Randomized phase II trial of FOLFIRI-panitumumab compared with FOLFIRI alone in patients with RAS wild-type circulating tumor DNA metastatic colorectal cancer beyond progression to first-line FOLFOX-panitumumab: the BEYOND study (GEMCAD 17-01)
Clin. transl. oncol. (Print)
; 24(11): 2155-2165, noviembre 2022. graf, tab
Article
in English
| IBECS
| ID: ibc-210143
Responsible library:
ES1.1
Localization: ES15.1 - BNCS
ABSTRACT
Panitumumab plus FOLFOX (P-FOLFOX) is standard first-line treatment for RAS wild-type (WT) metastatic colorectal cancer. The value of panitumumab rechallenge is currently unknown. We assessed addition of panitumumab to FOLFIRI (P-FOLFIRI) beyond progression to P-FOLFOX in patients with no RAS mutations in liquid biopsy (LB).MethodsIn this randomized phase II trial, patients were assigned (32 ratio) to second-line P-FOLFIRI (arm A) or FOLFIRI alone (arm B). LB for circulating tumor DNA analysis was collected at study entry and at disease progression. Primary endpoint was 6-month progression-free survival. Two-stage Simon design required 85 patients to be included (EudraCT 2017-004519-38).ResultsBetween February 2019 and November 2020, 49 patients were screened (16 RAS mutations in LB detected) and 31 included (18 assigned to arm A and 13 to arm B). The study was prematurely closed due to inadequate recruitment. Serious adverse events were more frequent in arm A (44% vs. 23%). Overall response rate was 33% (arm A) vs. 7.7% (arm B). Six-month progression-free survival rate was 66.7% (arm A) and 38.5% (arm B). Median progression-free survival was 11.0 months (arm A) and 4.0 months (arm B) (hazard ratio, 0.58). At disease progression, RAS or BRAF mutations in LB were found in 4/11 patients (36%) in arm A and 2/10 (20%) in arm B.ConclusionsThe BEYOND study suggests a meaningful benefit of P-FOLFIRI beyond progression to P-FOLFOX in metastatic colorectal cancer patients with WT RAS status selected by LB. This strategy deserves further investigation. (AU)
Full text:
Available
Collection:
National databases
/
Spain
Database:
IBECS
Main subject:
Camptothecin
/
Antineoplastic Combined Chemotherapy Protocols
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Leucovorin
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Colonic Neoplasms
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Fluorouracil
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Circulating Tumor DNA
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Antibodies, Monoclonal
Limits:
Humans
Language:
English
Journal:
Clin. transl. oncol. (Print)
Year:
2022
Document type:
Article
Institution/Affiliation country:
Complejo Hospitalario de Navarra/Spain
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Hospital Clínic de Barcelona/Spain
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Hospital Universitari Sant Joan de Reus/Spain
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Hospital Universitari i Politècnic La Fe/Spain
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Hospital de la Santa Creu i Sant Pau/Spain
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Vall dHebron University Hospital/Spain