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Original Articles: Clinical

Investigator and independent review committee exploratory assessment and verification of tumor response in a non-Hodgkin lymphoma study

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Pages 1332-1340 | Received 25 May 2016, Accepted 31 Aug 2016, Published online: 10 Oct 2016

References

  • Villaruz LC, Socinski MA. The clinical viewpoint: definitions, limitations of RECIST, practical considerations of measurement. Clin Cancer Res. 2013;19:2629–2636.
  • Ford R, Schwartz L, Dancey J, et al. Lessons learned from independent central review. Eur J Cancer. 2009;45:268–274.
  • Petrick N, Kim HJ, Clunie D, et al. Evaluation of 1D, 2D and 3D nodule size estimation by radiologists for spherical and non-spherical nodules through CT thoracic phantom imaging. In: Summers RM, van Ginneken B, editors. Proceedings from the 2011 SPIE medical imaging conference; 2011 Feb 12–17; Lake Buena Vista, Florida: SPIE, The International Society for Optical Engineering; 2011.
  • Hopper KD, Kasales CJ, Van Slyke MA, et al. Analysis of interobserver and intraobserver variability in CT tumor measurements. AJR Am J Roentgenol. 1996;167:851–854.
  • Thiesse P, Ollivier L, Di Stefano-Louineau D, et al. Response rate accuracy in oncology trials: reasons for interobserver variability. Groupe Francais d'Immunotherapie of the Federation Nationale des Centers de Lutte Contre le Cancer. J Clin Oncol. 1997;15:3507–3514.
  • Erasmus JJ, Gladish GW, Broemeling L, et al. Interobserver and intraobserver variability in measurement of non-small-cell carcinoma lung lesions: implications for assessment of tumor response. J Clin Oncol. 2003;21:2574–2582.
  • Dancey JE, Dodd LE, Ford R, et al. Recommendations for the assessment of progression in randomised cancer treatment trials. Eur J Cancer. 2009;45:281–289.
  • Amit O, Mannino F, Stone AM, et al. Blinded independent central review of progression in cancer clinical trials: results from a meta-analysis. Eur J Cancer. 2011;47:1772–1778.
  • Goldmacher GV, Raunig D. The imaging core lab perspective on glioblastoma imaging and response assessment in clinical trials. Neuro Oncol. 2014;16:vii48–vii50.
  • Hamilton TE, Barnhart D, Gow K, et al. Inter-rater reliability of surgical reviews for AREN03B2: a COG renal tumor committee study. J Pediatr Surg. 2014;49:154–158.
  • Tang PA, Pond GR, Chen EX. Influence of an independent review committee on assessment of response rate and progression-free survival in phase III clinical trials. Ann Oncol. 2010;21:19–26.
  • Zhang JJ, Zhang L, Chen H, et al. Assessment of audit methodologies for bias evaluation of tumor progression in oncology clinical trials. Clin Cancer Res. 2013;19:2637–2645.
  • Zhang JJ, Chen H, He K, et al. Evaluation of blinded independent central review of tumor progression in oncology clinical trials: a meta-analysis. Drug Inf J. 2013;47:167–174.
  • Floquet A, Vergote I, Colombo N, et al. Progression-free survival by local investigator versus independent central review: comparative analysis of the AGO-OVAR16 Trial. Gynecol Oncol. 2015;136:37–42.
  • FDA Briefing Document. Oncologic Drugs Advisory Committee Meeting: evaluation of radiologic review of progression-free survival in non-hematologic malignancies [Internet]. [cited 2012 Jul 24]. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM311141.pdf.
  • Flinn IW, van der Jagt R, Kahl BS, et al. Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study. Blood. 2014;123:2944–2952.
  • Kahl BS, Bartlett NL, Leonard JP, et al. Bendamustine is effective therapy in patients with rituximab-refractory, indolent B-cell non-Hodgkin lymphoma: results from a multicenter study. Cancer. 2010;116:106–114.
  • Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007;25:579–586.
  • Solal-Celigny P, Roy P, Colombat P, et al. Follicular lymphoma international prognostic index. Blood. 2004;104:1258–1265.
  • Bhattacharya S, Fyfe G, Gray RJ, et al. Role of sensitivity analyses in assessing progression-free survival in late-stage oncology trials. J Clin Oncol. 2009;27:5958–5964.
  • Cheson BD, Fisher RI, Barrington SF, et al. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014;32:3059–3068.