Table 2.
Details of prior therapies in the prior therapy subgroups (ITT population)
| Prior therapy type | RAM | No RAM | PAC (no RAM) | RAM + PAC | No RAM or PAC | IRI | No IRI | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FTD/ | Placebo | FTD/ | Placebo | FTD/ | Placebo | FTD/ | Placebo | FTD/ | Placebo | FTD/ | Placebo | FTD/ | Placebo | |
| TPI | TPI | TPI | TPI | TPI | TPI | TPI | ||||||||
| (n = 114) | (n = 55) | (n = 223) | (n = 115) | (n = 99) | (n = 37) | (n = 106) | (n = 48) | (n = 124) | (n = 78) | (n = 183) | (n = 98) | (n = 154) | (n = 72) | |
| Prior gastrectomy, n (%) | ||||||||||||||
| Yes | 57 (50) | 26 (47) | 90 (40) | 48 (42) | 42 (42) | 19 (51) | 53 (50) | 23 (48) | 48 (39) | 29 (37) | 80 (44) | 43 (44) | 67 (44) | 31 (43) |
| Prior radiotherapy, n (%) | ||||||||||||||
| Yes | 26 (23) | 13 (24) | 45 (20) | 13 (11) | 26 (26) | 5 (14) | 23 (22) | 12 (25) | 19 (15) | 8 (10) | 45 (25) | 16 (16) | 26 (17) | 10 (14) |
| Number of prior treatment regimens, n (%) | ||||||||||||||
| 2 | 28 (25) | 8 (15) | 98 (44) | 56 (49) | 30 (30) | 15 (41) | 27 (26) | 8 (17) | 68 (55) | 41 (53) | 29 (16) | 19 (19) | 97 (63) | 45 (62) |
| 3 | 39 (34) | 19 (35) | 95 (43) | 41 (36) | 48 (48) | 14 (38) | 37 (35) | 15 (31) | 47 (38) | 27 (35) | 94 (51) | 38 (39) | 40 (26) | 22 (31) |
| ≥ 4 | 47 (41) | 28 (51) | 30 (14) | 18 (16) | 21 (21) | 8 (22) | 42 (40) | 25 (52) | 9 (7) | 10 (13) | 60 (33) | 41 (42) | 17 (11) | 5 (7) |
| Prior systemic regimens for metastatic cancer, n (%)a | ||||||||||||||
| Fluoro-pyrimidinesb | 107 (94) | 53 (96) | 220 (99) | 110 (96) | 98 (99) | 33 (89) | 100 (94) | 47 (98) | 122 (98) | 77 (99) | 181 (99) | 93 (95) | 146 (95) | 70 (97) |
| Platinum-containing compoundsc | 103 (90) | 54 (98) | 214 (96) | 106 (92) | 95 (96) | 32 (86) | 95 (90) | 48 (100) | 119 (96) | 74 (95) | 171 (93) | 91 (93) | 146 (95) | 70 (97) |
| Taxanesd | 112 (98) | 54 (98) | 194 (87) | 92 (80) | 99 (100) | 37 (100) | 106 (100) | 48 (100) | 95 (77) | 55 (71) | 155 (85) | 74 (76) | 151 (98) | 72 (100) |
| Irinotecane | 112 (98) | 54 (98) | 113 (51) | 59 (51) | 42 (42) | 15 (41) | 63 (59) | 35 (73) | 71 (57) | 44 (56) | 183 (100) | 98 (100) | 0 | 0 |
| HER2-inhibitorsf | 29 (25) | 14 (26) | 30 (14) | 9 (8) | 22 (22) | 4 (11) | 28 (26) | 13 (27) | 8 (6) | 5 (6) | 30 (16) | 15 (15) | 29 (19) | 8 (11) |
| Immuno-therapy | 14 (12) | 5 (9) | 11 (5) | 2 (2) | 6 (6) | 1 (3) | 13 (12) | 3 (6) | 5 (4) | 1 (1) | 17 (9) | 4 (4) | 8 (5) | 3 (4) |
| Other | 30 (26) | 11 (20) | 46 (21) | 27 (24) | 21 (21) | 11 (30) | 28 (26) | 8 (17) | 25 (20) | 16 (21) | 42 (23) | 15 (15) | 34 (22) | 23 (32) |
FTD/TPI trifluridine/tipiracil, HER2 human epidermal growth factor receptor 2, IRI irinotecan, ITT intent-to-treat, PAC paclitaxel, RAM ramucirumab
aPatients could have received more than one category of treatment
bIncluded 5-fluorouracil, capecitabine, doxifluridine, S-1, tegafur and uracil/tegafur, and agents collected as 'other' and later remapped to ‘fluoropyrimidines’
cIncluded oxaliplatin, cisplatin, carboplatin, and agents collected as 'other' and later remapped to ‘platinum-containing compounds’
dIncluded docetaxel, paclitaxel, nab-paclitaxel (abraxane), and agents collected as 'other' and later remapped to ‘taxanes’
eIncluded irinotecan, CPT-11, and agents collected as 'other' and later remapped to ‘irinotecan’
fIncluded trastuzumab, pertuzumab, and TDM-1