Ultrahypofractionated Versus Normofractionated Preoperative Radiotherapy for Soft Tissue Sarcoma: A Multicenter, Prospective Real-World-Time Phase 2 Clinical Trial
Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. The Study Design and Participants
2.2. Treatment
2.3. Data Collection
2.4. Outcome Measures
2.5. Statistical Analysis
2.6. Quality Control
3. Results
3.1. Patients Characteristics
3.2. Local Recurrence-Free Survival
3.3. Overall Survival
3.4. Wound Revision
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Category | Definition/Examples |
---|---|
Major Wound Complications | Secondary operations required under general or regional anesthesia for wound treatment. |
Readmission to the hospital for wound care. | |
Invasive procedures for wound management. | |
Deep wound packing to an area of a wound measuring at least 2 cm in length. | |
Prolonged dressing changes or repeat surgery for revision of a split-thickness skin graft. | |
Wet dressings for longer than 4 weeks | |
Minor Wound Complications | Wound-edge necrosis requiring topical treatment such as silver sulfadiazine cream. |
Minor infections treated with oral antibiotics | |
Prolonged dry dressing not reaching the extent or duration of “prolonged dressing changes” defined under major complications. |
Characteristic | Overall, N = 138 1 | Normofractionation, N = 74 1 | Ultrahypofractionation, N = 64 1 | p-Value 2 |
---|---|---|---|---|
Gender | 0.83 | |||
Female | 63 (46%) | 33 (45%) | 30 (47%) | |
Male | 75 (54%) | 41 (55%) | 34 (53%) | |
Age | 59 (49, 73) | 59 (50, 74) | 61 (49, 72) | 0.90 |
Depth | 0.31 | |||
Epifascial | 22 (16%) | 9 (12%) | 13 (20%) | |
Retroperitoneal | 4 (2.9%) | 3 (4.1%) | 1 (1.6%) | |
Subfascial | 112 (81%) | 62 (84%) | 50 (78%) | |
Size | 83 (59, 120) | 87 (65, 121) | 74 (52, 110) | 0.14 |
Grading | 0.007 | |||
G1 | 13 (9.4%) | 6 (8.1%) | 7 (11%) | |
G2 | 37 (27%) | 27 (36%) | 10 (16%) | |
G3 | 72 (52%) | 30 (41%) | 42 (66%) | |
(Unknown) | 16 (12%) | 11 (15%) | 5 (7.8%) | |
Necrosis | 40 (10, 90) | 60 (10, 90) | 20 (5, 69) | 0.002 |
Indication | 0.11 | |||
First presentation | 119 (86%) | 67 (91%) | 52 (81%) | |
Recurrence | 19 (14%) | 7 (9.5%) | 12 (19%) | |
Hyperthermia | 1 (1.0%) | 1 (2.8%) | 0 (0%) | 0.4 |
Boost | 2 (2.0%) | 2 (5.6%) | 0 (0%) | 0.13 |
Predicted 5y OS using Sarculator or Persarc | 0.78 (0.66, 0.88) | 0.77 (0.63, 0.85) | 0.82 (0.68, 0.90) | 0.10 |
Status | 0.40 | |||
AWD | 32 (23%) | 16 (22%) | 16 (25%) | |
DOD | 31 (23%) | 20 (27%) | 11 (17%) | |
NED | 75 (54%) | 38 (51%) | 37 (58%) | |
Wound revision | 17 (12%) | 9 (12%) | 8 (13%) | 0.93 |
Fractionation Type | Study | Design | Number of Patients | Total Dose | Dose/Fraction | Duration (Weeks) | Wound Complication Rate | Local Control |
---|---|---|---|---|---|---|---|---|
nRT | Canter et al. (2010) [36] | Prospective | 25 | 50 | 2 | 5 | 28% | 100% at 3-years |
Shah et al. (2012) [35] | Prospective | 30 | 50 | 2 | 5 | 23% | 100% at 5 years | |
O’Sullivan et al. (2022) [5] | Phase III | 94 | 50 | 2 | 5 | 35% | 92% at 3.3 years | |
Studer et al. (2018) [6] | Retrospective | 67 | 50 | 2 | 5 | 7% | 98% at 3 years | |
hRT | Guadagnolo et al. (2022) [25] | Phase II | 120 | 42.75 | 2.85 | 3 | 31% | - |
uhRT | Kosela-Paterczyk et al. (2016) [17] | Phase II | 32 | 25 | 5 | 1 | 29% | 90% at 5 years |
Kalbasi et al. (2020) [15] | Phase II | 52 | 30 | 6 | 1 | 32% | 94% at 2 years | |
Bedi et al. (2022) [11] | Phase II | 32 | 35 | 7 | 1 | 25% | 100% at 3 years | |
Present study (2024) | Comparative Phase II | 64 (of 138) | 25 | 5 | 1 | 12% | 94.8% at 2.2 years |
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Heesen, P.; Di Lonardo, M.; Ciobanu-Caraus, O.; Schelling, G.; Zwahlen, D.; Bode-Lesniewska, B.; Glanzmann, C.; Studer, G.; Fuchs, B., on behalf of the Swiss Sarcoma Network. Ultrahypofractionated Versus Normofractionated Preoperative Radiotherapy for Soft Tissue Sarcoma: A Multicenter, Prospective Real-World-Time Phase 2 Clinical Trial. Cancers 2024, 16, 4063. https://doi.org/10.3390/cancers16234063
Heesen P, Di Lonardo M, Ciobanu-Caraus O, Schelling G, Zwahlen D, Bode-Lesniewska B, Glanzmann C, Studer G, Fuchs B on behalf of the Swiss Sarcoma Network. Ultrahypofractionated Versus Normofractionated Preoperative Radiotherapy for Soft Tissue Sarcoma: A Multicenter, Prospective Real-World-Time Phase 2 Clinical Trial. Cancers. 2024; 16(23):4063. https://doi.org/10.3390/cancers16234063
Chicago/Turabian StyleHeesen, Philip, Michele Di Lonardo, Olga Ciobanu-Caraus, Georg Schelling, Daniel Zwahlen, Beata Bode-Lesniewska, Christoph Glanzmann, Gabriela Studer, and Bruno Fuchs on behalf of the Swiss Sarcoma Network. 2024. "Ultrahypofractionated Versus Normofractionated Preoperative Radiotherapy for Soft Tissue Sarcoma: A Multicenter, Prospective Real-World-Time Phase 2 Clinical Trial" Cancers 16, no. 23: 4063. https://doi.org/10.3390/cancers16234063
APA StyleHeesen, P., Di Lonardo, M., Ciobanu-Caraus, O., Schelling, G., Zwahlen, D., Bode-Lesniewska, B., Glanzmann, C., Studer, G., & Fuchs, B., on behalf of the Swiss Sarcoma Network. (2024). Ultrahypofractionated Versus Normofractionated Preoperative Radiotherapy for Soft Tissue Sarcoma: A Multicenter, Prospective Real-World-Time Phase 2 Clinical Trial. Cancers, 16(23), 4063. https://doi.org/10.3390/cancers16234063