Signal Detection in Monoclonal and New Agents in Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Observational [Patient Registry]

Summary: 
      Non Hodgkin lymphoma (NHL) is the 5th cancer in France. Advances in NHL therapy have resulted
      in improved cure rates with a 5 year relative survival rate estimated at 55% and a 5-year
      prevalence estimate of 27,750 cases. Since 2000, the addition of anti-CD20 antibody to the
      standard treatment regimen composed of cyclophosphamide, doxorubicin, vincristine, and
      prednisone (CHOP) led for the first time to decline of the specific mortality.

      After treatment, patients with NHL experienced elevated risks for therapy-related leukemia,
      several solid tumors and late toxicities such as cardiovascular or neuro-psychiatric diseases
      which impact on quality of life. However little is known concerning long-term toxicity of
      this class of new agents so called "targeted drugs" such as anti-CD20.

      The primary objective of this cohort study is to estimate long term toxicity in NHL patients
      (i.e. 10 to 20 years) using data already collected (i.e. internal analysis) and to compare
      drugs consumption to that of controls (i.e. external analysis).
    

Detailed description: 
      The French public healthcare system perspective developed a unique SNIIR-AM (interregimens
      National Information Health Insurance system.) data base that contains up to 18 TeraOctet of
      medical consumption data (consultations, exams and drug prescriptions and hospitalization,
      yes/no). Its main limitation to detect disproportionate consumption after cancer care is the
      lack of data available on socio-demographic, pre-diagnostic patient and disease
      characteristics.

      The LYSA (Lymphoma Study Association) is a national cooperative group which is world pioneer
      in NHL treatment with novel agents. Patient's bio clinical and demographic characteristics
      (n=10.000) are fully monitored and stocked in a data base registered in 2006 by the French
      National Cancer Institute (INCA). The cooperative network of 100 LYSA centre allows following
      all the patients on long term (up to 20 years after diagnosis).

      Then, the mixture of these two sources of data will offer a unique material at the nation
      scale to detect signal of late onset disease, possibly linked to the initial cancer
      treatment.

      Statistical Methods Disproportionate reporting of drugs consumption in fields of
      neuro-psychiatric troubles, cardio-vascular diseases, anti-cancer agents, antibiotics and
      antiviral agents will be extract from the French public healthcare database (external
      analysis). An economical study is embedded.

      As the LYSA data contained all fully monitored patients' bio clinical and demographic
      characteristics, special attention will be paid to the addition of new agents, in particular
      anti-CD20 antibody, to the cytotoxic chemotherapy regimens in conjunction with other
      well-known risk factors (e.g. tobacco, obesity, comorbidities; internal analysis).

      Data will be reported according to the initial NHL treatment strategy and cross-validated by
      long-term medical consultations. Multivariate analysis will be computed to account for
      competing risks.

      Results No studies have yet been published in France on the use of care issues in long
      remission or cure of cancer. There are very few international publications on this subject
      and they lacked of statistical power or follow up.

      The present project follows the recommendation from the French Medicine Academy which in its
      March 15, 2011 decision call for more rigorous follow up of new agents in Oncology. In
      addition, this project is in concordance with the so named "plan cancer 2" from the INCA
      which aimed to focus on sequels in cancer survivors. If the results of this study are
      relevant, the investigators should have to run through the consumption of care, a good
      objective (unbiased) indicator of healing and Health-related quality of life (HRQL) in cancer
      survivors.

      Such an indicator could help to learn about survivors recovery after their cancer, with or
      without differences according to the patient characteristics, initial location of the cancer,
      its treatment and possible iatrogenic complications.
    

Intervention name(s): questionnaire
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The database of patients in therapeutic trials LYSA, French group treated more than 10,000
        patients over the last 20 years