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

Oki 2014.

Study characteristics
Methods Secondary citation(s)
  • NA


Language of publication
  • English


Study design
  • Retrospective, single‐centre study


Study centre(s)
  • MD Anderson Cancer Center, Houston, Texas, USA


Country
  • USA


Median follow‐up time (range)
  • 45 months

Participants Number of included participants
  • Total: 325

  • 229 participants with PET2 analysed

  • 96 participants with PET3 excluded post‐hoc


Inclusion criteria
  • Classic HL

  • Treatment with ABVD

  • Availability of interim PET scan


Exclusion criteria
  • Additional treatment (e.g. with brentuximab vedotin or rituximab) except for radiotherapy


Consent
  • Not reported


Recruitment period
  • January 2001 to May 2011


Age (range, in years)
  • Group I (early‐stage non‐bulky): 32 (median, 18‐77)

  • Group II (stage II bulky): 36 (20‐60)

  • Group III (advanced stage IPS ≤ 2): 30 (19‐79)

  • Group IV (advanced stage IPS ≥ 3): 49 (19‐84)


Ethnic group(s)
  • Not reported


Stages of disease
  • All stages


Comorbidities
  • Not reported


Therapy regimen
  • ABVD with or without radiotherapy

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


Definition of prognostic factor(s)
  • Not reported


Timing of prognostic factor measurement
  • After 2 or 3 cycles of ABVD


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

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

  • Independent assessment by 3 nuclear medicine physicians


Was the same definition and method for measurement used in all participants?
  • No, 10 participants had only PET without CT scan


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 diagnosis to disease progression, relapse or death from any cause


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


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)?
  • 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


Statistical method
  • Kaplan‐Meier survival curves with log‐rank test per subgroup

  • Univariable Cox proportional hazard models


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.


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

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


'Other prognostic factors (covariates)'
  • High risk

  • Disease stage not accounted for.


Statistical analysis and reporting
  • High risk

  • Exclusion of participants with PET3 during analysis due to lack of prognostic value. Stratification according to disease stage resulted in small sample sizes per subgroup.


Outcome: Adverse events
Not reported
Notes Conflict of interest
  • No conflict of interest to disclose for the study.


Funding
  • Not reported