Table 3. . Summary of neoadjuvant trials using chemoradiation strategies including patients with borderline resectable or locally advanced disease.
| Study (year) | Patients (n) | Regimen | Resection rate (%) | R0 rate (% of resected) | Median OS (months) | Ref. |
|---|---|---|---|---|---|---|
| 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] |
| Landry (2010) randomized Phase II | 21 BR | Gem + RT (50.4 Gy) | 30 | 33 | 19.4 (all) | [63] |
| |
|
Gem + RT (50.4 Gy) vs Gem + Cis + 5-FU + RT (50.4 Gy) |
22 |
50 |
13.4 (all), 26.3 (R) |
|
| Katz retrospective (2012) |
129 BR |
Gem then Gem + RT (30 Gy) vs Gem + Cis + 5-FU + RT (50.4 Gy) |
84 78 |
95 |
33 (all) |
[78] |
| Barugola retrospective (2012) |
362 BR |
Gem then Gem + RT vs Gem alone |
NR |
NR |
NR |
[79] |
| Kang retrospective (2012) |
202 BR |
Gem + RT |
91 |
87 |
26.3 (all) |
[80] |
| McClaine retrospective (2010) |
109 BR |
Gem + RT |
46 |
67 |
23.3 (all) |
[81] |
| Turrini retrospective (2009) |
160 BR |
5-FU + Cis + RT (45 Gy) |
18 |
100 |
24 (all) |
[34] |
| Stokes (2011) |
40 BR |
Cape + RT (50.4 Gy) |
40 |
88 |
23 (R), 12 (all) |
[68] |
| Patel (2011) |
17 BR |
GTX + IMRT (45 Gy micro, 50 Gy gross) |
64 |
89 |
15 (all) |
[66] |
| Small (2008) |
9 BR, 16 R |
Gem + RT (26 Gy) |
33 borderline |
94 (all) |
NR |
[67] |
| Massucco (2006) |
10 BR, 18 UR |
Gem ± Ox + RT (45 Gy) |
39 borderline |
87 (all) |
21 (R), 10 (UR), 15.4 (all) |
[64] |
| Mehta (2001) |
15 BR |
5-FU + RT (50.4–56 Gy) |
60 |
100 |
30 (R), 8 (UR) |
[65] |
| Chuong (2013) |
73 |
Gem then SBRT |
56 |
96 |
16.4 (all) |
[82] |
| Shinchi prospective (2002) |
31 UR |
5-FU ± RT (50.4 Gy) |
NR |
NR |
13.3 (RT), 6.4 (no RT) |
[76] |
| Tinkl prospective (2009) |
120 UR |
Gem + RT (50.4–55.8 Gy) |
31.6 |
92 |
25 (all) |
[72] |
| Kim Phase I (2013) |
38 UR |
Gem + Ox + RT (27 Gy) |
28.9 |
64 |
12.5 (all) |
[56] |
| Huguet Phase II and III (2007) |
167 |
FOLFUGEM, Gem + Ox, Gem then Gem + RT (55 Gy) Gem + Ox |
NR |
NR |
13.1 (all) |
[69] |
| Krishnan prospective (2007) |
247 UR 76 |
Gem then Gem + RT (30–55 Gy) 5-FU, Gem, Cape |
NR |
NR |
9.1 (all) |
[70] |
| Mukhergee (2013) randomized Phase II |
74 UR, 38 UR |
Gem or Cape then Gem or Cape + RT (58 Gy) Gem or Cape |
NR |
NR |
15.2 (Gem), 13.4 (Cape) |
[72] |
| Leone prospective (2013) |
15 BR, 24 UR |
Gem + Ox then Gem + RT (50.4 Gy) |
28.2 |
100 |
27.8 (BR), 13.3 (UR) |
[71] |
| Polistina prospective (2010) | 33 UR | Gem then Gem + SBRT (30 Gy, 3 fractions) | 8 | 66 | 10.6 (all) | [73] |
5-FU: 5 fluorouracil; Bev: Bevacizumab; BR: Borderline resectable; Cape: Capecitabine; Cis: Cisplatin ; FOLFIRINOX: 5-fluorouracil, oxaliplatin, irinotecan, and leucovorin; Gem: Gemcitabine; GTX: Gemcitabine, docetaxel and capecitabine; Gy: Gray; IMRT: Intensity-modulated radiation therapy; IORT: Intraoperative radiation therapy; NR: Not reported; Ox: Oxaliplatin; R: Resectable; RT: Radiotherapy; S1: Pral 5-fluorouracil; SBRT: Stereotactic body radiotherapy; Tax: Docetaxel; UR: Unresectable.