Table 1.
Selected modern trials evaluating the role of non-stereotactic CRT in potentially resectable (R – BR) pancreatic adenocarcinoma.
| Study | Study design | N | Resectability status (classification used) | RT regimen: dose (Gy)/# | RT technique | CT | Resection rate (%) |
R0 resection rate (%) |
Median survival (months) |
||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Surgery alone | CRT | Surgery alone | CRT | All | Res. | Not Res. | |||||||
| Versteijne et al.60 | Phase III | Arm A: 127 Arm B: 119 |
R/BR (DPCG, 2012) |
Arm A: – Arm B: 36/15 |
VMAT, IMRT or 3D | Arm A: – Arm B: gem (S + 1 cycle after CRT) |
72 | 61 | 40 | 71 | Arm A: 14.3 Arm B: 16 |
Arm A: 19.2 Arm B: 35.2ᴽ |
NR |
| Jang et al.†61 | Phase II/III | Arm A: 23 Arm B: 27 |
BR (NCCN) |
Arm A: – Arm B: 54/30 |
3D | Arm A: – Arm B: gem (S) |
78 | 63 | 33.3 | 82.4 | Arm A: 12 Arm B: 21ᴽ |
NR | NR |
| Pietrasz et al.62 | Retrospective | Group A: 57 Group B: 49 |
BR (NCCN) |
Group A: – Group B: 54/30 |
IMRT (80%) – 3D (20%) | Group A: I = FOLFIRINOX (median 6 cycles) Group B: I + S = 5-FU or capecitabine |
NA | NA | NA | Group A & B: 80.2 | NA | 44.7◊
ᴽ
Group A: 35.5◊ Group B: 62.9◊ ᴽ |
NA |
| Nagakawa et al.63 | Phase II | 27 | BR-A (own definition, derived from NCCN) |
50.4/28 | IMRT | I: gem (2 cycles) S: gem/S-1 |
NA | 70 | NA | 95 | 22.4 | 22.9 | 9.3 |
| Fujii et al.47 | Observational | Group A: 416 Group B: 88 |
R/BR-A/BR-PV (own definition, derived from NCCN) |
Group A: – Group B: 50.4/28 |
NR | Group A: – Group B: S = S-1 |
R: 88 BR-PV: 82 BR-A: 68 |
R: 92 BR-PV: 93ᴽ BR-A: 70 |
R: 70 BR-PV: 61 BR-A: 31 |
R: 86ᴽ
BR-PV: 96ᴽ BR-A: 71ᴽ |
R:
CRT: 28.6 Surgery alone: 33.7 BR-PV: CRT: 28.4ᴽ Surgery alone: 20.1 BR-A: CRT: 18.1ᴽ Surgery alone: 10 |
NR | NR |
| Katz et al.64 (Alliance A021101) | Phase II | 22 | BR (Intergroup criteria) |
50.4/28 | IMRT or 3D | I: mFOLFIRINOX (4 cycles) S: capecitabine |
NA | 68 | NA | 93 | 21.7 | NR | NR |
| Casadei et al.*55 | Phase III | Arm A: 20 Arm B: 18 |
R (Ishikawa) |
Arm A: – Arm B: 54/30 |
3D | Arm A: – I: gem (2 cycles) S: gem |
75 | 61 | 25 | 39 | Arm A: 19.5 Arm B: 22.4 |
NR | NR |
| Golcher et al.*65 | Randomised phase II | Arm A: 33 Arm B: 33 |
R/BR (own definition) |
Arm A: – Arm B: 55.8/31 |
3D | S: gem/cisplatin | 67 | 58 | 48 | 52 | Arm A: 14.4 Arm B: 17.4 |
Arm A: 18.9 Arm B: 25 |
NR |
| Dholakia et al.66 | Retrospective | 50 | BR (AHPBA/SSO/SSAT) |
NR | VMAT or IMRT or 3D | I: 5-FU/oxaliplatin or FOLFIRINOX S: gem +/–oxaliplatin or capecitabine |
NA | 58 | NA | 93 | 17.2 | 22.9 | 13 |
| Kim et al.48 | Phase II | 68 | R/BR/LAPC (NCCN 2008) |
30/15 | 3D | S: gem/oxaliplatin (+ 1 cycle after) | NA | R: 57 BR: 72 |
NA | 84 | 18.2 R: 26.5 BR: 18.4 |
27.1 | 10.9 |
| Turrini et al.49 | Phase II | 34 | R (own definition) |
45/25 | 3D | S: docetaxel | NA | 50 | NA | 100 | 15.5 | 32 | 11 |
#, number of fractions; 5-FU, 5-fluorouracil; AHPBA/SSO/SSAT, American Hepatopancreaticobiliary Association/Society of Surgical Oncology/Society for surgery of the Alimentary Tract; BR(-A/PV), borderline resectable (due to arterial abutment/due to exclusive involvement of the portal vein system); CRT, chemoradiotherapy; CT, chemotherapy; DPCG, Dutch Pancreatic Cancer Group; FOLFIRINOX, oxaliplatin, irinotecan, leucovorin and fluorouracil, Gy, Gray; I, induction; S, sensitizer; Gem, gemcitabine; IMRT, intensity-modulated radiation therapy; N, number of patients; NA, not applicable; NCCN, National Comprehensive Cancer Network; NR, not reported; R, resectable; RT, radiation therapy; S-1, combination Tegafur/gimeracil/oteracil; VMAT, volumetric modulated arc therapy.
Early termination due to efficacy.
Statistically positive results in favour of CRT arm.
Closed early due to poor accrual.
Results for BR population only.