diagnosed with primary stage IA to IIIB NSCLC as per seventh edition AJCC whose tumour was deemed resectable between 01 January 2013 and 31 December 2017 and followed up until at least 31 December 2020, as per the medical records with availability of at least 12 months of follow-up data from the index date (date of diagnosis of early-stage [IA to stage IIIB] resectable NSCLC), unless patient died within 12 months of diagnosis.
Exclusion Criteria:
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Patients with a concomitant cancer at the time of diagnosis of NSCLC, except for nonmetastatic nonmelanoma skin cancers, or in situ or benign neoplasms; a cancer will be considered concomitant if it occurs within 5 years of NSCLC diagnosis
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Patients diagnosed with stage IV NSCLC
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Histology of the tumour is small cell lung cancer, neuroendocrine in origin, or a mixed histologic type with small cell and non-small cell lung cancers.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Alexandria | Egypt | ||
| 2 | Research Site | Cairo | Egypt | ||
| 3 | Research Site | Giza | Egypt | ||
| 4 | Research Site | Hong Kong | Hong Kong |
Sponsors and Collaborators
- AstraZeneca
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D133FR00169