Association Between Granulocyte Colony Stimulating Factor (G-CSF) use and Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) Among Elderly Patients With Breast (Stage I-III), lung (Stage I-III) or Prostate (Stage I-IV) Cancer

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• 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

• Anatomical Therapeutic Chemical (ATC) code:
  (L03AA) Colony stimulating factors

  Colony stimulating factors
• Medical condition to be studied:
  Breast cancer

  Myelodysplastic syndrome

  Acute myeloid leukaemia

Population studied

• Short description of the study population:
  Any patients diagnosed with stage I-III breast, lung, prostate cancer between January 1, 2001 and December 31, 2014 and who satisfy the inclusion and exclusion; criteria will be included in the study.; Inclusion Criteria; Patients must satisfy the following criteria:; − Chemotherapy following first diagnosis of breast (stage I-III), lung (stage I-III) or prostate (stage I-IV) cancer; − Index date (Sixtieth day without chemotherapy following last dose of first chemotherapy course) between Jan 1, 2001 and Dec 31, 2014; − Alive and at least 66 years of age at index date; − Continuous enrollment in both Part A and Part B Medicare for at least 12 months prior to the index date; Exclusion Criteria; Patients must not have any of the following criteria:; − Breast, lung, or prostate cancer is not their first primary cancer diagnosis; − Breast, lung, or prostate breast cancer diagnosis identified only at autopsy or on their death certificate; − Men with breast cancer diagnosis; − Unknown stage at first cancer diagnosis; − End-stage renal disease (ESRD) any time prior to the index date.; − Enrolled in Health maintenance organization (HMO) any time during the study period; − Diagnosed with MDS/AML or any other second primary cancer diagnosis any time prior to the index date.
• Age groups:
  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:
  Breast cancer, Myelodysplastic syndrome, Acute myeloid leukaemia patients
• Estimated number of subjects:
  56000

Study design details

• Main study objective:
  Among breast, lung, and prostate cancer patients, assess risk of developing second primary myelodysplastic syndromes or acute myeloid leukemia by treatment modality
• Outcomes:
  myelodysplastic syndromes or acute myeloid leukemia, Competing risk events: death, second primary malignancy (not MDS or AML), censoring
• Data analysis plan:
  Time at risk for developing MDS/AML begins 60 days after end of last treatment. AML ascertained from SEER registry primary malignancy field. MDS from 2001-2009 ascertained by presence of 2 diagnosis codes in claims. 2010+ MDS ascertained by SEER registry primary malignancy field. Cox hazard models to estimate risk of developing MDS/AML.

Documents

Study results

01.09.01 Clinical Study Report 2020-03-19 20160176 Original_Redacted