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

Zinzani 2012.

Study characteristics
Methods Secondary citation(s)
  • Zinzani 2006


Language of publication
  • English


Study design
  • Retrospective, multi‐centre study (2 centres)


Study centre(s)
  • Bologna and Florence, Italy


Country
  • Italy


Median follow‐up time (range)
  • 45 months (6‐100)

Participants Number of included participants
  • 304


Inclusion criteria
  • Diagnosed with HL


Exclusion criteria
  • Other treatment regimens than ABVD

  • Secondary lymphomas

  • Continuation of therapy during data analysis


Consent
  • Yes; written informed consent


Recruitment period
  • June 1997 to June 2009


Age (range, in years)
  • 32 (13‐78)


Ethnic group(s)
  • Not reported


Stages of disease
  • All stages


Comorbidities
  • Assessed, but not reported


Therapy regimen
  • ABVD dependent on disease stage: early stages 6x ABVD or 4x ABVD with radiotherapy; advanced stages 6x ABVD

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


Definition of prognostic factor(s)
  • Not reported


Timing of prognostic factor measurement
  • After cycle 2 of ABVD


Method for measurement (use of specific scale and cut‐off)
  • Juweid criteria

  • PET positive considered if focal FDG uptake that could not be attributed to physiological biodistribution, benign uptake or normal anatomy, with clearly increased activity relative to the background, excluding participants with minimal residual uptake

  • 2 experienced board‐certified nuclear medicine physicians interpreted all scans


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)?
  • No

Outcome(s) Primary outcome(s) and definition(s)
  • Response at the end of first‐line treatment and at follow‐up


Secondary outcome(s) and definition(s)
  • Progression‐free survival (PFS), defined as time from diagnosis to first observation of progressive disease or death from any cause

  • Overall survival (OS), defined as time from diagnosis to time of most recent visit or death


Timing of outcome measurement
  • At 9 years (for PFS and OS)


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)?
  • No

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

  • OS: 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

  • Clear description of participants and study characteristics.


Study attrition
  • Low risk

  • No loss to follow‐up.


Prognostic factor measurement
  • Low risk

  • Adequate measurement and description. Prognostic factor measured the same way for all participants. No blinding of assessors.


Outcome: Overall survival
Outcome measurement
  • Low risk

  • Clear definition of outcome. Outcome measured the same way for all participants.


'Other prognostic factors (covariates)'
  • High risk

  • Disease stage not accounted for.


Statistical analysis and reporting
  • Low risk

  • Statistical method appropriate for the data.


Outcome: Progression‐free survival
Outcome measurement
  • Low risk

  • Clear definition of outcome. Outcome measured the same way for all participants.


'Other prognostic factors (covariates)'
  • High risk

  • Disease stage not accounted for.


Statistical analysis and reporting
  • Low risk

  • Statistical method appropriate for the data.


Outcome: Adverse events
Not reported
Notes Conflict of interest
  • None


Funding
  • This work was partially supported by BolognAIL (Bologna, Italy).

ABVD: adriamycin/doxorubicin, bleomycin, vinblastine and dacarbazine; BEACOPP: bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone; ePET: early positron emission tomography; FDG: [18F]‐fluorodeoxy‐D‐glucose; HL: Hodgkin lymphoma; HR: hazard ratio; IF‐RT: involved‐field radiation therapy; ITT: intention‐to‐treat; IQR: interquartile range; NPV: negative predictive value; OS: overall survival; PET: positron emission tomography; PET‐CT: positron emission tomography computed tomography; PFS: progression‐free survival; PPV: positive predictive value.