Conventional transarterial chemoembolization combined with systemic therapy versus systemic therapy alone as second-line treatment for unresectable colorectal liver metastases: randomized clinical trial.

Abstract

BACKGROUND:

The combination of conventional transarterial chemoembolization (cTACE) and systemic therapy has the potential to treat chemotherapy-refractory unresectable colorectal liver metastases (CRLMs). This study aimed to compare survival after this combined treatment versus systemic chemotherapy alone.

METHODS:

This single-centre RCT included patients with unresectable CRLMs that progressed after first-line treatment. Patients were randomized on a 1 : 1 basis to either systemic chemotherapy with or without cTACE, without further stratification. The primary outcome was progression-free survival (PFS). Secondary outcomes were overall response rate, disease control rate, conversion rate to liver resection, overall survival, and adverse events.

RESULTS:

Of 180 patients recruited, 168 were randomized. Eighty-five patients in arm A received systemic chemotherapy plus cTACE and 83 in arm B received systemic chemotherapy alone. Median PFS was longer in arm A than B (6.7 versus 3.8 months; hazard ratio (HR) 0.67, 95 per cent c.i. 0.49 to 0.91; P = 0.009), but did not translate into prolonged median overall survival (18.4 versus 14.8 months; HR = 0.92, 0.62 to 1.36; P = 0.669). Overall response rates (20 versus 22 per cent; P = 0.788) and conversion rate to liver resection (18 versus 16 per cent; P = 0.730) were no different between arms A and B. The disease control rate was higher in arm A than arm B (67 versus 51 per cent; P = 0.030). No adverse event higher than grade 3 according to the Common Terminology Criteria for Adverse Events was observed during treatment.

CONCLUSION:

Systemic chemotherapy plus cTACE is a safe option as second-line treatment for unresectable colorectal liver metastases, with a modest effect on PFS. Registration number: NCT03783559 (http://www.clinicaltrials.gov).

• Authors: Y Liu, W Chang, B Zhou, Y Wei, W Tang, F Liang, Y Chen, Z Yan, M Lv, L Ren, J Xu
• Journal: The British journal of surgery (Br J Surg) Vol. 108 Issue 4 Pg. 373-379 (04 30 2021) ISSN: 1365-2168 [Electronic] England
• PMID: 33611431 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author(s) 2021. Published by Oxford University Press on behalf of BJS Society Ltd. All rights reserved. For permissions, please email: [email protected].

Chemical References

• Antineoplastic Agents
• Organoplatinum Compounds
• Leucovorin
• Fluorouracil

Topics

• Antineoplastic Agents (administration & dosage, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, therapeutic use)
• Chemoembolization, Therapeutic (methods)
• Colorectal Neoplasms (pathology)
• Combined Modality Therapy
• Craniofacial Dysostosis
• Female
• Fluorouracil (administration & dosage, therapeutic use)
• Humans
• Leucovorin (administration & dosage, therapeutic use)
• Limb Deformities, Congenital
• Liver Neoplasms (secondary, therapy)
• Male
• Middle Aged
• Organoplatinum Compounds (administration & dosage, therapeutic use)
• Progression-Free Survival
• Survival Analysis
• Treatment Outcome