Table 3.
Selected historical and modern trials evaluating the role of SBRT for pancreatic adenocarcinoma.
| Study | Study design | N | Res. status | Dose (Gy)/# | RT machine | CT | Resection rate (%) | R0 resection rate (%) | LC (at 1 year, %) | Grade ⩾3 GI toxicity (%) |
Median survival from diagnosis (months) |
||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acute | Late | All | Res | ||||||||||
| Main historical studies with single fraction | |||||||||||||
| Koong et al.107 | Phase I | 15 | LAPC | 15–25/1 | Cyberknife | I (20%): gem-based | / | / | 77 100 (for the six patients at 25 Gy) |
33 | / | 11 | / |
| Koong et al.108 | Phase II | 16 | LAPC | 25/1 | Cyberknife | / | / | / | 94 | 12.5 | / | 7.7 | / |
| Schellenberg et al.109 | Case series | 16 | LAPC | 25/1 | Cyberknife | I/C: gem | / | / | 100 | 18.6 | / | 11.4 | |
| Chang et al.110 | Retrospective | 77 | R (3%)/LAPC (78%)/M+ (19%) | 25/1 | Cyberknife | / | 1 | NR | 84 | 5 | 9 | 11.9 LAPC: 11.5 |
NR |
| Schellenberg et al.111 | Phase II | 20 | LAPC | 25/1 | Cyberknife | I/C: gem | / | / | 94 | 15 | 5 | 11.8 | / |
| Goyal et al.112 | Case series | 19 | LAPC/Recurrence (10%) | 20–30/1–3 | Cyberknife | I (68%): 5-FU or gem-based | / | / | 65 | 0 | 16 | 14.4 | / |
| Rajagopalan et al.113 | Retrospective | 12 | BR (58%)/LAPC (42%) | 24–36/1–3 | Cyberknife/Linac | I (92%): gem-based | 11.4 | 91.7 | NR | 0 | 16.7 | 47.2 | NR |
| Main modern hypofractionated SBRT studies including mainly LAPC ¥ | |||||||||||||
| Moningi et al.114 | Retrospective | 74 14 |
LAPC BR |
25–33/5 | Linac | I (87.5%): gem-based or FOLFIRINOX | LAPC: 20 BR: 29 |
All: 84 | All: 61 | 3.4 | 5.7 | LAPC: 18.4 BR: 14.4 |
All: 20.2 |
| Herman et al.115 | Phase II | 49 | LAPC | 33/5 | Linac | I: gem (up to 3weeks) C: gem |
8 | 100 | 78 | 12.2 | 10 | 13.9 | 22.2 |
| Comito et al.116 | Phase II | 45 | LAPC | 45/6 | Linac | I: gem-based (71%) | / | / | 87 | 0 | 0 | 19 | / |
| Zhong et al.117 | Retrospective | 631 | LAPC | 40/5 | NR | I (87%): NR | 10.8 | 92 | NR | NR | NR | 13.9 | NR |
| Gurka et al.118 | Retrospective | 28 6 4 |
LAPC BR Medically inoperable |
25–30/5 | Cyberknife | I/S: 5-FU, capecitabine, gem or FOLFOX | 0 | / | 79 | 5 | 8 | All: 14.3 | / |
| Jumeau et al.119 | Retrospective | 17 4 |
LAPC Local recurrence |
30–35/5–6 | Cyberknife | I (38%): gem or FOLFIRINOX | / | / | 67 | 5 | 5 | 22 | / |
| Jung et al.120 | Retrospective | 95 | LAPC | 24–36 (median 28)/4 | Linac | I (14%)/C (81%): gem-based or FOLFIRINOX | 7.4 | 57 | 80 | 3.2 | 3.2 | 16.7 | NR |
| Suker et al.128 | Phase II | 50 | LAPC | 40/5 | NR | I: FOLFIRINOX | 12 | 100 | Median: 20 months | 10 | NR | 15 | 23 |
| Main modern hypofractionated SBRT trials including mainly BR PDAC | |||||||||||||
| Chuong et al.121 | Retrospective | 57 16 |
BR LAPC |
25–30/5 (SIB TVI 35–50 Gy) | Linac | I: gem-based (3 cycles) | 56 0 |
97 / |
81 (Not resected only) | 0 | 5.3 | 16.4 15 |
19.3 / |
| Mellon et al.122 | Retrospective | 110 49 |
BR LAPC |
28–30/5 (SIB TVI 50 Gy) | Linac | I: gem-based or FOLFIRINOX | 51 10 |
96 100 |
78 (Not resected only) | 2 | 7 | 19.2 15 |
All: 34.2 |
| Chuong et al.123 | Retrospective | 36 | BR | 25–30/5 (SIB TVI up to 40 Gy) | Linac | I: gem-based, mainly GTX | 100 | 97.2 | 100 | 0 | NR | 22.5 | / |
| Mellon et al.124 | Retrospective | 150 72 |
BR LAPC |
25–30/5 (SIB TVI 50 Gy) | Linac | I: gem-based mainly GTX or FOLFIRINOX (3 cycles) | 51 11 |
All: 97.5 | NR | NR | NR | NR | All: 37.5 |
| Quan et al.125 | Phase II | 19 16 |
BR LAPC |
36/3 | NR | I: gem/capecitabine (4 cycles) | 53 12.5 |
All: 91.7 | 63 78 |
0 | 0 | 28.3 14.3 |
31 24.6 |
| Palta et al.†121 | Prospective (Abstract) | 16 9 |
BR R |
25/5 | NR | I: gem/nab-paclitaxel (2 cycles) | All: 68 | All: 93 | 77 | 0 | / | All: 24 | NR |
| Kharofa et al.127 | Phase II | 15 3 |
BR R |
25/5 (SIB TVI 33 Gy) | NR | I: gem/nab-paclitaxel or FOLFIRINOX (3 months) | All: 67 | All: 92 | 50 | 0 | 0 | All: 21 | All: 31 |
#, number of fractions; BR, borderline resectable; C, consolidation; CRT, chemoradiotherapy; CT, chemotherapy; FOLFIRINOX, oxaliplatin, irinotecan, leucovorin and fluorouracil; FOLFOX, oxaliplatin, leucovorin, and fluorouracil; Gem, gemcitabine; GI, gastrointestinal; GTX, gemcitabine/docetaxel/capecitabine; Gy, Gray; I, induction; LAPC, locally advanced pancreatic cancer; LC, local control; Linac, linear accelerator; N, number of patients; NA, not applicable; NR, not reported; R, resectable; RT, radiation therapy; S, sensitizer; SBRT, stereotactic body radiation therapy; SIB, simultaneous-integrated boost; TVI, tumour–vessel interface.
Results concerns LAPC only even if other PDAC status were included in the studies, excepted if clearly mentioned in the table.