Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Safety study (incl. comparative)

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

PEMETREXED
CARBOPLATIN

Medical condition to be studied

Non-small cell lung cancer
Population studied

Short description of the study population

Non-small cell lung cancer (NSCLC) patients with evidence of initiating Pem/Carbo AUC5 or Pem/Carbo AUC6 on or after the date of NSCLC diagnosis. During 04 February 2004 (the date that Pemetrexed was first approved by FDA in the US) and 31 May 2014 (30 days before the last date that the data are available in the database), among all patients
with only 1 primary tumour type and valid age information, those who meet the following criteria will be included in the study:
1) Patients were diagnosed with lung cancer as a primary cancer (at least one ICD-9-CM code in 162.2, 162.3, 162.4, 162.5, 162.8, or162.9, or a TUMOR TYPE value of
“Lung Cancer”), excluding those who had a small cell histology (ICD-O-3 code 8002, 8041-8045, or a cancer subtype recorded as “SCLC” [small cell lung cancer] in the
IMS Oncology EMR); and
2) Patients initiated the Pem/Carbo AUC5 or Pem/Carbo AUC6 after the lung cancer diagnosis. The date of Pem/Carbo AUC5 or Pem/Carbo AUC6 initiation is the index date, excluding those who started on Pemetrexed/Carboplatin/Bevacizumab and then switched to Pem/Carbo AUC5 or Pem/Carbo AUC6 and those who started on Pem/Carbo AUC5 or Pem/Carbo AUC6 and then switched to Pemetrexed/Carboplatin/Bevacizumab; and
3) Patients must be 18 years of age or older on the index date, have valid gender and weight information, at least one non-missing serum creatinine test result during the period from 7 days prior to the index date until 7 days after the index date, and valid dose record for the index carboplatin prescription; and
4) Patient’s oncology practice must be stable between the index date and end of record in the database, or 30 June 2014, whichever 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

700
Study design details

Main study objective

The purpose of this study is to evaluate the safety profiles of Non Small Cell Lung Cancer (NSCLC) patients treated with Pemetrexed /Carboplatin (Pem/Carbo) AUC5 and Pem/Carbo AUC6.

Outcomes

Primary objectives are, in NSCLC patients treated with Pem/Carbo AUC5 or Pem/Carbo AUC6,1) To describe patient demographic and clinical characteristics.2) To estimate the crude incidence proportions and incidence rates of the safety outcomes.3) If data allow, to estimate the incidence rate, rate difference, and HR of safety outcomes in adjusted analyses. If data allow, the secondary objectives include conducing subgroup analysis to further examine the safety profiles of the NSCLC patients treated with Pem/Carbo AUC5 or Pem/Carbo AUC6 in those who were below 70 and who were 70 years or older

Data analysis plan

Analyses will be conducted in a cohort of NSCLC patients treated with Pem/Carbo AUC5 or Pem/Carbo AUC6, in IMS Oncology between 04 February 2004 and 30 June 2014.Descriptive statistics will be used to describe baseline demographic and clinical characteristics of patients treated with Pem/Carbo AUC5 or Pem/Carbo AUC6. Crude incidence rates of safety outcomes among patients treated with Pem/Carbo AUC5 or Pem/Carbo AUC6 will be calculated. The frequency and incidence rate of the safety outcomes with 95% CIs will be estimated based on the first occurrence of these safety events.If data allow, the adjusted incidence rates, rate difference, and HR of treatment-emergent safety outcomes will be estimated. Propensity score stratification will be used to adjust for differences in the distribution of baseline characteristics. Cox regression models will be used to compare time-to-event in the Pem/Carbo AUC5 and Pem/Carbo AUC6 cohorts. All analysis will be carried out using SAS (version 9.2).