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
3902 - The efficacy of preoperative breast cancer chemotherapy without anti-HER2-targeted treatment – single center experience in setting of no reimbursement in Poland (2011-2015)
Presenter: Agnieszka Badora-Rybicka
Session: Poster Display session 2
Resources:
Abstract
4733 - A Multicentre, International Neoadjuvant (NA), Randomized, Double-blind Phase III Trial comparing FULVESTRANT to a combination of FULVESTRANT and PALBOCICLIB in patients with operable Luminal Breast Cancer (SAFIA Trial)
Presenter: Jean-Marc Nabholtz
Session: Poster Display session 2
Resources:
Abstract
5227 - Outcome of Non-metastatic Male Breast Cancer: 222 patients
Presenter: Ulku Yalcintas Arslan
Session: Poster Display session 2
Resources:
Abstract
5943 - Effects of delayed initiation of adjuvant trastuzumab for non-metastatic, Her2 positive breast cancer in a limited resources setting: ML25232 study final results
Presenter: Samir Beslija
Session: Poster Display session 2
Resources:
Abstract
1725 - Final results of scalp cooling for hair preservation: A single- institution prospective study.
Presenter: Dario Loparco
Session: Poster Display session 2
Resources:
Abstract
3713 - Adjuvant Systemic Therapy in Women with Early Breast Cancer and Intermediate Prosigna ROR Scores: Is Chemotherapy Use Declining? Evidence From a Large Practice
Presenter: Lowell Hart
Session: Poster Display session 2
Resources:
Abstract
818 - Management of early breast cancer in women over 90: A 10 year experience
Presenter: Emily Coffey
Session: Poster Display session 2
Resources:
Abstract
1141 - Evolution in the risk of adverse events of adjuvant endocrine therapy in postmenopausal women with early- stage breast cancer.
Presenter: Daniel Reinhorn
Session: Poster Display session 2
Resources:
Abstract
2277 - Hepatitis B screening and incidence of flare among non-metastatic breast cancer patients treated with anthracyclines
Presenter: Zewen Zhang
Session: Poster Display session 2
Resources:
Abstract
2781 - Effect of denosumab on low bone mineral density in postmenopausal Japanese early breast cancer patients receiving aromatase nhibitors : 36-month results
Presenter: Koichi Sakaguchi
Session: Poster Display session 2
Resources:
Abstract