Levels of absolute survival benefit for systemic therapies of advanced cancer. a call for standards.

Research on systemic interventions in patients with advanced stage malignancies should be systematised with an emphasis on the absolute gain in survival for the median patient. Such information is most meaningful with relatively large-scale evidence. Here, we summarise the survival impact of 36 interventions compared against other interventions or no treatment for advanced stage malignancies in meta-analyses of individual patient data or in selected recent (2000-2002) randomised trials with >300 randomised subjects. Although 16 interventions showed a formally statistically significant survival benefit against the comparator arm, this exceeded 3 months in only 7 cases. We propose a standardised categorisation of the median survival prolongation in trials and meta-analyses. Level 0: no proven survival benefit; level I: 0-3 months; level II: >3-6 months; level III: >6-24 months; and level IV: more than 24 months. These standardised levels may be incorporated into clinical practice guidelines for individual care and policy-making.