Real-world Treatment Patterns and Associated Outcomes in Patients With Resectable Early-stage Non-small Cell Lung Cancer

AstraZeneca748 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

748

Conditions

Non-small Cell Lung Cancer

Eligibility

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult female and male patients aged ≥18 years or 'adults' according to age of majority as defined by the local regulations on index date 2. 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 3. 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: 1. 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 2. Patients diagnosed with stage IV NSCLC 3. 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.

Locations (25)

Research Site

Sydney, New South Wales, Australia

Research Site

Brisbane, Queensland, Australia

Research Site

Perth, Western Australia, Australia

Research Site

Alexandria, Egypt

Research Site

Cairo, Egypt

Research Site

Sohag, Egypt

Research Site

Hong Kong, Hong Kong

Research Site

Howrah, Kolkata, India, India

Research Site

Bangalore, India

Research Site

Delhi, India

...and 15 more locations

Outcomes

Primary Outcomes

Proportion of patients per treatment modalities

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

Time frame: 3 Years

Duration of treatment

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

Time frame: 3 years

Survival rate

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.

Time frame: 3 Years

Secondary Outcomes

Demographic characteristics

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

Time frame: 3 Years

Eastern Cooperative Oncology performance status Group characteristics

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

Time frame: 3 Years

Histological type

Proportion of Histological type (adenocarcinoma, adenosquamous carcinoma, bronchioalveolar carcinoma, large-cell carcinoma, and NSCLC not otherwise specified)

Time frame: 3 Yewars

Clinical-pathological Tumor stage

Tumor Staging as per seventh edition AJCC (IA, IB, IIA, IIB, IIIA, IIIB) with lymph node metastasis status (N0, N1, and N2)

Time frame: 3 Years

TNM staging at index diagnosis

Time frame: 1 Month

Genetic alterations

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 \[TP53\]

Time frame: 3 Years

Survival rates at pre-defined landmark timepoints (other than 3-year)

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

Time frame: 1 Years

Prevalence of EGFR mutations

Proportion of patients with EGFR mutation-positive status

Time frame: 3 Years

Prevalence of PD-L1 expression

Proportion of patients with PD-L1 positivity at various cut-off points (\<1%, ≥1% to \<25%, ≥25% to \<50%, and ≥50%)

Time frame: 3 Years