Abstract 5697
Background
We aimed to investigate the association between blood cell count-based immuno-inflammatory parameters, clinico-pathological characteristics and clinical outcomes in patients (pts) with RAS wt, metastatic colorectal cancer (mCRC) randomized to panitumumab (pani) plus FOLFOX4 induction followed by maintenance with pani +/- 5FU/LV in the phase 2 Valentino study.
Methods
Pts in the intention-to-treat population (n = 229) were screened for the availability of pre-treatment complete blood cell count. We focused on neutrophil-to-lymphocyte ratio (NLR), absolute monocyte count (AMC) and platelet count (PC). NLR and AMC were defined high if ≥ 4 and 900/mcl, respectively, based on literature data. PC was defined high if > of the median value of the study population. The Kaplan-Meier method and Cox proportional hazards regression model were used for survival analyses.
Results
A total of 215 pts were included. NLR and AMC were significantly associated with ECOG PS. AMC and PC were associated with the presence of synchronous metastases and primary tumor resection. After a median follow-up of 26.7 months, high NLR was associated with worse progression-free survival [PFS] (HR 1.51, p = 0.015) and overall survival [OS] (HR 2.18, p < 0.001), as well as high AMC (HR for PFS 1.85, p = 0.003; HR for OS 2.49, p < 0.001) and high PC (HR for PFS 1.65, p = 0.001; HR for OS 1.85, p = 0.003). In the multivariable models, only PC confirmed its independent association with both clinical outcomes (HR for PFS 1.71, p < 0.001; HR for OS 1.70, p = 0.01), while AMC was only independently associated with PFS (HR 2.44, p = 0.03) and NLR did not demonstrate any significant association. The PFS benefit of adding 5-FU/LV to pani in the maintenance setting was independent from NLR and AMC (interaction p = 0.15 and p = 0.48, respectively), but was retained only in the subgroup with low PC (interaction p = 0.04). No significantly association with response or disease control was observed.
Conclusions
In pts with RAS wt, mCRC randomized in the Valentino study, baseline PC showed and independent association with OS and PFS and baseline AMC was independently associated with PFS. Pts with high PC did not derive any PFS benefit from the addiction of 5-FU/LV to pani in the maintenance setting.
Clinical trial identification
NCT02476045.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Amgen.
Disclosure
S. Lonardi: Honoraria (self): Roche; Honoraria (self): Amgen; Honoraria (self): Bayer; Honoraria (self): Merck-Serono; Honoraria (self): Servier; Honoraria (self): Bristol-Myers Squibb. L. Rimassa: Honoraria (self): AstraZeneca; Honoraria (self): AbbVie; Honoraria (self): Lilly; Honoraria (self): Bayer; Honoraria (self): Sirtex Medical; Honoraria (self): Italfarmaco; Honoraria (self): Sanofi; Honoraria (self): ArQule; Honoraria (self): Baxter; Honoraria (self): Ipsen; Honoraria (self): Exelixis; Honoraria (self): Amgen; Honoraria (self): Incyte; Honoraria (self): Celgene. A. Zaniboni: Honoraria (self): Sanofi; Honoraria (self): Amgen; Honoraria (self): Bayer; Honoraria (self): Merck-Serono; Honoraria (self): Roche. A. Sartore-Bianchi: Honoraria (self): Sanofi; Honoraria (self): Amgen; Honoraria (self): Bayer; Honoraria (self): Merck-Serono; Honoraria (self): Roche. M. Di Bartolomeo: Honoraria (self): Amgen; Honoraria (self): Roche; Honoraria (self): Lilly; Honoraria (self): Servier; Honoraria (self): Incyte; Honoraria (self): Celgene. F.G.M. De Braud: Honoraria (self): Amgen; Honoraria (self): Roche; Honoraria (self): Novartis. F. Pietrantonio: Honoraria (self): Sanofi; Honoraria (self): Amgen; Honoraria (self): Bayer; Honoraria (self): Merck-Serono; Honoraria (self): Roche; Honoraria (self): Servier. All other authors have declared no conflicts of interest.
Resources from the same session
1619 - Meta-analysis of KRAS Mutation as prognostic factor in patients (pts.) with resection of colorectal (CRC) liver metastases: Tumor burden and Sideness analysis.
Presenter: Maria Romina Luca
Session: Poster Display session 2
Resources:
Abstract
2104 - Clinical implications of regorafenib-induced hypothyroidism in metastatic colorectal cancer refractory to standard therapies: A prospective evaluation
Presenter: Jwa Hoon Kim
Session: Poster Display session 2
Resources:
Abstract
2143 - Clinical impact of BRAF V600E mutations in patients (pts) with resectable solitary colorectal liver metastases (CRLM)
Presenter: Shin Kobayashi
Session: Poster Display session 2
Resources:
Abstract
3136 - Trifluridine/tipiracil in metastatic colorectal cancer: an updated multicentre real-world analysis on efficacy, safety and predictive factors.
Presenter: Chara Stavraka
Session: Poster Display session 2
Resources:
Abstract
4234 - Correlation between p53 expression and clinical outcome in RAS/BRAF wild type metastatic colorectal cancer patients receiving later-line irinotecan-cetuximab
Presenter: Eleonora Lai
Session: Poster Display session 2
Resources:
Abstract
4287 - Safety and effectiveness of aflibercept + FOLFIRI for the treatment of patients with metastatic colorectal cancer (mCRC): OZONE secondary analyses
Presenter: Ian Chau
Session: Poster Display session 2
Resources:
Abstract
1820 - A Phase Ib study of the safety and efficacy of atezolizumab (atezo) + bevacizumab (bev) + cobimetinib (cobi) in patients (pts) with metastatic colorectal cancer (mCRC)
Presenter: Johanna Bendell
Session: Poster Display session 2
Resources:
Abstract
5644 - Development and validation of a metastasis-associated immune prognostic model for concurrent metastatic colorectal cancer
Presenter: Zhiwen Luo
Session: Poster Display session 2
Resources:
Abstract
4704 - Evaluation of safety, immunogenicity and preliminary efficacy of PolyPEPI1018 vaccine in subjects with metastatic colorectal cancer (mCRC) with a predictive biomarker
Presenter: Joleen Hubbard
Session: Poster Display session 2
Resources:
Abstract
3266 - Morphology of tumor-associated macrophages dictates the prognosis of patients with colorectal liver metastases.
Presenter: Matteo Donadon
Session: Poster Display session 2
Resources:
Abstract