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©The Author(s) 2015.
World J Gastroenterol. Nov 7, 2015; 21(41): 11621-11635
Published online Nov 7, 2015. doi: 10.3748/wjg.v21.i41.11621
Published online Nov 7, 2015. doi: 10.3748/wjg.v21.i41.11621
Table 3 Phase III studies on second-line therapy in metastatic gastric cancer
Ref. | II-line treatment (mg/m2) | Total pts | Performance Status, (ECOG/WHO) (%) | Median ORR (%) | MedianPFS(mo) | MedianOS(mo) | Hazard ratio | Toxicity,grade3-4 (%) |
Thuss-Patience et al[62], 2011 | Iri 250 cycle 1; 350 subsequent cycles | 21/19 | 0-1/2 - 81/19 | 0 | 2.5 | 4.0 | 0.48, P = 0.012 | D/FN/L/A - 26/16/21/11 |
BSC | 19 | 0-1/2 - 74/26 | NR | NR | 2.4 | NR | ||
Kang et al[63], 2012 | Dtx 60 d1 q3w; | 133 | 0/1 - 54/46 | 13.0 | NR | 5.3 | 0.657, P = 0.007 | Doc: N/A/F/Ano/D/S - 15/30/26/6/3/3 |
Iri 150 d1 q2w | Iri: N/A/F/Ano/D/S - 18/32/10/5/8/5 | |||||||
BSC | 69 | 0/1 - 52/48 | NR | NR | 3.8 | N/A/F/D/S - 2/23/27/10/5/2 | ||
Hironaka et al[64], 2013 | Iri 150 d1/d15 q4w | 112 | 0-1/2 - 96.4/3.6 | 13.61 | 2.31 | 8.4 | 1.13, P = 0.38 | L/N/A/FN/Ano/Neu/D/AST/Na - 19.1/39.1/30/9.1/17.3/0/4.5/8.2/15.5 |
Ptx 80 d1/d8/d15 q4w | 111 | 0-1/2 - 96.3/3.7 | 20.91 | 3.61 | 9.5 | L/N/A/FN/Ano/Neu/D/AST/Na - 20.4/28.7/21.3/2.8/7.4/7.4/0.9/3.7/3.7 | ||
Ford et al[65], 2014 | Doc 75 d1 q3w | 84 | 0/1/2 - 28/55/17 | 7.0 | 29% (at 24 wk) | 5.2 | 0.67, P = 0.01 | N/A/FN/I/H/P/Neu - 15/6/7/15/1/11/4 |
BSC | 84 | 0/1/2 - 28/60/14 | NR | NR | 3.6 | N/A/FN/I/H/P/Neu - 0/5/0/3/6/20/4 | ||
Higuchi et al[66], 2014 | Iri 60 d1 q2w; | 64 | 0/1 - 69/31 | 22.01 | 3.8 | 10.71 | 1.00, P = 0.982 | N/A/FN/T/D/Ano/F - 13/16/0/0/2/6/3 |
Cis 30 d1 q2w | ||||||||
Iri 150 d1 q4w | 66 | 0/1 - 68/32 | 16.01 | 2.8 | 10.11 | N/A/FN/T/D/Ano/F - 36/18/5/2/6/11/6 | ||
Nishikawa et al[67], 2015 | Iri 60 d1 q2w; | 84 | 0/1 - 81/19 | 16.91 | 4.61 | 13.91 | 0.834, P = 0.288 | N/A/T/D/Ano/F - 35/16/1/0/6/9 |
P 30 d1 q2w | ||||||||
Iri 150 d1 q4w | 84 | 0/1 - 75/25 | 15.41 | 4.11 | 12.71 | N/A/T/D/Ano/F - 28/4/0/3/9/4 | ||
Fuchs et al[69], 2014 | Ram 8 mg/kg d1 q2w | 238 | 0/1/2 - 28/72/0 | 3.41 | 2.1 | 5.2 | 0.776, P = 0.047 | A/F/AbP/Dys/Dyn/Hyt/B/Prot/VTE - 6/6/6/2/2/8/3/< 1/1 |
BSC | ||||||||
Placebo | 117 | 0/1/2 - 26/73/0 | 3.01 | 1.3 | 3.8 | A/F/AbP/Dys/Dyn/Hyt/B/Prot/VTE - 8/10/3/4/6/3/3//< 1 | ||
BSC | ||||||||
Wilke et al[70], 2014 | Ram 8 mg/kg d1,15 q4w | 330 | 0/1 - 35/65 | 27 | 4.4 | 9.6 | 0.807, P = 0.017 | N/A/Leu/T/F/Neu/D/H/Hyt/Prot/HepF/VTE - 41/9/18/2/8/4/4/15/1/4/2 |
Ptx 80 d1/d8/d15 q4w | ||||||||
Placebo | 335 | 0/1 - 43/57 | 16 | 2.9 | 7.4 | N/A/Leu/T/F/Neu/D/H/Hyt/Prot/HepF/VTE - 19/9/6/2/5/5/1/4/3/0/3/2 | ||
Ptx 80 d1/d8/d15 q4w | ||||||||
Satoh et al[76], 2014 | Lap 1500 mg once daily | 132 | 0/1 - 45/55 | 27 | 5.51 | 12.21 | 0.84, P = 0.2 | (experienced in > 10% of pts) N/A/Lym/F/Neu/D - 57/11/29/5/< 1/18 |
Ptx 80 d1,d8,d15 q4w | ||||||||
Placebo | 129 | 0/1 - 37/63 | 9 | 4.41 | 10.51 | (experienced in > 10% of pts) N/A/Lym/F/Neu/D - 31/6/2/< 1/0/2 | ||
Ptx 80 d1,d8,d15 q4w | ||||||||
Dutton et al[77], 2014 | Gef 500 mg/d daily | 224 | 0/1/2 - 25/52/22 | 24 (DC) | 1.57 | 3.731 | 0.90, P = 0.293 | D/F/Sk/Rep/I/Hem/Vas/Met - 6/10/20/12/3/7/7/6 |
Placebo | 225 | 0/1/2 - 25/55/20 | 16 (DC) | 1.17 | 3.671 | D/F/Sk/Rep/I/Hem/Vas/Met - 1/5/< 1/12/4/4/5/7 |
- Citation: Kanagavel D, Fedyanin M, Tryakin A, Tjulandin S. Second-line treatment of metastatic gastric cancer: Current options and future directions. World J Gastroenterol 2015; 21(41): 11621-11635
- URL: https://www.wjgnet.com/1007-9327/full/v21/i41/11621.htm
- DOI: https://dx.doi.org/10.3748/wjg.v21.i41.11621