Treatment of metastatic lung cancer: The ESMO Clinical Benefit Scale (ESMO CBS) (#5)
ESMO feels strongly that it is important to present clear and unbiased statements regarding the magnitude of the clinical benefit (CB) for new therapeutic approaches and has developed a validated tool to assess the CB of anti-cancer interventions to society and patients. The validity and robustness of the ESMO CBS are derived from 1) Clinically relevant assumptions: that cure takes precedence over deferral of death, direct endpoints such as survival and QoL take precedence over surrogates such as PFS or RR and that the interpretation of the evidence for benefit derived from indirect primary outcomes (such as PFS, pCR or RR ) may be influenced by secondary outcome data . 2) Coherence: The science of outcome evaluation and statistical analysis is well developed as is the understanding of the relative strengths and weakness of the usual measured outcomes survival and QoL, and their surrogates 3) Wide applicability over a range of diseases and a range of prognoses. 4) Statistical validity, 5) Transparent processes and 6) Peer review. In the ESMO CBS, curative treatments are graded A, B C and non curative treatments are graded 1,2,3,4,5, The highest scores indicate a very high level of CB with substantial benefit in either improving likely hood of cure (ESMO CBS A or B) or improving overall survival and quality of life (ESMO CBS 4 and 5). The lowest score, 1, indicates a non-curative treatment with a very small benefits, such as response rate that are outweighed by toxicity. Intermediate scores of 3 and 2 represent diminishing grades of clinical benefit.As part of the validation process and peer review the ESMO CBS was applied to a wide range of recent treatments in different disease settings cluding lung cancer. The findings of the ESMO CBS for lung cancer treatments revealed a score range of 1-4 these will be presented.