Correcetions to “A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS)”

In the original manuscript, there were two errors. In Table 6, the scoring for ramucirumab vs placebo in the RAISE trial should acknowledge the reported 2- year survival advantage of 5–10%. This would result in an upgrade of the ESMO-MCBS score to 3.Table 6Field testing ESMO-MCBS v1.0: Colorectal CancerCOLORECTAL CANCERMedicationTrial nameSettingPrimary outcomePFS controlPFS gainPFS HROS controlOS gainOS HRQoLToxicityESM0- MCBSrefFOLFOX4 +/-panitumumabPRIME1st line metastatic (Post hoc KRAS, NRAS BRAF WT)PFS7.9 mth2.3 mth0.72 (0.58-0.90)20.2 mth5.8 mth0.78 (0.62-0.99)4[62]Panitumumab + mFOLFOX6 vs bevacizumab +mFOLFOX6PEAK1st line metastatic (KRAS-WT)PFSNS24.3 mth9.9 mth0.62 (0.44-0.89)4*unbalanced crossover[103]FOLFIRI +/- cetuximabCRYSTAL1st line metastaticstratified for KRAS-WT (Post hoc KRAS, NRAS WT)PFS8.4 mth3.0 mth0.56 (0.41-0.76)20.2 mth8.2 mth0.69 (0.54-0.88)4[65]Cetuximab vs best supportive careRefractory metastatic KRAS-WTOS1.9 mth1.8 mth0.4 (0.30-0.54)4.8 mth4.7 mth0.55 (0.41-0.7404[104]FOLFOX4 +/-panitumumabPRIME1st line metastatic KRAS-WTPFS8 mth1.6 mth0.80 (0.66-0.97)19.4 mth4.4 mth0.83 (0.70-0.98)3[60, 61]FOLFIRI +/- cetuximabCRYSTAL1st line metastaticstratified for KRAS-WTPFS8.4 mth1.5 mth0.70 (0.56-0.87)20 mth3.5 mth0.80 (0.67-0.95)3[63, 64]ILF +/- bevacizumab1st line metastaticOS15.6 mth4.7 mth0.66 (0.54–0.81)3[105]FOLFIRI +/- panitumumab2nd line metastatic KRAS-WTPFS3.9 mth2 mth0.73 (0.59-0.90)3[106]FOLFOX + /- bevacizumab vs bevacizumab aloneE32002nd line metastatic after FOLFIRIOS10.8 mth2.1 mth0.75 (0.63–0.89)2[107]Panitumumab, vs best supportive care3rd line metastaticstratified for KRASPFS7.3 wk5 wk0.45 (0.34-0.59)2[108]FOLFIRI bevacizumab vs FOLFOXIRI bevacizumab1st line metastaticPFS9.7 mth2.4 mth0.75 (0.62-0.90)NS2[109]TAS-102 vs placeboCONCOURSE3rd line or beyond metastaticOS5.3 mth1.8 mth0.68 (.058-0.81)2[110]Regorafenib vs placeboCORRECT3rd line metastaticOS5 mth1.4 mth077 (0.64-0.94)1[111]2nd line chemotherapy +/-bevacizumabML181472nd line beyond progression on bevacizumabOS9.6 mth1.5 mth0·81 (0·69–0·94)1[112]FOLFIRI + /- afliberceptVELOUR2nd line after oxaliplatin based treatmentOS4.7 mth2.2 mth0.76 (0.66-0.87)12 .1 mth1.5 mth0.82 (0.71–0.94)1[113]FOLFIRI +/-RamucirumabRAISE2nd line metastatic after bevacizumab, oxaliplatin, fluoropyrimidineOS11.7 mth1.6 mth, 5-10% gain in 2 year survival0.84 (0.73-0.97)3[114]* unbalanced crossover Open table in a new tab In Appendix 1 form 2a of the ESMO-MCBS v1.0 the criteria for grade 2 was incorrectly stated. For studies with control median OS < 12 months the criteria should be HR > 0.65–0.70 AND Gain 1.5–2.4 months. For studies with control median OS >12 months the criteria should be HR > 0.70–0.75 AND Gain 1.5–2.9 months. The corrected Table and Appendix are as below. Form 2a: for therapies that are not likely to be curative with primary endpoint of OSView Large Image Figure ViewerDownload Hi-res image Download (PPT)View Large Image Figure ViewerDownload Hi-res image Download (PPT) A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS)Annals of OncologyVol. 26Issue 8PreviewThe value of any new therapeutic strategy or treatment is determined by the magnitude of its clinical benefit balanced against its cost. Evidence for clinical benefit from new treatment options is derived from clinical research, in particular phase III randomised trials, which generate unbiased data regarding the efficacy, benefit and safety of new therapeutic approaches. To date, there is no standard tool for grading the magnitude of clinical benefit of cancer therapies, which may range from trivial (median progression-free survival advantage of only a few weeks) to substantial (improved long-term survival).