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

Rossi 2014.

Study characteristics
Methods Secondary citation(s)
  • NA


Language of publication
  • English


Study design
  • Retrospective, single‐centre study


Study centre(s)
  • Hospital of Dijon, France


Country
  • France


Median follow‐up time (range)
  • 50 months (22‐71)

Participants Number of included participants
  • 59


Inclusion criteria
  • First diagnosis of classic HL


Exclusion criteria
  • Positive serology for HIV


Consent
  • Yes; written informed consent


Recruitment period
  • January 2007 to January 2010


Age (range, in years)
  • 35.5 (16‐76)


Ethnic group(s)
  • Not reported


Stages of disease
  • All stages


Comorbidities
  • Not reported, except for exclusion of HIV positive participants


Therapy regimen
  • Anthracycline‐based chemotherapy dependent on disease stage: stages I‐II 4‐6x chemotherapy with radiotherapy; stages III‐IV 8x chemotherapy

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


Definition of prognostic factor(s)
  • Whole‐body PET‐CT scan


Timing of prognostic factor measurement
  • After 2 cycles of chemotherapy


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

  • ΔSUVmax (PET0‐PET2) dichotomized by applying the ROC approach

  • Independent review by 2 nuclear medicine physicians


Was the same definition and method for measurement used in all participants?
  • Different scanner used for 4 participants


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), defined as the time from the beginning of treatment until progression, relapse, or death from any cause or the date of last follow‐up

  • Time to progression (TTP), defined as time from the date of the first course of chemotherapy to any treatment failure, including progression, relapse, or death related to lymphoma, or the date of last follow‐up (participants with death from other cause were censored at the time of death)


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


Timing of outcome measurement
  • At 4 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)?
  • 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 univariate analysis for each outcome
  • PFS: all


Statistical method
  • Kaplan‐Meier product limit method with log‐rank test


How was the prognostic factor treated?
  • Binary


Multivariable analysis: Yes
Total number of participants included in multivariable analysis for each outcome
  • PFS: all


Statistical method
  • Cox proportional hazards regression models per outcome


How was the prognostic factor treated?
  • Binary


Number of candidate covariates
  • 2


List of all candidate covariates
  • ΔSUVmax (PET0‐PET2)

  • International prognosis score (IPS)

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.


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

  • Clear definition. Outcome measured the same way for all participants. Blinding not reported.


'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
  • The costs of publication of this article were defrayed in part by the payment of page charges. Therefore, and solely to indicate this fact, this article is hereby marked “advertisement” in accordance with 18 USC section 1734. No potential conflict of interest relevant to this article was reported.


Funding
  • Not reported