Skip to main content
. 2020 Jan 13;2020(1):CD012643. doi: 10.1002/14651858.CD012643.pub3

Markova 2012.

Study characteristics
Methods Secondary citation(s)
  • Markova 2009


Language of publication
  • English


Study design
  • Retrospective, single‐centre study


Study centre(s)
  • Prague, institution not reported


Country
  • Czech Republic


Median follow‐up time (range)
  • 52 months

Participants Number of included participants
  • 69


Inclusion criteria
  • Newly diagnosed, histologically proven HL

  • Clinical stage IIB with large mediastinal mass and/or extranodal disease, stage III or IV

  • Age 18‐60 years


Exclusion criteria
  • Presence of any concurrent disease precluding protocol treatment

  • Composite lymphoma

  • Previous malignancy

  • Previous chemo‐ or radiotherapy

  • Pregnancy or lactation

  • Diabetes mellitus and elevated fasting blood sugar level >130 mg/dl (exclusion from PET)


Consent
  • Not reported


Recruitment period
  • January 2004 to February 2008


Age (range, in years)
  • 30.7 (± 8.4)


Ethnic group(s)
  • Not reported


Stages of disease
  • IIB to IVB


Comorbidities
  • None, due to exclusion criteria


Therapy regimen
  • Treatment according to the HD15 trial of the German Hodgkin Study Group (GHSG) randomly assigned to either 8 cycles of BEACOPPescalated, 6 cycles of BEACOPPescalated or 8 cycles of time‐condensed BEACOPP14baseline

  • Local radiotherapy for participants with partial remission with residual mass ≥2.5cm and positive PET scan after chemotherapy

Prognostic factor(s) Prognostic factor(s)
  • Interim PET


Definition of prognostic factor(s)
  • Not reported


Timing of prognostic factor measurement
  • After cycle 4 of chemotherapy, as close as possible to cycle 5


Method for measurement (use of specific scale and cut‐off)
  • A local nuclear medicine physician interpreted all interim‐PET scans

  • PET‐positive defined as focal or diffuse uptake above background in a location incompatible with normal anatomy or physiology, without a specific standardised uptake cut‐off value; PET‐negative defined as no uptake, or increased uptake at the site of residual mass with an intensity lower or equal to the mediastinal blood pool


Was the same definition and method for measurement used in all participants?
  • Yes


Were prognostic factor(s) assessed blinded for outcome(s), and for each other (if relevant)?
  • Not reported

Outcome(s) Primary outcome(s) and definition(s)
  • Progression‐free survival (PFS), defined as the time from diagnosis to the first evidence of progression or relapse, or death from any cause


Secondary outcome(s) and definition(s)
  • None


Timing of outcome measurement
  • After cycle 4, 6/8 and 3 months after completion of chemotherapy


Was the same definition and method for measurement used in all participants?
  • Yes


Was/were outcome(s) assessed blinded for prognostic factor(s), and for each other (if relevant)?
  • Not reported

Missing data Participants with any missing value?
  • No


If yes, how were missing data handled?
  • Not applicable

Analysis Univariable analysis: Yes
Total number of participants included in univariable analysis for each outcome
  • PFS: all


Statistical method
  • Kaplan‐Meier (survival analysis)

  • Log‐rank test (comparison between groups)


How was the prognostic factor treated?
  • Binary


Multivariable analysis: No
Risk of bias (QUIPS) Study participation
  • Low risk

  • All eligible participants included. Clear description of participants and study characteristics. Consecutive sampling. Inclusion and exclusion criteria provided.


Study attrition
  • Low risk

  • No loss to follow‐up.


Prognostic factor measurement
  • Moderate risk

  • Prognostic factor measured differently: PET4 scans reviewed locally (at the centre) by one physician, whereas PET6/8 assessment included central review.


Outcome: Overall survival
Not reported
Outcome: Progression‐free survival
Outcome measurement
  • Low risk

  • Outcome measured the same way for all participants.


'Other prognostic factors (covariates)'
  • Low risk

  • Only advanced stages included.


Statistical analysis and reporting
  • Low risk

  • Statistical method in univariable analysis appropriate for the data.


Outcome: Adverse events
Not reported
Notes Conflict of interest
  • Not reported


Funding
  • Not reported