| Home > Articles > Published articles > 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 : |
(Institut d'Investigació Biomèdica Sant Pau) (IOB-Teknon) (Institut d'Investigació Biomèdica Sant Pau) (Hospital Clínic i Provincial de Barcelona)
| Date: | 2022 |
| Abstract: | Purpose: 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). Methods: In this randomized phase II trial, patients were assigned (3:2 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). Results: Between 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. Conclusions: The 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. |
| Grants: | Agència de Gestió d'Ajuts Universitaris i de Recerca 2014-SGR-474 Agència de Gestió d'Ajuts Universitaris i de Recerca 2017-SGR-1174 Instituto de Salud Carlos III PI13/01728 Instituto de Salud Carlos III PI19/00740 |
| Note: | Altres ajuts: Fundació la Marató de TV3 (201330.10); Fundacion Olga Torres (Modalitat A. 2019/2020); Spanish Association Against Cancer (AECC, PROYE19040POST_001). |
| Rights: | Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.  |
| Language: | Anglès |
| Document: | Article ; recerca ; Versió publicada |
| Subject: | Colorectal cancer ; Metastatic disease ; Second line therapy ; Panitumumab ; Liquid biopsy |
| Published in: | Clinical & translational oncology, Vol. 24 Núm. 11 (november 2022) , p. 2155-2165, ISSN 1699-3055 |
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