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

Straus 2011.

Study characteristics
Methods Secondary citation(s)
  • Kostakoglu 2012


Language of publication
  • English


Study design
  • Prospective phase 2, multi‐centre (29 centres), clinical trial


Study centre(s)
  • 29 Cancer and Leukemia Group B (CALGB) institutions


Country/Countries
  • Not reported


Median follow‐up time (range)
  • Not reported

Participants Number of included participants
  • Total: 99

  • With interim‐PET: 88


Inclusion criteria
  • Previously untreated, histologically confirmed, classic HL with clinical stages I or II, measurable through physical examination or imaging studies


Exclusion criteria
  • Bulky disease


Consent
  • Yes; written


Recruitment period
  • 15 May 2004 to 29 September 2006


Age (range, in years)
  • 37 (18‐80)


Ethnic group(s)
  • Not reported


Stages of disease
  • Stages I ‐ IIB


Comorbidities
  • Not reported


Therapy regimen
  • 6 cycles of AVG administered on days 1 and 15 per cycle

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


Definition of prognostic factor(s)
  • Not reported


Timing of prognostic factor measurement
  • 1 to 2 weeks after completion of cycle 2 of AVG


Method for measurement (use of specific scale and cut‐off)
  • Visual assessment was performed using International Harmonization Project criteria

  • Central review by 2 independent reviewers and an adjudicator


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)?
  • Yes

Outcome(s) Primary outcome(s) and definition(s)
  • Complete response, defined as complete remission or complete remission unconfirmed after 6 cycles of chemotherapy


Secondary outcome(s) and definition(s)
  • Progression‐free survival (PFS), measured from study entry until relapse

  • Adverse events (AEs), defined as toxicity including grade 3 or greater myelosuppression


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)?
  • Not reported

Missing data Participants with any missing value?
  • No


If yes, how were missing data handled?
  • None

Analysis Univariable analysis: Yes
Total number of participants included in univariable analysis for each outcome
  • Complete response: none

  • PFS: 88


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

  • Loss to follow‐up reported (n = 2).


Prognostic factor measurement
  • Low risk

  • Adequate measurement and description. PET2 available for n = 88 out of a total of n = 99 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 stages I ‐ IIB included.


Statistical analysis and reporting
  • Low risk

  • Statistical method in univariable analysis appropriate for the data.

Notes Conflict of interest
  • The publication costs of this article were defrayed in part by page charge payment. Therefore, and solely to indicate this fact, this article is hereby marked ‘‘advertisement’’ in accordance with 18 USC section 1734.The authors declare no competing financial interests.


Funding
  • This work was supported by the National Cancer Institute: CA77651 (D.J.S., H.S.), CA33601 (J.L.J.), CA32291 (A.S.L., G.P.C.), CA77440 (N.L.B.), CA04457 (L.K.), CA77658 (N.C.H., S.‐H.J.), CA32291 (R.W.T.), CA47642 (M.E.J.), and CA77597 (B.D.C.). This work was supported in part by the Lymphoma Foundation, Adam Spector Fund for Hodgkin Research, the Ernest & Jeanette Dicker Charitable Foundation, and Mr Daniel Moon and Family (for D.J.S.). This work was also supported by CALGB (National Cancer Institute) with partial support by Eli Lilly and Company. The research for CALGB 50203 was supported in part by grants from the National Cancer Institute (CA31946) to the CALGB (Dr Monica M. Bertagnolli, Chair) and to the CALGB Statistical Center (Dr Stephen George, CA33601). The content of this manuscript is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute.