| Literature DB >> 33851063 |
Thilo Schuler1,2, Michael Back1,3, George Hruby1,3, Susan Carroll1, Dasantha Jayamanne1, Andrew Kneebone1,3, Mark Stevens1, Gillian Lamoury1,3, Marita Morgia1, Shelley Wong1, Kylie Grimberg1, Stephanie Roderick1, Jeremy Booth1,4, Thomas Eade1,3.
Abstract
PURPOSE: Our purpose was to report outcomes of a novel palliative radiation therapy protocol that omits computed tomography simulation and prospectively collects electronic patient-reported outcomes (ePROs). METHODS AND MATERIALS: Patients receiving extracranial, nonstereotactic, linear accelerator-based palliative radiation therapy who met inclusion criteria (no mask-based immobilization and a diagnostic computed tomography within 4 weeks) were eligible. Global pain was scored with the 11-point numerical pain rating scale (NPRS). Patients were coded as having osseous or soft tissue metastases and no/mild versus severe baseline pain (NPRS ≥ 5). Pain response at 4 weeks was measured according to the international consensus (no analgesia adjustment). Transition to ePRO questionnaires was completed in 3 phases. Initially, pain assessments were collected on paper for 11 months, then pilot ePROs for 1 month and then, after adjustments, revised ePROs from 1 year onwards. ePRO feasibility criteria were established with reference to the paper-based process and published evidence.Entities:
Year: 2020 PMID: 33851063 PMCID: PMC8039552 DOI: 10.1016/j.adro.2020.100632
Source DB: PubMed Journal: Adv Radiat Oncol ISSN: 2452-1094
Figure 1Conceptual model: Evolution of palliative RT and rationale of study. Abbreviations: 3D-CRT = 3D conformal RT; IMRT = intensity modulated RT; RT = radiation therapy; VMAT = volumetric modulated arc RT.
Figure 2Strengthening the Reporting of Observational Studies in Epidemiology flow diagram of screening, treatment, electronic patient-reported outcomes (ePROs) monitoring, and analysis stages.
Figure 3Proportion of palliative patients treated on computed tomography (CT) simulation-free (Sim-free) pathway by month.
Baseline patient characteristics of treated patients
| Osseous group | Nonosseous group | No baseline NPRS recorded | All patients | |||
|---|---|---|---|---|---|---|
| NPRS 0-4 | NPRS 5-10 | NPRS 0-4 | NPRS 5-10 | (n = 33) | (n = 160) | |
| (n = 37) | (n = 58) | (n = 24) | (n = 8) | |||
| Age | ||||||
| Min. | 42 | 28 | 54 | 61 | 21 | 21 |
| P25 | 64 | 62 | 71 | 68 | 54 | 62.8 |
| Median | 72 | 71 | 76 | 73 | 69 | 71.5 |
| P75 | 79 | 77 | 79 | 77 | 80 | 78 |
| Max. | 96 | 91 | 94 | 90 | 98 | 98 |
| Sex | ||||||
| Female | ||||||
| n (%) | 20 (54) | 35 (60) | 16 (67) | 4 (50) | 22 (67) | 97 (61) |
| Male | 17 (46) | 23 (40) | 8 (33) | 4 (50) | 11 (33) | 63 (39) |
| Cancer type | ||||||
| Lung | ||||||
| n (%) | 4 (11) | 17 (29) | 6 (25) | 0 (0) | 10 (30) | 37 (23) |
