Comparing Common Safety Outcomes in Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients Treated with Various First-line Platinum-containing Chemotherapy Combination Regimens (H3E-MC-B026)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  BEVACIZUMAB

  CARBOPLATIN

  CISPLATIN

  DOCETAXEL

  PEMETREXED

  PACLITAXEL

Population studied

• Short description of the study population:
  Stage IIIB/IV NSCLC patients who received one of the selected chemotherapy regimens on or after the date of NSCLC diagnosis. From 26 September 2008 (the date that Pemetrexed was first approved for first-line treatment of NSCLC by the FDA in the US) and 30 November 2014 (1 month before the last date that the data are available in the database), among all patients with only one primary tumor type and valid age information, those who meet the following criteria were included in the study:; 1) Patients were diagnosed with lung cancer as a primary cancer (at least one ICD-9-CM code indicating lung cancer, or a TUMOR TYPE value of “Lung Cancer”) with at least an ICD-O-3 code indicating non-small cell histology (Howlader et al. 2014), or a cancer subtype recorded as “NSCLC” records in the IMS Oncology electronic medical records (EMR); and; 2) The staging information indicating locally advanced or metastatic disease; 3) Patients initiated the first-line treatment including Pem/Cis, Pem/Carbo, Pem/Bev/Carbo,Pac/Carbo, Pac/Bev/Carbo, or Doc/Carbo after the lung cancer diagnosis. The date of any of the above first-line treatment initiation is the index date; and; 4) Patients must be 18 years of age or older on the index date; and; 5) Patient’s oncology practice must be stable between the index date and end of record in the database, or 31 December 2014, whichever comes first.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Non-small cell lung cancer patients
• Estimated number of subjects:
  2600

Study design details

• Main study objective:
  To evaluate the safety outcomes among Stage IIIB/IV NSCLC patients treated with Pemetrexed+Cisplatin, Pemetrexed+Carboplatin, Pemetrexed+Bevacizumab+Carboplatin, Paclitaxel+Carbopltain, Paclitaxel+Bevacizumab+Carboplatin, or Docetaxel+Carboplatin
• Outcomes:
  To estimate the crude incidence proportions and rates of the safety outcomes among the NSCLC patients receiving 1st line treatment with selected chemotherapy regimens, to describe demographic and clinical characteristics of each treatment group, if sample size allows, to compare the safety outcomes between the treatment groups by hazard ratio by adjusting patient and clinical characteristics. If sample size allows, to conduct subgroup analyses to further examine the safety profiles of the NSCLC patients treated with the regimens in those who were below 70 and who were 70 years or older.
• Data analysis plan:
  The primary analysis of this protocol is to describe the incident safety outcomes after index date in patients who were administered at least one of the selected chemotherapy regimens. If sample size allows, adjusted incidence rates, rate difference and hazard ratios will be estimated among the comparable patients with the application of the propensity score stratification method.