Table 5.

Currently available drugs and their indications for advanced solid tumors passing the postulated OS threshold values for the mCMO in the 18 pivotal trials reporting OS data on more than 20 patients at risk at the late term of 2 and 3 years: “LARGE”

Level of required benefitPrognostic groupDrugs meeting both criteria of absolute and proportional OS increaseDrugs meeting either criteria of absolute or proportional OS increase
High<9 moNab-Paclitaxel-pancreas (P; ref. 36)
9–12 mo
12–18 mo
>18 moSunitinib-GIST (A; ref. 22)
Medium<9 moTemsirolimus-kidney (A; ref. 6); Nab-Paclitaxel-pancreas (P; ref. 36)
9–12 moRadium223-prostate (45); Erlotinib-lung (16)Bevacizumab-lung (P; ref. 18); Radium223-prostate (A+P; ref. 45); Bevacizumab-colon (P; ref. 25); Erlotinib-lung (A+P; ref. 16)
12–18 mo
>18 moCetuximab-head and neck (A; ref. 38); Sunitinib-GIST (A; ref. 22)
Low<9 moNab-Paclitaxel-pancreas (36); Temsirolimus-kidney (6); Ipilimumab-melanoma (40)Nab-Paclitaxel-pancreas (A+P; ref. 36); Temsirolimus-kidney (A+P; ref. 6); Ipilimumab-melanoma (A+P; ref. 40)
9–12 moTrastuzumab-gastric (41); Radium223-prostate (45); Bevacizumab-lung (18); Erlotinib-lung (16); Bevacizumab-colon (25)Trastuzumab-gastric (A+P; ref. 41); Radium223-prostate (A+P; ref. 45); Bevacizumab-lung (A+P; ref. 18); Erlotinib-lung (A+P; ref. 16); Bevacizumab-colon (A+P; ref. 25)
12–18 mo
>18 moSunitinib-GIST (22)Trastuzumab-breast (A; ref. 12); Cetuximab-head and neck (A; ref. 38); Sunitinib-GIST (A+P; ref. 22)

NOTE: A and P in parenthesis next to each agent indicate which specific parameter of “LARGE” was met in each trial.

Abbreviations: A, absolute increase in OS; P, proportional increase in OS.