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closeRole of PROs in supplementing clinical prognostic models for HCC
Posted by jrees on 27 Jun 2016 at 19:17 GMT
Development and Validation of a New Prognostic System for Patients with Hepatocellular Carcinoma. PLoS Med. 2016 Apr 26;13(4):e1002006. doi: 10.1371/journal.pmed.1002006. eCollection 2016
JRE Rees, AGK McNair, JM Blazeby Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK
Farinati and co-authors present a comprehensively tested model for the predication of overall survival in hepatocellular cancer (HCC). The work included >5000 patients with both early and advanced disease of a broad range of aetiologies. The patients studied received treatments including surgery, transplantation, ablative therapies and best supportive care. The final prognostic model included a composite measure of tumour stage defined by the authors and known as ITA.LI.CA, the ECOG (Eastern Co-operative Oncology Group) performance status test assessed by an observer, alpha feto-protein levels and the Child-Pugh score. Each of these measures in a multivariate model were prognostic and their ability to predict outcome was externally validated in an independent cohort (1).
This approach is useful, however we think that there is an important limitation. This model does not include baseline patient reported outcome (PRO) data.
A large number of studies in a wide range of advanced epithelial and haematological malignancies have demonstrated the prognostic value of PRO scores (2-4). The prognostic value of PRO data in HCC has been described more recently (5-7). The published studies enrolling patients with advanced HCC show that improved scores for role function (6, 7), physical function(5) and appetite (5), when assessed with the EORTC QLQ-C30 questionnaire, were associated with better survival. In addition, higher scores for the Spitzer Quality of Life (QoL) Index (0-10 scale) are also associated with improved survival (5).
The addition of PROs to a number of clinical prognostic models in HCC improve their ability to predict survival (5, 7). When the CLIP clinical prognostic model for HCC incorporates the Spitzer Quality of Life (QoL) Index (0-10 scale) score the models ability to independently predict survival is improved (5). Whilst supplementing the CLIP / GRETCH / BCLC or BoBar clinical prognostic models for HCC with EORTC QLQ-C30 scale values (expressed as continuous variables) sees an improvement in each of the models ability to predict survival (7). Findings supporting the hypothesis that PROs may be more sensitive indicators of disease progression and reflect subtle physiological changes.
It is therefore proposed that this new model considers the inclusion of PRO data – which may improve its precision and be of added value in shared clinical decision making.
References
1. Farinati F, Vitale A, Spolverato G, Pawlik TM, Huo TL, Lee YH, et al. Development and Validation of a New Prognostic System for Patients with Hepatocellular Carcinoma. PLoS Med. 2016;13(4):e1002006.
2. Gotay CC, Kawamoto CT, Bottomley A, Efficace F. The prognostic significance of patient-reported outcomes in cancer clinical trials. J Clin Oncol. 2008;26(8):1355-63.
3. Stukenborg GJ, Blackhall LJ, Harrison JH, Dillon PM, Read PW. Longitudinal patterns of cancer patient reported outcomes in end of life care predict survival. Support Care Cancer. 2016;24(5):2217-24.
4. Secord AA, Coleman RL, Havrilesky LJ, Abernethy AP, Samsa GP, Cella D. Patient-reported outcomes as end points and outcome indicators in solid tumours. Nat Rev Clin Oncol. 2015;12(6):358-70.
5. Bonnetain F, Paoletti X, Collette S, Doffoel M, Bouche O, Raoul JL, et al. Quality of life as a prognostic factor of overall survival in patients with advanced hepatocellular carcinoma: results from two French clinical trials. Qual Life Res. 2008;17(6):831-43.
6. Yeo W, Mo FK, Koh J, Chan AT, Leung T, Hui P, et al. Quality of life is predictive of survival in patients with unresectable hepatocellular carcinoma. Ann Oncol. 2006;17(7):1083-9.
7. Diouf M, Filleron T, Barbare JC, Fin L, Picard C, Bouche O, et al. The added value of quality of life (QoL) for prognosis of overall survival in patients with palliative hepatocellular carcinoma. J Hepatol. 2013;58(3):509-21.