Table 1.
Characteristics and outcomes of analyzed studies
| Author, year | Study design | Inclusion criteria | Patients (with pain) | Stage | Technique | PTV | Dose prescription | RT dose, median (range) | EQD2 α/β: 10 (median) | EQD2 α/β: 3 (median) | % of patients receiving chemotherapy“ | Pain response rate, % (criteria) | Pain-free survival (months) | Grade 3-4 toxicity % (scale) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
| ||||||||||||||
| Hoyer et al, 20054 | Phase I-II | LA | 22 (15) | T1–3N0M0 | SBRT with standard LINAC | GTV+edema+5–10 mm | PTV encompassed by 67% isodose | 45 Gy in three fractions | 93.8 | 162.0 | NA | NR | At 2 weeks increased pain (P: 0.008)b | Gastric-duodenal mucositis/ulceration: 18.0 Gastric perforation: 4.5 (WHO) |
| Seo et al, 20095 | Phase I | LA, no duodenal invasion, <3 N+ | 30 (18) | t4: 100.0% N1: 30.0% | RRS | GTV+2 mm (4 mm CC) | To isodose covering 97% of PTV | 40 Gy in 2 Gy/fraction (3D-CRT)+16.5 Gy (14-17) SF RRS boost | 76.4 | 104.4 | 70.0a (6 before RT; 15 concurrent to 3D-CRT) | RAA: 55.6 (NR) | NR | Acute: duodenal obstruction 3.3; late 0.0 (RTOG) |
| Didolkar et al 20106 | Retrospective | LA | 85 (Moderate: 21.2%, severe: 15.3%) | LA M1: 24.7c | RSBRT | GTV+3 mm | To 80% isodose | 25.5 Gy in three fractions (15-30) | 39.3 | 58.6 | 100 after | CR: 48.4 PR: 51.6d (0-10 scale) | 18-24 weeks | Acute: duodenitis (14.1) gastritis (12.9) diarrhea (3.5); late: hemorrhage/obstruction (8.2) (CTC 2.0) |
| Shen et al, 20107 | Case series | LA | 20 (15) | Stage 11-111 | RSBRT | GTV+3-5 mm | V75%>95% | 45 Gy (32-55) in four (3-6) fractions | 79.7 | 128.2 | NA | “Pain relief”: 90.0 (VAS) | NR | Acute: 0.0 Late: 0.0 (RTOG) |
| Polistina et al, 20108 | Case series | LA <6 cm | 23 (NR) | N1: 60.8% | RSBRT | NR | NR | 30 Gy in three fractions | 50.0 | 78.0 | 100a and after | No significant reduction (VAS) | NR | Acute: 0.0 Late: 0.0 (CTC 3.0) |
| Rwigema et al, 20119 | Retrospective | LA or MI' | 71 (16) | LA: 56 Rec: 16 M1: 11 R1:,7 | RRS or LINAC | GTV+2 mm | To 80%-89% isodose | 24 Gy SF (18-25) | 68.0 | 129.6 | 90a and/or after | CR: 81.3 (NR) | NR | Acute GI: 4.2 Late: 0.0 (NR) |
| Macchia et al, 201210 | Phase I | LA | 16 (9) | T4: 87.5%f Rec: 12.5%f | SBRT with standard LINAC | GTV+>10 mm | ICRU-62 | 25 Gy in five fractions (20-35) | 31.3 | 40.0 | 100a | CR: 25.0 PR: 31.3 RAA: 40.0 (NR) | NR | Acute: 0.0 Late: duodenal bleeding: 6.2 (RTOG) |
| Wild et al, 201311 | Retrospective | LA or Rec (previous RT) | 18 (7) | LA: 16.7% Rec: 83.3% | SBRT | ITV+1-3 mm | To isodose surrounding PTV | 25 Gy in five fractions (20-27) | 31.3 | 40.0 | 28 after SBRT | 57 “Effective palliation” (NR) | NR | Acute: 0.0 Late: small bowel obstruction: 6.0 (NR) |
