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
3392 - Post-hoc analysis of the nintedanib exposure-response relationships in the CHIVA trial in advanced ovarian cancer: (a GINECO study)
Presenter: Skerdi HAVIARI
Session: Poster Display session 2
Resources:
Abstract
714 - The feasibility and efficacy of gonadotropin-releasing hormone agonists for prevention of chemotherapy-induced ovarian insufficiency in patient with malignant ovarian germ cell tumors
Presenter: Min Kyu Kim
Session: Poster Display session 2
Resources:
Abstract
1753 - Ex vivo cytotoxicity and in vivo antitumor activity of a novel highly selective STAT3 inhibitor YHO-1701 for ovarian and endometrial cancer
Presenter: Kosei Hasegawa
Session: Poster Display session 2
Resources:
Abstract
3739 - Mutational landscapes and tumor mutational burden expression in endometrial cancer
Presenter: Yingli Zhang
Session: Poster Display session 2
Resources:
Abstract
2109 - Clinical features and frequency of mismatch repair protein deficiency in ovarian clear cell and endometrioid carcinoma patients.
Presenter: Kazuhiro Takehara
Session: Poster Display session 2
Resources:
Abstract
4554 - Prospective study evaluating white adipose tissue inflammation and clinicopathologic features in endometrial cancer
Presenter: Lea Moukarzel
Session: Poster Display session 2
Resources:
Abstract
3645 - Cancer-specific survival with or without adjuvant chemotherapy in high-risk stage I endometrial cancer
Presenter: Jenny Ko
Session: Poster Display session 2
Resources:
Abstract
3394 - Pembrolizumab in Patients with MSI-H Advanced Endometrial Cancer from the KEYNOTE-158 Study
Presenter: David Omalley
Session: Poster Display session 2
Resources:
Abstract
3388 - Who drops out of cervical cancer screening? Results from the EDIFICE 6 survey
Presenter: Thibault de La Motte Rouge
Session: Poster Display session 2
Resources:
Abstract
2485 - Identification of a RNA-Seq Based Signature to Improve Prognostic for Uterine Sarcoma
Presenter: Jian-Guo Zhou
Session: Poster Display session 2
Resources:
Abstract