Table 2. . Summary of neoadjuvant trials including patients eligible for upfront resection.
| Study (year) | Patients (n) | Regimen | Resection rate (%) | R0 rate (% of resected) | Median OS (months) | Ref. |
|---|---|---|---|---|---|---|
| Palmer randomized Phase II (2007) | 24 | Gem | 38 | 25 | 45 R | [10] |
| |
26 |
Gem + Cis |
69 |
46 |
7 UR, 10 all |
|
| Heinrich Phase II (2008) |
28 |
Gem + Cis |
93 |
80 |
19 R, 26.5 all |
[50] |
| Tajima Phase I (2012) |
34 |
Gem + S-1 |
100 |
85 |
56% at 2 years |
[51] |
| O'Reilly Phase II (2014) |
38 |
Gem + Ox |
71 |
74 |
27 (all) |
[52] |
| Faris retrospective (2013) |
35 |
FOLFIRINOX only in 2 + CRT in 20 without response |
55 |
42 |
NR |
[53] |
| Evans prospective (1992) |
28 |
5-FU + RT (50.4 Gy) + IORT |
61 |
50 |
18 (R), 4 (UR) |
[35] |
| Pisters prospective (1998) |
35 |
5-FU+ RT (30 Gy) + IORT |
57 |
51 |
25 (R), 7 (UR) |
[36] |
| Pisters prospective (2002) |
35 |
Paclitaxel RT + (30 Gy) + IORT |
57 |
34 |
19 (R), 10 (UR) |
[43] |
| Turrini Phase II (2010) |
34 |
Tax + RT (45 Gy) |
50 |
100 |
32 (all) |
[54] |
| Evans Phase II (2008) |
86 |
Gem + RT (30 Gy) |
74 |
89 |
22.7 (all), 34 (R), 7 (UR) |
[6] |
| Varadhachary Phase II (2008) |
90 |
Gem + Cis + GemRT (30 Gy) |
66 |
96 |
17.4 (all), 31 (R) |
[16] |
| Sho (2013) |
61 |
Gem + RT (50.4–54 Gy) |
97 |
92 |
NR |
[55] |
| Van Buren Phase II (2013) |
59 |
Fixed dose rate Gem + Bev + RT (30 Gy) |
73 |
88 |
16.8 (all), 19.7 (R) |
[48] |
| Kim Phase II (2013) |
23 R, 39 BR, 6 UR |
Gem + Ox + RT (30 Gy) |
63 |
84 |
18.2 (all), 27.1 (R), 10.9 (UR) |
[56] |
| Pipas Phase II (2012) |
4 R, 23 BR, 6 UR |
Gem + cetuximab + RT (54 Gy) |
100 R 76 (all) |
92 (all) |
24.3 (all) |
[57] |
| Faris retrospective (2013) |
22 |
FOLFIRINOX ± CRT |
55 |
42 |
NR |
[53] |
| Shinoto Phase I (2013) | 26 | 30.0–36.8 GyE carbon-ion RT | 81 | 90 | 18.6 (all) | [58] |
5-FU: 5 fluorouracil; Bev: Bevacizumab; BR: Borderline resectable; Cis: Cisplatin ; CRT: Chemoradiation; FOLFIRINOX: 5-fluorouracil, oxaliplatin, irinotecan, and leucovorin; Gem: Gemcitabine; Gy: Gray; NR: Not reported; Ox: Oxaliplatin; R: Resectable; RT: Radiotherapy; S1: Pral 5-fluorouracil; Tax: Docetaxel; UR: Unresectable.