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
3353 - Results of the 3rd interim analysis of C-Patrol: A non-interventional study on olaparib in German routine clinical practice
Presenter: Jalid Sehouli
Session: Poster Display session 2
Resources:
Abstract
740 - A real-world analysis of the treatment of advanced ovarian cancer with PARPIs
Presenter: Alejandra Martinez de Pinillos
Session: Poster Display session 2
Resources:
Abstract
5867 - Incidence of tumour BRCA1/2 variants in relapsed, platinum-sensitive ovarian, fallopian tube and primary peritoneal cancer
Presenter: Robert Morgan
Session: Poster Display session 2
Resources:
Abstract
2966 - Frequency of mutations in 21 hereditary breast and ovarian cancer susceptibility genes among 882 high-risk individuals
Presenter: Jihong Liu
Session: Poster Display session 2
Resources:
Abstract
1687 - BRCA testing of 1,284 Brazilian patients for hereditary breast and ovarian cancer in a routine diagnostic setting
Presenter: Fernanda Milanezi
Session: Poster Display session 2
Resources:
Abstract
3162 - A multi-center integrative study on cancer predisposition genes in Chinese patients with epithelial ovarian carcinoma
Presenter: Changbin Zhu
Session: Poster Display session 2
Resources:
Abstract
5993 - Incidental Early Occult Ovarian Cancer after Risk-Reducing Salpingo-Oophorectomy in BRCA1/2 Mutation Carriers followed in a Community Public Hospital
Presenter: Begona Grana Suarez
Session: Poster Display session 2
Resources:
Abstract
5334 - Response to chemotherapy in ovarian cancer (OC) patients with or without prior breast cancer (BC), stratified by BRCA mutation (BRCAm) status
Presenter: Angela George
Session: Poster Display session 2
Resources:
Abstract
4565 - Advanced ovarian cancer: is residual disease after debulking surgery affected by genetics factors involved in angiogenesis and immunity pathways?
Presenter: Michele Bartoletti
Session: Poster Display session 2
Resources:
Abstract
3251 - Surrogate endpoint of progression-free (PFS) and overall survival (OS) for advanced ovarian cancer (AOC) patients (pts) treated with neo-adjuvant chemotherapy (NACT): Results of the CHIVA randomized phase II GINECO study
Presenter: Fabrice Lecuru
Session: Poster Display session 2
Resources:
Abstract