MORPHEUS Phase II–III Study: A Pre-Planned Interim Safety Analysis and Preliminary Results
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design and Participants
2.2. Procedures
2.3. Outcomes
2.4. Statistical Analysis
3. Results
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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EBRT (n = 20) | IGAEBT (n = 20) | |
---|---|---|
Age (median, range) | 67.5 (42–89) | 64.5 (46–87) |
Age (mean, std) | 69.7 (12.2) | 68.0 (12.0) |
Male Sex, n (%) | 15 (75) | 12 (60) |
Tumor stage, n (%) | ||
cT2 | 8 (40) | 6 (30) |
cT3 | 12 (60) | 14 (70) |
cN0 | 20 (100) | 20 (100) |
Tumor location, n (%) | ||
Mid-third (5 to 10 cm from anal verge) | 9 (45) | 7 (35) |
Lower-third (5 cm from anal verge) | 11 (55) | 13 (65) |
Tumor length on sagittal MRI view, n (%) | ||
<3 cm | 6 (30) | 6 (30) |
≥3 cm | 14 (70) | 14 (70) |
Pathology, n (%) | ||
Well differentiated | 8 (40) | 8 (40) |
Moderately differentiated | 9 (45) | 8 (40) |
Not specified | 3 (15) | 4 (20) |
Toxicities | EBRT | IGAEBT |
---|---|---|
(n = 20) | (n = 20) | |
Chemoradiotherapy Toxicities | 18 (90) | 15 (75) |
Anemia, n (%) | 8 (40) | 7 (35) |
G1 | 5 (25) | 5 (25) |
G2 | 3 (15) | 2 (10) |
≥G3 | 0 (0) | 0 (0) |
Leukopenia, n (%) | 2 (10) | 4 (20) |
G1 | 0 (0) | 2 (10) |
G2 | 2 (10) | 1 (5) |
≥G3 | 0 (0) | 1 (5) |
Diarrhea, n (%) | 17 (85) | 10 (50) |
G1 | 9 (45) | 7 (35) |
G2 | 8 (40) | 3 (15) |
≥G3 | 0 (0) | 0 (0) |
Radio-dermatitis, n (%) | 16 (80) | 12 (60) |
G1 | 2 (10) | 3 (15) |
G2 | 13 (65) | 8 (40) |
≥G3 | 1 (5) | 1 (5) |
IGAEBT Toxicities | ||
Proctitis, n (%) | NA | 18 (90) |
G1 | NA | 13 (65) |
G2 | NA | 3 (15) |
≥G3 | NA | 2 (10) |
Death, n (%) | 0 (0) | 2 (10) |
Outcome | EBRT (n = 12 pts) | IGAEBT (n = 2 pts) |
---|---|---|
Urinary tract trauma infection | 4 | 0 |
Abdominal wall infection | 1 | 1 |
Abscess | 3 | 1 |
Delirium | 1 | 0 |
Presacral bleeding | 1 | 1 |
Rectal prolapse | 1 | 0 |
Anastomotic leak | 1 | 0 |
Cardiopulmonary events | 1 | 0 |
Small bowel obstruction | 1 | 0 |
Post-surgery arm neuropathy | 1 | 0 |
COPD exacerbation | 1 | 0 |
Urinary infection trauma | 2 | 0 |
Ongoing intra-abdominal abscess | 1 | 0 |
Right arm neuropathy | 1 | 0 |
Re-operation | 2 | 0 |
Treatment | Patients | Events | Person-Years | Incidence Rate (95% CI) a | HR (95% CI) | p-Value | Adjusted HR (95% CI) b | p-Value |
---|---|---|---|---|---|---|---|---|
EBRT | 20 | 12 | 24.0 | 61.1 (27.7–134.8) | Ref | Ref | ||
IGAEBT | 20 | 4 | 46.9 | 9.2 (3.2–26.4) | 0.23 (0.07–0.71) | 0.011 | 0.13 (0.03–0.50) | 0.003 |
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Garant, A.; Vasilevsky, C.-A.; Boutros, M.; Khosrow-Khavar, F.; Kavan, P.; Diec, H.; Des Groseilliers, S.; Faria, J.; Ferland, E.; Pelsser, V.; et al. MORPHEUS Phase II–III Study: A Pre-Planned Interim Safety Analysis and Preliminary Results. Cancers 2022, 14, 3665. https://doi.org/10.3390/cancers14153665
Garant A, Vasilevsky C-A, Boutros M, Khosrow-Khavar F, Kavan P, Diec H, Des Groseilliers S, Faria J, Ferland E, Pelsser V, et al. MORPHEUS Phase II–III Study: A Pre-Planned Interim Safety Analysis and Preliminary Results. Cancers. 2022; 14(15):3665. https://doi.org/10.3390/cancers14153665
Chicago/Turabian StyleGarant, Aurelie, Carol-Ann Vasilevsky, Marylise Boutros, Farzin Khosrow-Khavar, Petr Kavan, Hugo Diec, Sylvain Des Groseilliers, Julio Faria, Emery Ferland, Vincent Pelsser, and et al. 2022. "MORPHEUS Phase II–III Study: A Pre-Planned Interim Safety Analysis and Preliminary Results" Cancers 14, no. 15: 3665. https://doi.org/10.3390/cancers14153665