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Comparable outcomes of patients eligible vs ineligible for SWOG leukemia studies.

Publication ,  Journal Article
Statler, A; Othus, M; Erba, HP; Chauncey, TR; Radich, JP; Coutre, S; Advani, A; Nand, S; Ravandi, F; Mukherjee, S; Sekeres, MA
Published in: Blood
June 21, 2018

Patients may be deemed ineligible for a clinical trial for reasons that do not directly impact efficacy or safety. We identified reasons for ineligibility and compared outcomes of ineligible with eligible patients treated on Southwest Oncology Group (SWOG) Leukemia Committee protocols. Patients enrolled in SWOG phase 2, 2/3, or 3 protocols open since 2005 were analyzed for eligibility status, reasons for ineligibility, baseline characteristics, Eastern Cooperative Oncology Group (ECOG) performance status (PS), serious adverse events (SAEs), complete remission (CR) status, and overall survival. A total of 2361 patients were enrolled in the 13 included studies. Of these, 247 (10%) were deemed ineligible; 78 were excluded from analyses, and 169 were included. Of the 169 included in analyses, 60% (101/169) were excluded due to missing baseline documentation. Baseline characteristics comparing ineligible to eligible patients were similar, with the exception of ECOG PS for S0325 (P = .02) and S0530 (P = .002). In multivariable analyses, neither the proportion of patients with ECOG PS ≥ 2 (P = .12) nor the rate of grade 5 SAEs (P = .62) differed between groups. There was no difference in survival between eligible and ineligible patients (P = .25), and CR rates were similar, with the exception of S0325 (P < .001) and S0703 (P = .004). The findings of this study suggest that nonessential eligibility criteria can be less restrictive, thus expanding patient enrollment and avoiding protocol deviations. The clinical trials included in this study were registered at www.clincialtrials.gov as #NCT00085709, #NCT00066794, #NCT00070499, #NCT00109837, #NCT00093418, #NCT00492856, #NCT00337168, #NCT00352365, #NCT00658814, #NCT00792948, #NCT00945815, #NCT00840177, and #NCT01522976.

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Published In

Blood

DOI

EISSN

1528-0020

Publication Date

June 21, 2018

Volume

131

Issue

25

Start / End Page

2782 / 2788

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Survival Analysis
  • Middle Aged
  • Male
  • Leukemia
  • Immunology
  • Humans
  • Female
  • Eligibility Determination
 

Citation

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Statler, A., Othus, M., Erba, H. P., Chauncey, T. R., Radich, J. P., Coutre, S., … Sekeres, M. A. (2018). Comparable outcomes of patients eligible vs ineligible for SWOG leukemia studies. Blood, 131(25), 2782–2788. https://doi.org/10.1182/blood-2018-01-826693
Statler, Abby, Megan Othus, Harry P. Erba, Thomas R. Chauncey, Jerald P. Radich, Steven Coutre, Anjali Advani, et al. “Comparable outcomes of patients eligible vs ineligible for SWOG leukemia studies.Blood 131, no. 25 (June 21, 2018): 2782–88. https://doi.org/10.1182/blood-2018-01-826693.
Statler A, Othus M, Erba HP, Chauncey TR, Radich JP, Coutre S, et al. Comparable outcomes of patients eligible vs ineligible for SWOG leukemia studies. Blood. 2018 Jun 21;131(25):2782–8.
Statler, Abby, et al. “Comparable outcomes of patients eligible vs ineligible for SWOG leukemia studies.Blood, vol. 131, no. 25, June 2018, pp. 2782–88. Pubmed, doi:10.1182/blood-2018-01-826693.
Statler A, Othus M, Erba HP, Chauncey TR, Radich JP, Coutre S, Advani A, Nand S, Ravandi F, Mukherjee S, Sekeres MA. Comparable outcomes of patients eligible vs ineligible for SWOG leukemia studies. Blood. 2018 Jun 21;131(25):2782–2788.

Published In

Blood

DOI

EISSN

1528-0020

Publication Date

June 21, 2018

Volume

131

Issue

25

Start / End Page

2782 / 2788

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Survival Analysis
  • Middle Aged
  • Male
  • Leukemia
  • Immunology
  • Humans
  • Female
  • Eligibility Determination