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Precision radiotherapy for metastatic spinal cord compression: Final results of the PRE-MODE Trial.

Abstract

PURPOSE/OBJECTIVE

To investigate precision radiotherapy for metastatic spinal cord compression (MSCC) and compare it to conventional radiotherapy.

METHODS AND MATERIALS

In a multi-center phase 2 study, 40 patients received 5Gyx5 of precision radiotherapy (38 volume modulated arc therapy, 2 intensity-modulated radiotherapy) for MSCC and were evaluated for local progression-free survival (LPFS), motor function, ambulatory status, sensory function, sphincter dysfunction, pain, distress, overall survival (OS) and toxicity. Maximum spinal cord dose was 101.5% (myelopathy risk <0.03%) of the prescription dose. Patients were compared to a historical control group conventionally irradiated with 4Gyx5 (propensity-score analysis). The equivalent dose in 2Gy-fractions of 5Gyx5 is similar to 3Gyx10, which results in better LPFS than 4Gyx5. It was assumed that 5Gyx5 is also superior to 4Gyx5 for LPFS. (ClinicalTrials.gov-identifier: XXX) RESULTS: Six-month rates of LPFS and OS were 95.0% and 42.6%, respectively. Improvement of motor function occurred in 24 patients (60%). Thirty-three patients (82.5%) were ambulatory following radiotherapy. Eight of 16 patients (50.0%) with sensory deficits improved. Pain and distress relief were reported by 61.9% and 54.2% of patients at 1 month following radiotherapy. Grade 3 toxicities occurred in one patient, grade 2 toxicities in another 3 patients. Of the control group, 664 patients qualified for the propensity-score analysis. 5Gyx5 was significantly superior to 4Gyx5 regarding LPFS (p=0.026), but not regarding motor function (p=0.51) or OS (p=0.82).

CONCLUSIONS

Precision radiotherapy with 5Gyx5 was well tolerated and effective, and appeared superior to 4Gyx5 regarding LPFS. The retrospective nature of the historic control group, which may have led to a hidden selection bias, needs to be considered when interpreting the results.

Authors+Show Affiliations

Department of Radiation Oncology, University of Lübeck, Luebeck, Germany. Electronic address: Rades.Dirk@gmx.net.Department of Radiation Oncology, Cruces University Hospital, Barakaldo, Vizcaya, Spain.Department of Radiation Oncology, Consorcio Hospital Provincial de Castellon, Castellon, Spain; Department of Radiation Oncology, University and Polytechnic Hospital La Fe, Valencia, Spain.Department of Radiotherapy, Institute of Oncology Ljubljana, Ljubljana, Slovenia.Department of Radiotherapy, Institute of Oncology Ljubljana, Ljubljana, Slovenia.Department of Radiotherapy, Institute of Oncology Ljubljana, Ljubljana, Slovenia.Radiation Oncology Department, University Clinic Tbilisi, Tbilisi, Georgia.Radiation Oncology Department, University Clinic Tbilisi, Tbilisi, Georgia.Department of Radiation Oncology, University Hospital HM Sanchinarro, Madrid, Spain.Department of Radiation Oncology, University Hospital HM Sanchinarro, Madrid, Spain.Department of Radiation Oncology, University Hospital Salamanca, Salamanca, Spain.Department of Radiation Oncology, ICO - University Hospital Germans Trias i Pujol, Badalona, Spain.Centre for Clinical Trials Lübeck, Luebeck, Germany.Department of Radiation Oncology, University of Lübeck, Luebeck, Germany.Department of Radiation Oncology, Mayo Clinic Scottsdale, Arizona, U.S.A.Department of Oncology and Palliative Units, Zealand University Hospital, Naestved, Denmark.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31812719

