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. 2020 Jan 13;2020(1):CD012643. doi: 10.1002/14651858.CD012643.pub3

Zaucha 2017.

Study characteristics
Methods Secondary citation(s)
  • NA


Language of publication
  • English


Study design
  • Prospective, observational, multi‐centre study (11 centres)


Study centre(s)
  • 11 haemato‐oncology centres


Country
  • Poland


Median follow‐up time (range)
  • 44.7 months (12.7–90.2)*


*Data for surviving participants only
Participants Number of included participants
  • 310 registered participants, out of which 24 were excluded from analysis due to treatment intensification based on PET1 and/or clinical symptoms of active HL


Inclusion criteria
  • Newly diagnosed with classic HL


Exclusion criteria
  • Absent/poor‐quality PET‐CT images


Consent
  • Yes; written informed consent


Recruitment period
  • January 2008 to October 2014


Age (range, in years)
  • 30.8 (median, 18–80)


Ethnic group(s)
  • Not reported


Stages of disease
  • All stages


Comorbidities
  • Not reported


Therapy regimen
  • ABVD dependent on disease stage: stages I‐IIA 2‐4x ABVD with radiotherapy or 6x ABVD; stages IIB‐IV 6‐8x ABVD with or without radiotherapy

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


Definition of prognostic factor(s)
  • Whole‐body scan (mandibular angle to one third upper femur)


Timing of prognostic factor measurement
  • 11‐13 days after end of ABVD cycle 1 (PET1)

  • Additional scan after ABVD cycle 2 for participants with a PET1 score of 3‐5 (PET2)


Method for measurement (use of specific scale and cut‐off)
  • Deauville 5‐point scoring system

  • Scores 1‐3 considered negative, scores 4‐5 considered positive

  • 6 reviewers interpreted all scans using the blinded independent central review method, disagreements were resolved in a joint session


Was the same definition and method for measurement used in all participants?
  • No; PET2 only administered to participants with a PET1 score of 3‐5


Were prognostic factor(s) assessed blinded for outcome(s), and for each other (if relevant)?
  • Yes

Outcome(s) Primary outcome(s) and definition(s)
  • Progression‐free survival (PFS), not defined


Secondary outcome(s) and definition(s)
  • Kinetics of response


Timing of outcome measurement
  • At 3 years


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)?
  • Yes

Missing data Participants with any missing value?
  • Yes; only 198 participants had PET2 scans


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

Analysis Univariable analysis: Yes
Total number of participants included in univariable analysis for each outcome
  • 286 (PET1) / 198 (PET2)


Statistical method
  • Kaplan‐Meier (survival analysis)

  • Cox proportional hazard regression analysis (HR between treatment groups)


How was the prognostic factor treated?
  • Binary


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

  • Clear description of participants and study characteristics.


Study attrition
  • Low risk


Prognostic factor measurement
  • Moderate risk

  • Adequate measurement and description. Prognostic factor measured the same way for all participants. However, while PET1 scans were available for all participants, the availability of PET2 scans was dependent on the result of PET1. No further scans were performed if PET1 was negative


Outcome: Overall survival
Not reported as a primary endpoint in the publication. IPD data were available and used to calculate the HR and SE for this outcome.
Outcome: Progression‐free survival
Outcome measurement
  • High risk

  • No definition of outcome.


'Other prognostic factors (covariates)'
  • High risk

  • Disease stage not accounted for.


Statistical analysis and reporting
  • High risk

  • No detailed description of analysis.


Outcome: Adverse events
Not reported
Notes Conflict of interest
  • The authors have declared no conflicts of interest.


Funding
  • No funders to report.