Abstracts from the current literature By Ripal T. Gandhi, MD, FSIR, and Suvranu Ganguli, MD, FSIR
This column alerts SIR members to abstracts that may have an impact on their practice and how they converse with referring clinicians. If you would like to suggest abstracts you feel should be included, email us at
gandhi@baptisthealth.net or
suvranu.ganguli@
bmc.org.
J Clin Oncol 2021 Sep 20;JCO2101839. doi: 10.1200/JCO.21.01839.
Radioembolization with chemotherapy for colorectal liver metastases: A randomized, open- label, international, multicenter, phase III trial
Mulcahy M, Mahvash A, Pracht M, Montazeri A, Bandula S, Martin RCG, Herrmann K, Brown E, Zuckerman D, Wilson G, Kim T, Weaver A, Ross P, Harris WP, Graham J, Mills J, Esteban AY, Johnson MS, Sofocleous CT, Padia SA, Lewandowski RJ, Garin E, Sinclair P, Salem R, EPOCH investigators
Purpose: To study the impact of transarterial yttrium-90 radioembolization (TARE) in combination with second-line systemic chemotherapy for colorectal liver metastases (CLM).
Methods: In this international, multicenter, open-label phase III trial, patients with CLM who progressed on oxaliplatin- or irinotecan-based first-line therapy were randomly assigned 1:1 to receive second-line chemotherapy with or without TARE. The two primary end points were progression-free survival (PFS) and hepatic PFS (hPFS), assessed by blinded independent central review. Random assignment was performed using a web- or voice-based system stratified by unilobar or bilobar disease, oxaliplatin- or irinotecan-based first-line chemotherapy, and KRAS mutation status.
Results: Four hundred twenty-eight patients from 95 centers in North America, Europe and Asia were randomly assigned to chemotherapy with or without TARE; this represents the intention-to-treat population and included 215 patients in the TARE plus chemotherapy group and 213 patients in the chemotherapy alone group. The hazard ratio (HR) for PFS was 0.69 (95% CI, 0.54 to 0.88; 1-sided P = .0013), with a median PFS of 8.0 (95% CI, 7.2 to 9.2) and 7.2 (95% CI, 5.7 to 7.6) months, respectively. The HR for hPFS was 0.59 (95% CI, 0.46 to 0.77; 1-sided P < .0001), with a median hPFS of 9.1 (95% CI, 7.8 to 9.7) and 7.2 (95% CI, 5.7 to 7.6) months, respectively. Objective response rates were 34.0% (95% CI, 28.0 to 40.5) and 21.1% (95% CI, 16.2 to 27.1; 1-sided P = .0019) for the TARE and chemotherapy groups, respectively. Median overall survival was 14.0 (95% CI, 11.8 to 15.5) and 14.4 months (95% CI, 12.8 to 16.4; 1-sided P = .7229) with a HR of 1.07 (95% CI, 0.86 to 1.32) for TARE and chemotherapy groups, respectively. Grade 3 adverse events were reported more frequently with TARE (68.4% vs. 49.3%). Both groups received full chemotherapy dose intensity.
Conclusion: The addition of TARE to systemic therapy for second-line CLM led to longer PFS and hPFS. Further subset analyses are needed to better define the ideal patient population that would benefit from TARE.
36 IRQ | WINTER 2022
JACC Cardiovasc Interv. 2021 Jun 28;14(12):1364-1373. doi: 10.1016/j. jcin.2021.04.049.
Randomized trial comparing standard versus ultrasound-assisted thrombolysis for submassive pulmonary embolism: The SUNSET sPE trial
Avgerinos ED, Jaber W, Lacomis J, Markel K, McDaniel M, Rivera-Lebron BN, Ross CR, Sechrist J, Toma C, Chaer R, SUNSET sPE collaborators
Objectives: The aim of this trial was to determine whether ultrasound-assisted thrombolysis (USAT) is superior to standard catheter-directed thrombolysis (SCDT) in pulmonary arterial thrombus reduction for patients with submassive pulmonary embolism (sPE).
Background: Catheter-directed therapy has been increasingly used in sPE and massive pulmonary embolism as a decompensation prevention and potentially lifesaving procedure. It is unproved whether USAT is superior to SCDT using traditional multiple-side-hole catheters in the treatment of patients with pulmonary embolism.
Methods: Adults with sPE were enrolled. Participants were randomized 1:1 to USAT or SCDT. The primary outcome was 48-hour clearance of pulmonary thrombus assessed by pre- and postprocedural computed tomographic angiography using a refined Miller score. Secondary outcomes included improvement in right ventricular-to-left ventricular ratio, intensive care unit and hospital stay, bleeding, and adverse events up to 90 days.
Results: Eighty-one patients with acute sPE were randomized and were available for analysis. The mean total dose of alteplase for USAT was 19 ± 7 mg and for SCDT was 18 ± 7 mg (P = 0.53), infused over 14 ± 6 and 14 ± 5 hours, respectively (P = 0.99). In the USAT group, the mean raw pulmonary arterial thrombus score was reduced from 31 ± 4 at baseline to 22 ± 7 (P < 0.001). In the SCDT group, the score was reduced from 33 ± 4 to 23 ± 7 (P < 0.001). There was no significant difference in mean thrombus score reduction between the 2 groups (P = 0.76). The mean reduction in right ventricular/left ventricular ratio from baseline (1.54 ± 0.30 for USAT, 1.69 ± 0.44 for SCDT) to 48 hours was 0.37 ± 0.34 in the USAT group and 0.59 ± 0.42 in the SCDT group (P = 0.01). Major bleeding (1 stroke and 1 vaginal bleed requiring transfusion) occurred in 2 patients, both in the USAT group.
Conclusions: In the SUNSET sPE (Standard vs. Ultrasound- Assisted Catheter Thrombolysis for Submassive Pulmonary Embolism) trial, patients undergoing USAT had similar pulmonary arterial thrombus reduction compared with those undergoing SCDT, using comparable mean lytic doses and durations of lysis.
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