Citation

Rades, Dirk, et al. "Precision Radiotherapy for Metastatic Spinal Cord Compression: Final Results of the PRE-MODE Trial." International Journal of Radiation Oncology, Biology, Physics, 2019.
Rades D, Cacicedo J, Conde-Moreno AJ, et al. Precision radiotherapy for metastatic spinal cord compression: Final results of the PRE-MODE Trial. Int J Radiat Oncol Biol Phys. 2019.
Rades, D., Cacicedo, J., Conde-Moreno, A. J., Segedin, B., But-Hadzic, J., Groselj, B., ... Hollaender, N. H. (2019). Precision radiotherapy for metastatic spinal cord compression: Final results of the PRE-MODE Trial. International Journal of Radiation Oncology, Biology, Physics, doi:10.1016/j.ijrobp.2019.11.401.
Rades D, et al. Precision Radiotherapy for Metastatic Spinal Cord Compression: Final Results of the PRE-MODE Trial. Int J Radiat Oncol Biol Phys. 2019 Dec 5; PubMed PMID: 31812719.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Precision radiotherapy for metastatic spinal cord compression: Final results of the PRE-MODE Trial. AU - Rades,Dirk, AU - Cacicedo,Jon, AU - Conde-Moreno,Antonio J, AU - Segedin,Barbara, AU - But-Hadzic,Jasna, AU - Groselj,Blaz, AU - Kevlishvili,Gvantsa, AU - Lomidze,Darejan, AU - Jurio,Raquel Ciervide, AU - Rubio,Carmen, AU - Perez-Romasanta,Luis A, AU - Alvarez-Gracia,Ana, AU - Olbrich,Denise, AU - Doemer,Claudia, AU - Schild,Steven E, AU - Hollaender,Niels H, Y1 - 2019/12/05/ PY - 2019/07/30/received PY - 2019/11/12/revised PY - 2019/11/25/accepted PY - 2019/12/9/entrez PY - 2019/12/10/pubmed PY - 2019/12/10/medline KW - historical control group KW - local progression-free survival KW - metastatic spinal cord compression KW - phase 2 trial KW - precision radiotherapy JF - International journal of radiation oncology, biology, physics JO - Int. J. Radiat. Oncol. Biol. Phys. N2 - PURPOSE/OBJECTIVE: To investigate precision radiotherapy for metastatic spinal cord compression (MSCC) and compare it to conventional radiotherapy. METHODS AND MATERIALS: In a multi-center phase 2 study, 40 patients received 5Gyx5 of precision radiotherapy (38 volume modulated arc therapy, 2 intensity-modulated radiotherapy) for MSCC and were evaluated for local progression-free survival (LPFS), motor function, ambulatory status, sensory function, sphincter dysfunction, pain, distress, overall survival (OS) and toxicity. Maximum spinal cord dose was 101.5% (myelopathy risk <0.03%) of the prescription dose. Patients were compared to a historical control group conventionally irradiated with 4Gyx5 (propensity-score analysis). The equivalent dose in 2Gy-fractions of 5Gyx5 is similar to 3Gyx10, which results in better LPFS than 4Gyx5. It was assumed that 5Gyx5 is also superior to 4Gyx5 for LPFS. (ClinicalTrials.gov-identifier: XXX) RESULTS: Six-month rates of LPFS and OS were 95.0% and 42.6%, respectively. Improvement of motor function occurred in 24 patients (60%). Thirty-three patients (82.5%) were ambulatory following radiotherapy. Eight of 16 patients (50.0%) with sensory deficits improved. Pain and distress relief were reported by 61.9% and 54.2% of patients at 1 month following radiotherapy. Grade 3 toxicities occurred in one patient, grade 2 toxicities in another 3 patients. Of the control group, 664 patients qualified for the propensity-score analysis. 5Gyx5 was significantly superior to 4Gyx5 regarding LPFS (p=0.026), but not regarding motor function (p=0.51) or OS (p=0.82). CONCLUSIONS: Precision radiotherapy with 5Gyx5 was well tolerated and effective, and appeared superior to 4Gyx5 regarding LPFS. The retrospective nature of the historic control group, which may have led to a hidden selection bias, needs to be considered when interpreting the results. SN - 1879-355X UR - https://www.unboundmedicine.com/medline/citation/31812719/Precision_radiotherapy_for_metastatic_spinal_cord_compression:_Final_results_of_the_PRE-MODE_Trial L2 - https://linkinghub.elsevier.com/retrieve/pii/S0360-3016(19)34460-8 DB - PRIME DP - Unbound Medicine ER -