Table 1.
Selected phase II and III trials of first-line non-platinum-based chemotherapy for patients with advanced gastric cancer
| Ref. | Year | Phase | Tx | Dose (mg/m2 per day) | Cycle | Patients (n) | RR | Median TTP/TTF/PFS (mo) | Median OS (mo) | P value for OS |
| Vanhoefer et al[37] | 2000 | III | FAM | (5FU: 1500, A: 30, M: 1500) | (D1, D1, and D15, 4 wk) | 85 | 12% | 3.3 | 6.7 | - |
| FC | (F: 1000, C: 100) | (D1-5 and D2, 4 wk) | 81 | 20% | 4.1 | 7.2 | 0.77 | |||
| ELF | (L: 300, E: 120, F: 500) | (D1-5, 3 wk) | 79 | 9% | 3.3 | 7.2 | 0.73 | |||
| Boku et al[18] | 2009 | III | F | F: 800 | D1-5, 4 wk | 234 | - | 2.9 | 10.8 | - |
| IC | (I: 70, C: 80) | (D1,15 and D1, 4 wk) | 236 | - | 4.8 | 12.3 | 0.0551 | |||
| S | S: 80 | D1-28, 6 wk | 234 | - | 4.2 | 11.4 | < 0.0012 | |||
| Ohtsu et al[19] (JCOG 9205) | 2003 | III | F | F: 800 | D1-5, 4 wk | 105 | 11.4% | 1.9 | 7.1 | - |
| FC | (F: 800, C: 20) | (D1-5 and D1-5, 4 wk) | 105 | 34.3% | 3.9 | 7.6 | 0.34 | |||
| U/T3 | U/T: 750 | - | 70 | 8.6% | 2.4 | 6.0 | 0.11 | |||
| Kim et al[59] | 2005 | II | DX | D: 75 | D1, 3 wk | 32 | 43.8% | 5.1 | 8.4 | - |
| X: 2000 | D1-14, 3 wk | |||||||||
| Giordano et al[60] (NCCTG) | 2006 | II | DX | D: 75 | D1, 3 wk | 44 | 39% | 4.2 | 9.4 | - |
| X: 1650 | D1-14, 3 wk | |||||||||
| Jeung et al[54] | 2011 | II (random) | DS | (D: 35, S: 70) | (D1, 8 and D1-14, 3 wk) | 39 | 46% | 7.3 | 16.0 | 0.019 |
| DC | (D: 35, C: 35) | (D1, 8 and D1, 8, 3 wk) | 41 | 24% | 4.8 | 8.2 | ||||
| Park et al[50] | 2006 | II (random) | PF | (P: 175, F: 500) | (D1 and D1-5, 3 wk) | 38 | 42% | 3.6 | 9.9 | - |
| DF | (D: 75, F: 500) | (D1 and D1-5, 3 wk) | 39 | 33% | 4.2 | 9.3 | ||||
| Mochiki et al[44] | 2012 | II (random) | SP | (S: 80, P: 60) | (D1-14 and D1, 8, 15, 4 wk) | 42 | 52.3% | 9.0 | 16.0 | 0.084 |
| SC | (S: 80, C: 60) | (D1-21 and D8, 5 wk) | 41 | 48.7% | 6.0 | 17.0 | ||||
| Pozzo et al[51] | 2004 | II (random) | ILF | (I: 80, L: 500, F: 2000) | (D1, weekly, 6 wk) | 74 | 42.4% | 6.5 | 10.7 | 0.0018 |
| IC | (I: 200, C: 60) | (D1 and D1, 3 wk) | 72 | 32.1% | 4.2 | 6.9 | ||||
| Narahara et al[48] (GC0301/TOP-002) | 2011 | III | IS | (S: 80, I: 80) | (D1-21, 5 wk, D1 and 15, 5 wk) | 164 | 41.5% | 4.5 | 12.8 | 0.233 |
| S | S: 80 | D1-28, 6 wk | 162 | 26.9% | 3.6 | 10.5 | ||||
| Moehler et al[46] | 2010 | II (random) | IX | (I: 250, X: 2000) | (D1 and D1-14, 3 wk) | 57 | 37.7% | 4.2 | 10.2 | - |
| CX | (C: 80, X: 2000) | (D1 and D1-14, 3 wk) | 55 | 42.0% | 4.8 | 7.9 | ||||
| Oh et al[49] | 2007 | II | IX | (I: 130, X: 3500) | (D1,15 and D1-15, 3 wk) | 55 | 43.6% | 5.0 | 11.0 | - |
| Baek et al[55] | 2006 | II | IX | (I:100, X: 2000) | (D1, 8 and D1-14, 3 wk) | 41 | 46.3% | 5.1 | 8.6 | - |
| Bouché et al[57] (FFCD 9803) | 2004 | II | LF | (L: 200, F: 400/600) | (D1-2, 2 wk) | 45 | 13% | 3.2 | 6.8 | - |
| LFC | (L: 200, F: 400/600, C: 50) | (D1-2, 2 wk) | 44 | 27% | 4.9 | 9.5 | ||||
| LFI | (F: 200, F: 400/600, I: 180) | (D1-2, 2 wk) | 45 | 40% | 6.9 | 11.3 | ||||
| Dank et al[58] | 2008 | III | IFL | (I: 80, L: 500, F: 2000) | (D1, weekly, 6 wk) | 172 | 31.8% | 5.0 | 9.0 | 0.53 |
| CF | (C: 100, F:1000) | (D1 and D1-5, 4 wk) | 165 | 25.8% | 4.2 | 8.7 |
1
Superiority compared to 5-fluorouracil (5FU) alone;
2
Non-inferiority compared to 5FU alone;
3
With weekly bolus infusion of mitomycin 5 mg/m2. Tx: Treatment; TTP: Time to progression; TTF: Time to treatment failure; PFS: Progression-free survival; OS: Overall survival; F: 5FU; A: Adriamycin; M: Methotrexate; C: Cisplatin; E: Etoposide; L: Leucovorin; I: Irinotecan; S: S-1; U/T: Uracil and tegafur; D: Docetaxel; X: Capecitabine; P: Paclitaxel.