Final results of the CAVE trial in RAS wild type metastatic colorectal cancer patients treated with cetuximab plus avelumab as rechallenge therapy: Neutrophil to lymphocyte ratio predicts survival.


Journal

Clinical colorectal cancer
ISSN: 1938-0674
Titre abrégé: Clin Colorectal Cancer
Pays: United States
ID NLM: 101120693

Informations de publication

Date de publication:
06 2022
Historique:
received: 17 10 2021
revised: 20 12 2021
accepted: 11 01 2022
pubmed: 2 2 2022
medline: 31 5 2022
entrez: 1 2 2022
Statut: ppublish

Résumé

High neutrophil-to-lymphocyte ratio (NLR) is a poor prognostic factor in metastatic colorectal cancer (mCRC). Here we provide final results of CAVE mCRC trial, of cetuximab plus avelumab rechallenge in chemo-refractory mCRC patients and investigated the predictive role of NLR. All the 77 patients enrolled were included in the analysis. A cut-off of 3 was used to correlate baseline NLR with with overall survival (OS) and with progression free survival (PFS), in intention to treat (ITT) and in circulating tumor DNA (ctDNA) RAS/BRAF Wild Type (WT) patients. In ITT population, NLR <3 (49%) group had median overall survival (mOS) of 17.8 months, vs. 8.9 months in NLR ≥ 3 group (51%) [HR 0.50, (CI 95% 0.3-0.8), P = .006]. Median progression free survival (mPFS) was 3.9 months in NLR <3 group and 3.5 months in NLR≥3 [HR 0.79, (CI 95% 0.5-1.24), P = .3]. In ctDNA RAS/BRAF WT population, mOS was 22 months in NLR <3 group (48%), vs. 8.9 months in NLR ≥3 group (52%), [HR 0.38, (CI 95% 0.19-0.75), P = .005]. A trend towards increased mPFS was observed in patients with NLR <3 versus NLR ≥3: 5.3 vs. 3.6 months [HR: 0.79, (CI 95% 0.44-1.4), P = .43]. In contrast, NLR did not correlate either with PFS or OS in ctDNA RAS/BRAF mutated patients. In the exploratory analysis of the CAVE mCRC trial, baseline NLR <3 significantly correlated with improved survival and may represent a potential predictive biomarker of cetuximab plus avelumab rechallenge activity in ctDNA RAS/BRAF WT patients, that must be confirmed in randomized studies.

Sections du résumé

BACKGROUND
High neutrophil-to-lymphocyte ratio (NLR) is a poor prognostic factor in metastatic colorectal cancer (mCRC). Here we provide final results of CAVE mCRC trial, of cetuximab plus avelumab rechallenge in chemo-refractory mCRC patients and investigated the predictive role of NLR.
METHODS
All the 77 patients enrolled were included in the analysis. A cut-off of 3 was used to correlate baseline NLR with with overall survival (OS) and with progression free survival (PFS), in intention to treat (ITT) and in circulating tumor DNA (ctDNA) RAS/BRAF Wild Type (WT) patients.
RESULTS
In ITT population, NLR <3 (49%) group had median overall survival (mOS) of 17.8 months, vs. 8.9 months in NLR ≥ 3 group (51%) [HR 0.50, (CI 95% 0.3-0.8), P = .006]. Median progression free survival (mPFS) was 3.9 months in NLR <3 group and 3.5 months in NLR≥3 [HR 0.79, (CI 95% 0.5-1.24), P = .3]. In ctDNA RAS/BRAF WT population, mOS was 22 months in NLR <3 group (48%), vs. 8.9 months in NLR ≥3 group (52%), [HR 0.38, (CI 95% 0.19-0.75), P = .005]. A trend towards increased mPFS was observed in patients with NLR <3 versus NLR ≥3: 5.3 vs. 3.6 months [HR: 0.79, (CI 95% 0.44-1.4), P = .43]. In contrast, NLR did not correlate either with PFS or OS in ctDNA RAS/BRAF mutated patients.
CONCLUSION
In the exploratory analysis of the CAVE mCRC trial, baseline NLR <3 significantly correlated with improved survival and may represent a potential predictive biomarker of cetuximab plus avelumab rechallenge activity in ctDNA RAS/BRAF WT patients, that must be confirmed in randomized studies.

Identifiants

pubmed: 35101346
pii: S1533-0028(22)00005-6
doi: 10.1016/j.clcc.2022.01.005
pii:
doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0
Circulating Tumor DNA 0
Proto-Oncogene Proteins B-raf EC 2.7.11.1
avelumab KXG2PJ551I
Cetuximab PQX0D8J21J

Types de publication

Clinical Trial Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

141-148

Informations de copyright

Copyright © 2022 Elsevier Inc. All rights reserved.

Auteurs

Davide Ciardiello (D)

Oncologia Medica, Dipartimento di Medicina di Precisione, Università degli Studi della Campania "L. Vanvitelli", Naples, Italy; Oncologia Medica, Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy. Electronic address: davideciardiello@yahoo.it.

Vincenzo Famiglietti (V)

Oncologia Medica, Dipartimento di Medicina di Precisione, Università degli Studi della Campania "L. Vanvitelli", Naples, Italy.

Stefania Napolitano (S)

Oncologia Medica, Dipartimento di Medicina di Precisione, Università degli Studi della Campania "L. Vanvitelli", Naples, Italy.

Lucia Esposito (L)

Oncologia Medica, Dipartimento di Medicina di Precisione, Università degli Studi della Campania "L. Vanvitelli", Naples, Italy.

Filippo Pietrantonio (F)

Oncologia Medica, Istituto Nazionale dei Tumori di Milano, Milan, Italy.

Antonio Avallone (A)

Oncologia Medica, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale" - IRCCS, Naples, Italy.

Evaristo Maiello (E)

Oncologia Medica, Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.

Chiara Cremolini (C)

Oncologia Medica, Azienda Ospedaliera Universitaria, Università di Pisa, Pisa, Italy.

Teresa Troiani (T)

Oncologia Medica, Dipartimento di Medicina di Precisione, Università degli Studi della Campania "L. Vanvitelli", Naples, Italy.

Erika Martinelli (E)

Oncologia Medica, Dipartimento di Medicina di Precisione, Università degli Studi della Campania "L. Vanvitelli", Naples, Italy.

Fortunato Ciardiello (F)

Oncologia Medica, Dipartimento di Medicina di Precisione, Università degli Studi della Campania "L. Vanvitelli", Naples, Italy.

Giulia Martini (G)

Oncologia Medica, Dipartimento di Medicina di Precisione, Università degli Studi della Campania "L. Vanvitelli", Naples, Italy.

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Classifications MeSH