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

Okosun 2012.

Study characteristics
Methods Secondary citation(s)
  • NA


Language of publication
  • English


Study design
  • Retrospective, multi‐centre study (6 centres)


Study centre(s)
  • 6 centres in London, UK


Country
  • UK


Median follow‐up time (range)
  • 27 months

Participants Number of included participants
  • 23


Inclusion criteria
  • Newly diagnosed, histologically confirmed classic HL

  • Advanced stage

  • HIV positivity


Exclusion criteria
  • None


Consent
  • Not reported


Recruitment period
  • June 2007 to August 2010


Age (range, in years)
  • 42 (median, 32‐60)


Ethnic group(s)
  • Not reported


Stages of disease
  • Advanced stages: stage III –IV or stage IIB with at least one adverse prognostic factor


Comorbidities
  • HIV positive participants only


Therapy regimen
  • Treatment for HL: standard ABVD therapy

  • Treatment for HIV: HAART (two NRTIs in combination with either a non‐NRTI or a boosted protease inhibitor) antiretroviral therapy; G‐CSF per centre protocol; prophylaxis for Pneumocystis jiroveci

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


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


Timing of prognostic factor measurement
  • After 2‐3 cycles of ABVD, within the week before start of the next cycle


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

  • Assessed at 3 established PET centres by own nuclear medicine physician and central review by nuclear medicine expert


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 disease progression or relapse or last follow‐up


Secondary outcome(s) and definition(s)
  • Overall survival (OS), defined as the time from diagnosis to death from any cause

  • Complete remission, defined as the disappearance of all disease manifestations at the end of therapy


Timing of outcome measurement
  • At 2 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

  • OS: not applicable, since no participants died


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


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. Three participants did not have a staging PET, no reasons for missing PET provided.


Study attrition
  • Low risk

  • No loss to follow‐up. Length of follow‐up reported. Participants without interim PET (n = 11) excluded.


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)'
  • Low risk

  • Only unfavourable and advanced stages included.


Statistical analysis and reporting
  • High risk

  • Small sample size for some events (only two participants with positive interim PET result).


Outcome: Adverse events
Not reported
Notes Conflict of interest
  • All authors have no conflicts of interest or disclaimers to declare.


Funding
  • Not reported