Thomas J Vogl1, Christian Marko1, Marcel C Langenbach1, Nagy N N Naguib1, Natalie Filmann2, Renate Hammerstingl1, Tatjana Gruber-Rouh3. 1. Department of Diagnostic and Interventional Radiology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt, Germany. 2. Institute of Biostatistics and Mathematical Modeling, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt, Germany. 3. Department of Diagnostic and Interventional Radiology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt, Germany. tgruberrouh@googlemail.com.
Abstract
OBJECTIVES: To prospectively evaluate the therapy response of third-line TACE with DSM or lipiodol in the treatment of CRLM using MRI. METHODS: In this prospective, randomized, single-center trial, patients were randomly assigned to receive TACE therapy with either lipiodol or DSM as the embolization agent. Therapy response was evaluated using MRI. Local tumor response was determined according to RECIST 1.1, and survival data was analyzed using the Kaplan-Meier estimator. RESULTS:Fifty patients (35 male, 15 female) were randomized and included in the survival analysis, whereas 31 patients completed therapy and were considered for evaluation of tumor responses (cTACE: n = 13, DSM-TACE: n = 18). In the cTACE group, PR was observed in 23%, SD in 15%, and PD in 62%. In the DSM-TACE-group, PR was observed in 22% of patients, SD in 56%, and PD in 22% (p = 0.047). In addition, the DSM-TACE group showed statistically significant tumor volume reduction (p = 0.006). Median apparent diffusion coefficient values were not significantly different between both groups at baseline (p = 0.26) and study endpoint (p = 0.83). Median survival in the cTACE group was 13 months (95% confidence interval, range 5-40 months) compared to 16 months (95% confidence interval, range 1-48 months) in the DSM-TACE group, exhibiting no statistically significant difference (p = 0.75). CONCLUSION:DSM-TACE showed a significant difference reducing tumor volume and in tumor response according to RECIST 1.1 compared to cTACE. Thus, patients with CRLM might not only benefit from short embolization effect of DSM-TACE but also from better tumor responses. Apparent diffusion coefficients were not significantly different between both groups and cannot be used as a biomarker for monitoring for therapeutic effect of TACE. KEY POINTS: • To our knowledge, this is the first prospective study that directly compared cTACE and DSM-TACE in patients with CRLM. • DSM-TACE showed a significant difference reducing tumor volume (p = 0.006) and in tumor response according to RECIST 1.1 (p = 0.047) compared to cTACE. • Survival analysis showed a median survival of 13 months in the cTACE group compared to 16 months in the DSM-TACE group (p = 0.75).
RCT Entities:
OBJECTIVES: To prospectively evaluate the therapy response of third-line TACE with DSM or lipiodol in the treatment of CRLM using MRI. METHODS: In this prospective, randomized, single-center trial, patients were randomly assigned to receive TACE therapy with either lipiodol or DSM as the embolization agent. Therapy response was evaluated using MRI. Local tumor response was determined according to RECIST 1.1, and survival data was analyzed using the Kaplan-Meier estimator. RESULTS: Fifty patients (35 male, 15 female) were randomized and included in the survival analysis, whereas 31 patients completed therapy and were considered for evaluation of tumor responses (cTACE: n = 13, DSM-TACE: n = 18). In the cTACE group, PR was observed in 23%, SD in 15%, and PD in 62%. In the DSM-TACE-group, PR was observed in 22% of patients, SD in 56%, and PD in 22% (p = 0.047). In addition, the DSM-TACE group showed statistically significant tumor volume reduction (p = 0.006). Median apparent diffusion coefficient values were not significantly different between both groups at baseline (p = 0.26) and study endpoint (p = 0.83). Median survival in the cTACE group was 13 months (95% confidence interval, range 5-40 months) compared to 16 months (95% confidence interval, range 1-48 months) in the DSM-TACE group, exhibiting no statistically significant difference (p = 0.75). CONCLUSION:DSM-TACE showed a significant difference reducing tumor volume and in tumor response according to RECIST 1.1 compared to cTACE. Thus, patients with CRLM might not only benefit from short embolization effect of DSM-TACE but also from better tumor responses. Apparent diffusion coefficients were not significantly different between both groups and cannot be used as a biomarker for monitoring for therapeutic effect of TACE. KEY POINTS: • To our knowledge, this is the first prospective study that directly compared cTACE and DSM-TACE in patients with CRLM. • DSM-TACE showed a significant difference reducing tumor volume (p = 0.006) and in tumor response according to RECIST 1.1 (p = 0.047) compared to cTACE. • Survival analysis showed a median survival of 13 months in the cTACE group compared to 16 months in the DSM-TACE group (p = 0.75).
Entities:
Keywords:
Colorectal cancer; Degradable starch microspheres; Lipiodol; Magnetic resonance imaging
Authors: Tatjana Gruber-Rouh; Christian Marko; Axel Thalhammer; Nour-Eldin Nour-Eldin; Marcel Langenbach; Martin Beeres; Nagy N Naguib; Stephan Zangos; Thomas J Vogl Journal: Br J Radiol Date: 2016-05-26 Impact factor: 3.039
Authors: Tatjana Gruber-Rouh; Nagy N N Naguib; Katrin Eichler; Hanns Ackermann; Stephan Zangos; Jörg Trojan; Martin Beeres; Marc Harth; Boris Schulz; Nour-Eldin Nour-Eldin A; Thomas J Vogl Journal: Int J Cancer Date: 2013-09-03 Impact factor: 7.396
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