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Guidelines for endpoint definitions in cancer trials. Bonnetain F DATECAN Project on behalf DATECAN steering committee Statisticians from CRLCC, EORTC, FFCD : Bellara C, Collette L, Dousseau A, Gourgou S, Kramar A, Ouali M, Mathoulin S. Rationale.

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slide1

Guidelines for endpoint definitionsin cancer trials

Bonnetain F

DATECAN Project

on behalf DATECAN steering committee

Statisticians from CRLCC, EORTC, FFCD : Bellara C, Collette L, Dousseau A, Gourgou S, Kramar A, Ouali M, Mathoulin S

slide2

Rationale

Review of randomized clinical trials in oncology(Mathoulin et coll. JCO 2008)

Medlinedatabases 2004: Cancer / RandomisedClinical Trial : 8 journals: Lancet, JAMA, BMJ, NEJM / BJC, JCO, JNCI, Cancer

Review of phase II (11) and phase III (104) randomized clinical trials

  • 1) Heterogeneity in the selection of ‘survival’ endpoints

2) Non-optimal survival endpoint definition

slide6

Summary

  • Definitions of guidelines in publications:
    • Without formal consensus (rather expert opinion)
    • Not often used
    • Available for only few cancer sites
  • Heterogeneity in:
    • The selection of time to event (survival) endpoints
    • The definitions of these endpoints
events contributing to dfs in adj colon cancer
Events contributing to DFS in adj Colon Cancer

MOSAIC/PETACC8 PETACC-3/ACCORD-02

  • Locoregional recurrence EE
  • Distant metastases EE
  • Second primary, same cancer E E
  • Second primary, other cancer IE
  • (Second primary, colorectal) EE
  • Death from same cancer EE
  • Death from other cancer E E
  • Non-cancer related death E E
  • Treatment related death E E
  • Loss to follow-up CC
  • DFS definitions
    • MOSAIC/PETACC8
    • relapse, death, 2nd colorectal cancer
      • 2nd cancer other than colorectal (ignored)
    • PETACC-3/ACCORD-02
      • relapse, death, 2nd colon cancer
      • 2nd cancer other than colon (event / RFS including only 2 nd colon cancer)
slide8

Summary

  • Consequences  Difficulties of interpretation
    • Comparison between trials
    • Different conclusions according to different definitions
  • Example: PETACC 03
    • (Van Cutsem E et al. J Clin Oncol 2009)(irinotecan / 5-fluorouracil (5-FU) / folinic acid (FA) versus 5-FU/FA in stage III colon cancer)
    • DFS (with second primary tumors)  Significant difference
    • DFS (without second primary tumors)  Non significant difference
slide9

Objective

To develop guidelines for survival endpoints definitions  standardization:

  • To define terminology
  • To define events and censoring process
slide10

Methods

  • Identification of selected cancer sites and relevant endpoints, based on literature review
  • For each cancer site

Develop guidelines with:

    • Consensus methods based on expert opinion obtained in a systematic manner
    • European consultation
    • Consultation of experts with various backgrounds (oncologist, surgeon, radiotherapist, biostatistician, …)
    • Later contact EMEA etc..
slide11

Target cancer sites

  • First year 2010 - 2011
    • Sarcomas
    • Pancreas cancer
    • Breast cancer
  • Following years:
    • Colo-Rectal cancer
    • GI cancer (Stomach) ± oesophagus
    • Kidney & Bladder cancer
    • Lymphomas
    • Head & Neck cancer
    • Lung cancer
slide13

Example of questionnaire (GI)

    • Should the following clinical events be regarded as events in the definition of the endpoint Disease Free survival (DFS)? Please place one tick  on each line.
  • Table 2 (Setting “no detectable disease” only)
slide15

EORTC Group contribution

  • To provide list of experts:
    • For participation in the design of the questionnaire (2-3)
      • Inclusion criteria
        • Experience in the specialty (>15 years: yes / no)
        • Principal investigator in clinical trials (>3: yes / no)
        • Participation in research projects (>3 : yes / no)
        • Publications in the specialty (>3: Yes / No)
    • For completion of the questionnaire (15-20)
      • Inclusion criteria
        • Experience in the specialty (>10 years: yes / no) (not strict)
        • Principal investigator in clinical trials (>1: yes / no)
        • Participation in research projects (>1 : yes / no)
        • Publications in the specialty (>3: Yes / No)
schedule
Schedule
  • January 2010 – May 2010
    • List and agreement of expert for Pilot Group and RC for Pancreatic, Sarcoma and Breast
  • May – Sept 2010
    • Creation of questionnaire forms
    • Validation and pre-test by pilot group (ongoing for breast)
    • Database constitution and validation (e-crf)
  • Since Nov 2010
    • First round consensus for Pancreatic and Sarcoma