| Tozzi et al, 201312 | Case series | LA or Rec ≤5 cm | 30 (11) | LA: 70% Rec: 30% | VMAT FFF | GTV+5 mm (10 mm CC) | CTV V95%=100% | 45 Gy in six fractions (36-45) | 65.5 | 95.0 | 100a | SAA: 63.6 RAA 36.4 (NRS) | NR | Acute: 0.0 Late: 0.0 (CTC 3.0) |
| Herman et al, 201513 | Phase II | LA | 49 (NR) | NR | SBRT (VMAT) | GTV+2-3 mm | V100%>90% | 33 Gy in five fractions | 45.7 | 63.4 | 90a 100 after |
Reduction of 8 points from baseline: 25 points (QLQ-PAN 26) | NR | Acute: duodenal ulcer: 2.0g; late: duodenal ulcer/bleeding: 6.4 (NR) |
| Su et al, 201514 | Retrospective | LA or MI | 25 (20) | LA: 25 M1: 16 | RSBRT | GTV+I-2 mm | V93%>97 | 36 Gy in three fractions (30-48 in three to four fractions) | 66.0 | 108.0 | 8a 8 after |
SAA: 50.0 RAA: 15.0 (NRS) | NR | Acute: 0.0 Late: 0.0 (NR) |
| Kim et al, 201315 | Retrospective | Not surgical candidates | 26 (16) | Stage I-IV | LINAC or RRS or RSBRT | GTV+2 mm | To 80%-93% isodose | 24 (24-36) Gy in one to three fractions | 68.0 | 135.0 | 15.0a 23.0 after |
Pain relief: 75.0 SAA: 31.3 (NR) | NR | Acute: 0.0 Late: 0.0 (RTOG/EORTC) |
| Comito et al, 201716 | Retrospective | Isolated Rec | 31 (20) | Local Rec | Rapidarc FFF | lTV+5 mm or GTV+5-7 mm | To mean PTV dose | 45 Gy in six fractions | 65.5 | 95.0 | 20a 77 after |
SAA: 58.0 RAA: 40.0 (NRS) | NR | Acute: 0.0 Late: 0.0 (CTCAE V.4.0) |
| Koong et al, 201717 | Retrospective | Previously irradiated local Rec | 23 (14) | Local Rec, M0 | RSBRT or standard LINAC | ITV+2-3 mm | NR | 25 Gy in five fractions | 31.3 | 40.0 | 26.1a | “Relative improvement” 57.1 (NR) | NR | Acute: GI (8.7); late: 0.0 (CTCAE v. 4.0) |
Notes:
Induction.
Of 12 patients evaluated at 3 months, 50% had “less pain”.
Previous RT: 34.1%.
Only patients with moderate/severe pain.
Prior RT: 21%.
Ten patients received SBRT as a boost after chemoradiation.
Elevated aspartate/alanine aminotransferase: 10%.
Abbreviations: 3D-CRT, 3D-conformal radiation therapy; CC, cranio-caudally; CR, complete response; CTCAE, Common Terminology Criteria for Adverse Events; CTC, Common Toxicity Criteria; CTV, clinical target volume; EORTC, European Organization for Research and Treatment of Cancer; EQD2, biologically equivalent doses in 2 Gy fractions; FFF, filter flattering free; GI, gastrointestinal; GTV, gross tumor volume; ICRU, International Commission on Radiation Units; ITV, internal tumor volume; LA, locally advanced; LINAC, linear accelerator; M, metastases; NA, not administered; N, nodes; NR, not reported; NRS, Numerical Rating Scale; PR, partial response; PTV, planning target volume; RAA, reduction of analgesic administration; Rec, recurrence; RRS, robotic radiosurgery; RSBRT, stereotactic radiosurgery; RT, radiation therapy; RTOG, Radiation Therapy Oncology Group; SAA, suspension of analgesic administration; SBRT, stereotactic RT; SF, single fraction; VAS, visual analog scale; VMAT, volumetric modulated arc therapy; WHO, World Health Organization.