Advertisement

The components of progression as explanatory variables for overall survival in the Response Evaluation Criteria in Solid Tumours 1.1 database

Published:April 10, 2014DOI:https://doi.org/10.1016/j.ejca.2014.03.014

      Abstract

      Purpose

      Progressive disease (PD) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 is defined as growth of measurable target lesions, presence of new lesions or unequivocal progression of non-target disease. In this manuscript we explored whether a more refined categorisation of tumour response and/or these components of progression, varying over time, can improve prediction of overall survival (OS) in the RECIST database.

      Methods

      Data were randomly selected from 13 randomised clinical trials (3758 patients with breast, lung or colorectal cancer). A maximum of five target lesions contributed to the sum of longest diameters. At each measurement time we determined: best target response as best % improvement from baseline; tumour growth of target lesions as worst % change and worst rate of increase (mm/week) from nadir; presence of new lesions and occurrence of non-target PD. OS was analysed by tumour type using Cox regression, adjusting for baseline sum and including these parameters as time-dependent covariates.

      Results

      36% of patients had new lesions, 28% non-target PD and 49% experienced target lesion growth (median strongest growth 1.5 mm/week). Regardless of tumour type, presence of new lesions (hazard ratio (HR) ranging 1.5–2.3) and non-target PD (HR 1.5–2.0) were strongly associated with worse OS. The explanatory value of tumour growth for OS was low compared to the other components.

      Conclusion

      Modelling target lesion tumour growth did not show a marked improvement in OS prediction over and above the other components. These analyses enable a better understanding of the role of each component in PD evaluation. Work is ongoing to incorporate this information into an updated version of RECIST with enhanced prediction of subsequent survival.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to European Journal of Cancer
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

      1. WHO handbook for reporting results of cancer treatment. Geneva (Switzerland): World Health Organization Offset Publication No 48; 1979.

        • Therasse P.
        • Arbuck S.G.
        • Eisenhauer E.A.
        • et al.
        New guidelines to evaluate the response to treatment in solid tumours (RECIST Guidelines).
        J Natl Cancer Inst. 2000; 92: 205-216
        • Eisenhauer E.A.
        • Therasse P.
        • Bogaerts J.
        • et al.
        New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).
        Eur J Cancer. 2009; 45: 228-247
        • Bogaerts J.
        • Ford R.
        • Sargent D.
        • et al.
        Individual patient data analysis to assess modifications to the RECIST criteria.
        Eur J Cancer. 2009; 45: 248-260
        • Heagerty P.J.
        • Zheng Y.
        Survival predictive accuracy and ROC curves.
        Biometrics. 2005; 61: 92-105
        • Cortazar P.
        • Zhang L.
        • Untch M.
        • et al.
        Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis.
        Lancet. 2014; https://doi.org/10.1016/S0140-6736(08)61345-8
        • Bonnefoi H.
        • Litière S.
        • Piccart M.
        • et al.
        Pathological complete response after neoadjuvant chemotherapy is an independent predictive factor irrespective of simplified breast cancer intrinsic subtypes: a landmark and two-step approach analyses from the EORTC 10994/BIG 1-00 phase III trial.
        Ann Oncol. 2014; https://doi.org/10.1093/annonc/mdu118
        • Bernard-Marty C.
        • Cardoso F.
        • Piccart M.J.
        Facts and controversies in systemic treatment of metastatic breast cancer.
        Oncologist. 2004; 9: 617-632
        • Dodd L.E.
        • Korn E.L.
        • Freidlin B.
        • et al.
        Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense?.
        J Clin Oncol. 2008; 26: 3791-3796
        • Dancey J.E.
        • Dodd L.E.
        • Ford R.
        • et al.
        Recommendations for the assessment of progression in randomised cancer treatment trials.
        Eur J Cancer. 2009; 45: 281-289

      Linked Article

      • Non-target progression – The fine line between objectivity and subjectivity
        European Journal of CancerVol. 50Issue 18
        • Preview
          We have read with great interest the article by Litière et al. ‘The components of progression as explanatory variables for overall survival in the Response Evaluation Criteria in Solid Tumours 1.1 database’ published recently in the European Journal of Cancer [1]. We were intrigued by the sub-categorisation of progressive disease into (i) progression of targeted lesions; (ii) occurrence of a new lesion and (iii) non-targeted progressive disease and the potential implications of these on clinical practice and research.
        • Full-Text
        • PDF