Table 5.
Major Phase III Trials of Chemotherapy for Unresectable or Recurrent Gastric Cancer.
| Trial name | Published
year |
No. of
patients |
Line of
treatment |
Treatment groups | Response
rate (%) |
MST
(months) |
P-value |
|---|---|---|---|---|---|---|---|
| JCOG9912 (58) | 2009 | 704 | 1st | 5-FU
Irinotecan + cisplatin S-1 |
9
38 28 |
10.8
12.3 11.4 |
0.0552*
(Irinotecan + cisplatin vs. 5-FU) 0.0005* (for non-inferiority of S-1 vs. 5-FU) |
| SPIRITS (59) | 2008 | 298 | 1st | S-1
CS |
31
54 |
11.0
13.0 |
0.04 |
| JCOG1013 (60) | 2018 | 741 | 1st | CS
DCS |
56.0
59.3 |
15.3
14.2 |
0.47* |
| G-SOX (61) | 2015 | 642 | 1st | CS
SOX |
52.2
55.7 |
13.1
14.1 |
0.0583
(for non-inferiority) |
| REAL-2 (62) | 2008 | 964 | 1st | ECF
ECX EOF EOX |
40.7
46.4 42.4 47.9 |
9.9
9.9 9.3 11.2 |
0.02
(ECF vs. EOX) |
| ToGA (63) | 2010 | 584 | 1st
(HER2-positive) |
Capecitabine/5-FU + cisplatin
Capecitabine/5-FU + cisplatin + trastuzumab |
35
47 |
11.1
13.8 |
0.0046 |
| RAINFALL (67) | 2018 | 645 | 1st | Capecitabine/5-FU + cisplatin
Capecitabine/5-FU + cisplatin + ramucirumab |
36
41 |
10.74
11.17 |
0.68 |
| REGARD (65) | 2014 | 355 | 2nd | Placebo
Ramucirumab |
3
3 |
3.8
5.2 |
0.047 |
| RAINBOW (66) | 2014 | 665 | 2nd | Paclitaxel
Paclitaxel + ramucirumab |
16
28 |
7.4
9.6 |
0.017 |
| ABSOLUTE (68) | 2017 | 741 | 2nd | weekly paclitaxel (w-Ptx)
weekly nab-paclitaxel (w-Nab) triweekly nab-paclitaxel (t-Nab) |
25
24 33 |
10.9
11.1 10.3 |
0.0085*
(for non-inferiority of w-Nab vs. w-Ptx) 0.062* (for non-inferiority of t-Nab vs. w-Ptx) |
| ATTRACTION-2 (69) | 2017 | 493 | ≥3rd | Placebo
Nivolumab |
0
11.2 |
4.14
5.26 |
< 0.0001 |
| KEYNOTE-061 (71) | 2018 | 395 | 2nd | Paclitaxel
Pembrolizumab |
13.6
15.8 |
8.3
9.1 |
0.042* |
* one-sided p-value.
Abbreviations: MST, median survival time; 5-FU, fluorouracil; CS, cisplatin plus S-1; DCS, docetaxel plus cisplatin plus S-1; SOX, S-1 plus oxaliplatin; ECF, epirubicin plus cisplatin plus fluorouracil; ECX, epirubicin plus cisplatin plus capecitabine; EOF, epirubicin plus oxaliplatin plus fluorouracil; EOX, epirubicin plus oxaliplatin plus capecitabine; nab-paclitaxel, nanoparticle albumin-bound paclitaxel.