| Prostate | 11 (30) | 10 (17) | 1 (4) | 0 (0) | 5 (15) | 17 (17) |
| Colorectal | 5 (14) | 5 (9) | 3 (13) | 1 (13) | 3 (9) | 17 (11) |
| Breast | 7 (19) | 7 (12) | 0 (0) | 0 (0) | 2 (6) | 16 (10) |
| Other | 10 (27) | 19 (33) | 14 (58) | 7 (88) | 13 (39) | 63 (39) |
| Performance status | ||||||
| ECOG 0 | ||||||
| n (%) | 9 (24) | 14 (24) | 5 (21) | 1 (13) | 6 (18) | 35 (22) |
| ECOG 1 | 16 (43) | 27 (47) | 6 (25) | 4 (50) | 13 (39) | 66 (41) |
| ECOG 2 | 8 (22) | 15 (26) | 11 (46) | 0 (0) | 11 (33) | 45 (28) |
| ECOG 3 | 3 (8) | 1 (2) | 2 (8) | 2 (25) | 2 (6) | 10 (6) |
| ECOG 4 | 1 (3) | 1 (2) | 0 (0) | 1 (13) | 1 (3) | 4 (3) |
| Baseline pain (NPRS score) | ||||||
| Min. | 0 | 5 | 0 | 5 | - | 0 |
| P25 | 0 | 6 | 0 | 6 | - | 1 |
| Median | 2 | 7 | 0 | 7 | - | 5 |
| P75 | 3 | 8 | 1 | 7 | - | 7 |
| Max. | 4 | 10 | 4 | 10 | - | 10 |
| Dose/fractionation | ||||||
| 8 Gy/1# | ||||||
| n (%) | 22 (59) | 31 (53) | 8 (33) | 2 (25) | 16 (48) | 80 (50) |
| 20 Gy/4-5# | 11 (30) | 16 (28) | 11 (46) | 3 (38) | 10 (30) | 51 (32) |
| 25 Gy/5# | 3 (8) | 4 (7) | 1 (4) | 1 (13) | 4 (12) | 13 (8) |
| Other | 1 (3) | 7 (12) | 4 (17) | 2 (25) | 3 (9) | 16 (10) |
| Treatment technique | ||||||
| 3D-CRT | ||||||
| n (%) | 23 (62) | 44 (76) | 16 (67) | 2 (25) | 26 (79) | 111 (69) |
| IMRT | 14 (38) | 14 (24) | 8 (33) | 6 (75) | 7 (21) | 49 (31) |
| Number of treatment sites | ||||||
| One (1) site | ||||||
| n (%) | 30 (81) | 46 (79) | 23 (96) | 8 (100) | 30 (91) | 137 (86) |
| Two (2) sites | 5 (14) | 9(16) | 1 (4) | 0 (0) | 1 (3) | 16 (10) |
| Three (3) sites | 2 (5) | 3 (15) | 0 (0) | 0 (0) | 2 (6) | 7 (4) |
Abbreviations: 3D-CRT = 3D conformal radiation therapy; ECOG = Eastern Cooperative Oncology Group; Gy = Gray; IMRT = intensity modulated radiation therapy; NPRS = numerical pain rating scale; P25 = 25th percentile; P75 = 75th percentile; # = fraction(s).
Pain response as per international consensus without analgesia adjustment, with comparison of severe osseous pain response outcomes against published results,
| Nonosseous cohort | Osseous cohort | Comparison of outcomes of osseous cohort with severe pain (NPRS 5-10) against published evidence | ||||||
|---|---|---|---|---|---|---|---|---|
| NPRS 0-4 | NPRS 5-10 | NPRS 0-4 | NPRS 5-10 | Randomized evidence | Nonrandomized evidence | |||
| No. of assessable patients | n = 19 | n = 3 | n = 21 | n = 41 | ||||
| OR | 21% | 100% | 24% | |||||
| CR | 21% | 33% | 14% | |||||
| Partial response | 0% | 67% | 10% | 56% | ||||
| Indeterminate response | 53% | 0% | 38% | 15% | ||||
| Pain progression | 26% | 0% | 38% | 7% | ||||
Abbreviations: CR = complete response; NPRS = numerical pain rating scale; OR = overall response.
Bold values are the part of comparison with published evidence.
P < .05.
Figure 4Patient-reported outcome (PRO) completeness at (A) baseline and (B) 4-weeks follow-up by phase.