Abstract 3203
Background
REACHIN trial met its primary endpoint of improving PFS in patients with biliary tract cancer (BTC) treated with regorafenib (R) as compared to placebo (P): Median (m) PFS for R was 3.0 months (mo) and 1.5 mo for P (HR = 0.49; 95% CI: 0.29-0.81, p = 0.005)1. We exploratory analyzed the benefit of R according to tumor location (TL): intra-hepatic (ICC), extra-hepatic (ECC), gallbladder (GB) or peri-hilar (PH). The early metabolic response (EMR) by treatment was evaluated by FDG PET/CT.
Methods
TL were recorded at randomization of 66 patients in REACHIN (NCT02162914). We analyzed mPFS (95%CI) according to TL. EMR was evaluated comparing FDG tumor metabolism at baseline and after 2 weeks of treatment in the 2 arms if there was at least one FDG positive lesion at baseline, with a Tumour/Liver-uptake-ratio ≥1.4 (MIMvista software).
Results
Table:
743P
R | R | R | P | P | P | |
---|---|---|---|---|---|---|
N | mPFS (mo) | 95%CI | N | mPFS (mo) | 95%CI | |
ICC | 23 | 3.0 | 1.5–4.9 | 19 | 1.5 | 1.1–2.1 |
ECC | 3 | 1.4 | 0.5-5.3 | 6 | 1.5 | 0.6–4.7 |
GB | 4 | 4.7 | 0.0-8.8 | 5 | 1.6 | 0.4-2 |
PH | 3 | 2.6 | 1.1-4.5 | 3 | 0.5 | 0.0-3.0 |
mPFS data are summarized in the table For PET study (29 patients, P n = 15/R n = 14), both ΔSUVmax, ΔMTV and ΔTLG (%change from baseline) show a significant decrease between baseline and FU scan in R (P = 0.0151*;0.037**; 0.0056**) as compared to P. Main tumour SUVmax was significantly decreased in R but not in P(P = 0.0353* vs 0.5614). Both TLG and MTV significantly increased in the P (p = 0.0004***; 0.0002***; ) while a stabilization was observed for R (P = 0.3910; 0.2412). There was no relevant treatment’s related impact on the reference-liver-uptake (P = 0.381(P); 0.6149(R)).
Conclusions
ICC location was predominant (64%). mPFS in P arm is similar according to TL. Despite exploratory value and small number of patients per tumor location, R seems superior to P in ICC, GB and PH. Despite limited number of patients, FDG PET/CT seems performant to discriminate EMR in patients treated with R as compared to P. Additional analysis are ongoing to estimate if these EMR also correlate with PFS and OS.
Clinical trial identification
NCT02162914.
Editorial acknowledgement
CUB Hôpital Erasme (Brussels, Belgium). Support from Bayer HealthCare. REACHIN is a BDGO cooperative study.
Legal entity responsible for the study
CUB Hôpital ERASME, Brussels, Belgium.
Funding
Bayer Healthcare.
Disclosure
A. Demols: Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (self): Bayer Healthcare. All other authors have declared no conflicts of interest. All other authors have declared no conflicts of interest.
Resources from the same session
5205 - Immune status of patients with different stages of colorectal cancer with and without circulating tumor cells
Presenter: Anastasia Sitkovskaya
Session: Poster Display session 2
Resources:
Abstract
5658 - Detection of 5-hydroxymethylcytosine in Circulating-Free DNA for Early Diagnosis of Colorectal Cancer
Presenter: Tianyu Liu
Session: Poster Display session 2
Resources:
Abstract
5779 - Detection of 5-hydroxymethylcytosine in Circulating-Free DNA for Prediction of The Efficacy of Conversion Therapy for Colorectal Cancer Liver Metastases
Presenter: Wenju Chang
Session: Poster Display session 2
Resources:
Abstract
4672 - mCRC gene profiling using the Idylla platform
Presenter: Christopher Bricogne
Session: Poster Display session 2
Resources:
Abstract
3393 - PIK3CA mutation in metastatic colorectal cancer (mCRC): association with clinico-pathological features and outcome
Presenter: Valentina Fanotto
Session: Poster Display session 2
Resources:
Abstract
1317 - Patient-Derived Xenografts (PDX) Identifies JMJD6 Inhibitor as an Effective Therapeutic Medicine in Colorectal Cancer.
Presenter: Feng Ye
Session: Poster Display session 2
Resources:
Abstract
1228 - DACH1 induced stemness of intestinal organoids by directly suppressing BMP signaling and contributes to intestinal tumorigenesis
Presenter: Xiang Hu
Session: Poster Display session 2
Resources:
Abstract
1147 - miR-148a inhibits early relapsed colorectal cancers and the secretion of VEGF by indirectly targeting HIF-1α under non-hypoxia/hypoxia conditions
Presenter: Hsiang-lin Tsai
Session: Poster Display session 2
Resources:
Abstract
1158 - Long noncoding RNA CASC21 promotes cell proliferation and metastasis in colon cancer.
Presenter: Qun Zhang
Session: Poster Display session 2
Resources:
Abstract
1259 - Prognostic and Predictive Impact On FMS-like Tyrosine Kinase 3 (FLT3) Amplification In Patients With Metastatic Colorectal Cancer
Presenter: Hiroko Hasegawa
Session: Poster Display session 2
Resources:
Abstract